Methylergonovine Maleate

Product NDC
17856-3655
11-digit product format
178563655
Labeler code
17856
Product ID
17856-3655_9c950e09-52c8-482e-b642-2b11b00116d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylergonovine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA211455
Marketing category
ANDA
Marketing start
2019-03-26
Marketing end
0000-00-00
Substance
METHYLERGONOVINE MALEATE
Active strength
0 mg/1
Pharmacologic classes
Ergolines [CS],Ergot Derivative [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 productproduct17856-3655IInactivated by FDA2026-08-11
excluded packagepackage17856-365517856-3655-1IInactivated by FDA2026-08-11

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-3655-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-3655-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-3655-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-3655-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-3655-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-3655-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-3655-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-3655-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-3655-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-3655-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-3655-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-3655-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-3655-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-3655-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-3655-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17856-3655-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-3655-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-3655-1bd6a592717d7…303034d00443…

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
A211455-001METHYLERGONOVINE MALEATEMETHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211455-001AB

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 UTC2026-02A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-203f01610625f2…
2019-09-15 20:21 UTC2019-09A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211455-001METHYLERGONOVINE MALEATE0.2MGTABLET / ORALAB2019-03-20cb3db0bc1861…

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 UTC2026-02A211455-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211455-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211455-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211455-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211455-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211455-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211455-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211455-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211455-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211455-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211455-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211455-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211455-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211455-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211455-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211455-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211455-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211455-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211455-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211455-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211455-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211455-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211455-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211455-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211455-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A211455-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211455-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211455-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211455-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211455-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211455-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211455-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211455-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211455-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211455-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211455-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211455-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211455-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211455-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211455-001AB1cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-3655-12022-01-28C16284748780-1d6a99b39-5280-a426-e053-dadaa90af4c2Methylergonovine Maleate Tablets USP A211455

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3655-1Methylergonovine Maleate100 in 1 BOX, UNIT-DOSETABLET1001
17856-3655-1Methylergonovine Maleate1 in 1 POUCHTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3655METHYLERGONOVINE MALEATE TABLET [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 2 package rows20200201_2fbdc9c4-b9d4-4796-adda-6144bdea0990.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylergonovine MaleateMETHYLERGONOVINE MALEATETeva Pharmaceuticals USA, Inc.d8e4b8ed-3289-4611-8a61-2392a4bf60722026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211455
application number: ANDA211455

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996824methylergonovine maleate 0.2 MG Oral TabletPSN2fbdc9c4-b9d4-4796-adda-6144bdea09901
996824methylergonovine maleate 0.2 MG Oral TabletSCD2fbdc9c4-b9d4-4796-adda-6144bdea09901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-3655-117856365501100 POUCH in 1 BOX, UNIT-DOSE (17856-3655-1) > 1 TABLET in 1 POUCH100 pouch2020-01-310000-00-00NoNoCurrent