ACETADOTE
These highlights do not include all the information needed to use ACETADOTE safely and effectively. See full prescribing information for ACETADOTE. ACETADOTE (acetylcysteine) injection, for intravenous useInitial U.S. Approval: 2004
Approved
Approval ID
472f158a-5ab9-4308-8e49-1116e6ea3d39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2023
Manufacturers
FDA
Cumberland Pharmaceuticals Inc.
DUNS: 069532880
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 Code66220-207
Application NumberNDA021539
Product Classification
M
Marketing Category
C73594
G
Generic Name
Acetylcysteine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 1, 2021
FDA Product Classification
INGREDIENTS (4)
AcetylcysteineActive
Quantity: 200 mg in 1 mL
Code: WYQ7N0BPYC
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
nitrogenInactive
Code: N762921K75
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT