CARBOPROST TROMETHAMINE

Product NDC
43598-919
11-digit product format
435980919
Labeler code
43598
Product ID
43598-919_b1121a1d-8942-a856-b89e-897fd580d20a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carboprost tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Dr. Reddy�s Laboratories Inc.
Application
ANDA211941
Marketing category
ANDA
Marketing start
2020-02-04
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-919-11CARBOPROST TROMETHAMINE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12
43598-919-58CARBOPROST TROMETHAMINE10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-919-11ML - Milliliter43598-919ca2d6d79-6db0-41a8-aca2-e4feebb3618b12020-03-10
43598-919-58ML - Milliliter43598-9190c711678-3a1d-404a-859c-07353f847b9912020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-919CARBOPROST TROMETHAMINE INJECTION, SOLUTION [DR. REDDY’S LABORATORIES INC.]2Current NDC, Legacy NDC, 2 package rows20241222_2fd306a6-bf50-a354-46e5-d9fa8da619af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSN2fd306a6-bf50-a354-46e5-d9fa8da619af2
2380141 ML carboprost 0.25 MG/ML InjectionSCD2fd306a6-bf50-a354-46e5-d9fa8da619af2
238014carboprost 250 MCG per 1 ML InjectionSY2fd306a6-bf50-a354-46e5-d9fa8da619af2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-919-11435980919111 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
43598-919-584359809195810 VIAL, SINGLE-DOSE in 1 CARTON (43598-919-58) / 1 mL in 1 VIAL, SINGLE-DOSE (43598-919-11) 2020-02-040000-00-00NoNoCurrent