Orenitram

Product NDC: 66302-361
11-digit product format: 663020361
Labeler code: 66302
Product ID: 66302-361_bd66c62e-4aee-4fd0-bc7d-f78994dd9e29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: treprostinil
Dosage form: KIT
Labeler: United Therapeutics Corporation
Application: NDA203496
Marketing category: NDA
Marketing start: 2023-02-14
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 66302-361_bd66c62e-4aee-4fd0-bc7d-f78994dd9e29
SPL ID: bd66c62e-4aee-4fd0-bc7d-f78994dd9e29
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Orenitram
Generic name: treprostinil
Dosage form: KIT
Marketing start: 2023-02-14
Marketing category: NDA
Application number: NDA203496
Listing expiration: 2026-12-31

openFDA Harmonized Identifiers

Field	Values
Unii	RUM6K67ESG
Rxcui	1488665, 1488667, 1488670, 1488671, 1488674, 1488675, 1488678, 1488679, 1858831, 1858833, 2630666, 2630667, 2630668, 2630669, 2630670, 2630671
Spl Set Id	8ed2003a-c801-411e-831e-d06079bb0d7c
Manufacturer Name	United Therapeutics Corporation

openFDA Package Details

Package NDC	Description	Marketing start	Sample
66302-361-28	1 KIT in 1 PACKAGE (66302-361-28) * 126 TABLET, EXTENDED RELEASE in 1 BLISTER PACK * 42 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2023-02-14	No

Related Records

Related UNII Ingredients

UNII	Preferred term	Registry number	Matched term
RUM6K67ESG	TREPROSTINIL	81846-19-7	treprostinil

Packages

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
66302-361-28	66302036128	1 KIT in 1 PACKAGE (66302-361-28) * 126 TABLET, EXTENDED RELEASE in 1 BLISTER PACK * 42 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 kit	2023-02-14	No	No	Historical

Related DailyMed Labels

Title	Manufacturer	Effective date	Type	Version
Orenitram	United Therapeutics Corporation	2024-11-20	HUMAN PRESCRIPTION DRUG LABEL	24