CARBOPROST TROMETHAMINE

Product NDC
46708-777
11-digit product format
467080777
Labeler code
46708
Product ID
46708-777_42caba7b-9569-472f-8962-6cf8d523fe79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBOPROST TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA217198
Marketing category
ANDA
Marketing start
2023-06-15
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
46708-777-01CARBOPROST TROMETHAMINE1 in 1 CARTONINJECTION, SOLUTION12
46708-777-01CARBOPROST TROMETHAMINE1 mL in 1 VIALINJECTION, SOLUTION12
46708-777-10CARBOPROST TROMETHAMINE1 mL in 1 VIALINJECTION, SOLUTION12
46708-777-10CARBOPROST TROMETHAMINE10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-777CARBOPROST TROMETHAMINE INJECTION, SOLUTION [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20240316_d74a448c-ba91-4490-8550-9e675c39b427.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSNd74a448c-ba91-4490-8550-9e675c39b4272
2380141 ML carboprost 0.25 MG/ML InjectionSCDd74a448c-ba91-4490-8550-9e675c39b4272
238014carboprost 250 MCG per 1 ML InjectionSYd74a448c-ba91-4490-8550-9e675c39b4272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-777-01467080777011 VIAL in 1 CARTON (46708-777-01) / 1 mL in 1 VIAL1 vial2023-06-15NoNoHistorical
46708-777-104670807771010 VIAL in 1 CARTON (46708-777-10) / 1 mL in 1 VIAL10 vial2023-06-15NoNoHistorical