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FLUCYTOSINE capsule


  1. Warning
  2. Indications And Usage
  3. Dosage And Administration
  4. References
  5. Package Label.principal Display Panel
  6. Package/label Display Panel
  7. Packaging Information
  8. Package/label Display Panel Carton 250 Mg
  9. Package/label Display Panel Blister 250 Mg
  10. Package/label Display Panel Carton -500 Mg
  11. Package/label Display Panel Blister 500 Mg
  12. Principal Display Panel - 250 Mg Capsule Bottle Label
  13. Principal Display Panel - 500 Mg Capsule Bottle Label
  14. Warning
  15. How Supplied/storage And Handling
  16. Dosage And Administration
  17. Principal Display Panel - 250mg Capsule Bottle Label
  18. Flucytosine Capsules, Usp Rx Only
  19. Pregnancy
  20. Flucytosine 250 Mg Container Label - 30 Count
  21. Flucytosine 500 Mg Container Label - 30 Count
  22. Flucytosine Capsules, Usp Rx Only
  23. Description
  24. Clinical Pharmacology
  25. Microbiology
  26. Indications & Usage
  27. Contraindications
  28. Warnings
  29. Precautions
  30. Pregnancy
  31. Adverse Reactions
  32. Overdosage
  33. Dosage & Administration
  34. How Supplied
  35. Flucytosine Capsule

Warning 

Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of Flucytosine Capsules USP.

Indications And Usage 

Flucytosine is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.

Candida:

Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.

Cryptococcus:

Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.

Flucytosine should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to flucytosine (see MICROBIOLOGY).

Dosage And Administration 

The usual dosage of flucytosine is 50 to 150 mg/kg/day administered in divided doses at 6-hour intervals. Nausea or vomiting may be reduced or avoided if the capsules are given a few at a time over a 15-minute period. If the BUN or the serum creatinine is elevated, or if there are other signs of renal impairment, the initial dose should be at the lower level (see WARNINGS).

Flucytosine should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to flucytosine (see MICROBIOLOGY).

References 

  1. Clinical and Laboratory Standards Institute. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard-Second Edition. NCCLS Document M27-A2, 2002 Volume 22, No 15, NCCLS, Wayne, PA, August 2002.

Manufactured by:

Novel Laboratories, Inc

Somerset, NJ 08873

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202

PI7700000201

Iss: 08/2017

Package Label.principal Display Panel 

Flucytosine Capsules USP, 250 mg

30 Capsules

250-30

Flucytosine Capsules USP, 500 mg

100 Capsules

500-100
FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43386-771
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06) FLUCYTOSINE 250 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
GELATIN (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SHELLAC (UNII: 46N107B71O)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POVIDONE (UNII: FZ989GH94E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Product Characteristics
Color GRAY (Opaque Body) , BLUE (Opaque Cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code NL771;250
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43386-771-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2017
2 NDC:43386-771-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204652 07/07/2017
FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43386-770
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06) FLUCYTOSINE 500 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
GELATIN (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POVIDONE (UNII: FZ989GH94E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Product Characteristics
Color WHITE (Opaque Body) , GRAY (Opaque Cap) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code NL770;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43386-770-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2017
2 NDC:43386-770-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204652 07/07/2017
Labeler - Lupin Pharmaceuticals,Inc. (089153071)
Registrant - Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Business Operations
Novel Laboratories, Inc. 793518643 ANALYSIS(43386-770, 43386-771) , MANUFACTURE(43386-770, 43386-771) , PACK(43386-770, 43386-771)

Revised: 11/2017 Lupin Pharmaceuticals,Inc.

