FDA Orange Book
Generic for Tindamax
Tindamax contains tinidazole. 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 Tindamax is tinidazole. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Tindamax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 500MG | Marketed (Rx) | AB | 3 | AB |
NDA 021618, held by MISSION PHARMACAL CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tinidazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 202044 | AB (A-rated, therapeutically equivalent) | April 30, 2012 | 250MG, 500MG |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 202489 | AB (A-rated, therapeutically equivalent) | October 9, 2013 | 250MG, 500MG |
| EDENBRIDGE PHARMACEUTICALS LLC | 203808 | AB (A-rated, therapeutically equivalent) | August 4, 2015 | 250MG, 500MG |
Tindamax NDC codes
Questions
Is there a generic for Tindamax?
Yes. The generic name for Tindamax is tinidazole. 3 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 Tindamax?
The active ingredient in Tindamax is tinidazole, 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.