Active ingredient
Methylergonovine
15 finished FDA listings contain Methylergonovine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- METHYLERGONOVINE MALEATE
- Dosage forms
- Injection, Injection, Solution, Tablet
- Routes
- Intramuscular, Intravenous, Oral
- Manufacturers / labelers
- 14
- Strengths listed
- .2 mg/1 · .2 mg/ml
- Brand names in FDA listings
- Methergine, Methylergonovine Maleate
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6883
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 090193 | AM REGENT | 2008-11-24 | 2 |
| ANDA 040889 | BRECKENRIDGE | 2010-09-13 | 5 |
| ANDA 091577 | CHARTWELL RX | 2011-05-02 | 1 |
| ANDA 210424 | GRANULES | 2018-05-15 | 3 |
| ANDA 211483 | AMNEAL PHARMS | 2018-09-10 | 1 |
| ANDA 211455 | TEVA PHARMS USA | 2019-03-20 | 1 |
| ANDA 212233 | TP ANDA HOLDINGS | 2020-05-01 | 1 |
| ANDA 211919 | RISING | 2021-01-15 | 1 |
Official labeling on DailyMed
- METHYLERGONOVINE MALEATE TABLET [TEVA PHARMACEUTICALS USA, INC.] · version 10 · 2026-09-02
- METHYLERGONOVINE MALEATE TABLET [MAJOR PHARMACEUTICALS] · version 3 · 2026-05-06
- METHYLERGONOVINE MALEATE INJECTION, SOLUTION [HF ACQUISITION CO. LLC. DBA HEALTHFIRST] · version 1 · 2026-03-26
- METHYLERGONOVINE MALEATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] · version 8 · 2026-03-05
- METHYLERGONOVINE MALEATE INJECTION, SOLUTION [PHARMACIST PHARMACEUTICAL, LLC] · version 7 · 2025-12-12
- METHYLERGONOVINE MALEATE INJECTION [BRECKENRIDGE PHARMACEUTICAL, INC.] · version 8 · 2025-09-18
- METHYLERGONOVINE MALEATE TABLET [RISING PHARMA HOLDINGS, INC.] · version 3 · 2025-06-23
- METHYLERGONOVINE MALEATE (METHYLERGONOVINE) TABLET [AMNEAL PHARMACEUTICALS NY LLC] · version 10 · 2025-06-20
- METHYLERGONOVINE MALEATE TABLET [GRANULES PHARMACEUTICALS INC.] · version 6 · 2025-06-18
- METHYLERGONOVINE MALEATE INJECTION [BRYANT RANCH PREPACK] · version 103 · 2024-06-06
- METHYLERGONOVINE MALEATE INJECTION [BRYANT RANCH PREPACK] · version 101 · 2024-06-03
- METHYLERGONOVINE MALEATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 3 · 2024-05-20
Showing the 12 most recent of 14 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.