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
4072b547-c242-4a40-8c91-5481b86cbf1e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2022
Manufacturers
FDA
Akorn
DUNS: 117693100
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetylcysteine
PRODUCT DETAILS
NDC Product Code17478-660
Application NumberANDA203173
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMarch 27, 2015
Generic NameAcetylcysteine
INGREDIENTS (4)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
AcetylcysteineActive
Quantity: 200 mg in 1 mL
Code: WYQ7N0BPYC
Classification: ACTIB
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Edetate DisodiumInactive
Quantity: 0.5 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT