FDA.reportPublic FDA data

CARBOPROST TROMETHAMINE

Product NDC
55150-459
11-digit product format
551500459
Labeler code
55150
Product ID
55150-459_1e7bd8be-a282-4c66-8e1f-bb3ef78c327a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBOPROST TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Eugia US LLC
Application
ANDA216939
Marketing category
ANDA
Marketing start
2023-05-25
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
55150-459-01CARBOPROST TROMETHAMINE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12
55150-459-10CARBOPROST TROMETHAMINE10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-459-01ML - Milliliter55150-459b28a9fd0-046d-4deb-a0c3-4395327ffb7212023-07-06
55150-459-10ML - Milliliter55150-4592c019eea-d505-42e6-a4c3-594c0872ac1c12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-459CARBOPROST TROMETHAMINE INJECTION, SOLUTION [EUGIA US LLC]1Current NDC, 2 package rows20230530_a4c3b724-8c36-4d18-86b1-5ecee40cfbf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSNa4c3b724-8c36-4d18-86b1-5ecee40cfbf42
2380141 ML carboprost 0.25 MG/ML InjectionSCDa4c3b724-8c36-4d18-86b1-5ecee40cfbf42
238014carboprost 250 MCG per 1 ML InjectionSYa4c3b724-8c36-4d18-86b1-5ecee40cfbf42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55150-459-01551500459011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
55150-459-105515004591010 VIAL, SINGLE-DOSE in 1 CARTON (55150-459-10) / 1 mL in 1 VIAL, SINGLE-DOSE (55150-459-01) 2023-05-25NoNoCurrent