FDA Orange Book
Generic for Methergine
Methergine contains methylergonovine. 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 Methergine is methylergonovine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Methergine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.2MG/ML | Discontinued | None | 2 | AP |
| tablet, oral | 0.2MG | Discontinued | None | 6 | AB |
NDA 006035, held by EDISON THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methylergonovine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMERICAN REGENT INC | 090193 | AP (A-rated, therapeutically equivalent) | November 24, 2008 | 0.2MG/ML |
| BRECKENRIDGE PHARMACEUTICAL INC | 040889 | AP (A-rated, therapeutically equivalent) | September 13, 2010 | 0.2MG/ML |
| CHARTWELL RX SCIENCES LLC | 091577 | AB (A-rated, therapeutically equivalent) | May 2, 2011 | 0.2MG |
| GRANULES PHARMACEUTICALS INC | 210424 | AB (A-rated, therapeutically equivalent) | May 15, 2018 | 0.2MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 211483 | AB (A-rated, therapeutically equivalent) | September 10, 2018 | 0.2MG |
| TEVA PHARMACEUTICALS USA INC | 211455 | AB (A-rated, therapeutically equivalent) | March 20, 2019 | 0.2MG |
| TP ANDA HOLDINGS LLC | 212233 | AB (A-rated, therapeutically equivalent) | May 1, 2020 | 0.2MG |
| RISING PHARMA HOLDINGS INC | 211919 | AB (A-rated, therapeutically equivalent) | January 15, 2021 | 0.2MG |
Questions
Is there a generic for Methergine?
Yes. The generic name for Methergine is methylergonovine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Methergine?
The active ingredient in Methergine is methylergonovine, 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.