Home NDC 27437-050 Methergine
Product NDC 27437-050
11-digit product format 274370050
Labeler code 27437
Product ID 27437-050_0c5bd53a-48a3-4892-aeaf-ea0abc73e612
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylergonovine maleate
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA091577
Marketing category ANDA
Marketing start 2016-04-04
Substance METHYLERGONOVINE MALEATE
Active strength .2 mg/1
Pharmacologic classes Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091577-001 METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091577-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091577-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB RS 2011-05-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methergine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLERGONOVINE MALEATE .2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IR84JPZ1RK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996824 Internal RxNorm lookup 996826 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 27437-050-01 Methergine 100 in 1 BOTTLE TABLET 100 3 27437-050-19 Methergine 7 in 1 BOTTLE TABLET 7 3 27437-050-56 Methergine 28 in 1 BOTTLE TABLET 28 3 27437-050-57 Methergine 12 in 1 BOTTLE TABLET 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27437-050 METHERGINE (METHYLERGONOVINE MALEATE) TABLET [LUPIN PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 4 package rows 20240322_3f04ca06-fe52-46d6-96cd-2e77ef6fa36f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27437-050-01 27437005001 100 TABLET in 1 BOTTLE (27437-050-01) 100 tablet 2016-04-04 0000-00-00 No No Current 27437-050-19 27437005019 7 TABLET in 1 BOTTLE (27437-050-19) 7 tablet 2016-04-04 0000-00-00 No No Current 27437-050-56 27437005056 28 TABLET in 1 BOTTLE (27437-050-56) 28 tablet 2016-04-04 0000-00-00 No No Current 27437-050-57 27437005057 12 TABLET in 1 BOTTLE (27437-050-57) 12 tablet 2016-04-04 0000-00-00 No No Current