FDA Orange Book
Generic for Migranal
Migranal contains dihydroergotamine. 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 Migranal is dihydroergotamine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Migranal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | 0.5MG/SPRAY | Marketed (Rx) | AB | 4 | AB |
NDA 020148, 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 dihydroergotamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 211393 | AB (A-rated, therapeutically equivalent) | February 28, 2020 | 0.5MG/SPRAY |
| CIPLA LTD | 212907 | AB (A-rated, therapeutically equivalent) | May 20, 2020 | 0.5MG/SPRAY |
| RUBICON RESEARCH LTD | 216881 | AB (A-rated, therapeutically equivalent) | June 22, 2023 | 0.5MG/SPRAY |
| SOMERSET THERAPEUTICS LLC | 215228 | AB (A-rated, therapeutically equivalent) | February 26, 2025 | 0.5MG/SPRAY |
Migranal NDC codes
Questions
Is there a generic for Migranal?
Yes. The generic name for Migranal is dihydroergotamine. 4 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 Migranal?
The active ingredient in Migranal is dihydroergotamine, 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.