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ENOXAPARIN SODIUM injection


  1. Patient Information
  2. Patients Should Also Be Informed:
  3. Manufactured For:
  4. Revised: 3/2019document Id:

Patient Information 

If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, they should be informed to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness. If any of these symptoms occur the patient should contact his or her physician immediately.

Additionally, the use of aspirin and other NSAID's may enhance the risk of hemorrhage. Their use should be discontinued prior to enoxaparin therapy whenever possible; if co-administration is essential, the patient's clinical and laboratory status should be closely monitored [seeDrug Interactions (7)].

Patients Should Also Be Informed: 

  • of the instructions for injecting Enoxaparin Sodium Injection if their therapy is to continue after discharge from the hospitals.
  • it may take them longer than usual to stop bleeding.
  • they may bruise and/or bleed more easily when they are treated with Enoxaparin Sodium Injection.
  • they should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician [seeWarnings and Precautions (5.1,5.5)].
  • to tell their physicians and dentists they are taking Enoxaparin Sodium Injection and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken [seeWarnings and Precautions (5.3)].
  • to tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAID's [seeDrug Interactions (7)].

Logo

Manufactured for Amerinet Choice by
Amphastar Pharmaceuticals, Inc.
Rancho Cucamonga, CA 91730 U.S.A.
Rev. 11/13

6956316D

Rx Only

Manufactured For: 

Fresenius Logo

Lake Zurich, IL 60047
www.fresenius-kabi.com/us

Made in India
Code No.: AP/DRUGS/103/97

451367A /Revised: March 2019

LEA-019547-01

Principal Display Panel - 30 mg per 0.3 mL Syringe Carton

NDC 63323-559-93
551993

Enoxaparin Sodium
Injection, USP
30mg per0.3mL

Rx ONLY
Single-Dose Syringes with
Automatic Safety Device
For Subcutaneous Injection
Sterile
Contains
10 x 0.3 mL Single-Dose Syringes

FRESENIUS
KABI

Principal Display Panel - 30 mg per 0.3 mL Syringe Carton

Principal Display Panel - 30 mg per 0.3 mL Syringe Blister

NDC 63323-559-21
Enoxaparin Sodium
Injection, USP
30mg per0.3mL

One 0.3 mL Sterile Single-Dose Syringe
with Automatic Safety Device

For Subcutaneous Injection Rx only

Principal Display Panel - 30 mg per 0.3 mL Syringe Blister

Principal Display Panel - 40 mg per 0.4 mL Syringe Carton

NDC 63323-564-97
556497

Enoxaparin Sodium
Injection, USP
40mg per0.4mL

Rx ONLY
Single-Dose Syringes with
Automatic Safety Device
For Subcutaneous Injection
Sterile
Contains
10 x 0.4 mL Single-Dose Syringes

FRESENIUS
KABI

Principal Display Panel - 40 mg per 0.4 mL Syringe Carton

Principal Display Panel - 40 mg per 0.4 mL Syringe Blister

NDC 63323-564-21
Enoxaparin Sodium
Injection, USP
40mg per0.4mL

One 0.4 mL Sterile Single-Dose Syringe
with Automatic Safety Device

For Subcutaneous Injection Rx only

Principal Display Panel - 40 mg per 0.4 mL Syringe Blister

Principal Display Panel - 60 mg per 0.6 mL Syringe Carton

NDC 63323-566-98
556698

Enoxaparin Sodium
Injection, USP
60mg per0.6mL

Rx ONLY
Single-Dose Syringes with
Automatic Safety Device
For Subcutaneous Injection
Sterile
Contains
10 x 0.6 mL Single-Dose Syringes

FRESENIUS
KABI

Principal Display Panel - 60 mg per 0.6 mL Syringe Carton

Principal Display Panel - 60 mg per 0.6 mL Syringe Blister

NDC 63323-566-21
Enoxaparin Sodium
Injection, USP
60mg per0.6mL

One 0.6 mL Sterile Single-Dose Syringe
with Automatic Safety Device

For Subcutaneous Injection Rx only

Principal Display Panel - 60 mg per 0.6 mL Syringe Blister

Principal Display Panel - 80 mg per 0.8 mL Syringe Carton

NDC 63323-584-99
558499

Enoxaparin Sodium
Injection, USP
80mg per0.8mL

Rx ONLY
Single-Dose Syringes with
Automatic Safety Device
For Subcutaneous Injection
Sterile
Contains
10 x 0.8 mL Single-Dose Syringes

FRESENIUS
KABI

Principal Display Panel - 80 mg per 0.8 mL Syringe Carton

Principal Display Panel - 80 mg per 0.8 mL Syringe Blister

NDC 63323-584-21
Enoxaparin Sodium
Injection, USP
80mg per0.8mL

One 0.8 mL Sterile Single-Dose Syringe
with Automatic Safety Device

For Subcutaneous Injection Rx only

Principal Display Panel - 80 mg per 0.8 mL Syringe Blister

Principal Display Panel - 100 mg per mL Syringe Carton

NDC 63323-586-96
558696

Enoxaparin Sodium
Injection, USP
100mg per mL

Rx ONLY
Single-Dose Syringes with
Automatic Safety Device
For Subcutaneous Injection
Sterile
Contains
10 x 1 mL Single-Dose Syringes

