Home NDC 69238-1605-2 Methylergonovine Maleate
Product NDC 69238-1605
Requested package NDC 69238-1605-2
11-digit product format 692381605
Labeler code 69238
Product ID 69238-1605_5c53f000-01eb-4042-bdb8-e569609413bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylergonovine
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA211483
Marketing category ANDA
Marketing start 2018-09-12
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A211483-001 METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211483-001 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 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211483-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2018-09-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 A211483-001 CGT 2019-03-20 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A211483-001 CGT 2019-03-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211483-001 CGT 2019-03-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211483-001 CGT 2019-03-20 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Methylergonovine Maleate
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996824 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69238-1605-2 Methylergonovine Maleate 12 in 1 BOTTLE TABLET 12 10 69238-1605-8 Methylergonovine Maleate 28 in 1 BOTTLE TABLET 28 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1605 METHYLERGONOVINE MALEATE (METHYLERGONOVINE) TABLET [AMNEAL PHARMACEUTICALS NY LLC] 8 Current NDC, Legacy NDC, 2 package rows 20201230_a7ec8dfe-9b58-4363-a709-c1b72ee67855.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 69238-1605-2 69238160502 12 TABLET in 1 BOTTLE (69238-1605-2) 12 tablet 2018-09-12 0000-00-00 No No Current