Package/label Display Panel  

Flucytosine Capsules USP, 500 mg

0054-0428-20, Rx only

carton-500mg-100tab-01.jpg
FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0427
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06) FLUCYTOSINE 250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Product Characteristics
Color GREEN (Grey) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 54;986
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0054-0427-25 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/17/2017
2 NDC:0054-0427-20 100 in 1 BOX, UNIT-DOSE 10/17/2017
2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206550 10/17/2017
FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0428
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06) FLUCYTOSINE 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Product Characteristics
Color GRAY (White) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code 54;866
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0054-0428-25 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/17/2017
2 NDC:0054-0428-20 100 in 1 BOX, UNIT-DOSE 10/17/2017
2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206550 10/17/2017
Labeler - West-Ward Pharmaceuticals Corp (080189610)
Establishment
Name Address ID/FEI Business Operations
West-Ward Columbus Inc. 058839929 MANUFACTURE(0054-0427, 0054-0428)

Revised: 2/2019 West-Ward Pharmaceuticals Corp

Packaging Information 

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Lupin Pharmaceuticals, Inc as follows:
(250 mg / 30 UD) NDC 60687-352-25 packaged from NDC 43386-771
(500 mg / 30 UD) NDC 60687-363-25 packaged from NDC 43386-770

Distributed by:
American Health Packaging
Columbus, OH 43217

8435225/1217F

Package/label Display Panel Carton 250 Mg 

250 mg Flucytosine Capusles Carton

NDC 60687- 352-25

Flucytosine
Capsules, USP

250 mg

30 Capsules (5 x 6) Rx Only

Each Capsule Contains:
Flucytosine .................................................................250 mg

Usual Dosage: See package insert for full
prescribing information.

Store at 25 C (77 F); excursions permitted between
15 to 30 C (59 to 86 F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is from
NDC # 43386-771, Lupin Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

735225
0435225/0619OS

Package/label Display Panel Blister 250 Mg 

250 mg Flucytosine Capsule Blister.

Flucytosine
Capsule, USP

250 mg

Package/label Display Panel Carton -500 Mg 

500 mg Flucytosine Capsule Carton

NDC 60687- 363-25

Flucytosine
Capsules, USP

500 mg

30 Capsules (5 x 6) Rx Only

Each Capsule Contains:
Flucytosine ................................................................ 500 mg

Usual Dosage: See package insert for full
prescribing information.

Store at 25 C (77 F); excursions permitted between
15 to 30 C (59 to 86 F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is from
NDC # 43386-770, Lupin Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

736325
0436325/0619OS

Package/label Display Panel Blister 500 Mg 

500 mg Flucytosine Capsule Blister

Flucytosine
Capsule, USP

500 mg

FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-352(NDC:43386-771)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06) FLUCYTOSINE 250 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SHELLAC (UNII: 46N107B71O)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Product Characteristics
Color gray (Opaque Body) , blue (Opaque Cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code NL771;250
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60687-352-25 30 in 1 BOX, UNIT-DOSE 01/15/2018
1 NDC:60687-352-95 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204652 01/15/2018
FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-363(NDC:43386-770)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06) FLUCYTOSINE 500 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SHELLAC (UNII: 46N107B71O)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Product Characteristics
Color white (Opaque Body) , gray (Opaque Cap) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code NL770;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60687-363-25 30 in 1 BOX, UNIT-DOSE 01/15/2018
1 NDC:60687-363-95 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204652 01/15/2018
Labeler - American Health Packaging (929561009)
Establishment
Name Address ID/FEI Business Operations
American Health Packaging 929561009 repack(60687-352, 60687-363)

Revised: 7/2019 American Health Packaging

Principal Display Panel - 250 Mg Capsule Bottle Label 

NDC 42494-339-01
Rx only

Flucytosine
Capsules

250 mg

100 Capsules

CAMERON
PHARMACEUTICALS 250mg-label.jpg

Principal Display Panel - 500 Mg Capsule Bottle Label 

NDC 42494-340-01
Rx only

Flucytosine
Capsules

500 mg

100 Capsules

CAMERON
PHARMACEUTICALS

500mg-label.jpg
FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42494-339
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Flucytosine (UNII: D83282DT06) (Flucytosine - UNII:D83282DT06) Flucytosine 250 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
TALC (UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color GRAY, GREEN Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code ANCOBON;250;ICN
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42494-339-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/26/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA017001 07/26/2017
FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42494-340
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Flucytosine (UNII: D83282DT06) (Flucytosine - UNII:D83282DT06) Flucytosine 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
TALC (UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color GRAY, WHITE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code ANCOBON;500;ICN
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42494-340-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/26/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA017001 07/26/2017
Labeler - Cameron Pharmaceuticals, LLC (078371442)
Establishment
Name Address ID/FEI Business Operations
Bausch Health Companies Inc. 253292734 MANUFACTURE(42494-339, 42494-340) , PACK(42494-339, 42494-340)

Revised: 5/2019 Cameron Pharmaceuticals, LLC

Warning  

Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of Flucytosine Capsules.

