FDA Orange Book
Generic for Dimetane-dx
Dimetane-dx contains brompheniramine, pseudoephedrine and dextromethorphan. 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 Dimetane-dx is brompheniramine, pseudoephedrine and dextromethorphan. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Dimetane-dx products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| syrup, oral | 2MG/5ML;10MG/5ML;30MG/5ML | Discontinued | None | 8 | AA |
NDA 019279, held by AH ROBINS CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic brompheniramine, pseudoephedrine and dextromethorphan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS US LLC | 205292 | AA (A-rated, therapeutically equivalent) | July 15, 2014 | 2MG/5ML;10MG/5ML;30MG/5ML |
| PHARMACEUTICAL ASSOCIATES INC | 202940 | AA (A-rated, therapeutically equivalent) | July 21, 2014 | 2MG/5ML;10MG/5ML;30MG/5ML |
| ACELLA PHARMACEUTICALS LLC | 203375 | AA (A-rated, therapeutically equivalent) | September 20, 2016 | 2MG/5ML;10MG/5ML;30MG/5ML |
| DR REDDYS LABORATORIES SA | 207676 | AA (A-rated, therapeutically equivalent) | December 4, 2018 | 2MG/5ML;10MG/5ML;30MG/5ML |
| CHARTWELL MOLECULAR HOLDINGS LLC | 213125 | AA (A-rated, therapeutically equivalent) | April 17, 2020 | 2MG/5ML;10MG/5ML;30MG/5ML |
| ADAPTIS PHARMA PRIVATE LTD | 211170 | AA (A-rated, therapeutically equivalent) | June 16, 2020 | 2MG/5ML;10MG/5ML;30MG/5ML |
| ALKEM LABORATORIES LTD | 210647 | AA (A-rated, therapeutically equivalent) | July 14, 2020 | 2MG/5ML;10MG/5ML;30MG/5ML |
| BIONPHARMA INC | 203997 | AA (A-rated, therapeutically equivalent) | September 30, 2020 | 2MG/5ML;10MG/5ML;30MG/5ML |
Questions
Is there a generic for Dimetane-dx?
Yes. The generic name for Dimetane-dx is brompheniramine, pseudoephedrine and dextromethorphan. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Dimetane-dx?
The active ingredient in Dimetane-dx is brompheniramine, pseudoephedrine and dextromethorphan, 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.