Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup
Approved
Approval ID
69dc729e-54ba-4d05-81cf-ac0abad7efa2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 20, 2018
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4165
Application NumberANDA205112
Product Classification
M
Marketing Category
C73584
G
Generic Name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2018
FDA Product Classification
INGREDIENTS (10)
Brompheniramine MaleateActive
Quantity: 2 mg in 5 mL
Code: IXA7C9ZN03
Classification: ACTIB
Pseudoephedrine HydrochlorideActive
Quantity: 30 mg in 5 mL
Code: 6V9V2RYJ8N
Classification: ACTIB
Dextromethorphan HydrobromideActive
Quantity: 10 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT