Home NDC 63629-2074 METHYLERGONOVINE MALEATE
Product NDC 63629-2074
11-digit product format 636292074
Labeler code 63629
Product ID 63629-2074_2305598a-f92d-4726-9c80-cd7edab2744a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylergonovine Maleate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Bryant Ranch Prepack
Application ANDA040889
Marketing category ANDA
Marketing start 2016-11-07
Substance METHYLERGONOVINE MALEATE
Active strength .2 mg/mL
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 A040889-001 METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040889-001 AP
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 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040889-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2010-09-13 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLERGONOVINE MALEATE .2 mg/mL
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 996828 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 63629-2074-1 METHYLERGONOVINE MALEATE 1 mL in 1 AMPULE INJECTION 1 103 63629-2074-1 METHYLERGONOVINE MALEATE 10 in 1 BOX INJECTION 10 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2074 METHYLERGONOVINE MALEATE INJECTION [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 2 package rows 20240606_8a6fe76c-d709-419e-885e-fa2ce07df27b.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE Pharmacist Pharmaceutical, LLC 17ee0c79-ac98-4400-ae77-985978fca07e 2025-12-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040889 application number: ANDA040889 METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE Breckenridge Pharmaceutical, Inc. 8bccff44-2a39-400a-b8a4-2eb5249fdbc8 2025-07-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040889 application number: ANDA040889 METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE Bryant Ranch Prepack 885b98d9-ba2c-48fb-b3b8-940e5f5e93d6 2024-05-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040889 application number: ANDA040889 METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE Bryant Ranch Prepack 8a6fe76c-d709-419e-885e-fa2ce07df27b 2024-05-29 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040889 application number: ANDA040889 ndc (product): 63629-2074 METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE HF Acquisition Co LLC, DBA HealthFirst c4c48277-eb9e-6150-e053-2a95a90ab21d 2024-05-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040889 application number: ANDA040889
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 63629-2074-1 63629207401 10 AMPULE in 1 BOX (63629-2074-1) / 1 mL in 1 AMPULE 10 ampule 2016-11-07 0000-00-00 No No Current