FDA Orange Book
Generic for Tazorac
Tazorac contains tazarotene. 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 Tazorac is tazarotene. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Tazorac products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.05% | Marketed (Rx) | AB | 3 | AB |
| cream, topical | 0.1% | Marketed (Rx) | AB | 2 | AB |
| gel, topical | 0.05% | Marketed (Rx) | AB | 3 | AB |
| gel, topical | 0.1% | Marketed (Rx) | AB | 3 | AB |
NDA 021184, 020600, held by CHARTWELL RX SCIENCES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tazarotene
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 208258 | AB (A-rated, therapeutically equivalent) | April 3, 2017 | 0.1% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 215433 | AB (A-rated, therapeutically equivalent) | September 13, 2022 | 0.05% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 214136 | AB (A-rated, therapeutically equivalent) | September 13, 2022 | 0.1% |
| SOLARIS PHARMA CORP | 213644 | AB (A-rated, therapeutically equivalent) | March 20, 2023 | 0.05%, 0.1% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 213079 | AB (A-rated, therapeutically equivalent) | April 25, 2023 | 0.05%, 0.1% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 217075 | AB (A-rated, therapeutically equivalent) | July 15, 2024 | 0.05% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 208662 | AB (A-rated, therapeutically equivalent) | March 10, 2025 | 0.05%, 0.1% |
| SOLARIS PHARMA CORP | 214560 | AB (A-rated, therapeutically equivalent) | November 24, 2025 | 0.05% |
Tazorac NDC codes
Questions
Is there a generic for Tazorac?
Yes. The generic name for Tazorac is tazarotene. 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 Tazorac?
The active ingredient in Tazorac is tazarotene, 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 Tazorac and Tazarotene
- What is Tazarotene used for?FDA label uses
- Is Tazarotene a controlled substance?Federal schedule
- Generic for FabiorFDA Orange Book
- Generic for AvageFDA Orange Book
- Generic for ArazloFDA Orange Book
- Retinoids listFDA drug class
- NDC 16110-042Tazorac NDC record
- NDC 16110-833Tazorac NDC record
- NDC 16110-915Tazorac NDC record