Carboprost Tromethamine

Product NDC
70594-112
11-digit product format
705940112
Labeler code
70594
Product ID
70594-112_855a4bbb-d273-4372-8221-8fcff32bee92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carboprost tromethamine
Dosage form
SOLUTION
Route
INTRAMUSCULAR
Labeler
Xellia Pharmaceuticals USA LLC
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
bf7dbc85-c3be-ce3e-e49f-8b9d8ea1ff7cProduct name520240515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-112-01Carboprost Tromethamine1 mL in 1 VIALSOLUTION12
70594-112-02Carboprost Tromethamine10 in 1 CARTONSOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-112-01ML - Milliliter70594-1128a616d81-cdb1-461d-909f-5a70ea3f6fad12024-02-14
70594-112-02ML - Milliliter70594-112d16e2a4c-f4d3-4011-9101-8afdfdd2e95912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-112CARBOPROST TROMETHAMINE SOLUTION [XELLIA PHARMACEUTICALS USA LLC]2Current NDC, 2 package rows20231108_8a1284cf-002f-4887-a3c0-d73d04b2b869.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSN8a1284cf-002f-4887-a3c0-d73d04b2b8692
2380141 ML carboprost 0.25 MG/ML InjectionSCD8a1284cf-002f-4887-a3c0-d73d04b2b8692
238014carboprost 250 MCG per 1 ML InjectionSY8a1284cf-002f-4887-a3c0-d73d04b2b8692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70594-112-01705940112011 mL in 1 VIAL1 mlHistorical
70594-112-027059401120210 VIAL in 1 CARTON (70594-112-02) / 1 mL in 1 VIAL (70594-112-01) 10 vial2023-11-01NoNoCurrent