Home NDC 0517-0740 Methylergonovine Maleate
Product NDC 0517-0740
11-digit product format 005170740
Labeler code 0517
Product ID 0517-0740_719ae836-9739-4cd3-8a4e-0eb6ca4bd75c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylergonovine Maleate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler American Regent, Inc.
Application ANDA090193
Marketing category ANDA
Marketing start 2010-06-21
Substance METHYLERGONOVINE MALEATE
Active strength .2 mg/mL
Pharmacologic classes Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A090193-001 METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP RS 2008-11-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090193-001 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 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP RS 2008-11-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP RS 2008-11-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP RS 2008-11-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP RS 2008-11-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP RS 2008-11-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP RS 2008-11-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090193-001 METHYLERGONOVINE MALEATE 0.2MG/ML INJECTABLE / INJECTION AP 2008-11-24 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/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 0517-0740-01 Methylergonovine Maleate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 8 0517-0740-20 Methylergonovine Maleate 20 in 1 CARTON INJECTION, SOLUTION 20 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHYLERGONOVINE MALEATE ACTIVE INGREDIENT IR84JPZ1RK METHYLERGONOVINE MALEATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 METHYLERGONOVINE ACTIVE MOIETY W53L6FE61V METHYLERGONOVINE MALEATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 MALEIC ACID INACTIVE INGREDIENT 91XW058U2C METHYLERGONOVINE MALEATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X METHYLERGONOVINE MALEATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R METHYLERGONOVINE MALEATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-0740 METHYLERGONOVINE MALEATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20201216_a9a3079e-b62b-4858-920e-d8f5cb38481e.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 · 2 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 0517-0740-01 00517074001 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 0517-0740-20 00517074020 20 VIAL, SINGLE-DOSE in 1 CARTON (0517-0740-20) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-0740-01) 2010-06-21 0000-00-00 No No Current