CARBOPROST TROMETHAMINE

Product NDC
65145-132
11-digit product format
651450132
Labeler code
65145
Product ID
65145-132_73448969-f24f-41bf-9898-879348af09f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carboprost tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Caplin Steriles Limited
Application
ANDA216882
Marketing category
ANDA
Marketing start
2025-01-20
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
65145-132-01CARBOPROST TROMETHAMINE1 mL in 1 VIALINJECTION, SOLUTION14
65145-132-10CARBOPROST TROMETHAMINE10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-132-01ML - Milliliter65145-13267b64e94-0afc-4478-bd1d-152a04243cbe12025-02-10
65145-132-10ML - Milliliter65145-1326fb9743f-51f1-4ef0-b0a6-5a7e75c5c94112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-132CARBOPROST TROMETHAMINE INJECTION, SOLUTION [CAPLIN STERILES LIMITED]4Current NDC, 2 package rows20250121_42736d6a-0ab3-4c3c-897d-406aad5a49c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSN42736d6a-0ab3-4c3c-897d-406aad5a49c24
2380141 ML carboprost 0.25 MG/ML InjectionSCD42736d6a-0ab3-4c3c-897d-406aad5a49c24
238014carboprost 250 MCG per 1 ML InjectionSY42736d6a-0ab3-4c3c-897d-406aad5a49c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-132-01651450132011 mL in 1 VIAL1 mlHistorical
65145-132-106514501321010 VIAL in 1 CARTON (65145-132-10) / 1 mL in 1 VIAL (65145-132-01) 10 vial2025-01-20NoNoCurrent