FDA Orange Book
Generic for Betatrex
Betatrex contains betamethasone valerate. 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 Betatrex is betamethasone valerate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Betatrex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | EQ 0.1% BASE | Discontinued | None | 2 | AB |
| lotion, topical | EQ 0.1% BASE | Discontinued | None | 1 | AB |
| ointment, topical | EQ 0.1% BASE | Discontinued | None | 2 | AB |
NDA 018862, 018867, 018863, 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 valerate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS MID ATLANTIC LLC | 070050 | AB (A-rated, therapeutically equivalent) | October 10, 1984 | EQ 0.1% BASE |
| ACTAVIS MID ATLANTIC LLC | 070051 | AB (A-rated, therapeutically equivalent) | October 10, 1984 | EQ 0.1% BASE |
| PHARMAZONE | 070052 | AB (A-rated, therapeutically equivalent) | July 31, 1985 | EQ 0.1% BASE |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 070069 | AB (A-rated, therapeutically equivalent) | December 19, 1985 | EQ 0.1% BASE |
| SUN PHARMA CANADA INC | 072041 | AB (A-rated, therapeutically equivalent) | January 6, 1988 | EQ 0.1% BASE |
Questions
Is there a generic for Betatrex?
Yes. The generic name for Betatrex is betamethasone valerate. 4 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 Betatrex?
The active ingredient in Betatrex is betamethasone valerate, 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.