Home NDC 63704-006 methylergonovine maleate
Product NDC 63704-006
11-digit product format 637040006
Labeler code 63704
Product ID 63704-006_84d562e7-4ac9-43d5-bcd6-af370975c027
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methylergonovine maleate
Dosage form TABLET
Route ORAL
Labeler Pharmacist Pharmaceutical, LLC
Application ANDA091577
Marketing category ANDA
Marketing start 2011-08-01
Marketing end 0000-00-00
Substance METHYLERGONOVINE MALEATE
Active strength 0 mg/1
Pharmacologic classes Ergolines [CS],Ergot Derivative [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63704-006-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63704-006-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63704-006-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63704-006-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63704-006-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63704-006-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63704-006-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63704-006-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63704-006-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63704-006-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63704-006-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63704-006-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 63704-006-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 63704-006-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 63704-006-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 63704-006-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 63704-006-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 63704-006-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63704-006-01 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63704-006-01 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63704-006-01 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63704-006-01 110d247fa046…a55b01930146…
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.
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 63704-006-01 methylergonovine maleate 100 in 1 BOTTLE TABLET 100 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded methylergonovine maleate ACTIVE INGREDIENT IR84JPZ1RK METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 methylergonovine ACTIVE MOIETY W53L6FE61V METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 acacia INACTIVE INGREDIENT 5C5403N26O METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 gelatin INACTIVE INGREDIENT 2G86QN327L METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 povidone INACTIVE INGREDIENT FZ989GH94E METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 starch, corn INACTIVE INGREDIENT O8232NY3SJ METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 tartaric acid INACTIVE INGREDIENT W4888I119H METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63704-006 METHYLERGONOVINE MALEATE TABLET [PHARMACIST PHARMACEUTICAL, LLC] 1 Legacy NDC, 1 package rows 20110802_83e4cc2a-a0df-41e4-955d-ee51f29c68cc.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Methergine METHYLERGONOVINE MALEATE Lupin Pharmaceuticals,Inc. 3f04ca06-fe52-46d6-96cd-2e77ef6fa36f 2024-03-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091577 application number: ANDA091577
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 63704-006-01 63704000601 100 in 1 BOTTLE Historical