remodulin

Generic: treprostinil

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

Drug Facts

Product Profile

Brand Name remodulin
Generic Name treprostinil
Labeler united therapeutics corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

treprostinil 8 mg/20mL

Manufacturer
United Therapeutics Corporation

Identifiers & Regulatory

Product NDC 66302-114
Product ID 66302-114_143d514e-fdcd-4766-ba47-0a75395e1f84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021272
Listing Expiration 2026-12-31
Marketing Start 2023-09-28

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 66302114
Hyphenated Format 66302-114

Supplemental Identifiers

RxCUI
349407 349408 349409 349410 352211 352212 352213 352214 2590175 2590177 2667748 2667750 2667752 2667754 2667756 2667758
UNII
059QF0KO0R 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 remodulin (source: ndc)
Generic Name treprostinil (source: ndc)
Application Number NDA021272 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 8 mg/20mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (66302-114-01) / 20 mL in 1 VIAL
source: ndc

Packages (1)

66302-114-01 1 VIAL in 1 BOX (66302-114-01) / 20 mL in 1 VIAL

Ingredients (1)

treprostinil (8 mg/20mL)

Linked Drug Pages (1)

Remodulin, Sterile Diluent for Remodulin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "143d514e-fdcd-4766-ba47-0a75395e1f84", "openfda": {"nui": ["N0000175416", "M0017817", "N0000009909"], "unii": ["059QF0KO0R", "RUM6K67ESG"], "rxcui": ["349407", "349408", "349409", "349410", "352211", "352212", "352213", "352214", "2590175", "2590177", "2667748", "2667750", "2667752", "2667754", "2667756", "2667758"], "spl_set_id": ["6c80bb38-e8db-4138-9f0d-dbbf9c673185"], "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 VIAL in 1 BOX (66302-114-01)  / 20 mL in 1 VIAL", "package_ndc": "66302-114-01", "marketing_start_date": "20230928"}], "brand_name": "Remodulin", "product_id": "66302-114_143d514e-fdcd-4766-ba47-0a75395e1f84", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Prostacycline Vasodilator [EPC]", "Prostaglandins I [CS]", "Vasodilation [PE]"], "product_ndc": "66302-114", "generic_name": "treprostinil", "labeler_name": "United Therapeutics Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Remodulin", "active_ingredients": [{"name": "TREPROSTINIL", "strength": "8 mg/20mL"}], "application_number": "NDA021272", "marketing_category": "NDA", "marketing_start_date": "20230928", "listing_expiration_date": "20261231"}