FDA Orange Book
Generic for Cafergot
Cafergot contains ergotamine and caffeine. 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 Cafergot is ergotamine and caffeine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book.
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Cafergot products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suppository, rectal | 100MG;2MG | Discontinued | None | 1 | None |
| tablet, oral | 100MG;1MG | Discontinued | None | 1 | None |
NDA 009000, 006620, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ergotamine and caffeine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| COSETTE PHARMACEUTICALS INC | 086557 | None (No TE code listed) | October 4, 1983 | 100MG;2MG |
| PHARMOBEDIENT CONSULTING LLC | 040590 | None (No TE code listed) | September 16, 2005 | 100MG;1MG |
Questions
Is there a generic for Cafergot?
Yes. The generic name for Cafergot is ergotamine and caffeine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Cafergot?
The active ingredient in Cafergot is ergotamine and caffeine, 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.