FRESENIUS
KABI

Principal Display Panel - 100 mg per mL Syringe Carton

Principal Display Panel - 100 mg per mL Syringe Blister

NDC 63323-586-21
Enoxaparin Sodium
Injection, USP
100mg per mL

One 1 mL Sterile Single-Dose Syringe
with Automatic Safety Device

For Subcutaneous Injection Rx only

Principal Display Panel - 100 mg per mL Syringe Blister

Principal Display Panel - 120 mg per 0.8 mL Syringe Carton

NDC 63323-655-99
556099

Enoxaparin Sodium
Injection, USP
120mg per0.8mL

Rx ONLY
Single-Dose Syringes with
Automatic Safety Device
For Subcutaneous Injection
Sterile
Contains
10 x 0.8 mL Single-Dose Syringes

FRESENIUS
KABI

Principal Display Panel - 120 mg per 0.8 mL Syringe Carton

Principal Display Panel - 120 mg per 0.8 mL Syringe Blister

NDC 63323-655-21
Enoxaparin Sodium
Injection, USP
120mg per0.8mL

One 0.8 mL Sterile Single-Dose Syringe
with Automatic Safety Device

For Subcutaneous Injection Rx only

Principal Display Panel - 120 mg per 0.8 mL Syringe Blister

Principal Display Panel - 150 mg per mL Syringe Carton

NDC 63323-589-94
558994

Enoxaparin Sodium
Injection, USP
150mg per mL

Rx ONLY
Single-Dose Syringes with
Automatic Safety Device
For Subcutaneous Injection
Sterile
Contains
10 x 1 mL Single-Dose Syringes

FRESENIUS
KABI

Principal Display Panel - 150 mg per mL Syringe Carton

Principal Display Panel - 150 mg per mL Syringe Blister

NDC 63323-589-21
Enoxaparin Sodium
Injection, USP
150mg per mL

One 1 mL Sterile Single-Dose Syringe
with Automatic Safety Device

For Subcutaneous Injection Rx only

Principal Display Panel - 150 mg per mL Syringe Blister
ENOXAPARIN SODIUM
enoxaparin sodium injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-559
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Enoxaparin Sodium(UNII: 8NZ41MIK1O) (Enoxaparin - UNII:E47C0NF7LV)Enoxaparin Sodium30 mg in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-559-9310 in 1 CARTON04/23/2019
1NDC:63323-559-211 in 1 BLISTER PACK
10.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07899004/23/2019
ENOXAPARIN SODIUM
enoxaparin sodium injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-564
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Enoxaparin Sodium(UNII: 8NZ41MIK1O) (Enoxaparin - UNII:E47C0NF7LV)Enoxaparin Sodium40 mg in 0.4 mL
Inactive Ingredients
Ingredient NameStrength
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-564-9710 in 1 CARTON04/23/2019
1NDC:63323-564-211 in 1 BLISTER PACK
10.4 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07899004/23/2019
ENOXAPARIN SODIUM
enoxaparin sodium injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-566
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Enoxaparin Sodium(UNII: 8NZ41MIK1O) (Enoxaparin - UNII:E47C0NF7LV)Enoxaparin Sodium60 mg in 0.6 mL
Inactive Ingredients
Ingredient NameStrength
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-566-9810 in 1 CARTON04/23/2019
1NDC:63323-566-211 in 1 BLISTER PACK
10.6 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07899004/23/2019
ENOXAPARIN SODIUM
enoxaparin sodium injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-584
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Enoxaparin Sodium(UNII: 8NZ41MIK1O) (Enoxaparin - UNII:E47C0NF7LV)Enoxaparin Sodium80 mg in 0.8 mL
Inactive Ingredients
Ingredient NameStrength
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-584-9910 in 1 CARTON04/23/2019
1NDC:63323-584-211 in 1 BLISTER PACK
10.8 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07899004/23/2019
ENOXAPARIN SODIUM
enoxaparin sodium injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-586
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Enoxaparin Sodium(UNII: 8NZ41MIK1O) (Enoxaparin - UNII:E47C0NF7LV)Enoxaparin Sodium100 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-586-9610 in 1 CARTON04/23/2019
1NDC:63323-586-211 in 1 BLISTER PACK
11 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07899004/23/2019
ENOXAPARIN SODIUM
enoxaparin sodium injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-655
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Enoxaparin Sodium(UNII: 8NZ41MIK1O) (Enoxaparin - UNII:E47C0NF7LV)Enoxaparin Sodium120 mg in 0.8 mL
Inactive Ingredients
Ingredient NameStrength
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-655-9910 in 1 CARTON05/01/2019
1NDC:63323-655-211 in 1 BLISTER PACK
10.8 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07899005/01/2019
ENOXAPARIN SODIUM
enoxaparin sodium injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-589
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Enoxaparin Sodium(UNII: 8NZ41MIK1O) (Enoxaparin - UNII:E47C0NF7LV)Enoxaparin Sodium150 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-589-9410 in 1 CARTON04/23/2019
1NDC:63323-589-211 in 1 BLISTER PACK
11 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07899004/23/2019
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Gland Pharma Limited918601238MANUFACTURE(63323-559, 63323-564, 63323-566, 63323-584, 63323-586, 63323-655, 63323-589)

Revised: 3/2019document Id: 

b10054cc-9c81-4bd1-939e-7a8907f74d1bSet id: a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148eVersion: 1Effective Time: 20190330Fresenius Kabi USA, LLC



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