FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiIR84JPZ1RK
Rxcui996824

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

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 tablet2023-08-01NoNoHistorical
70010-786-287001007862828 TABLET in 1 BOTTLE (70010-786-28) 28 tablet2023-08-01NoNoHistorical