METHYLERGONOVINE MALEATE

Product NDC
51662-1556
11-digit product format
516621556
Labeler code
51662
Product ID
51662-1556_18a70703-0305-f121-e063-6394a90a3713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLERGONOVINE MALEATE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA040889
Marketing category
ANDA
Marketing start
2021-06-14
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040889-001METHYLERGONOVINE MALEATEMETHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040889-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-133f01610625f2…
2019-09-15 20:21 UTC2019-09A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040889-001METHYLERGONOVINE MALEATE0.2MG/MLINJECTABLE / INJECTIONAP2010-09-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040889-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040889-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040889-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040889-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040889-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040889-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040889-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040889-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040889-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040889-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040889-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040889-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040889-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040889-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040889-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040889-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040889-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040889-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040889-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040889-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040889-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040889-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040889-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040889-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040889-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040889-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040889-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040889-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040889-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040889-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040889-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040889-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040889-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040889-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040889-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040889-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040889-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040889-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040889-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040889-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
METHYLERGONOVINE MALEATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLERGONOVINE MALEATE.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IR84JPZ1RKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996828Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c4c48277-eb9e-6150-e053-2a95a90ab21dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8d59645-13e1-4381-94b1-6ca9c8d64fc8Product name520210615
12fc2a28-7c95-8272-24e2-ad0f6361d10bProduct name220180723

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1556-1METHYLERGONOVINE MALEATE1 mL in 1 AMPULEINJECTION13
51662-1556-2METHYLERGONOVINE MALEATE1 in 1 POUCHINJECTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1556METHYLERGONOVINE MALEATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 2 package rows20240518_c4c48277-eb9e-6150-e053-2a95a90ab21d.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHYLERGONOVINE MALEATEMETHYLERGONOVINE MALEATEPharmacist Pharmaceutical, LLC17ee0c79-ac98-4400-ae77-985978fca07e2025-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040889
application number: ANDA040889
METHYLERGONOVINE MALEATEMETHYLERGONOVINE MALEATEBreckenridge Pharmaceutical, Inc.8bccff44-2a39-400a-b8a4-2eb5249fdbc82025-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040889
application number: ANDA040889
METHYLERGONOVINE MALEATEMETHYLERGONOVINE MALEATEBryant Ranch Prepack885b98d9-ba2c-48fb-b3b8-940e5f5e93d62024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040889
application number: ANDA040889
METHYLERGONOVINE MALEATEMETHYLERGONOVINE MALEATEBryant Ranch Prepack8a6fe76c-d709-419e-885e-fa2ce07df27b2024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040889
application number: ANDA040889
METHYLERGONOVINE MALEATEMETHYLERGONOVINE MALEATEHF Acquisition Co LLC, DBA HealthFirstc4c48277-eb9e-6150-e053-2a95a90ab21d2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040889
application number: ANDA040889
ndc (product): 51662-1556

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996828methylergonovine maleate 0.2 MG in 1 ML InjectionPSNc4c48277-eb9e-6150-e053-2a95a90ab21d3
9968281 ML methylergonovine maleate 0.2 MG/ML InjectionSCDc4c48277-eb9e-6150-e053-2a95a90ab21d3
996828methylergonovine maleate 0.2 MG per 1 ML InjectionSYc4c48277-eb9e-6150-e053-2a95a90ab21d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1556-1516621556011 mL in 1 AMPULE (51662-1556-1) 1 ml2021-06-140000-00-00NoNoCurrent
51662-1556-2516621556021 AMPULE in 1 POUCH (51662-1556-2) / 1 mL in 1 AMPULE (51662-1556-1) 1 ampule2021-06-14NoNoCurrent