Application 203496

Type: NDA
Sponsor: UNITED THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORENITRAM	TREPROSTINIL DIOLAMINE	TABLET, EXTENDED RELEASE;ORAL	EQ 0.125MG BASE	Yes	No
002	ORENITRAM	TREPROSTINIL DIOLAMINE	TABLET, EXTENDED RELEASE;ORAL	EQ 0.25MG BASE	Yes	No
003	ORENITRAM	TREPROSTINIL DIOLAMINE	TABLET, EXTENDED RELEASE;ORAL	EQ 1MG BASE	Yes	Yes
004	ORENITRAM	TREPROSTINIL DIOLAMINE	TABLET, EXTENDED RELEASE;ORAL	EQ 2.5MG BASE	Yes	No
005	ORENITRAM	TREPROSTINIL DIOLAMINE	TABLET, EXTENDED RELEASE;ORAL	EQ 5MG BASE	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N203496-001	ORENITRAM	TREPROSTINIL DIOLAMINE	EQ 0.125MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20
N203496-002	ORENITRAM	TREPROSTINIL DIOLAMINE	EQ 0.25MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20
N203496-003	ORENITRAM	TREPROSTINIL DIOLAMINE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-12-20
N203496-004	ORENITRAM	TREPROSTINIL DIOLAMINE	EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20
N203496-005	ORENITRAM	TREPROSTINIL DIOLAMINE	EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 45 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203496-001	9393203	2026-04-27	U-1877	Drug product	2016-07-22
N203496-001	7417070	2026-07-30		Drug substance	2014-01-09
N203496-001	11723887	2028-12-15		Drug substance	2023-08-15
N203496-001	9593066	2028-12-15		Drug substance	2017-03-14
N203496-001	9604901	2028-12-15		Drug substance, Delist requested	2017-03-28
N203496-001	8410169	2030-02-13		Drug product	2014-01-09
N203496-001	8349892	2031-01-22		Drug product	2014-01-09
N203496-001	8747897	2031-08-11	U-2724	Drug product	2014-06-13
N203496-001	8747897	2031-08-11	U-2725	Drug product	2014-06-13
N203496-002	9393203	2026-04-27	U-1877	Drug product	2016-07-22
N203496-002	7417070	2026-07-30		Drug substance	2014-01-09
N203496-002	11723887	2028-12-15		Drug substance	2023-08-15
N203496-002	8497393	2028-12-15		Drug substance, Delist requested	2014-01-09
N203496-002	9593066	2028-12-15		Drug substance	2017-03-14
N203496-002	8410169	2030-02-13		Drug product	2014-01-09
N203496-002	8349892	2031-01-22		Drug product	2014-01-09
N203496-002	8747897	2031-08-11	U-2724	Drug product	2014-06-13
N203496-002	8747897	2031-08-11	U-2725	Drug product	2014-06-13
N203496-003	9393203	2026-04-27	U-1877	Drug product	2016-07-22
N203496-003	7417070	2026-07-30		Drug substance	2014-01-09
N203496-003	11723887	2028-12-15		Drug substance	2023-08-15
N203496-003	8497393	2028-12-15		Drug substance, Delist requested	2014-01-09
N203496-003	9593066	2028-12-15		Drug substance	2017-03-14
N203496-003	8410169	2030-02-13		Drug product	2014-01-09
N203496-003	8349892	2031-01-22		Drug product	2014-01-09
N203496-003	8747897	2031-08-11	U-2724	Drug product	2014-06-13
N203496-003	8747897	2031-08-11	U-2725	Drug product	2014-06-13
N203496-004	9393203	2026-04-27	U-1877	Drug product	2016-07-22
N203496-004	7417070	2026-07-30		Drug substance	2014-01-09
N203496-004	11723887	2028-12-15		Drug substance	2023-08-15
N203496-004	8497393	2028-12-15		Drug substance, Delist requested	2014-01-09
N203496-004	9593066	2028-12-15		Drug substance	2017-03-14
N203496-004	8410169	2030-02-13		Drug product	2014-01-09
N203496-004	8349892	2031-01-22		Drug product	2014-01-09
N203496-004	8747897	2031-08-11	U-2724	Drug product	2014-06-13
N203496-004	8747897	2031-08-11	U-2725	Drug product	2014-06-13
N203496-005	9393203	2026-04-27	U-1877	Drug product	2017-02-09
N203496-005	7417070	2026-07-30		Drug substance	2017-02-09
N203496-005	11723887	2028-12-15		Drug substance	2023-08-15
N203496-005	9593066	2028-12-15		Drug substance	2017-03-14
N203496-005	9604901	2028-12-15		Drug substance, Delist requested	2017-03-28
N203496-005	8410169	2030-02-13		Drug product	2017-02-09
N203496-005	8349892	2031-01-22		Drug product	2017-02-09
N203496-005	8747897	2031-08-11	U-2724	Drug product	2017-02-09
N203496-005	8747897	2031-08-11	U-2725	Drug product	2017-02-09

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 5 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203496-001	ODE-272	2026-10-18
N203496-002	ODE-272	2026-10-18
N203496-003	ODE-272	2026-10-18
N203496-004	ODE-272	2026-10-18
N203496-005	ODE-272	2026-10-18

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 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203496-001	ORENITRAM	EQ 0.125MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-002	ORENITRAM	EQ 0.25MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-003	ORENITRAM	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-004	ORENITRAM	EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-005	ORENITRAM	EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203496-001	ORENITRAM	EQ 0.125MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203496-002	ORENITRAM	EQ 0.25MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203496-003	ORENITRAM	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203496-004	ORENITRAM	EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203496-005	ORENITRAM	EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203496-001	ORENITRAM	EQ 0.125MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203496-002	ORENITRAM	EQ 0.25MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203496-003	ORENITRAM	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203496-004	ORENITRAM	EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203496-005	ORENITRAM	EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203496-001	ORENITRAM	EQ 0.125MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203496-002	ORENITRAM	EQ 