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 use.Initial U.S. Approval: 2004
Approved
Approval ID
4505de2a-ef6f-4bb7-9845-1228afbe0a0e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 16, 2021
Manufacturers
FDA
Exela Pharma Sciences, LLC
DUNS: 831274399
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetylcysteine Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-0104
Application NumberANDA204797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetylcysteine Injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 16, 2021
FDA Product Classification
INGREDIENTS (4)
ACETYLCYSTEINEActive
Quantity: 200 mg in 1 mL
Code: WYQ7N0BPYC
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT