TYVASO
These highlights do not include all the information needed to use TYVASO safely and effectively. See full prescribing information for TYVASO. TYVASO (treprostinil) inhalation solution, for oral inhalation use Initial U.S. Approval: 2002
Approved
Approval ID
cbc31ab1-a80f-4b50-a3b1-39910b0fb609
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
United Therapeutics Corporation
DUNS: 965460025
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
treprostinil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66302-206
Application NumberNDA022387
Product Classification
M
Marketing Category
C73594
G
Generic Name
treprostinil
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2022
FDA Product Classification
INGREDIENTS (6)
treprostinilActive
Quantity: 1.74 mg in 2.9 mL
Code: RUM6K67ESG
Classification: ACTIB
trisodium citrate dihydrateInactive
Quantity: 18.3 mg in 2.9 mL
Code: B22547B95K
Classification: IACT
sodium chlorideInactive
Quantity: 18.9 mg in 2.9 mL
Code: 451W47IQ8X
Classification: IACT
sodium hydroxideInactive
Quantity: 0.6 mg in 2.9 mL
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Quantity: 11.7 mg in 2.9 mL
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT