FDA.reportPublic FDA data

TYVASO

Product NDC
66302-206
11-digit product format
663020206
Labeler code
66302
Product ID
66302-206_78a0b514-481a-4ea9-8ec6-8b60acdf2158
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
treprostinil
Dosage form
INHALANT
Route
ORAL
Labeler
United Therapeutics Corporation
Application
NDA022387
Marketing category
NDA
Marketing start
2009-08-14
Substance
TREPROSTINIL
Active strength
1.74 mg/2.9mL
Pharmacologic classes
Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TYVASO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TREPROSTINIL1.74 mg/2.9mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRUM6K67ESG
Rxcui857795, 857799

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d31d7280-9cbd-4e8c-ad8c-a830d9d6c4bfProduct name120260309
3a764347-294a-401b-979f-44c1c6bb101aProduct name120230126
5e14eefc-ad08-9fbf-a28c-67c518b16369Product name520210727
799cd7a2-692a-4730-993b-8b702e954a56Product name120200407

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66302-206-01TYVASO28 in 1 BOXINHALANT2832
66302-206-01TYVASO1 in 1 KITINHALANT132
66302-206-02TYVASO1 in 1 KITINHALANT132
66302-206-02TYVASO28 in 1 BOXINHALANT2832
66302-206-03TYVASO2.9 mL in 1 AMPULEINHALANT2.932
66302-206-03TYVASO4 in 1 BOXINHALANT432
66302-206-04TYVASO1 in 1 KITINHALANT132
66302-206-04TYVASO4 in 1 BOXINHALANT432

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66302-206-01ML - Milliliter66302-2068f391d44-9e23-4ad5-90fd-a9cab9349c1212012-07-24
66302-206-02ML - Milliliter66302-2066bb1135b-c664-47d2-b643-47606754eb6512012-07-24
66302-206-03ML - Milliliter66302-2061c587a30-98b1-4853-8b5d-165a24df729512012-07-24
66302-206-04ML - Milliliter66302-206947f7574-1019-4ba1-b561-d999d10d81bb12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
treprostinilACTIVE INGREDIENTRUM6K67ESGTYVASO (TREPROSTINIL) INHALANT [UNITED THERAPEUTICS CORP.]10
treprostinilACTIVE MOIETYRUM6K67ESGTYVASO (TREPROSTINIL) INHALANT [UNITED THERAPEUTICS CORP.]10
hydrochloric acidINACTIVE INGREDIENTQTT17582CBTYVASO (TREPROSTINIL) INHALANT [UNITED THERAPEUTICS CORP.]10
sodium chlorideINACTIVE INGREDIENT451W47IQ8XTYVASO (TREPROSTINIL) INHALANT [UNITED THERAPEUTICS CORP.]10
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRTYVASO (TREPROSTINIL) INHALANT [UNITED THERAPEUTICS CORP.]10
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITYVASO (TREPROSTINIL) INHALANT [UNITED THERAPEUTICS CORP.]10
waterINACTIVE INGREDIENT059QF0KO0RTYVASO (TREPROSTINIL) INHALANT [UNITED THERAPEUTICS CORP.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66302-206TYVASO (TREPROSTINIL) INHALANT [UNITED THERAPEUTICS CORPORATION]27Current NDC, Legacy NDC, 8 package rows20241222_cbc31ab1-a80f-4b50-a3b1-39910b0fb609.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857795treprostinil 1.74 MG/2.9 ML (0.6 MG/ML) Inhalation SolutionPSNcbc31ab1-a80f-4b50-a3b1-39910b0fb60932
857799TYVASO 1.74 MG/2.9 ML (0.6 MG/ML) Inhalation SolutionPSNcbc31ab1-a80f-4b50-a3b1-39910b0fb60932
857799treprostinil 0.6 MG/ML Inhalation Solution [Tyvaso]SBDcbc31ab1-a80f-4b50-a3b1-39910b0fb60932
857795treprostinil 0.6 MG/ML Inhalation SolutionSCDcbc31ab1-a80f-4b50-a3b1-39910b0fb60932
857795treprostinil 1.74 MG/2.9 ML (0.6 MG/ML) Inhalation SolutionSYcbc31ab1-a80f-4b50-a3b1-39910b0fb60932
857799Tyvaso 0.6 MG/ML Inhalation SolutionSYcbc31ab1-a80f-4b50-a3b1-39910b0fb60932
857799Tyvaso 1.74 MG per 2.9 ML Inhalation SolutionSYcbc31ab1-a80f-4b50-a3b1-39910b0fb60932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66302-206-01663020206011 BOX in 1 KIT (66302-206-01) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE1 box2009-08-140000-00-00NoNoCurrent
66302-206-02663020206021 BOX in 1 KIT (66302-206-02) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE1 box2009-08-140000-00-00NoNoCurrent
66302-206-03663020206034 AMPULE in 1 BOX (66302-206-03) / 2.9 mL in 1 AMPULE4 ampule2009-08-140000-00-00NoNoCurrent
66302-206-04663020206041 BOX in 1 KIT (66302-206-04) / 4 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE1 box2009-08-140000-00-00NoNoCurrent