FDA Orange Book
Generic for Retin-A
Retin-A contains tretinoin. 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 Retin-A is tretinoin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1. Generics match 5 of the 7 Retin-A products the Orange Book lists.
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Retin-A products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.025% | Marketed (Rx) | AB | 5 | AB |
| cream, topical | 0.05% | Marketed (Rx) | AB1 | 4 | AB1 |
| cream, topical | 0.1% | Marketed (Rx) | AB | 5 | AB |
| gel, topical | 0.01% | Marketed (Rx) | AB | 3 | AB |
| gel, topical | 0.025% | Marketed (Rx) | AB | 3 | AB |
| solution, topical | 0.05% | Discontinued | None | 0 | None |
| swab, topical | 0.05% | Discontinued | None | 0 | None |
NDA 019049, 017522, 017340, 017955, 017579, 016921, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tretinoin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS US LLC | 075264 | AB (A-rated, therapeutically equivalent) | December 24, 1998 | 0.025% |
| PADAGIS US LLC | 075265 | AB1 (A-rated, therapeutically equivalent) | December 24, 1998 | 0.05% |
| PADAGIS US LLC | 075213 | AB (A-rated, therapeutically equivalent) | December 24, 1998 | 0.1% |
| PADAGIS US LLC | 075529 | AB (A-rated, therapeutically equivalent) | February 22, 2000 | 0.025% |
| PADAGIS US LLC | 075589 | AB (A-rated, therapeutically equivalent) | June 11, 2002 | 0.01% |
| SUN PHARMA CANADA INC | 211645 | AB (A-rated, therapeutically equivalent) | January 22, 2019 | 0.1% |
| SUN PHARMA CANADA INC | 211644 | AB1 (A-rated, therapeutically equivalent) | January 25, 2019 | 0.05% |
| SUN PHARMA CANADA INC | 215713 | AB (A-rated, therapeutically equivalent) | January 5, 2023 | 0.025% |
| ZYDUS LIFESCIENCES LTD | 218561 | AB (A-rated, therapeutically equivalent) | April 25, 2024 | 0.1% |
| ALEMBIC PHARMACEUTICALS LTD | 217804 | AB (A-rated, therapeutically equivalent) | April 29, 2024 | 0.1% |
| AUROBINDO PHARMA LTD | 218246 | AB (A-rated, therapeutically equivalent) | January 13, 2025 | 0.01% |
| AUROBINDO PHARMA LTD | 218245 | AB (A-rated, therapeutically equivalent) | February 27, 2025 | 0.025% |
| ENCUBE ETHICALS PRIVATE LTD | 217588 | AB (A-rated, therapeutically equivalent) | March 3, 2025 | 0.01% |
| ENCUBE ETHICALS PRIVATE LTD | 217587 | AB (A-rated, therapeutically equivalent) | March 3, 2025 | 0.025% |
| ENCUBE ETHICALS PRIVATE LTD | 217831 | AB (A-rated, therapeutically equivalent) | July 10, 2025 | 0.025% |
| ALEMBIC PHARMACEUTICALS LTD | 218399 | AB (A-rated, therapeutically equivalent) | August 14, 2025 | 0.025% |
| ENCUBE ETHICALS PRIVATE LTD | 217833 | AB (A-rated, therapeutically equivalent) | February 10, 2026 | 0.1% |
| ENCUBE ETHICALS PRIVATE LTD | 217832 | AB1 (A-rated, therapeutically equivalent) | March 25, 2026 | 0.05% |
| ALEMBIC PHARMACEUTICALS LTD | 214590 | AB1 (A-rated, therapeutically equivalent) | June 11, 2026 | 0.05% |
| ZYDUS LIFESCIENCES LTD | 218560 | AB (A-rated, therapeutically equivalent) | September 15, 2026 | 0.025% |
Retin-A NDC codes
Questions
Is there a generic for Retin-A?
Yes. The generic name for Retin-A is tretinoin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1. Generics match 5 of the 7 Retin-A products the Orange Book lists.
What is the generic name for Retin-A?
The active ingredient in Retin-A is tretinoin, 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.
More on Retin-A and Tretinoin
- What is Retin-A used for?FDA label uses
- Is Retin-A a controlled substance?Federal schedule
- What is Tretinoin used for?FDA label uses
- Is Tretinoin a controlled substance?Federal schedule
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- Retinoids listFDA drug class
- NDC 0187-5160Retin-A NDC record
- NDC 0187-5162Retin-A NDC record
- NDC 0187-5164Retin-A NDC record