FDA Orange Book
Generic for Alphatrex
Alphatrex contains betamethasone dipropionate. 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 Alphatrex is betamethasone dipropionate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Alphatrex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | EQ 0.05% BASE | Discontinued | None | 5 | AB |
| ointment, topical | EQ 0.05% BASE | Discontinued | None | 4 | AB |
NDA 019138, 019143, held by SAVAGE LABORATORIES INC DIV ALTANA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic betamethasone dipropionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS MID ATLANTIC LLC | 070885 | AB (A-rated, therapeutically equivalent) | February 3, 1987 | EQ 0.05% BASE |
| ACTAVIS MID ATLANTIC LLC | 071012 | AB (A-rated, therapeutically equivalent) | February 3, 1987 | EQ 0.05% BASE |
| SUN PHARMA CANADA INC | 073552 | AB (A-rated, therapeutically equivalent) | April 30, 1992 | EQ 0.05% BASE |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 210217 | AB (A-rated, therapeutically equivalent) | October 12, 2018 | EQ 0.05% BASE |
| ZYDUS PHARMACEUTICALS USA INC | 208885 | AB (A-rated, therapeutically equivalent) | January 11, 2019 | EQ 0.05% BASE |
| ZYDUS LIFESCIENCES LTD | 214048 | AB (A-rated, therapeutically equivalent) | July 14, 2020 | EQ 0.05% BASE |
| TP ANDA HOLDINGS LLC | 215186 | AB (A-rated, therapeutically equivalent) | February 18, 2022 | EQ 0.05% BASE |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 215847 | AB (A-rated, therapeutically equivalent) | April 12, 2022 | EQ 0.05% BASE |
| AUROBINDO PHARMA LTD | 219348 | AB (A-rated, therapeutically equivalent) | January 26, 2026 | EQ 0.05% BASE |
Questions
Is there a generic for Alphatrex?
Yes. The generic name for Alphatrex is betamethasone dipropionate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Alphatrex?
The active ingredient in Alphatrex is betamethasone dipropionate, 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.