How Supplied/storage And Handling 

Flucytosine Capsules USP

The 250 mg capsules are supplied as green opaque cap and grey opaque body with 54 986 printed in black ink on the cap and body, containing a white to off-white powder.

NDC 0054-0427-25: Bottle of 100 Capsules

The 500 mg capsules are supplied as grey opaque cap and white opaque body with 54 866 printed in black ink on the cap and body, containing a white to off-white powder.

NDC 0054-0428-25: Bottle of 100 Capsules

Store at 20 to 25 C (68 to 77 F). [See USP Controlled Room Temperature.]

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10008275/03

Revised February 2019

Dosage And Administration 

The usual dosage of Flucytosine Capsules, USP are 50 to 150 mg/kg/day administered in divided doses at 6-hour intervals. Nausea or vomiting may be reduced or avoided if the capsules are given a few at a time over a 15-minute period. If the BUN or the serum creatinine is elevated, or if there are other signs of renal impairment, the initial dose should be at the lower level (see WARNINGS).

Flucytosine Capsules, USP should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine Capsules, USP (See MICROBIOLOGY).


Principal Display Panel - 250mg Capsule Bottle Label 

NDC 42543-902-01
100 Capsules
Flucytosine Capsules, USP
250 mg
Rx Only
Vensun Pharmaceuticals, Inc.

flucytosine-250mg

PRINCIPAL DISPLAY PANEL - 500 mg Capsule Bottle Label

NDC 42543-901-01
100 Capsules
Flucytosine Capsules, USP
500 mg
Rx Only
Vensun Pharmaceuticals, Inc.

flucytosine-500mg


FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42543-902
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06) FLUCYTOSINE 250 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE (UNII: J2B2A4N98G)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN (UNII: 2G86QN327L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code K;110
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42543-902-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/21/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207536 08/21/2016
FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42543-901
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06) FLUCYTOSINE 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE (UNII: J2B2A4N98G)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
Product Characteristics
Color GRAY (GRAY) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code K;111
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42543-901-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/21/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207536 08/21/2016
Labeler - Vensun Pharmaceuticals, Inc. (078310501)
Establishment
Name Address ID/FEI Business Operations
Recipharm Pharmaservices Pvt. Ltd. 871401927 ANALYSIS(42543-901, 42543-902) , MANUFACTURE(42543-901, 42543-902) , PACK(42543-901, 42543-902)

Revised: 3/2018 Vensun Pharmaceuticals, Inc.

Flucytosine Capsules, Usp Rx Only  

WARNING

Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of Flucytosine Capsules, USP.

Pregnancy 

Teratogenic Effects

Flucytosine was shown to be teratogenic (vertebral fusions) in the rat at doses of 40 mg/kg/day (298 mg/M 2/day or 0.051 times the human dose) administered on days 7 to 13 of gestation. At higher doses (700 mg/kg/day; 5208 mg/M 2/day or 0.89 times the human dose administered on days 9 to 12 of gestation), cleft lip and palate and micrognathia were reported. Flucytosine was not teratogenic in rabbits up to a dose of 100 mg/kg/day (1423 mg/M 2/day or 0.243 times the human dose) administered on days 6 to 18 of gestation. In mice, 400 mg/kg/day of flucytosine (1380 mg/M 2/day or 0.236 times the human dose) administered on days 7 to 13 of gestation was associated with a low incidence of cleft palate that was not statistically significant. Studies in pregnant rats have shown that flucytosine injected intraperitoneally crosses the placental barrier. There are no adequate and well-controlled studies in pregnant women. Flucytosine Capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Flucytosine Capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The efficacy and safety of Flucytosine Capsules have not been systematically studied in pediatric patients. A small number of neonates have been treated with 25 to 200 mg/kg/day of flucytosine, with and without the addition of amphotericin B, for systemic candidiasis. No unexpected adverse reactions were reported in these patients. It should be noted, however, that hypokalemia and acidemia were reported in one patient who received flucytosine in combination with amphotericin B, and anemia was observed in a second patient who received flucytosine alone. Transient thrombocytopenia was noted in two additional patients, one of whom also received amphotericin B.

