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ACETYLCYSTEINE injection, solution


  1. Patient Information
  2. Revised: 3/2017document Id:
  3. Manufactured For:
  4. Revised: 7/2019document Id:

Patient Information 

Hypersensitivity Reactions

Advise patients and caregivers that hypersensitivity reactions related to administration and infusion may occur during and after acetylcysteine treatment, including hypotension, wheezing, shortness of breath and bronchospasm[see Warnings and Precautions (5.1)].

For specific treatment information regarding the clinical management of acetaminophen overdose, please contact your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.

SAGENT
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in India
2017 Sagent Pharmaceuticals, Inc.

March 2017

SAGENT Pharmaceuticals

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

NDC 25021-812-30

Rx only

Acetylcysteine Injection

6 grams per 30 mL

(200 mg per mL)

For Intravenous Use

Must be Further Diluted

30 mL Single-Dose Vial

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Vial Label
ACETYLCYSTEINE
acetylcysteine injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25021-812
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetylcysteine(UNII: WYQ7N0BPYC) (acetylcysteine - UNII:WYQ7N0BPYC)acetylcysteine200 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
edetate disodium(UNII: 7FLD91C86K)
sodium hydroxide(UNII: 55X04QC32I)
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25021-812-304 in 1 CARTON04/15/2018
130 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09168404/15/2018
Labeler -Sagent Pharmaceuticals (796852890)

Revised: 3/2017document Id: 

03af619a-c07f-4a4f-9232-099046048fb5Set id: c206c659-16ea-444a-8c60-8a3343400adaVersion: 8Effective Time: 20170315Sagent Pharmaceuticals

Manufactured For: 

Fresenius Kabi

Lake Zurich, IL 60047

Made in India
www.fresenius-kabi.com/us

451618/Issued: February 2019



prxlogo

PACKAGE LABEL - PRINCIPAL DISPLAY - Acetylcysteine 30 mL Single Dose Vial Label

NDC 63323-963-41

PRX963030
Acetylcysteine Injection
6 grams per 30 mL
(200 mg per mL)


MUST BE FURTHER DILUTED PRIOR TO INTRAVENOUS USE.
Discard unused portion.
30 mL
Single Dose Vial Rx only
prxvialPDP




PACKAGE LABEL - PRINCIPAL DISPLAY - Acetylcysteine 30 mL Single Dose Vial Carton Panel

NDC 63323-963-44
PRX963030
Acetylcysteine Injection
6 grams per 30 mL
(200 mg per mL)


MUST BE FURTHER DILUTED PRIOR TO INTRAVENOUS USE.
Discard unused portion.

4 x 30 mL
Single Dose Vials

PREMIERProRx

PRX ctnPDP

ACETYLCYSTEINE
acetylcysteine injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-963
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETYLCYSTEINE(UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC)ACETYLCYSTEINE200 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM(UNII: 7FLD91C86K)0.5 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-963-444 in 1 CARTON11/09/2012
1NDC:63323-963-4130 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20064411/09/2012
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Gland Pharma Limited918601238analysis(63323-963) , api manufacture(63323-963) , manufacture(63323-963) , pack(63323-963)

Revised: 7/2019document Id: 

8cca5814-e1dc-eb9e-e053-2995a90a46daSet id: 8cca4e4c-85a2-d575-e053-2995a90a6599Version: 1Effective Time: 20190702Fresenius Kabi USA, LLC



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