FDA.reportPublic FDA data

METHERGINE

Product NDC
12634-179
11-digit product format
126340179
Labeler code
12634
Product ID
12634-179_0048d662-23c4-4e28-815e-ce094951da05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLERGONOVINE MALEATE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Apotheca, Inc.
Application
NDA006035
Marketing category
NDA
Marketing start
2006-12-27
Marketing end
0000-00-00
Substance
METHYLERGONOVINE MALEATE
Active strength
0 mg/1
Pharmacologic classes
Ergolines [CS],Ergot Derivative [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8d59645-13e1-4381-94b1-6ca9c8d64fc8Product name520210615
12fc2a28-7c95-8272-24e2-ad0f6361d10bProduct name220180723

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12634-179-002020-01-31C16284748780-19d75b9d0-d3a2-f424-e053-dadaa90a57ceMethergine® (methylergonovine maleate) Tablets, USP Rx only
12634-179-802020-01-31C16284748780-19d75b9d0-d3a2-f424-e053-dadaa90a57ceMethergine® (methylergonovine maleate) Tablets, USP Rx only
12634-179-822020-01-31C16284748780-19d75b9d0-d3a2-f424-e053-dadaa90a57ceMethergine® (methylergonovine maleate) Tablets, USP Rx only
12634-179-852020-01-31C16284748780-19d75b9d0-d3a2-f424-e053-dadaa90a57ceMethergine® (methylergonovine maleate) Tablets, USP Rx only
12634-179-912020-01-31C16284748780-19d75b9d0-d3a2-f424-e053-dadaa90a57ceMethergine® (methylergonovine maleate) Tablets, USP Rx only
12634-179-962020-01-31C16284748780-19d75b9d0-d3a2-f424-e053-dadaa90a57ceMethergine® (methylergonovine maleate) Tablets, USP Rx only
12634-179-982020-01-31C16284748780-19d75b9d0-d3a2-f424-e053-dadaa90a57ceMethergine® (methylergonovine maleate) Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-179-00METHERGINE10 in 1 BOTTLE, PLASTICTABLET, COATED101
12634-179-80METHERGINE20 in 1 BOTTLE, PLASTICTABLET, COATED201
12634-179-82METHERGINE12 in 1 BOTTLE, PLASTICTABLET, COATED121
12634-179-85METHERGINE15 in 1 BOTTLE, PLASTICTABLET, COATED151
12634-179-91METHERGINE1 in 1 BLISTER PACKTABLET, COATED11
12634-179-96METHERGINE6 in 1 BOTTLE, PLASTICTABLET, COATED61
12634-179-98METHERGINE8 in 1 BOTTLE, PLASTICTABLET, COATED81

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLERGONOVINE MALEATEACTIVE INGREDIENTIR84JPZ1RKMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
METHYLERGONOVINEACTIVE MOIETYW53L6FE61VMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
acaciaINACTIVE INGREDIENT5C5403N26OMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
maleic acidINACTIVE INGREDIENT91XW058U2CMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94EMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
sucroseINACTIVE INGREDIENTC151H8M554METHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMETHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-179METHERGINE (METHYLERGONOVINE MALEATE) TABLET, COATED [APOTHECA, INC.]1Legacy NDC, 7 package rows20100225_b91d1729-2e8e-4398-9a0d-02763bcfe284.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996826methergine 0.2 MG Oral TabletPSNb91d1729-2e8e-4398-9a0d-02763bcfe2841
996824methylergonovine maleate 0.2 MG Oral TabletPSNb91d1729-2e8e-4398-9a0d-02763bcfe2841
996826methylergonovine maleate 0.2 MG Oral Tablet [Methergine]SBDb91d1729-2e8e-4398-9a0d-02763bcfe2841
996824methylergonovine maleate 0.2 MG Oral TabletSCDb91d1729-2e8e-4398-9a0d-02763bcfe2841
996826Methergine 0.2 MG Oral TabletSYb91d1729-2e8e-4398-9a0d-02763bcfe2841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-179-001263401790010 in 1 BOTTLE, PLASTICHistorical
12634-179-801263401798020 in 1 BOTTLE, PLASTICHistorical
12634-179-821263401798212 in 1 BOTTLE, PLASTICHistorical
12634-179-851263401798515 in 1 BOTTLE, PLASTICHistorical
12634-179-91126340179911 in 1 BLISTER PACKHistorical
12634-179-96126340179966 in 1 BOTTLE, PLASTICHistorical
12634-179-98126340179988 in 1 BOTTLE, PLASTICHistorical