Home NDC 66302-206-01 TYVASO
Product NDC 66302-206
Requested package NDC 66302-206-01
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022387-001 TYVASO TREPROSTINIL 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022387-001 10376525 2027-05-14 U-1849 2020-04-29 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 N022387-001 11826327 2042-02-03 U-3749 2023-11-28
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 7 · 266 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 2680178bc6a6…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base TYVASO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TREPROSTINIL 1.74 mg/2.9mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RUM6K67ESG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857795 Internal RxNorm lookup 857799 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66302-206 TYVASO (TREPROSTINIL) INHALANT [UNITED THERAPEUTICS CORPORATION] 27 Current NDC, Legacy NDC, 8 package rows 20241222_cbc31ab1-a80f-4b50-a3b1-39910b0fb609.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 Marketing end Sample Exclude flag Status 66302-206-01 66302020601 1 BOX in 1 KIT (66302-206-01) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE 1 box 2009-08-14 0000-00-00 No No Current