Carboprost Tromethamine

Product NDC
25021-477
11-digit product format
250210477
Labeler code
25021
Product ID
25021-477_8dcc3692-6db4-4b95-9ee9-c81db12c5d12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carboprost Tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Sagent Pharmaceuticals
Application
ANDA217198
Marketing category
ANDA
Marketing start
2025-12-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-477-01Carboprost Tromethamine10 in 1 CARTONINJECTION, SOLUTION101
25021-477-01Carboprost Tromethamine1 mL in 1 VIALINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-477-01ML - Milliliter25021-47733aef6e7-77f2-43fa-bc2e-000dbc05d41112026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSNffc3a941-4d73-4273-a879-1565133a4d5d1
2380141 ML carboprost 0.25 MG/ML InjectionSCDffc3a941-4d73-4273-a879-1565133a4d5d1
238014carboprost 250 MCG per 1 ML InjectionSYffc3a941-4d73-4273-a879-1565133a4d5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-477-012502104770110 VIAL in 1 CARTON (25021-477-01) / 1 mL in 1 VIAL10 vial2025-12-01NoNoHistorical