Carboprost Tromethamine

Product NDC
62559-900
11-digit product format
625590900
Labeler code
62559
Product ID
62559-900_37e95735-c3ac-4ba1-9c23-9065f3511cc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carboprost Tromethamine
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA215901
Marketing category
ANDA
Marketing start
2024-12-20
Substance
CARBOPROST TROMETHAMINE
Active strength
250 ug/mL
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carboprost Tromethamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOPROST TROMETHAMINE250 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU4526F86FJ
Rxcui238014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
bf7dbc85-c3be-ce3e-e49f-8b9d8ea1ff7cProduct name520240515
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-900-01Carboprost Tromethamine10 in 1 CARTONINJECTION102
62559-900-11Carboprost Tromethamine1 mL in 1 VIAL, SINGLE-DOSEINJECTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-900CARBOPROST TROMETHAMINE INJECTION [ANI PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20241222_4dcda284-cfea-4b95-b432-a3d5af536e63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSN4dcda284-cfea-4b95-b432-a3d5af536e632
2380141 ML carboprost 0.25 MG/ML InjectionSCD4dcda284-cfea-4b95-b432-a3d5af536e632
238014carboprost 250 MCG per 1 ML InjectionSY4dcda284-cfea-4b95-b432-a3d5af536e632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62559-900-016255909000110 VIAL, SINGLE-DOSE in 1 CARTON (62559-900-01) / 1 mL in 1 VIAL, SINGLE-DOSE (62559-900-11) 2024-12-20NoNoHistorical
62559-900-11625590900111 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical