Home NDC 72964-012 Yutrepia
Product NDC 72964-012
11-digit product format 729640012
Labeler code 72964
Product ID 72964-012_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 53 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213005-001 YUTREPIA TREPROSTINIL SODIUM EQ 0.0265MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 N213005-002 YUTREPIA TREPROSTINIL SODIUM EQ 0.053MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 N213005-003 YUTREPIA TREPROSTINIL SODIUM EQ 0.0795MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 N213005-004 YUTREPIA TREPROSTINIL SODIUM EQ 0.106MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23
Orange Book patents# Current patent rows page 1 of 1 · 24 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N213005-001 YUTREPIA EQ 0.0265MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-002 YUTREPIA EQ 0.053MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-003 YUTREPIA EQ 0.0795MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-004 YUTREPIA EQ 0.106MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213005-001 YUTREPIA EQ 0.0265MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-002 YUTREPIA EQ 0.053MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-003 YUTREPIA EQ 0.0795MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-004 YUTREPIA EQ 0.106MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213005-001 YUTREPIA EQ 0.0265MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213005-002 YUTREPIA EQ 0.053MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213005-003 YUTREPIA EQ 0.0795MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213005-004 YUTREPIA EQ 0.106MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213005-001 YUTREPIA EQ 0.0265MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213005-002 YUTREPIA EQ 0.053MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213005-003 YUTREPIA EQ 0.0795MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213005-004 YUTREPIA EQ 0.106MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213005-001 YUTREPIA EQ 0.0265MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213005-002 YUTREPIA EQ 0.053MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213005-003 YUTREPIA EQ 0.0795MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213005-004 YUTREPIA EQ 0.106MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 116 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N213005-001 10898494 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-001 11660304 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-001 11712442 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-001 11744835 2037-05-05 Drug product 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-001 11744836 2037-05-05 Drug product 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-001 12390475 2037-05-05 Drug product 2025-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-002 10898494 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-002 11660304 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-002 11712442 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-002 11744835 2037-05-05 Drug product 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-002 11744836 2037-05-05 Drug product 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-002 12390475 2037-05-05 Drug product 2025-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-003 10898494 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-003 11660304 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-003 11712442 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-003 11744835 2037-05-05 Drug product 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-003 11744836 2037-05-05 Drug product 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-003 12390475 2037-05-05 Drug product 2025-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-004 10898494 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-004 11660304 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-004 11712442 2037-05-05 U-4200 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-004 11744835 2037-05-05 Drug product 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-004 11744836 2037-05-05 Drug product 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213005-004 12390475 2037-05-05 Drug product 2025-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213005-001 10898494 2037-05-05 U-4200 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-001 11660304 2037-05-05 U-4200 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-001 11712442 2037-05-05 U-4200 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-001 11744835 2037-05-05 Drug product 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-001 11744836 2037-05-05 Drug product 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-001 12390475 2037-05-05 Drug product 2025-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-002 10898494 2037-05-05 U-4200 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-002 11660304 2037-05-05 U-4200 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-002 11712442 2037-05-05 U-4200 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-002 11744835 2037-05-05 Drug product 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-002 11744836 2037-05-05 Drug product 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-002 12390475 2037-05-05 Drug product 2025-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-003 10898494 2037-05-05 U-4200 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-003 11660304 2037-05-05 U-4200 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-003 11712442 2037-05-05 U-4200 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213005-003 11744835 2037-05-05 Drug product 2025-06-13 011fe1cb6892…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Yutrepia
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TREPROSTINIL SODIUM 53 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7JZ75N2NT6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2714659 Internal RxNorm lookup 2714664 Internal RxNorm lookup 2714666 Internal RxNorm lookup 2714668 Internal RxNorm lookup 2714670 Internal RxNorm lookup 2714672 Internal RxNorm lookup 2714674 Internal RxNorm lookup 2714676 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72964-012-01 Yutrepia 7 in 1 CARTON CAPSULE 7 3 72964-012-01 Yutrepia 4 in 1 BLISTER PACK CAPSULE 4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72964-012 YUTREPIA (TREPROSTINIL) CAPSULE [LIQUIDIA TECHNOLOGIES, INC.] 1 Current NDC, 2 package rows 20250529_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72964-012-01 72964001201 7 BLISTER PACK in 1 CARTON (72964-012-01) / 4 CAPSULE in 1 BLISTER PACK / 1 CAPSULE in 1 CAPSULE 7 blister pack 2025-05-23 No No Current