FDA Orange Book
Generic for Vandazole
Vandazole 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 Vandazole 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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Vandazole products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, vaginal | 0.75% | Marketed (Rx) | BX | 7 | AB |
NDA 021806, held by TEVA PHARMACEUTICALS USA. 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% |
Vandazole NDC codes
Questions
Is there a generic for Vandazole?
Yes. The generic name for Vandazole 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 Vandazole?
The active ingredient in Vandazole 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.
More on Vandazole and Metronidazole
- What is Metronidazole used for?FDA label uses
- Is Metronidazole a controlled substance?Federal schedule
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- Generic for MetrolotionFDA Orange Book
- Generic for LikmezFDA Orange Book
- Generic for ProtostatFDA Orange Book
- Nitroimidazole Antimicrobials listFDA drug class
- NDC 0245-0860Vandazole NDC record