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 (acetylcysteine), for intravenous use Initial U.S. Approval: 2004
Approved
Approval ID
3e2e187e-2445-43b1-b66c-b828e2adf022
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2023
Manufacturers
FDA
Xellia Pharmaceuticals USA LLC
DUNS: 116768762
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 Code70594-111
Application NumberANDA217182
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetylcysteine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2023
FDA Product Classification
INGREDIENTS (1)
ACETYLCYSTEINEActive
Quantity: 200 mg in 1 mL
Code: WYQ7N0BPYC
Classification: ACTIB