FDA Orange Book
Generic for Tapazole
Tapazole contains methimazole. 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 Tapazole is methimazole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Tapazole products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 8 | AB |
| tablet, oral | 5MG | Discontinued | None | 8 | AB |
NDA 007517, held by KING PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methimazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 040350 | AB (A-rated, therapeutically equivalent) | March 29, 2000 | 10MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 040411 | AB (A-rated, therapeutically equivalent) | March 27, 2001 | 10MG, 5MG |
| AIPING PHARMACEUTICAL INC | 040547 | AB (A-rated, therapeutically equivalent) | February 18, 2005 | 10MG, 5MG |
| HERITAGE PHARMA LABS INC | 040734 | AB (A-rated, therapeutically equivalent) | December 14, 2007 | 10MG, 5MG |
| RISING PHARMA HOLDINGS INC | 202068 | AB (A-rated, therapeutically equivalent) | March 7, 2012 | 10MG, 5MG |
| MACLEODS PHARMACEUTICALS LTD | 209827 | AB (A-rated, therapeutically equivalent) | May 24, 2023 | 10MG, 5MG |
| BIONPHARMA INC | 218149 | AB (A-rated, therapeutically equivalent) | September 25, 2023 | 10MG, 5MG |
| SQUARE PHARMACEUTICALS PLC | 218830 | AB (A-rated, therapeutically equivalent) | February 5, 2025 | 10MG, 5MG |
Questions
Is there a generic for Tapazole?
Yes. The generic name for Tapazole is methimazole. 8 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 Tapazole?
The active ingredient in Tapazole is methimazole, 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.