FDA Orange Book
Generic for Amerge
Amerge contains naratriptan. 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 Amerge is naratriptan. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Amerge products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 1MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 2.5MG BASE | Discontinued | None | 3 | AB |
NDA 020763, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic naratriptan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 090381 | AB (A-rated, therapeutically equivalent) | July 7, 2010 | EQ 1MG BASE, EQ 2.5MG BASE |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 200502 | AB (A-rated, therapeutically equivalent) | February 28, 2011 | EQ 1MG BASE, EQ 2.5MG BASE |
| ORBION PHARMACEUTICALS PRIVATE LTD | 091441 | AB (A-rated, therapeutically equivalent) | April 30, 2012 | EQ 1MG BASE, EQ 2.5MG BASE |
Questions
Is there a generic for Amerge?
Yes. The generic name for Amerge is naratriptan. 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 Amerge?
The active ingredient in Amerge is naratriptan, 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.