orenitram

Generic: treprostinil

Labeler: united therapeutics corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name orenitram
Generic Name treprostinil
Labeler united therapeutics corporation
Dosage Form KIT
Manufacturer
United Therapeutics Corporation

Identifiers & Regulatory

Product NDC 66302-362
Product ID 66302-362_bd66c62e-4aee-4fd0-bc7d-f78994dd9e29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203496
Listing Expiration 2026-12-31
Marketing Start 2023-02-14

Pharmacologic Class

Established (EPC)
prostacycline vasodilator [epc]
Chemical Structure
prostaglandins i [cs]
Physiologic Effect
vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66302362
Hyphenated Format 66302-362

Supplemental Identifiers

RxCUI
1488665 1488667 1488670 1488671 1488674 1488675 1488678 1488679 1858831 1858833 2630666 2630667 2630668 2630669 2630670 2630671
UNII
RUM6K67ESG
NUI
N0000175416 M0017817 N0000009909

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name orenitram (source: ndc)
Generic Name treprostinil (source: ndc)
Application Number NDA203496 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 0.125 mg
  • 0.25 mg
  • 1 mg
  • 2.5 mg
  • 5 mg
source: label
Packaging
  • 1 KIT in 1 PACKAGE (66302-362-56) * 126 TABLET, EXTENDED RELEASE in 1 BLISTER PACK * 210 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

66302-362-56 1 KIT in 1 PACKAGE (66302-362-56) * 126 TABLET, EXTENDED RELEASE in 1 BLISTER PACK * 210 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Orenitram ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "bd66c62e-4aee-4fd0-bc7d-f78994dd9e29", "openfda": {"nui": ["N0000175416", "M0017817", "N0000009909"], "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"], "pharm_class_cs": ["Prostaglandins I [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Prostacycline Vasodilator [EPC]"], "manufacturer_name": ["United Therapeutics Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 PACKAGE (66302-362-56)  *  126 TABLET, EXTENDED RELEASE in 1 BLISTER PACK *  210 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "66302-362-56", "marketing_start_date": "20230214"}], "brand_name": "Orenitram", "product_id": "66302-362_bd66c62e-4aee-4fd0-bc7d-f78994dd9e29", "dosage_form": "KIT", "product_ndc": "66302-362", "generic_name": "treprostinil", "labeler_name": "United Therapeutics Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orenitram", "application_number": "NDA203496", "marketing_category": "NDA", "marketing_start_date": "20230214", "listing_expiration_date": "20261231"}