Acetylcysteine
ACETYLCYSTEINE SOLUTION, USP
Approved
Approval ID
8fd7b5d8-f6b1-4d0a-9ec6-446c5f89762a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5670
Application NumberANDA072324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetylcysteine
Product Specifications
Route of AdministrationORAL, RESPIRATORY (INHALATION)
Effective DateSeptember 24, 2012
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ACETYLCYSTEINEActive
Quantity: 200 mg in 1 mL
Code: WYQ7N0BPYC
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT