Carboprost Tromethamine

Product NDC
42571-435
11-digit product format
425710435
Labeler code
42571
Product ID
42571-435_1559494c-862d-5b1f-e063-6294a90af8e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carboprost Tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Micro Labs Limited
Application
ANDA218013
Marketing category
ANDA
Marketing start
2024-08-01
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
42571-435-54Carboprost Tromethamine1 mL in 1 VIALINJECTION, SOLUTION11
42571-435-72Carboprost Tromethamine10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-435CARBOPROST TROMETHAMINE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [MICRO LABS LIMITED]1Current NDC, 2 package rows20240802_a8a6acbf-81db-4fe3-aec8-ee7aa7af4d32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSNa8a6acbf-81db-4fe3-aec8-ee7aa7af4d321
2380141 ML carboprost 0.25 MG/ML InjectionSCDa8a6acbf-81db-4fe3-aec8-ee7aa7af4d321
238014carboprost 250 MCG per 1 ML InjectionSYa8a6acbf-81db-4fe3-aec8-ee7aa7af4d321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42571-435-54425710435541 mL in 1 VIAL1 mlHistorical
42571-435-724257104357210 VIAL in 1 CARTON (42571-435-72) / 1 mL in 1 VIAL (42571-435-54) 10 vial2024-08-01NoNoCurrent