FDA Orange Book

Generic for Actifed W/ Codeine

Actifed W/ Codeine contains codeine, pseudoephedrine and triprolidine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Actifed W/ Codeine is codeine, pseudoephedrine and triprolidine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

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Actifed W/ Codeine products in the Orange Book

Actifed W/ Codeine products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
syrup, oral10MG/5ML;30MG/5ML;1.25MG/5MLDiscontinuedNone1None

NDA 012575, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic codeine, pseudoephedrine and triprolidine

Approved generic versions of Actifed W/ Codeine
CompanyANDATE codeApprovedStrengths
AVERION LIFE SCIENCES INC088704None (No TE code listed)March 22, 198510MG/5ML;30MG/5ML;1.25MG/5ML

Questions

Is there a generic for Actifed W/ Codeine?

Yes. The generic name for Actifed W/ Codeine is codeine, pseudoephedrine and triprolidine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

What is the generic name for Actifed W/ Codeine?

The active ingredient in Actifed W/ Codeine is codeine, pseudoephedrine and triprolidine, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

More on Actifed W/ Codeine and Codeine, Pseudoephedrine and Triprolidine

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