Flucytosine 250 Mg Container Label - 30 Count 

Sigmapharm Laboratories, LLC

NDC 42794- 009-08

Flucytosine Capsules, USP

250 mg

30 Capsules

Rx only

250-30

Flucytosine 500 Mg Container Label - 30 Count 

Sigmapharm Laboratories, LLC

NDC 42794- 010-08

Flucytosine Capsules, USP

500 mg

30 Capsules

Rx Only

500-30

FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42794-009
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06) FLUCYTOSINE 250 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
TALC (UNII: 7SEV7J4R1U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Product Characteristics
Color green, white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 9
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42794-009-08 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201566 06/01/2018
FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42794-010
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06) FLUCYTOSINE 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GELATIN (UNII: 2G86QN327L)
Product Characteristics
Color gray, yellow Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42794-010-08 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201566 06/01/2018
Labeler - Sigmapharm Laboratories, LLC (556234636)
Registrant - Sigmapharm Laboratories, LLC (556234636)
Establishment
Name Address ID/FEI Business Operations
Sigmapharm Laboratories, LLC 556234636 manufacture(42794-009, 42794-010) , analysis(42794-009, 42794-010)

Revised: 4/2019 Sigmapharm Laboratories, LLC

Flucytosine Capsules, Usp Rx Only 

WARNING

Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of Flucytosine Capsules, USP.

Description 

Flucytosine Capsules USP, an antifungal agent, is available as 250 mg and 500 mg capsules for oral administration. In addition to the active ingredient of flucytosine USP, each capsule contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and pregelatinized starch. The gelatin capsule shells contains: D&C Yellow #10, FD&C Green #3, FD&C Red #40, gelatin and titanium dioxide. The 250 mg capsule also contains: FD&C Blue #1 and FD&C Yellow #6. In addition to the ingredients listed above, each capsule contains: ammonium hydroxide, ethanol, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze used in the black monogramming ink.

Chemically, flucytosine is 5-fluorocytosine, a fluorinated pyrimidine which is related to fluorouracil and floxuridine. It is a white to off-white powder with a molecular weight of 129.09 and the following structural formula:

chem.jpg

Clinical Pharmacology 

Flucytosine is rapidly and virtually completely absorbed following oral administration. Flucytosine is not metabolized significantly when given orally to man. Bioavailability estimated by comparing the area under the curve of serum concentrations after oral and intravenous administration showed 78% to 89% absorption of the oral dose. Peak serum concentrations of 30 to 40 mcg/mL were reached within 2 hours of administration of a 2 g oral dose to normal subjects. Other studies revealed mean serum concentrations of approximately 70 to 80 mcg/mL 1 to 2 hours after a dose in patients with normal renal function receiving a 6-week regimen of flucytosine (150 mg/kg/day given in divided doses every 6 hours) in combination with amphotericin B. The half-life in the majority of healthy subjects ranged between 2.4 and 4.8 hours. Flucytosine is excreted via the kidneys by means of glomerular filtration without significant tubular reabsorption. More than 90% of the total radioactivity after oral administration was recovered in the urine as intact drug. Flucytosine is deaminated (probably by gut bacteria) to 5-fluorouracil. The area under the curve (AUC) ratio of 5-fluorouracil to flucytosine is 4%. Approximately 1% of the dose is present in the urine as the -fluoro- -ureido-propionic acid metabolite. A small portion of the dose is excreted in the feces.

The half-life of flucytosine is prolonged in patients with renal insufficiency; the average half-life in nephrectomized or anuric patients was 85 hours (range: 29.9 to 250 hours). A linear correlation was found between the elimination rate constant of flucytosine and creatinine clearance.

In vitro studies have shown that 2.9% to 4% of flucytosine is protein-bound over the range of therapeutic concentrations found in the blood. Flucytosine readily penetrates the blood-brain barrier, achieving clinically significant concentrations in cerebrospinal fluid.

