Home NDC 40032-140-01 Methylergonovine Maleate
Product NDC 40032-140
Requested package NDC 40032-140-01
11-digit product format 400320140
Labeler code 40032
Product ID 40032-140_afedb0c3-649c-4df6-b037-b6bc71946a56
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylergonovine Maleate
Dosage form TABLET
Route ORAL
Labeler Novel Laboratories, Inc.
Application ANDA091577
Marketing category ANDA
Marketing start 2011-06-15
Marketing end 0000-00-00
Substance METHYLERGONOVINE MALEATE
Active strength 0 mg/1
Pharmacologic classes Ergolines [CS],Ergot Derivative [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 15 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 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…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 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 40032-140-01 Methylergonovine Maleate 100 in 1 BOTTLE TABLET 100 2 40032-140-07 Methylergonovine Maleate 7 in 1 BOTTLE TABLET 7 2 40032-140-28 Methylergonovine Maleate 28 in 1 BOTTLE TABLET 28 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHYLERGONOVINE MALEATE ACTIVE INGREDIENT IR84JPZ1RK METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1 METHYLERGONOVINE ACTIVE MOIETY W53L6FE61V METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1 ACACIA INACTIVE INGREDIENT 5C5403N26O METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1 TARTARIC ACID INACTIVE INGREDIENT W4888I119H METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-140 METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.] 2 Legacy NDC, 3 package rows 20180110_fa75ef56-dcf4-4c3e-bea4-161893e09685.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 Units Marketing start Marketing end Sample Exclude flag Status 40032-140-01 40032014001 100 TABLET in 1 BOTTLE (40032-140-01) 100 tablet 2011-06-15 0000-00-00 No No Current