Methylergonovine Maleate

Product NDC
69238-1605
11-digit product format
692381605
Labeler code
69238
Product ID
69238-1605_5c53f000-01eb-4042-bdb8-e569609413bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylergonovine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211483
Marketing category
ANDA
Marketing start
2018-09-12
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1605-2Methylergonovine Maleate12 in 1 BOTTLETABLET1210
69238-1605-8Methylergonovine Maleate28 in 1 BOTTLETABLET2810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1605METHYLERGONOVINE MALEATE (METHYLERGONOVINE) TABLET [AMNEAL PHARMACEUTICALS NY LLC]8Current NDC, Legacy NDC, 2 package rows20201230_a7ec8dfe-9b58-4363-a709-c1b72ee67855.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996824methylergonovine maleate 0.2 MG Oral TabletPSNa7ec8dfe-9b58-4363-a709-c1b72ee6785510
996824methylergonovine maleate 0.2 MG Oral TabletSCDa7ec8dfe-9b58-4363-a709-c1b72ee6785510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1605-26923816050212 TABLET in 1 BOTTLE (69238-1605-2) 12 tablet2018-09-120000-00-00NoNoCurrent
69238-1605-86923816050828 TABLET in 1 BOTTLE (69238-1605-8) 28 tablet2018-09-120000-00-00NoNoCurrent