FDA Orange Book
Generic for Metrogel-vaginal
Metrogel-vaginal 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-vaginal is metronidazole. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Metrogel-vaginal and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Metrogel-vaginal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, vaginal | 0.75% | Discontinued | None | 7 | AB |
NDA 020208, 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 metronidazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 211786 | AB (A-rated, therapeutically equivalent) | July 2, 2019 | 0.75% |
| AMVIKA PHARMA LLC | 213648 | AB (A-rated, therapeutically equivalent) | October 14, 2021 | 0.75% |
| GLENMARK PHARMACEUTICALS LTD | 215794 | AB (A-rated, therapeutically equivalent) | January 27, 2022 | 0.75% |
| ENCUBE ETHICALS PRIVATE LTD | 215610 | AB (A-rated, therapeutically equivalent) | June 16, 2023 | 0.75% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 216323 | AB (A-rated, therapeutically equivalent) | July 12, 2023 | 0.75% |
| SCIEGEN PHARMACEUTICALS INC | 216750 | AB (A-rated, therapeutically equivalent) | December 31, 2024 | 0.75% |
| AUROBINDO PHARMA LTD | 218485 | AB (A-rated, therapeutically equivalent) | September 25, 2026 | 0.75% |
Metrogel-vaginal NDC codes
Questions
Is there a generic for Metrogel-vaginal?
Yes. The generic name for Metrogel-vaginal 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-vaginal?
The active ingredient in Metrogel-vaginal 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.