0.25MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203496-003	ORENITRAM	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203496-004	ORENITRAM	EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203496-005	ORENITRAM	EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203496-001	ORENITRAM	EQ 0.125MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203496-002	ORENITRAM	EQ 0.25MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203496-003	ORENITRAM	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203496-004	ORENITRAM	EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203496-005	ORENITRAM	EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203496-001	ORENITRAM	EQ 0.125MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203496-002	ORENITRAM	EQ 0.25MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203496-003	ORENITRAM	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203496-004	ORENITRAM	EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203496-005	ORENITRAM	EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203496-001	ORENITRAM	EQ 0.125MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203496-002	ORENITRAM	EQ 0.25MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203496-003	ORENITRAM	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203496-004	ORENITRAM	EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203496-005	ORENITRAM	EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203496-001	ORENITRAM	EQ 0.125MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203496-002	ORENITRAM	EQ 0.25MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203496-003	ORENITRAM	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203496-004	ORENITRAM	EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203496-005	ORENITRAM	EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-10-07	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 69 · 2,736 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	N203496-001	9393203	2026-04-27	U-1877	Drug product	2016-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-001	7417070	2026-07-30		Drug substance	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-001	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-001	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-001	9604901	2028-12-15		Drug substance, Delist requested	2017-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-001	8410169	2030-02-13		Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-001	8349892	2031-01-22		Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-001	8747897	2031-08-11	U-2725	Drug product	2014-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-001	8747897	2031-08-11	U-2724	Drug product	2014-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-002	9393203	2026-04-27	U-1877	Drug product	2016-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-002	7417070	2026-07-30		Drug substance	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-002	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-002	8497393	2028-12-15		Drug substance, Delist requested	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-002	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-002	8410169	2030-02-13		Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-002	8349892	2031-01-22		Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-002	8747897	2031-08-11	U-2725	Drug product	2014-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-002	8747897	2031-08-11	U-2724	Drug product	2014-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-003	9393203	2026-04-27	U-1877	Drug product	2016-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-003	7417070	2026-07-30		Drug substance	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-003	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-003	8497393	2028-12-15		Drug substance, Delist requested	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-003	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-003	8410169	2030-02-13		Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-003	8349892	2031-01-22		Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-003	8747897	2031-08-11	U-2724	Drug product	2014-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-003	8747897	2031-08-11	U-2725	Drug product	2014-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-004	9393203	2026-04-27	U-1877	Drug product	2016-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-004	7417070	2026-07-30		Drug substance	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-004	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-004	8497393	2028-12-15		Drug substance, Delist requested	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-004	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-004	8410169	2030-02-13		Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-004	8349892	2031-01-22		Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-004	8747897	2031-08-11	U-2725	Drug product	2014-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-004	8747897	2031-08-11	U-2724	Drug product	2014-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-005	9393203	2026-04-27	U-1877	Drug product	2017-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-005	7417070	2026-07-30		Drug substance	2017-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-005	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-005	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 310 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N203496-001	ODE-272	2026-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-002	