FDA Orange Book
Generic for Zomig
Zomig contains zolmitriptan. 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 Zomig is zolmitriptan. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Zomig products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, nasal | 2.5MG/SPRAY | Marketed (Rx) | AB | 1 | AB |
| spray, nasal | 5MG/SPRAY | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 2.5MG | Discontinued | None | 9 | AB |
| tablet, oral | 5MG | Discontinued | None | 9 | AB |
NDA 021450, 020768, held by AMNEAL PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic zolmitriptan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLENMARK PHARMACEUTICALS LTD | 201779 | AB (A-rated, therapeutically equivalent) | May 14, 2013 | 2.5MG, 5MG |
| JUBILANT GENERICS LTD | 202279 | AB (A-rated, therapeutically equivalent) | November 20, 2014 | 2.5MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 204232 | AB (A-rated, therapeutically equivalent) | September 30, 2015 | 2.5MG, 5MG |
| AUROBINDO PHARMA LTD | 207021 | AB (A-rated, therapeutically equivalent) | May 11, 2016 | 2.5MG, 5MG |
| AJANTA PHARMA LTD | 204041 | AB (A-rated, therapeutically equivalent) | May 20, 2016 | 2.5MG, 5MG |
| PLD ACQUISITIONS LLC | 207867 | AB (A-rated, therapeutically equivalent) | February 27, 2017 | 2.5MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 206973 | AB (A-rated, therapeutically equivalent) | June 30, 2017 | 2.5MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 203019 | AB (A-rated, therapeutically equivalent) | July 11, 2018 | 2.5MG, 5MG |
| ORBION PHARMACEUTICALS PRIVATE LTD | 203726 | AB (A-rated, therapeutically equivalent) | October 21, 2019 | 2.5MG, 5MG |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 212469 | AB (A-rated, therapeutically equivalent) | September 30, 2021 | 2.5MG/SPRAY, 5MG/SPRAY |
Zomig NDC codes
Questions
Is there a generic for Zomig?
Yes. The generic name for Zomig is zolmitriptan. 10 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 Zomig?
The active ingredient in Zomig is zolmitriptan, 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.