FDA.reportPublic FDA data

Yutrepia

Product NDC
72964-011
11-digit product format
729640011
Labeler code
72964
Product ID
72964-011_92c4515d-7de1-4bde-9ee9-f350696ba98d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
treprostinil
Dosage form
CAPSULE
Route
RESPIRATORY (INHALATION)
Labeler
Liquidia Technologies, Inc.
Application
NDA213005
Marketing category
NDA
Marketing start
2025-05-23
Substance
TREPROSTINIL SODIUM
Active strength
26.5 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
Yutrepia
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TREPROSTINIL SODIUM26.5 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7JZ75N2NT6
Rxcui2714659, 2714664, 2714666, 2714668, 2714670, 2714672, 2714674, 2714676

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72964-011-01Yutrepia7 in 1 CARTONCAPSULE73
72964-011-01Yutrepia4 in 1 BLISTER PACKCAPSULE43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72964-011-01EA - Each72964-011c77cd08d-3b75-48d0-8530-c6273b59668912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72964-011YUTREPIA (TREPROSTINIL) CAPSULE [LIQUIDIA TECHNOLOGIES, INC.]1Current NDC, 2 package rows20250529_e8f6d534-115c-440e-bdbb-b443a29bb468.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2714674treprostinil 106 MCG Inhalation PowderPSNe8f6d534-115c-440e-bdbb-b443a29bb4683
2714659treprostinil 26.5 MCG Inhalation PowderPSNe8f6d534-115c-440e-bdbb-b443a29bb4683
2714666treprostinil 53 MCG Inhalation PowderPSNe8f6d534-115c-440e-bdbb-b443a29bb4683
2714670treprostinil 79.5 MCG Inhalation PowderPSNe8f6d534-115c-440e-bdbb-b443a29bb4683
2714676Yutrepia 106 MCG Inhalation PowderPSNe8f6d534-115c-440e-bdbb-b443a29bb4683
2714664Yutrepia 26.5 MCG Inhalation PowderPSNe8f6d534-115c-440e-bdbb-b443a29bb4683
2714668Yutrepia 53 MCG Inhalation PowderPSNe8f6d534-115c-440e-bdbb-b443a29bb4683
2714672Yutrepia 79.5 MCG Inhalation PowderPSNe8f6d534-115c-440e-bdbb-b443a29bb4683
2714664treprostinil 0.0265 MG Inhalation Powder [Yutrepia]SBDe8f6d534-115c-440e-bdbb-b443a29bb4683
2714668treprostinil 0.053 MG Inhalation Powder [Yutrepia]SBDe8f6d534-115c-440e-bdbb-b443a29bb4683
2714672treprostinil 0.0795 MG Inhalation Powder [Yutrepia]SBDe8f6d534-115c-440e-bdbb-b443a29bb4683
2714676treprostinil 0.106 MG Inhalation Powder [Yutrepia]SBDe8f6d534-115c-440e-bdbb-b443a29bb4683
2714659treprostinil 0.0265 MG Inhalation PowderSCDe8f6d534-115c-440e-bdbb-b443a29bb4683
2714666treprostinil 0.053 MG Inhalation PowderSCDe8f6d534-115c-440e-bdbb-b443a29bb4683
2714670treprostinil 0.0795 MG Inhalation PowderSCDe8f6d534-115c-440e-bdbb-b443a29bb4683
2714674treprostinil 0.106 MG Inhalation PowderSCDe8f6d534-115c-440e-bdbb-b443a29bb4683
2714674treprostinil 106 MCG (as treprostinil sodium) Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714674treprostinil 106 MCG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714659treprostinil 26.5 MCG (equivalent to treprostinil sodium 28 MCG) Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714659treprostinil 26.5 MCG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714666treprostinil 53 MCG (as treprostinil sodium) Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714666treprostinil 53 MCG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714670treprostinil 79.5 MCG (as treprostinil sodium) Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714670treprostinil 79.5 MCG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714664Yutrepia 0.0265 MG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714668Yutrepia 0.053 MG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714672Yutrepia 0.0795 MG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714676Yutrepia 0.106 MG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714676Yutrepia 106 MCG (as treprostinil sodium) Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714676Yutrepia 106 MCG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714664Yutrepia 26.5 MCG (equivalent to treprostinil sodium 28 MCG) Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714664Yutrepia 26.5 MCG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714668Yutrepia 53 MCG (as treprostinil sodium) Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714668Yutrepia 53 MCG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714672Yutrepia 79.5 MCG (as treprostinil sodium) Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683
2714672Yutrepia 79.5 MCG Inhalation PowderSYe8f6d534-115c-440e-bdbb-b443a29bb4683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72964-011-01729640011017 BLISTER PACK in 1 CARTON (72964-011-01) / 4 CAPSULE in 1 BLISTER PACK / 1 CAPSULE in 1 CAPSULE7 blister pack2025-05-23NoNoHistorical