Acetylcysteine
These highlights do not include all the information needed to use ACETYLCYSTEINE INJECTION safely and effectively. See full prescribing information for ACETYLCYSTEINE INJECTION. ACETYLCYSTEINE Injection, for intravenous useInitial U.S. Approval: 2004
Approved
Approval ID
f811ddfc-d7c1-4637-ae81-80c38a77cb80
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 25, 2025
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetylcysteine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-946
Application NumberANDA213693
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetylcysteine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 25, 2025
FDA Product Classification
INGREDIENTS (4)
AcetylcysteineActive
Quantity: 200 mg in 1 mL
Code: WYQ7N0BPYC
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT