Remodulin

Product NDC
66302-114
11-digit product format
663020114
Labeler code
66302
Product ID
66302-114_143d514e-fdcd-4766-ba47-0a75395e1f84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
treprostinil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
United Therapeutics Corporation
Application
NDA021272
Marketing category
NDA
Marketing start
2023-09-28
Substance
TREPROSTINIL
Active strength
8 mg/20mL
Pharmacologic classes
Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
RUM6K67ESGTREPROSTINIL81846-19-7TREPROSTINIL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66302-114-01663020114011 VIAL in 1 BOX (66302-114-01) / 20 mL in 1 VIAL1 vial2023-09-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
RemodulinUnited Therapeutics Corporation2025-07-18HUMAN PRESCRIPTION DRUG LABEL33