Methylergonovine Maleate

Product NDC
70010-786
11-digit product format
700100786
Labeler code
70010
Product ID
70010-786_37bde3cf-2f92-a516-e063-6394a90a006a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylergonovine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA210424
Marketing category
ANDA
Marketing start
2018-05-25
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70010-78670010-786-01DDiscontinued by firm2026-08-11
excluded packagepackage70010-78670010-786-07DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570010-786-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570010-786-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670010-786-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670010-786-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170010-786-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3170010-786-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870010-786-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2870010-786-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170010-786-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2170010-786-07cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070010-786-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1070010-786-07cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170010-786-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3170010-786-07302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070010-786-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2070010-786-07ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070010-786-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1070010-786-070efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870010-786-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0870010-786-07ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370010-786-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0370010-786-07367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970010-786-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0970010-786-07557ba5c1ecfa…9c80585c8c6e…

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
A210424-001METHYLERGONOVINE MALEATEMETHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210424-001AB

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 UTC2026-02A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210424-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2018-05-15cb3db0bc1861…

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 UTC2026-02A210424-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210424-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210424-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210424-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210424-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210424-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210424-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210424-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210424-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210424-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210424-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210424-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210424-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210424-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210424-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210424-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210424-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210424-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210424-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210424-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210424-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210424-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210424-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210424-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210424-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A210424-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210424-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210424-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210424-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210424-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210424-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210424-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210424-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210424-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210424-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210424-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210424-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210424-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210424-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210424-001AB1cb3db0bc1861…

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/1

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
996824Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b49b1e4c-de20-446d-b80a-75c7f0d41ddfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8d59645-13e1-4381-94b1-6ca9c8d64fc8Product name520210615
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
12fc2a28-7c95-8272-24e2-ad0f6361d10bProduct name220180723

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70010-786-01Methylergonovine Maleate100 in 1 BOTTLETABLET1006
70010-786-07Methylergonovine Maleate7 in 1 BOTTLETABLET76
70010-786-12Methylergonovine Maleate12 in 1 BOTTLETABLET126
70010-786-28Methylergonovine Maleate28 in 1 BOTTLETABLET286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-786-12EA - Each70010-786cba66418-eb7e-4a9f-b9a6-4d6bfac87ac012023-12-05
70010-786-28EA - Each70010-7869e338956-d86a-4b7e-80bd-c13e7b85635f12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-786METHYLERGONOVINE MALEATE TABLET [GRANULES PHARMACEUTICALS INC.]5Current NDC, 4 package rows20230728_b49b1e4c-de20-446d-b80a-75c7f0d41ddf.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylergonovine MaleateMETHYLERGONOVINE MALEATEMajor Pharmaceuticalsc7f19e89-8b52-4033-9914-f3b41fe0790d2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210424
application number: ANDA210424
Methylergonovine MaleateMETHYLERGONOVINE MALEATEAmerican Health Packaging98ad5af1-bde6-4137-a599-b6354d664da42025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210424
application number: ANDA210424
Methylergonovine MaleateMETHYLERGONOVINE MALEATEGranules Pharmaceuticals Inc.b49b1e4c-de20-446d-b80a-75c7f0d41ddf2025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210424
application number: ANDA210424
ndc (product): 70010-786

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996824methylergonovine maleate 0.2 MG Oral TabletPSNb49b1e4c-de20-446d-b80a-75c7f0d41ddf6
996824methylergonovine maleate 0.2 MG Oral TabletSCDb49b1e4c-de20-446d-b80a-75c7f0d41ddf6
996824methylergonovine maleate 0.2 MG Oral TabletPSNc7f19e89-8b52-4033-9914-f3b41fe0790d3
996824methylergonovine maleate 0.2 MG Oral TabletSCDc7f19e89-8b52-4033-9914-f3b41fe0790d3
996824methylergonovine maleate 0.2 MG Oral TabletPSN98ad5af1-bde6-4137-a599-b6354d664da42
996824methylergonovine maleate 0.2 MG Oral TabletSCD98ad5af1-bde6-4137-a599-b6354d664da42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70010-786-0170010078601100 in 1 BOTTLEHistorical
70010-786-07700100786077 in 1 BOTTLEHistorical
70010-786-127001007861212 TABLET in 1 BOTTLE (70010-786-12) 12 tablet2023-08-01NoNoCurrent
70010-786-287001007862828 TABLET in 1 BOTTLE (70010-786-28) 28 tablet2023-08-01NoNoCurrent