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
0298bda7-0edf-99c7-8266-ab45bb5c6e16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2023
Manufacturers
FDA
Almaject, Inc.
DUNS: 116626205
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 Code72611-860
Application NumberANDA215620
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACETYLCYSTEINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 30, 2022
FDA Product Classification
INGREDIENTS (4)
ACETYLCYSTEINEActive
Quantity: 200 mg in 1 mL
Code: WYQ7N0BPYC
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT