Methylergonovine Maleate

Product NDC
0904-7282
11-digit product format
009047282
Labeler code
0904
Product ID
0904-7282_27b7ce37-49f0-451f-b574-393564cd9435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylergonovine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA210424
Marketing category
ANDA
Marketing start
2024-09-13
Substance
METHYLERGONOVINE MALEATE
Active strength
.2 mg/1
Pharmacologic classes
Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylergonovine Maleate
Listing expiration
2027-12-31

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
0904-7282-10Methylergonovine Maleate20 in 1 CARTONTABLET203
0904-7282-10Methylergonovine Maleate1 in 1 BLISTER PACKTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7282-10EA - Each0904-7282e6b15067-66c7-4ec6-8b8a-eb58fc4ec08a12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7282METHYLERGONOVINE MALEATE TABLET [MAJOR PHARMACEUTICALS]1Current NDC, 2 package rows20240915_c7f19e89-8b52-4033-9914-f3b41fe0790d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996824methylergonovine maleate 0.2 MG Oral TabletPSNc7f19e89-8b52-4033-9914-f3b41fe0790d3
996824methylergonovine maleate 0.2 MG Oral TabletSCDc7f19e89-8b52-4033-9914-f3b41fe0790d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7282-100090472821020 BLISTER PACK in 1 CARTON (0904-7282-10) / 1 TABLET in 1 BLISTER PACK20 blister pack2024-09-13NoNoHistorical