CARBOPROST TROMETHAMINE

Product NDC
81665-202
11-digit product format
816650202
Labeler code
81665
Product ID
81665-202_4cded8b1-0f1c-219d-e063-6294a90a64e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carboprost tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Omnivium Pharmaceuticals LLC
Application
ANDA213118
Marketing category
ANDA
Marketing start
2025-05-15
Substance
CARBOPROST TROMETHAMINE
Active strength
250 ug/mL
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CARBOPROST TROMETHAMINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOPROST TROMETHAMINE250 ug/mL

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
81665-202-01CARBOPROST TROMETHAMINE1 mL in 1 AMPULEINJECTION, SOLUTION11
81665-202-10CARBOPROST TROMETHAMINE10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81665-202-01ML - Milliliter81665-202d99b1556-fb6d-43d7-bfd4-032fa26f887012025-11-13
81665-202-10ML - Milliliter81665-2029f95bf7f-688e-421b-b3da-9ec6276548b912025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSN84efd1c0-6323-4469-9535-237f96fcb3831
2380141 ML carboprost 0.25 MG/ML InjectionSCD84efd1c0-6323-4469-9535-237f96fcb3831
238014carboprost 250 MCG per 1 ML InjectionSY84efd1c0-6323-4469-9535-237f96fcb3831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81665-202-01816650202011 mL in 1 AMPULE (81665-202-01) 1 ml2025-05-15NoNoHistorical
81665-202-108166502021010 AMPULE in 1 CARTON (81665-202-10) / 1 mL in 1 AMPULE (81665-202-01) 10 ampule2025-05-15NoNoHistorical