Carboprost Tromethamine

Product NDC
83270-002
11-digit product format
832700002
Labeler code
83270
Product ID
83270-002_461f80d0-b66d-f093-e063-6294a90a8893
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carboprost Tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
ONESOURCE SPECIALTY PHARMA LIMITED
Application
ANDA216897
Marketing category
ANDA
Marketing start
2023-11-01
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
83270-002-10Carboprost Tromethamine10 in 1 CARTONINJECTION, SOLUTION101
83270-002-10Carboprost Tromethamine1 mL in 1 VIALINJECTION, SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83270-002CARBOPROST TROMETHAMINE INJECTION, SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED]3Current NDC20250523_6484c309-2041-4c25-a233-9d1fb6da583c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSN461f80d0-b66c-f093-e063-6294a90a88931
2380141 ML carboprost 0.25 MG/ML InjectionSCD461f80d0-b66c-f093-e063-6294a90a88931
238014carboprost 250 MCG per 1 ML InjectionSY461f80d0-b66c-f093-e063-6294a90a88931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83270-002-108327000021010 VIAL in 1 CARTON (83270-002-10) / 1 mL in 1 VIAL10 vial2023-11-01NoNoCurrent