tyvaso

Generic: treprostinil

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

Drug Facts

Product Profile

Brand Name tyvaso
Generic Name treprostinil
Labeler united therapeutics corporation
Dosage Form INHALANT
Routes
ORAL
Active Ingredients

treprostinil 1.74 mg/2.9mL

Manufacturer
United Therapeutics Corporation

Identifiers & Regulatory

Product NDC 66302-206
Product ID 66302-206_5e5649be-a5bb-4f39-9b52-c5e0bad4dc01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022387
Listing Expiration 2026-12-31
Marketing Start 2009-08-14

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 66302206
Hyphenated Format 66302-206

Supplemental Identifiers

RxCUI
857795 857799
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 tyvaso (source: ndc)
Generic Name treprostinil (source: ndc)
Application Number NDA022387 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.74 mg/2.9mL
source: ndc
Packaging
  • 1 BOX in 1 KIT (66302-206-01) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE
  • 1 BOX in 1 KIT (66302-206-02) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE
  • 4 AMPULE in 1 BOX (66302-206-03) / 2.9 mL in 1 AMPULE
  • 1 BOX in 1 KIT (66302-206-04) / 4 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE
source: ndc

Packages (4)

66302-206-01 1 BOX in 1 KIT (66302-206-01) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE 66302-206-02 1 BOX in 1 KIT (66302-206-02) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE 66302-206-03 4 AMPULE in 1 BOX (66302-206-03) / 2.9 mL in 1 AMPULE 66302-206-04 1 BOX in 1 KIT (66302-206-04) / 4 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE

Ingredients (1)

treprostinil (1.74 mg/2.9mL)

Linked Drug Pages (1)

TYVASO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5e5649be-a5bb-4f39-9b52-c5e0bad4dc01", "openfda": {"nui": ["N0000175416", "M0017817", "N0000009909"], "unii": ["RUM6K67ESG"], "rxcui": ["857795", "857799"], "spl_set_id": ["cbc31ab1-a80f-4b50-a3b1-39910b0fb609"], "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 BOX in 1 KIT (66302-206-01)  / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE", "package_ndc": "66302-206-01", "marketing_start_date": "20090814"}, {"sample": false, "description": "1 BOX in 1 KIT (66302-206-02)  / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE", "package_ndc": "66302-206-02", "marketing_start_date": "20090814"}, {"sample": false, "description": "4 AMPULE in 1 BOX (66302-206-03)  / 2.9 mL in 1 AMPULE", "package_ndc": "66302-206-03", "marketing_start_date": "20090814"}, {"sample": false, "description": "1 BOX in 1 KIT (66302-206-04)  / 4 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE", "package_ndc": "66302-206-04", "marketing_start_date": "20090814"}], "brand_name": "TYVASO", "product_id": "66302-206_5e5649be-a5bb-4f39-9b52-c5e0bad4dc01", "dosage_form": "INHALANT", "pharm_class": ["Prostacycline Vasodilator [EPC]", "Prostaglandins I [CS]", "Vasodilation [PE]"], "product_ndc": "66302-206", "generic_name": "treprostinil", "labeler_name": "United Therapeutics Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TYVASO", "active_ingredients": [{"name": "TREPROSTINIL", "strength": "1.74 mg/2.9mL"}], "application_number": "NDA022387", "marketing_category": "NDA", "marketing_start_date": "20090814", "listing_expiration_date": "20261231"}