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 Initial U.S. Approval: 2004.
Approved
Approval ID
8cca4e4c-85a2-d575-e053-2995a90a6599
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code63323-963
Application NumberANDA200644
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetylcysteine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 2, 2019
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETYLCYSTEINEActive
Quantity: 200 mg in 1 mL
Code: WYQ7N0BPYC
Classification: ACTIB
EDETATE DISODIUMInactive
Quantity: 0.5 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT