FDA Orange Book
Generic for Valisone
Valisone 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 Valisone is betamethasone valerate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Valisone products the Orange Book lists.
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Valisone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | EQ 0.01% BASE | Discontinued | None | 0 | None |
| 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 016322, 016932, 016740, held by SCHERING CORP SUB SCHERING PLOUGH CORP. 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 Valisone?
Yes. The generic name for Valisone is betamethasone valerate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Valisone products the Orange Book lists.
What is the generic name for Valisone?
The active ingredient in Valisone 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.