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
NDC Product Code54868-5670
Application NumberANDA072324
Marketing CategoryC73584
Route of AdministrationORAL, RESPIRATORY (INHALATION)
Effective DateSeptember 24, 2012
Generic NameAcetylcysteine
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