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
NDC Product Code66220-207
Application NumberNDA021539
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateOctober 1, 2021
Generic NameAcetylcysteine
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