Acetylcysteine
Solution, USP
Approved
Approval ID
5558a5f5-e821-473b-7d8a-5d33d09f0586
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2020
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 2
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 Code0409-3308
Application NumberANDA074037
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACETYLCYSTEINE
Product Specifications
Route of AdministrationORAL, RESPIRATORY (INHALATION)
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ACETYLCYSTEINEActive
Quantity: 200 mg in 1 mL
Code: WYQ7N0BPYC
Classification: ACTIB
EDETATE DISODIUMInactive
Quantity: 0.5 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ACETYLCYSTEINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-3307
Application NumberANDA073664
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACETYLCYSTEINE
Product Specifications
Route of AdministrationORAL, RESPIRATORY (INHALATION)
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (4)
EDETATE DISODIUMInactive
Quantity: 0.25 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ACETYLCYSTEINEActive
Quantity: 100 mg in 1 mL
Code: WYQ7N0BPYC
Classification: ACTIB