FDA Orange Book
Generic for Diprosone
Diprosone 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 Diprosone is betamethasone dipropionate. 10 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 Diprosone products the Orange Book lists.
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Diprosone 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 |
| disc, topical | EQ 0.1% BASE | Discontinued | None | 0 | None |
| lotion, topical | EQ 0.05% BASE | Discontinued | None | 3 | AB |
| ointment, topical | EQ 0.05% BASE | Discontinued | None | 4 | AB |
NDA 017536, 017829, 017781, 017691, 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 dipropionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 070275 | AB (A-rated, therapeutically equivalent) | August 12, 1985 | EQ 0.05% BASE |
| 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 |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 071467 | AB (A-rated, therapeutically equivalent) | August 10, 1987 | EQ 0.05% BASE |
| PADAGIS US LLC | 072538 | AB (A-rated, therapeutically equivalent) | January 31, 1990 | 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 Diprosone?
Yes. The generic name for Diprosone is betamethasone dipropionate. 10 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 Diprosone products the Orange Book lists.
What is the generic name for Diprosone?
The active ingredient in Diprosone 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.