ACETYLCYSTEINE- acetylcysteine injection, solution 
Cadila Healthcare Limited

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ACETYLCYSTEINE INJECTION

PRINCIPAL DISPLAY PANEL – Vial Label

NDC 70771-1412-1

Acetylcysteine Injection

6 g/30 mL

(200 mg/mL)

MUST BE FURTHER DILUTED

PRIOR TO INTRAVENOUS USE

30 mL Sterile

Rx only

vial label

PRINCIPAL DISPLAY PANEL – Carton Label

NDC 70771-1412-8

Acetylcysteine Injection

6 g/30 mL

(200 mg/mL)

MUST BE FURTHER DILUTED

PRIOR TO INTRAVENOUS USE

4 X 30 mL Sterile Vials

Rx only

carton
ACETYLCYSTEINE 
acetylcysteine injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1412
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)  
NITROGEN (UNII: N762921K75)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1412-84 in 1 CARTON01/17/2019
1NDC:70771-1412-130 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20816601/17/2019
Labeler - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1412) , MANUFACTURE(70771-1412)

Revised: 10/2020
Document Id: 5237b85b-a643-42b8-83af-1def8f2449db
Set id: c09faafd-af53-4fed-ae87-d16494758945
Version: 2
Effective Time: 20201012
 
Cadila Healthcare Limited