tyvaso dpi

Generic: treprostinil

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

Drug Facts

Product Profile

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

treprostinil 48 ug/1

Manufacturer
United Therapeutics Corporation

Identifiers & Regulatory

Product NDC 66302-648
Product ID 66302-648_81912284-3d3a-430e-a55e-df239b084535
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214324
Listing Expiration 2026-12-31
Marketing Start 2022-05-23

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 66302648
Hyphenated Format 66302-648

Supplemental Identifiers

RxCUI
2602751 2602754 2602756 2602758 2602760 2602762 2602764 2602766 2602767 2602768 2602769 2602770 2602771 2602772 2602773 2602774 2641906 2641907 2641911 2641912 2641913 2641914 2697737 2697739 2727470 2727471 2727472 2727473
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 dpi (source: ndc)
Generic Name treprostinil (source: ndc)
Application Number NDA214324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 48 ug/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 KIT (66302-648-03) / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK
source: ndc

Packages (1)

66302-648-03 4 BLISTER PACK in 1 KIT (66302-648-03) / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK

Ingredients (1)

treprostinil (48 ug/1)

Linked Drug Pages (1)

Tyvaso DPI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "81912284-3d3a-430e-a55e-df239b084535", "openfda": {"nui": ["N0000175416", "M0017817", "N0000009909"], "unii": ["RUM6K67ESG"], "rxcui": ["2602751", "2602754", "2602756", "2602758", "2602760", "2602762", "2602764", "2602766", "2602767", "2602768", "2602769", "2602770", "2602771", "2602772", "2602773", "2602774", "2641906", "2641907", "2641911", "2641912", "2641913", "2641914", "2697737", "2697739", "2727470", "2727471", "2727472", "2727473"], "spl_set_id": ["ddc3d400-bcb3-4b09-aae2-0768b10a5b0f"], "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": "4 BLISTER PACK in 1 KIT (66302-648-03)  / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK", "package_ndc": "66302-648-03", "marketing_start_date": "20220523"}], "brand_name": "Tyvaso DPI", "product_id": "66302-648_81912284-3d3a-430e-a55e-df239b084535", "dosage_form": "INHALANT", "pharm_class": ["Prostacycline Vasodilator [EPC]", "Prostaglandins I [CS]", "Vasodilation [PE]"], "product_ndc": "66302-648", "generic_name": "treprostinil", "labeler_name": "United Therapeutics Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tyvaso DPI", "active_ingredients": [{"name": "TREPROSTINIL", "strength": "48 ug/1"}], "application_number": "NDA214324", "marketing_category": "NDA", "marketing_start_date": "20220523", "listing_expiration_date": "20261231"}