ODE-272	2026-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-003	ODE-272	2026-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-004	ODE-272	2026-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203496-005	ODE-272	2026-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203496-001	ODE-272	2026-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203496-002	ODE-272	2026-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203496-003	ODE-272	2026-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203496-004	ODE-272	2026-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203496-005	ODE-272	2026-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203496-001	ODE-272	2026-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203496-002	ODE-272	2026-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203496-003	ODE-272	2026-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203496-004	ODE-272	2026-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203496-005	ODE-272	2026-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203496-001	ODE-272	2026-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203496-002	ODE-272	2026-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203496-003	ODE-272	2026-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203496-004	ODE-272	2026-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203496-005	ODE-272	2026-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203496-001	ODE-272	2026-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203496-002	ODE-272	2026-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203496-003	ODE-272	2026-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203496-004	ODE-272	2026-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203496-005	ODE-272	2026-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203496-001	ODE-272	2026-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203496-002	ODE-272	2026-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203496-003	ODE-272	2026-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203496-004	ODE-272	2026-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203496-005	ODE-272	2026-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203496-001	ODE-272	2026-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203496-002	ODE-272	2026-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203496-003	ODE-272	2026-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203496-004	ODE-272	2026-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203496-005	ODE-272	2026-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203496-001	ODE-272	2026-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203496-002	ODE-272	2026-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203496-003	ODE-272	2026-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203496-004	ODE-272	2026-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203496-005	ODE-272	2026-10-18	`2680178bc6a6…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orenitram	TREPROSTINIL	United Therapeutics Corporation	8ed2003a-c801-411e-831e-d06079bb0d7c	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203496 application number: NDA203496 ndc (product): 66302-325 ndc (product): 66302-310 ndc (product): 66302-302 ndc (product): 66302-300 ndc (product): 66302-350

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66302-300	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-300	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-300	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-300	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-300	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-300	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-302	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-302	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-302	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-302	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-302	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-302	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-310	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-310	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-310	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-310	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-310	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-310	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-325	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-325	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-325	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-325	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-325	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-325	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-350	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-350	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current
66302-350	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-350	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-350	Orenitram	treprostinil	United Therapeutics Corporation	NDA	Current
66302-350	Orenitram	treprostinil	United Therapeutics Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84389	SUPPL	2025-12-12
67028	SUPPL	2021-04-12
60618	SUPPL	2019-10-22
60597	SUPPL	2019-10-21
48753	SUPPL	2017-06-16
48715	SUPPL	2017-06-14
47005	SUPPL	2017-01-27
46981	SUPPL	2017-01-24
40306	SUPPL	2016-02-11
10227	SUPPL	2016-01-28
24436	ORIG	2014-12-09
22924	ORIG	2014-12-09
40305	SUPPL	2014-10-09
10226	SUPPL	2014-10-08
32433	ORIG	2013-12-24
19478	ORIG	2013-12-23