FDA.reportPublic FDA data

Methylergonovine Maleate

Product NDC
40032-140
11-digit product format
400320140
Labeler code
40032
Product ID
40032-140_afedb0c3-649c-4df6-b037-b6bc71946a56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylergonovine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA091577
Marketing category
ANDA
Marketing start
2011-06-15
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
40032-140-012024-01-30C16284748780-11030e365-1db6-111a-e063-dadaa90a10e2Methylergonovine Maleate Tablets, USP
40032-140-072024-01-30C16284748780-11030e365-1db6-111a-e063-dadaa90a10e2Methylergonovine Maleate Tablets, USP
40032-140-282024-01-30C16284748780-11030e365-1db6-111a-e063-dadaa90a10e2Methylergonovine Maleate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-140-01Methylergonovine Maleate100 in 1 BOTTLETABLET1002
40032-140-07Methylergonovine Maleate7 in 1 BOTTLETABLET72
40032-140-28Methylergonovine Maleate28 in 1 BOTTLETABLET282

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLERGONOVINE MALEATEACTIVE INGREDIENTIR84JPZ1RKMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1
METHYLERGONOVINEACTIVE MOIETYW53L6FE61VMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1
ACACIAINACTIVE INGREDIENT5C5403N26OMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HMETHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-140METHYLERGONOVINE MALEATE TABLET [NOVEL LABORATORIES, INC.]2Legacy NDC, 3 package rows20180110_fa75ef56-dcf4-4c3e-bea4-161893e09685.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996824methylergonovine maleate 0.2 MG Oral TabletPSNfa75ef56-dcf4-4c3e-bea4-161893e096852
996824methylergonovine maleate 0.2 MG Oral TabletSCDfa75ef56-dcf4-4c3e-bea4-161893e096852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-140-0140032014001100 TABLET in 1 BOTTLE (40032-140-01) 100 tablet2011-06-150000-00-00NoNoCurrent
40032-140-07400320140077 TABLET in 1 BOTTLE (40032-140-07) 7 tablet2011-06-150000-00-00NoNoCurrent
40032-140-284003201402828 TABLET in 1 BOTTLE (40032-140-28) 28 tablet2011-06-150000-00-00NoNoCurrent