CARBOPROST TROMETHAMINE

Product NDC
71839-137
11-digit product format
718390137
Labeler code
71839
Product ID
71839-137_8447d4f1-d286-4aa0-a379-a673518da045
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carboprost tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
BE Pharmaceuticals Inc.
Application
ANDA216882
Marketing category
ANDA
Marketing start
2023-05-11
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71839-137-01CARBOPROST TROMETHAMINE1 mL in 1 VIALINJECTION, SOLUTION11
71839-137-10CARBOPROST TROMETHAMINE10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71839-137-01ML - Milliliter71839-137ee614e2b-e1c2-449e-9af9-b1b9fa559f7512023-06-06
71839-137-10ML - Milliliter71839-1370bff65af-3806-4433-9546-db73a1ec992812023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71839-137CARBOPROST TROMETHAMINE INJECTION, SOLUTION [BE PHARMACEUTICALS INC.]1Current NDC, 2 package rows20230511_8447d4f1-d286-4aa0-a379-a673518da045.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSN8447d4f1-d286-4aa0-a379-a673518da0451
2380141 ML carboprost 0.25 MG/ML InjectionSCD8447d4f1-d286-4aa0-a379-a673518da0451
238014carboprost 250 MCG per 1 ML InjectionSY8447d4f1-d286-4aa0-a379-a673518da0451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71839-137-01718390137011 mL in 1 VIAL1 mlHistorical
71839-137-107183901371010 VIAL in 1 CARTON (71839-137-10) / 1 mL in 1 VIAL (71839-137-01) 10 vial2023-05-11NoNoCurrent