FDA.reportPublic FDA data

Methylergonovine Maleate

Product NDC
43386-140
11-digit product format
433860140
Labeler code
43386
Product ID
43386-140_16ee131d-1b49-4b13-9e23-e915401e7093
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylergonovine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals,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
43386-140-012024-01-30C16284748780-11030e365-1fcc-111a-e063-dadaa90a10e2Methylergonovine Maleate Tablets, USP
43386-140-072024-01-30C16284748780-11030e365-1fcc-111a-e063-dadaa90a10e2Methylergonovine Maleate Tablets, USP
43386-140-122024-01-30C16284748780-11030e365-1fcc-111a-e063-dadaa90a10e2Methylergonovine Maleate Tablets, USP
43386-140-282024-01-30C16284748780-11030e365-1fcc-111a-e063-dadaa90a10e2Methylergonovine Maleate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-140-01Methylergonovine Maleate100 in 1 BOTTLETABLET1003
43386-140-07Methylergonovine Maleate7 in 1 BOTTLETABLET73
43386-140-12Methylergonovine Maleate12 in 1 BOTTLETABLET123
43386-140-28Methylergonovine Maleate28 in 1 BOTTLETABLET283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-140-01EA - Each43386-140a8fab3eb-9f89-4eb3-ab64-782e6dad6c5512012-07-24
43386-140-07EA - Each43386-140f67746cb-906a-4a77-9dc1-e2fe62d6172e12013-11-04
43386-140-12EA - Each43386-1405568ee02-0d98-4c52-a4bf-ea1c70fdff9512018-06-11
43386-140-28EA - Each43386-140ad84f625-c4a4-4c93-a4cb-03128f0820ae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLERGONOVINE MALEATEACTIVE INGREDIENTIR84JPZ1RKMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2
METHYLERGONOVINEACTIVE MOIETYW53L6FE61VMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2
ACACIAINACTIVE INGREDIENT5C5403N26OMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HMETHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-140METHYLERGONOVINE MALEATE TABLET [LUPIN PHARMACEUTICALS,INC.]3Legacy NDC, 4 package rows20171117_f617b954-71b9-4bef-aeb2-f87eb9f04ef6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996824methylergonovine maleate 0.2 MG Oral TabletPSNf617b954-71b9-4bef-aeb2-f87eb9f04ef63
996824methylergonovine maleate 0.2 MG Oral TabletSCDf617b954-71b9-4bef-aeb2-f87eb9f04ef63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-140-0143386014001100 TABLET in 1 BOTTLE (43386-140-01) 100 tablet2011-06-150000-00-00NoNoCurrent
43386-140-07433860140077 TABLET in 1 BOTTLE (43386-140-07) 7 tablet2011-06-150000-00-00NoNoCurrent
43386-140-124338601401212 TABLET in 1 BOTTLE (43386-140-12) 12 tablet2017-11-100000-00-00NoNoCurrent
43386-140-284338601402828 TABLET in 1 BOTTLE (43386-140-28) 28 tablet2011-06-150000-00-00NoNoCurrent