FDA.reportPublic FDA data

METHYLERGONOVINE MALEATE

Product NDC
51991-144
11-digit product format
519910144
Labeler code
51991
Product ID
51991-144_56e09e25-eeaa-4dab-9acc-96622117ee64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylergonovine Maleate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA040889
Marketing category
ANDA
Marketing start
2016-11-07
Substance
METHYLERGONOVINE MALEATE
Active strength
.2 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIR84JPZ1RK
Rxcui996828

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-144-17METHYLERGONOVINE MALEATE1 mL in 1 AMPULEINJECTION18
51991-144-17METHYLERGONOVINE MALEATE10 in 1 BOXINJECTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-144-17ML - Milliliter51991-14408f511eb-6c16-46a0-b813-7dc4ad768f8d12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-144METHYLERGONOVINE MALEATE INJECTION [BRECKENRIDGE PHARMACEUTICAL, INC.]7Current NDC, Legacy NDC, 2 package rows20240328_8bccff44-2a39-400a-b8a4-2eb5249fdbc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996828methylergonovine maleate 0.2 MG in 1 ML InjectionPSN8a6fe76c-d709-419e-885e-fa2ce07df27b103
9968281 ML methylergonovine maleate 0.2 MG/ML InjectionSCD8a6fe76c-d709-419e-885e-fa2ce07df27b103
996828methylergonovine maleate 0.2 MG per 1 ML InjectionSY8a6fe76c-d709-419e-885e-fa2ce07df27b103
996828methylergonovine maleate 0.2 MG in 1 ML InjectionPSN885b98d9-ba2c-48fb-b3b8-940e5f5e93d6101
9968281 ML methylergonovine maleate 0.2 MG/ML InjectionSCD885b98d9-ba2c-48fb-b3b8-940e5f5e93d6101
996828methylergonovine maleate 0.2 MG per 1 ML InjectionSY885b98d9-ba2c-48fb-b3b8-940e5f5e93d6101
996828methylergonovine maleate 0.2 MG in 1 ML InjectionPSN8bccff44-2a39-400a-b8a4-2eb5249fdbc88
9968281 ML methylergonovine maleate 0.2 MG/ML InjectionSCD8bccff44-2a39-400a-b8a4-2eb5249fdbc88
996828methylergonovine maleate 0.2 MG per 1 ML InjectionSY8bccff44-2a39-400a-b8a4-2eb5249fdbc88
996828methylergonovine maleate 0.2 MG in 1 ML InjectionPSNc4c48277-eb9e-6150-e053-2a95a90ab21d3
9968281 ML methylergonovine maleate 0.2 MG/ML InjectionSCDc4c48277-eb9e-6150-e053-2a95a90ab21d3
996828methylergonovine maleate 0.2 MG per 1 ML InjectionSYc4c48277-eb9e-6150-e053-2a95a90ab21d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-144-175199101441710 AMPULE in 1 BOX (51991-144-17) / 1 mL in 1 AMPULE10 ampule2016-11-070000-00-00NoNoCurrent