FDA.reportPublic FDA data

Tyvaso DPI

Product NDC
66302-680
11-digit product format
663020680
Labeler code
66302
Product ID
66302-680_81912284-3d3a-430e-a55e-df239b084535
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
treprostinil
Dosage form
INHALANT
Route
ORAL
Labeler
United Therapeutics Corporation
Application
NDA214324
Marketing category
NDA
Marketing start
2024-10-24
Substance
TREPROSTINIL
Active strength
80 ug/1
Pharmacologic classes
Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tyvaso DPI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TREPROSTINIL80 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRUM6K67ESG
Rxcui2602751, 2602754, 2602756, 2602758, 2602760, 2602762, 2602764, 2602766, 2602767, 2602768, 2602769, 2602770, 2602771, 2602772, 2602773, 2602774, 2641906, 2641907, 2641911, 2641912

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
66302-680-03Tyvaso DPI7 in 1 BLISTER PACKINHALANT714
66302-680-03Tyvaso DPI4 in 1 KITINHALANT414

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66302-680TYVASO DPI (TREPROSTINIL) INHALANT TYVASO DPI (TREPROSTINIL) KIT [UNITED THERAPEUTICS CORPORATION]11Current NDC, 2 package rows20241222_ddc3d400-bcb3-4b09-aae2-0768b10a5b0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2602770{112 (treprostinil 0.016 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 28 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 16-32-48 MCG Titration Pack]BPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641914{112 (treprostinil 0.016 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 16-48-64 MCG Maintenance Pack]BPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602768{112 (treprostinil 0.016 MG Inhalation Powder [Tyvaso]) / 84 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 16-32 MCG Titration Pack]BPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602774{112 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 32-48 MCG Maintenance Pack]BPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641907{112 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 32-64 MCG Maintenance Pack]BPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641912{112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 48-64 MCG Maintenance Pack]BPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2727471{112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.08 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 48-80 MCG Maintenance Pack]BPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2727473{112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.08 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 64-80 MCG Maintenance Pack]BPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602772{16 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 16 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 32-48 MCG Institutional Pack]BPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602769{112 (treprostinil 0.016 MG Inhalation Powder) / 112 (treprostinil 0.032 MG Inhalation Powder) / 28 (treprostinil 0.048 MG Inhalation Powder) } PackGPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641913{112 (treprostinil 0.016 MG Inhalation Powder) / 112 (treprostinil 0.048 MG Inhalation Powder) / 112 (treprostinil 0.064 MG Inhalation Powder) } PackGPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602767{112 (treprostinil 0.016 MG Inhalation Powder) / 84 (treprostinil 0.032 MG Inhalation Powder) } PackGPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602773{112 (treprostinil 0.032 MG Inhalation Powder) / 112 (treprostinil 0.048 MG Inhalation Powder) } PackGPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641906{112 (treprostinil 0.032 MG Inhalation Powder) / 112 (treprostinil 0.064 MG Inhalation Powder) } PackGPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641911{112 (treprostinil 0.048 MG Inhalation Powder) / 112 (treprostinil 0.064 MG Inhalation Powder) } PackGPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2727470{112 (treprostinil 0.048 MG Inhalation Powder) / 112 (treprostinil 0.08 MG Inhalation Powder) } PackGPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2727472{112 (treprostinil 0.064 MG Inhalation Powder) / 112 (treprostinil 0.08 MG Inhalation Powder) } PackGPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602771{16 (treprostinil 0.032 MG Inhalation Powder) / 16 (treprostinil 0.048 MG Inhalation Powder) } PackGPCKddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602751treprostinil 16 MCG Inhalation PowderPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602767treprostinil 16-32 MCG Titration Pack, 112 (16 MCG), 84 (32 MCG)PSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602769treprostinil 16-32-48 MCG Titration Pack, 112 (16 MCG), 112 (32 MCG), 28 (48 MCG)PSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641913treprostinil 16-48-64 MCG Maintenance Pack, 112 (16 MCG), 112 (48 MCG), 112 (64 MCG)PSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602756treprostinil 32 MCG Inhalation PowderPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602771treprostinil 32-48 MCG Institutional Pack, 16 (32 MCG), 16 (48 MCG)PSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602773treprostinil 32-48 MCG Maintenance Pack, 112 (32 MCG), 112 (48 MCG)PSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641906treprostinil 32-64 MCG Maintenance Pack, 112 (32 MCG), 112 (64 MCG)PSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602760treprostinil 48 MCG Inhalation PowderPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641911treprostinil 