Pharmacokinetics in Pediatric Patients

Limited data are available regarding the pharmacokinetics of Flucytosine administered to neonatal patients being treated for systemic candidiasis. After five days of continuous therapy, median peak levels in infants were 19.6 mcg/mL, 27.7 mcg/mL, and 83.9 mcg/mL at doses of 25 mg/kg (N=3), 50 mg/kg (N=4), and 100 mg/kg (N=3), respectively. Mean time to peak serum levels was of 2.5 1.3 hours, similar to that observed in adult patients. A good deal of interindividual variability was noted, which did not correlate with gestational age. Some patients had serum levels > 100 mcg/mL, suggesting a need for drug level monitoring during therapy. In another study, serum concentrations were determined during flucytosine therapy in two patients (total assays performed =10). Median serum flucytosine concentrations at steady state were calculated to be 57 10 mcg/mL (doses of 50 to 125 mg/kg/day, normalized to 25 mg/kg per dose for comparison). In three infants receiving flucytosine 25 mg/kg/day (four divided doses), a median flucytosine half-life of 7.4 hours was observed, approximately double that seen in adult patients. The concentration of flucytosine in the cerebrospinal fluid of one infant was 43 mcg/mL 3 hours after a 25 mg oral dose, and ranged from 20 to 67 mg/L in another neonate receiving oral doses of 120 to 150 mg/kg/day.

Microbiology 

Mechanism of Action

Flucytosine is taken up by fungal organisms via the enzyme cytosine permease. Inside the fungal cell, flucytosine is rapidly converted to fluorouracil by the enzyme cytosine deaminase. Fluorouracil exerts its antifungal activity through the subsequent conversion into several active metabolites, which inhibit protein synthesis by being falsely incorporated into fungal RNA or interfere with the biosynthesis of fungal DNA through the inhibition of the enzyme thymidylate synthetase.

Activity In Vitro:

Flucytosine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections.

Candida albicans
Cryptococcus neoformans

Susceptibility Testing:

For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

Drug Resistance:

Flucytosine resistance may arise from a mutation of an enzyme necessary for the cellular uptake or metabolism of flucytosine or from an increased synthesis of pyrimidines, which compete with the active metabolites of flucytosine (fluorinated antimetabolites). Resistance to flucytosine has been shown to develop during monotherapy after prolonged exposure to the drug.

Drug Combination:

Antifungal synergism between flucytosine and polyene antibiotics, particularly amphotericin B has been reported in vitro. Flucytosine is usually administered in combination with amphotericin B due to lack of cross-resistance and reported synergistic activity of both drugs.

Indications & Usage 

Flucytosine Capsules, USP are indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.

Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.

Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.

Flucytosine Capsules, USP should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine Capsules, USP (See MICROBIOLOGY).


Contraindications 

Flucytosine should not be used in patients with a known hypersensitivity to the drug.

Warnings 

Flucytosine must be given with extreme caution to patients with impaired renal function. Since flucytosine is excreted primarily by the kidneys, renal impairment may lead to accumulation of the drug. Flucytosine serum concentrations should be monitored to determine the adequacy of renal excretion in such patients. Dosage adjustments should be made in patients with renal insufficiency to prevent progressive accumulation of active drug.

Flucytosine must be given with extreme caution to patients with bone marrow depression. Patients may be more prone to depression of bone marrow function if they: 1) have a hematologic disease, 2) are being treated with radiation or drugs which depress bone marrow, or 3) have a history of treatment with such drugs or radiation. Bone marrow toxicity can be irreversible and may lead to death in immunosuppressed patients. Frequent monitoring of hepatic function and of the hematopoietic system is indicated during therapy.

Precautions 

General

Before therapy with flucytosine is instituted, electrolytes (because of hypokalemia) and the hematologic and renal status of the patient should be determined (see WARNINGS). Close monitoring of the patient during therapy is essential.

Laboratory Tests

Since renal impairment can cause progressive accumulation of the drug, blood concentrations and kidney function should be monitored during therapy. Hematologic status (leucocyte and thrombocyte count) and liver function (alkaline phosphatase, SGOT and SGPT) should be determined at frequent intervals during treatment as indicated.

