FDA.reportPublic FDA data

CARBOPROST TROMETHAMINE

Product NDC
43598-917
11-digit product format
435980917
Labeler code
43598
Product ID
43598-917_36c90ebd-a088-a3fb-a94b-6a602af0ddb3
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-917-11CARBOPROST TROMETHAMINE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12
43598-917-58CARBOPROST TROMETHAMINE10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-917-11ML - Milliliter43598-917f989f625-9c5a-4f20-b239-9a558cfec91e12020-03-10
43598-917-58ML - Milliliter43598-9173c0fa75b-8d48-4054-93cf-618e5217d2f812020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-917CARBOPROST TROMETHAMINE INJECTION, SOLUTION [DR. REDDY’S LABORATORIES INC.]2Current NDC, Legacy NDC, 2 package rows20241222_1fc164ae-9964-17b3-4b92-d25b0ddb805e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSN1fc164ae-9964-17b3-4b92-d25b0ddb805e2
2380141 ML carboprost 0.25 MG/ML InjectionSCD1fc164ae-9964-17b3-4b92-d25b0ddb805e2
238014carboprost 250 MCG per 1 ML InjectionSY1fc164ae-9964-17b3-4b92-d25b0ddb805e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-917-11435980917111 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
43598-917-584359809175810 VIAL, SINGLE-DOSE in 1 CARTON (43598-917-58) / 1 mL in 1 VIAL, SINGLE-DOSE (43598-917-11) 2020-02-040000-00-00NoNoCurrent