Home NDC 0093-3655-28 Methylergonovine Maleate
Product NDC 0093-3655
Requested package NDC 0093-3655-28
11-digit product format 000933655
Labeler code 0093
Product ID 0093-3655_d3b4efa0-99c0-40c2-96ae-f5a0b598aa27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylergonovine Maleate
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA211455
Marketing category ANDA
Marketing start 2019-03-26
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 A211455-001 METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211455-001 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 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211455-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2019-03-20 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 Methylergonovine Maleate
Listing expiration 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-3655-22 Methylergonovine Maleate 12 in 1 BOTTLE TABLET 12 6 0093-3655-28 Methylergonovine Maleate 28 in 1 BOTTLE TABLET 28 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-3655 METHYLERGONOVINE MALEATE TABLET [TEVA PHARMACEUTICALS USA, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20250412_d8e4b8ed-3289-4611-8a61-2392a4bf6072.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 0093-3655-28 00093365528 28 TABLET in 1 BOTTLE (0093-3655-28) 28 tablet 2019-03-26 0000-00-00 No No Current