Drug Interactions

Cytosine arabinoside, a cytostatic agent, has been reported to inactivate the antifungal activity of flucytosine by competitive inhibition. Drugs which impair glomerular filtration may prolong the biological half-life of flucytosine.

Drug/Laboratory Test Interactions

Measurement of serum creatinine levels should be determined by the Jaffe reaction, since flucytosine does not interfere with the determination of creatinine values by this method. Most automated equipment for measurement of creatinine makes use of the Jaffe reaction.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Flucytosine has not undergone adequate animal testing to evaluate carcinogenic potential. The mutagenic potential of flucytosine was evaluated in Ames-type studies with five different mutants of S. typhimurium and no mutagenicity was detected in the presence or absence of activating enzymes. Flucytosine was nonmutagenic in three different repair assay systems (i.e., rec, uvr and pol).

There have been no adequate trials in animals on the effects of flucytosine on fertility or reproductive performance. The fertility and reproductive performance of the offspring (F1 generation) of mice treated with 100 mg/kg/day (345 mg/M2/day or 0.059 times the human dose), 200 mg/kg/day (690 mg/M2/day or 0.118 times the human dose) or 400 mg/kg/day (1380 mg/M2/day or 0.236 times the human dose) of flucytosine on days 7 to 13 of gestation was studied; the in utero treatment had no adverse effect on the fertility or reproductive performance of the offspring.

Pregnancy

Teratogenic Effects

Flucytosine was shown to be teratogenic (vertebral fusions) in the rat at doses of 40 mg/kg/day (298 mg/M2/day or 0.051 times the human dose) administered on days 7 to 13 of gestation. At higher doses (700 mg/kg/day; 5208 mg/M2/day or 0.89 times the human dose administered on days 9 to 12 of gestation), cleft lip and palate and micrognathia were reported. Flucytosine was not teratogenic in rabbits up to a dose of 100 mg/kg/day (1423 mg/M2/day or 0.243 times the human dose) administered on days 6 to 18 of gestation. In mice, 400 mg/kg/day of flucytosine (1380 mg/M2/day or 0.236 times the human dose) administered on days 7 to 13 of gestation was associated with a low incidence of cleft palate that was not statistically significant. Studies in pregnant rats have shown that flucytosine injected intraperitoneally crosses the placental barrier. There are no adequate and well-controlled studies in pregnant women. Flucytosine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from flucytosine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The efficacy and safety of flucytosine have not been systematically studied in pediatric patients. A small number of neonates have been treated with 25 to 200 mg/kg/day of flucytosine, with and without the addition of amphotericin B, for systemic candidiasis. No unexpected adverse reactions were reported in these patients. It should be noted, however, that hypokalemia and acidemia were reported in one patient who received flucytosine in combination with amphotericin B, and anemia was observed in a second patient who received flucytosine alone. Transient thrombocytopenia was noted in two additional patients, one of whom also received amphotericin B.

Pregnancy 

Teratogenic Effects. Pregnancy Category C

Flucytosine was shown to be teratogenic (vertebral fusions) in the rat at doses of 40 mg/kg/day (298 mg/M2/day or 0.051 times the human dose) administered on days 7 to 13 of gestation. At higher doses (700 mg/kg/day; 5208 mg/M2/day or 0.89 times the human dose administered on days 9 to 12 of gestation), cleft lip and palate and micrognathia were reported. Flucytosine was not teratogenic in rabbits up to a dose of 100 mg/kg/day (1423 mg/M2/day or 0.243 times the human dose)administered on days 6 to 18 of gestation. In mice, 400 mg/kg/day of flucytosine (1380 mg/M2/day or 0.236 times the human dose) administered on days 7 to 13 of gestation was associated with a low incidence of cleft palate that was not statistically significant. Studies in pregnant rats have shown that flucytosine injected intraperitoneally crosses the placental barrier. There are no adequate and well-controlled studies in pregnant women. Flucytosine Capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Flucytosine Capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The efficacy and safety of Flucytosine Capsules have not been systematically studied in pediatric patients. A small number of neonates have been treated with 25 to 200 mg/kg/day of flucytosine, with and without the addition of amphotericin B, for systemic candidiasis. No unexpected adverse reactions were reported in these patients. It should be noted, however, that hypokalemia and acidemia were reported in one patient who received flucytosine in combination with amphotericin B, and anemia was observed in a second patient who received flucytosine alone. Transient thrombocytopenia was noted in two additional patients, one of whom also received amphotericin B.

