Home NDC 83400-100 Methylergonovine Maleate
Product NDC 83400-100
11-digit product format 834000100
Labeler code 83400
Product ID 83400-100_24b0446f-9cfa-4544-b677-8ff15e98ebcd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylergonovine maleate
Dosage form TABLET
Route ORAL
Labeler Volley Pharmaceuticals, LLC
Application ANDA212233
Marketing category ANDA
Marketing start 2024-03-15
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 A212233-001 METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212233-001 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.
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 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212233-001 METHYLERGONOVINE MALEATE 0.2MG TABLET / ORAL AB 2020-05-01 a50c72e98297…
Observed Orange Book normalized TE history# 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83400-100-12 Methylergonovine Maleate 12 in 1 BOTTLE TABLET 12 1 83400-100-28 Methylergonovine Maleate 28 in 1 BOTTLE TABLET 28 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83400-100 METHYLERGONOVINE MALEATE TABLET [VOLLEY PHARMACEUTICALS, LLC] 1 Current NDC, 2 package rows 20240323_0a318b77-d280-4571-992f-82e2e0a57c9b.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 Sample Exclude flag Status 83400-100-12 83400010012 12 TABLET in 1 BOTTLE (83400-100-12) 12 tablet 2024-03-15 No No Current 83400-100-28 83400010028 28 TABLET in 1 BOTTLE (83400-100-28) 28 tablet 2024-03-15 No No Current