Methylergonovine Maleate

Product NDC
16571-735
11-digit product format
165710735
Labeler code
16571
Product ID
16571-735_6fc367d7-31bb-415b-bb35-367a81dd5bfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylergonovine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA211919
Marketing category
ANDA
Marketing start
2021-01-15
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-735-01Methylergonovine Maleate100 in 1 BOTTLETABLET1003
16571-735-17Methylergonovine Maleate7 in 1 BOTTLETABLET73
16571-735-21Methylergonovine Maleate12 in 1 BOTTLETABLET123
16571-735-28Methylergonovine Maleate28 in 1 BOTTLETABLET283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-735-21EA - Each16571-73522cb614e-f898-4908-b533-06444749fed412021-06-02
16571-735-28EA - Each16571-735da1931c4-c819-4704-84d0-8da5893e4d3712021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-735METHYLERGONOVINE MALEATE TABLET [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 4 package rows20211125_465b292b-0e0e-4a55-894e-90234efe2a12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996824methylergonovine maleate 0.2 MG Oral TabletPSN465b292b-0e0e-4a55-894e-90234efe2a123
996824methylergonovine maleate 0.2 MG Oral TabletSCD465b292b-0e0e-4a55-894e-90234efe2a123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-735-0116571073501100 TABLET in 1 BOTTLE (16571-735-01) 100 tablet2021-01-150000-00-00NoNoCurrent
16571-735-17165710735177 TABLET in 1 BOTTLE (16571-735-17) 7 tablet2021-01-150000-00-00NoNoCurrent
16571-735-211657107352112 TABLET in 1 BOTTLE (16571-735-21) 12 tablet2021-01-150000-00-00NoNoCurrent
16571-735-281657107352828 TABLET in 1 BOTTLE (16571-735-28) 28 tablet2021-01-150000-00-00NoNoCurrent