Yutrepia

Product NDC
72964-014
11-digit product format
729640014
Labeler code
72964
Product ID
72964-014_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
106 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213005-001YUTREPIATREPROSTINIL SODIUMEQ 0.0265MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23
N213005-002YUTREPIATREPROSTINIL SODIUMEQ 0.053MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23
N213005-003YUTREPIATREPROSTINIL SODIUMEQ 0.0795MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23
N213005-004YUTREPIATREPROSTINIL SODIUMEQ 0.106MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213005-001108984942037-05-05U-42002025-06-13
N213005-001116603042037-05-05U-42002025-06-13
N213005-001117124422037-05-05U-42002025-06-13
N213005-001117448352037-05-05Drug product2025-06-13
N213005-001117448362037-05-05Drug product2025-06-13
N213005-001123904752037-05-05Drug product2025-08-29
N213005-002108984942037-05-05U-42002025-06-13
N213005-002116603042037-05-05U-42002025-06-13
N213005-002117124422037-05-05U-42002025-06-13
N213005-002117448352037-05-05Drug product2025-06-13
N213005-002117448362037-05-05Drug product2025-06-13
N213005-002123904752037-05-05Drug product2025-08-29
N213005-003108984942037-05-05U-42002025-06-13
N213005-003116603042037-05-05U-42002025-06-13
N213005-003117124422037-05-05U-42002025-06-13
N213005-003117448352037-05-05Drug product2025-06-13
N213005-003117448362037-05-05Drug product2025-06-13
N213005-003123904752037-05-05Drug product2025-08-29
N213005-004108984942037-05-05U-42002025-06-13
N213005-004116603042037-05-05U-42002025-06-13
N213005-004117124422037-05-05U-42002025-06-13
N213005-004117448352037-05-05Drug product2025-06-13
N213005-004117448362037-05-05Drug product2025-06-13
N213005-004123904752037-05-05Drug product2025-08-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N213005-001NP2028-05-23
N213005-002NP2028-05-23
N213005-003NP2028-05-23
N213005-004NP2028-05-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N213005-001YUTREPIAEQ 0.0265MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-002YUTREPIAEQ 0.053MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-003YUTREPIAEQ 0.0795MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-004YUTREPIAEQ 0.106MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213005-001YUTREPIAEQ 0.0265MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-002YUTREPIAEQ 0.053MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-003YUTREPIAEQ 0.0795MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-004YUTREPIAEQ 0.106MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213005-001YUTREPIAEQ 0.0265MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213005-002YUTREPIAEQ 0.053MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213005-003YUTREPIAEQ 0.0795MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213005-004YUTREPIAEQ 0.106MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N213005-001YUTREPIAEQ 0.0265MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213005-002YUTREPIAEQ 0.053MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213005-003YUTREPIAEQ 0.0795MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213005-004YUTREPIAEQ 0.106MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213005-001YUTREPIAEQ 0.0265MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213005-002YUTREPIAEQ 0.053MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213005-003YUTREPIAEQ 0.0795MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213005-004YUTREPIAEQ 0.106MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N213005-001108984942037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-001116603042037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-001117124422037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-001117448352037-05-05Drug product2025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-001117448362037-05-05Drug product2025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-001123904752037-05-05Drug product2025-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-002108984942037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-002116603042037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-002117124422037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-002117448352037-05-05Drug product2025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-002117448362037-05-05Drug product2025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-002123904752037-05-05Drug product2025-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-003108984942037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-003116603042037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-003117124422037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-003117448352037-05-05Drug product2025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-003117448362037-05-05Drug product2025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-003123904752037-05-05Drug product2025-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-004108984942037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-004116603042037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-004117124422037-05-05U-42002025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-004117448352037-05-05Drug product2025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-004117448362037-05-05Drug product2025-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-004123904752037-05-05Drug product2025-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213005-001108984942037-05-05U-42002025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-001116603042037-05-05U-42002025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-001117124422037-05-05U-42002025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-001117448352037-05-05Drug product2025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-001117448362037-05-05Drug product2025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-001123904752037-05-05Drug product2025-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-002108984942037-05-05U-42002025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-002116603042037-05-05U-42002025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-002117124422037-05-05U-42002025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-002117448352037-05-05Drug product2025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-002117448362037-05-05Drug product2025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-002123904752037-05-05Drug product2025-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-003108984942037-05-05U-42002025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-003116603042037-05-05U-42002025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-003117124422037-05-05U-42002025-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-003117448352037-05-05Drug product2025-06-13011fe1cb6892…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N213005-001NP2028-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-002NP2028-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-003NP2028-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N213005-004NP2028-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213005-001NP2028-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-002NP2028-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-003NP2028-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213005-004NP2028-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213005-001NP2028-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213005-002NP2028-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213005-003NP2028-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213005-004NP2028-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N213005-001NP2028-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213005-002NP2028-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213005-003NP2028-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213005-004NP2028-05-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213005-001NP2028-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213005-002NP2028-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213005-003NP2028-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213005-004NP2028-05-23a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TREPROSTINIL SODIUM106 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7JZ75N2NT6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2714659Internal RxNorm lookup
2714664Internal RxNorm lookup
2714666Internal RxNorm lookup
2714668Internal RxNorm lookup
2714670Internal RxNorm lookup
2714672Internal RxNorm lookup
2714674Internal RxNorm lookup
2714676Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8f6d534-115c-440e-bdbb-b443a29bb468Available on FDA.report

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
72964-014-01Yutrepia4 in 1 BLISTER PACKCAPSULE43
72964-014-01Yutrepia7 in 1 CARTONCAPSULE73

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72964-014-01EA - Each72964-0148b8e5318-0252-4062-8bf4-219a7601977412025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72964-014YUTREPIA (TREPROSTINIL) CAPSULE [LIQUIDIA TECHNOLOGIES, INC.]1Current NDC, 2 package rows20250529_e8f6d534-115c-440e-bdbb-b443a29bb468.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YutrepiaTREPROSTINILLiquidia Technologies, Inc.e8f6d534-115c-440e-bdbb-b443a29bb4682025-09-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 213005
application number: NDA213005
ndc (product): 72964-014

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
72964-014-01729640014017 BLISTER PACK in 1 CARTON (72964-014-01) / 4 CAPSULE in 1 BLISTER PACK / 1 CAPSULE in 1 CAPSULE7 blister pack2025-05-23NoNoCurrent