FDA Orange Book
Generic for Metrogel
Metrogel contains metronidazole. 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 Metrogel is metronidazole. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Metrogel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 0.75% | Discontinued | None | 5 | AB |
| gel, topical | 1% | Marketed (Rx) | AB | 4 | AB |
NDA 019737, 021789, held by GALDERMA LABORATORIES LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic metronidazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 077018 | AB (A-rated, therapeutically equivalent) | June 6, 2006 | 0.75% |
| ENCUBE ETHICALS PRIVATE LTD | 077547 | AB (A-rated, therapeutically equivalent) | July 13, 2006 | 0.75% |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 077819 | AB (A-rated, therapeutically equivalent) | July 18, 2006 | 0.75% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 078178 | AB (A-rated, therapeutically equivalent) | January 19, 2011 | 0.75% |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 204651 | AB (A-rated, therapeutically equivalent) | March 14, 2017 | 1% |
| ALEMBIC PHARMACEUTICALS LTD | 212646 | AB (A-rated, therapeutically equivalent) | September 3, 2021 | 1% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 216692 | AB (A-rated, therapeutically equivalent) | January 23, 2023 | 1% |
| AUROBINDO PHARMA LTD | 218941 | AB (A-rated, therapeutically equivalent) | October 15, 2024 | 1% |
| ZYDUS LIFESCIENCES LTD | 220095 | AB (A-rated, therapeutically equivalent) | February 13, 2026 | 0.75% |
Metrogel NDC codes
Questions
Is there a generic for Metrogel?
Yes. The generic name for Metrogel is metronidazole. 7 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 Metrogel?
The active ingredient in Metrogel is metronidazole, 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.