48-64 MCG Maintenance Pack, 112 (48 MCG), 112 (64 MCG)PSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2727470treprostinil 48-80 MCG Titration Pack, 112 (48 MCG), 112 (80 MCG)PSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602764treprostinil 64 MCG Inhalation PowderPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2727472treprostinil 64-80 MCG Titration Pack, 112 (64 MCG), 112 (80 MCG)PSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2697737treprostinil 80 MCG Inhalation PowderPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602754TYVASO DPI 16 MCG Inhalation PowderPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602768Tyvaso DPI 16-32 MCG Titration PackPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602770Tyvaso DPI 16-32-48 MCG Titration PackPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641914Tyvaso DPI 16-48-64 MCG Maintenance PackPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602758TYVASO DPI 32 MCG Inhalation PowderPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602772Tyvaso DPI 32-48 MCG Institutional PackPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602774Tyvaso DPI 32-48 MCG Maintenance PackPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641907Tyvaso DPI 32-64 MCG Maintenance PackPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602762TYVASO DPI 48 MCG Inhalation PowderPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641912Tyvaso DPI 48-64 MCG Maintenance PackPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2727471Tyvaso DPI 48-80 MCG Maintenance PackPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602766TYVASO DPI 64 MCG Inhalation PowderPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2727473Tyvaso DPI 64-80 MCG Maintenance PackPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2697739TYVASO DPI 80 MCG Inhalation PowderPSNddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602754treprostinil 0.016 MG Inhalation Powder [Tyvaso]SBDddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602758treprostinil 0.032 MG Inhalation Powder [Tyvaso]SBDddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602762treprostinil 0.048 MG Inhalation Powder [Tyvaso]SBDddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602766treprostinil 0.064 MG Inhalation Powder [Tyvaso]SBDddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2697739treprostinil 0.08 MG Inhalation Powder [Tyvaso]SBDddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602751treprostinil 0.016 MG Inhalation PowderSCDddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602756treprostinil 0.032 MG Inhalation PowderSCDddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602760treprostinil 0.048 MG Inhalation PowderSCDddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602764treprostinil 0.064 MG Inhalation PowderSCDddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2697737treprostinil 0.08 MG Inhalation PowderSCDddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602751treprostinil 16 MCG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602767treprostinil 16-32 MCG Titration Pack, 112 (16 MCG), 84 (32 MCG)SYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602769treprostinil 16-32-48 MCG Titration Pack, 112 (16 MCG), 112 (32 MCG), 28 (48 MCG)SYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641913treprostinil 16-48-64 MCG Maintenance Pack, 112 (16 MCG), 112 (48 MCG), 112 (64 MCG)SYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602756treprostinil 32 MCG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602771treprostinil 32-48 MCG Institutional Pack, 16 (32 MCG), 16 (48 MCG)SYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602773treprostinil 32-48 MCG Maintenance Pack, 112 (32 MCG), 112 (48 MCG)SYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641906treprostinil 32-64 MCG Maintenance Pack, 112 (32 MCG), 112 (64 MCG)SYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602760treprostinil 48 MCG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2641911treprostinil 48-64 MCG Maintenance Pack, 112 (48 MCG), 112 (64 MCG)SYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2727470treprostinil 48-80 MCG Titration Pack, 112 (48 MCG), 112 (80 MCG)SYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602764treprostinil 64 MCG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2727472treprostinil 64-80 MCG Titration Pack, 112 (64 MCG), 112 (80 MCG)SYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2697737treprostinil 80 MCG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602754Tyvaso 0.016 MG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602758Tyvaso 0.032 MG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602762Tyvaso 0.048 MG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602766Tyvaso 0.064 MG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2697739Tyvaso 0.08 MG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602754Tyvaso 16 MCG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602758Tyvaso 32 MCG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602762Tyvaso 48 MCG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2602766Tyvaso 64 MCG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14
2697739Tyvaso 80 MCG Inhalation PowderSYddc3d400-bcb3-4b09-aae2-0768b10a5b0f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66302-680-03663020680034 BLISTER PACK in 1 KIT (66302-680-03) / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK4 blister pack2024-10-24NoNoCurrent