Adverse Reactions 

The adverse reactions which have occurred during treatment with flucytosine are grouped according to organ system affected.

Cardiovascular: Cardiac arrest, myocardial toxicity, ventricular dysfunction.

Respiratory: Respiratory arrest, chest pain, dyspnea.

Dermatologic: Rash, pruritus, urticaria, photosensitivity.

Gastrointestinal: Nausea, emesis, abdominal pain, diarrhea, anorexia, dry mouth, duodenal ulcer, gastrointestinal hemorrhage, acute hepatic injury including hepatic necrosis with possible fatal outcome in debilitated patients, hepatic dysfunction, jaundice, ulcerative colitis, enterocolitis, bilirubin elevation, increased hepatic enzymes.

Genitourinary: Azotemia, creatinine and BUN elevation, crystalluria, renal failure.

Hematologic: Anemia, agranulocytosis, aplastic anemia, eosinophilia, leukopenia, pancytopenia, thrombocytopenia, and fatal cases of bone marrow aplasia.

Neurologic: Ataxia, hearing loss, headache, paresthesia, parkinsonism, peripheral neuropathy, pyrexia, vertigo, sedation, convulsions.

Psychiatric: Confusion, hallucinations, psychosis.

Miscellaneous: Fatigue, hypoglycemia, hypokalemia, weakness, allergic reactions, Lyell s syndrome.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage 

There is no experience with intentional overdosage. It is reasonable to expect that overdosage may produce pronounced manifestations of the known clinical adverse reactions. Prolonged serum concentrations in excess of 100 mcg/mL may be associated with an increased incidence of toxicity, especially gastrointestinal (diarrhea, nausea, vomiting), hematologic (leukopenia, thrombocytopenia) and hepatic (hepatitis).

In the management of overdosage, prompt gastric lavage or the use of an emetic is recommended. Adequate fluid intake should be maintained, by the intravenous route if necessary, since flucytosine is excreted unchanged via the renal tract. The hematologic parameters should be monitored frequently; liver and kidney function should be carefully monitored. Should any abnormalities appear in any of these parameters, appropriate therapeutic measures should be instituted.

Since hemodialysis has been shown to rapidly reduce serum concentrations in anuric patients, this method may be considered in the management of overdosage.

Dosage & Administration 

The usual dosage of Flucytosine Capsules is 50 to 150 mg/kg/day administered in divided doses at 6-hour intervals. Nausea or vomiting may be reduced or avoided if the capsules are given a few at a time over a 15-minute period. If the BUN or the serum creatinine is elevated, or if there are other signs of renal impairment, the initial dose should be at the lower level (see WARNINGS).

Flucytosine Capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine Capsules (see MICROBIOLOGY).

How Supplied 

Flucytosine Capsules are supplied as capsules containing 250 mg and 500 mg flucytosine.

Flucytosine Capsules, USP 250 mg (opaque green and opaque white) are imprinted " 9" on cap and body.

Bottles of 30 capsules (NDC 42794-009-08)


Flucytosine Capsules, USP 500 mg (opaque grey and opaque yellow) are imprinted " 10" on cap and body.

Bottles of 30 capsules (NDC 42794-010-08)

Store at 25 C (77 F); excursions permitted between 15 - 30 C (59 - 86 F) [see USP Controlled Room Temperature].

KEEP OUT OF REACH OF CHILDREN

Sigmapharm Laboratories, LLC

Bensalem, PA 19020

OS010A-02 REV.0118

Flucytosine Capsule 

Label Image
FLUCYTOSINE
flucytosine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-0084(NDC:64980-179)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06) FLUCYTOSINE 250 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
TALC (UNII: 7SEV7J4R1U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Product Characteristics
Color green, white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 9
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68151-0084-0 1 in 1 BOTTLE; Type 0: Not a Combination Product 11/03/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201566 11/03/2011
Labeler - Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Business Operations
Carilion Materials Management 079239644 REPACK(68151-0084)

Revised: 7/2017 Carilion Materials Management



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