Remodulin

Product NDC: 66302-105
11-digit product format: 663020105
Labeler code: 66302
Product ID: 66302-105_143d514e-fdcd-4766-ba47-0a75395e1f84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: treprostinil
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: United Therapeutics Corporation
Application: NDA021272
Marketing category: NDA
Marketing start: 2002-05-22
Substance: TREPROSTINIL
Active strength: 100 mg/20mL
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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021272-001	REMODULIN	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21
N021272-002	REMODULIN	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21
N021272-003	REMODULIN	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21
N021272-004	REMODULIN	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21
N021272-005	REMODULIN	TREPROSTINIL	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2021-07-30
N021272-006	REMODULIN	TREPROSTINIL	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28
N021272-007	REMODULIN	TREPROSTINIL	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28
N021272-008	REMODULIN	TREPROSTINIL	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021272-001	AP
N021272-002	AP
N021272-003	AP
N021272-004	AP

Orange Book patents#

Current patent rows page 1 of 1 · 40 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021272-001	8653137	2028-09-05	U-1437		2014-02-18
N021272-001	8658694	2028-09-05	U-1437		2014-02-25
N021272-001	11723887	2028-12-15		Drug substance	2023-08-15
N021272-001	9593066	2028-12-15		Drug substance	2017-03-14
N021272-001	7999007	2029-03-29	U-1437	Drug product	2011-08-23
N021272-002	8653137	2028-09-05	U-1437		2014-02-18
N021272-002	8658694	2028-09-05	U-1437		2014-02-25
N021272-002	11723887	2028-12-15		Drug substance	2023-08-15
N021272-002	9593066	2028-12-15		Drug substance	2017-03-14
N021272-002	7999007	2029-03-29	U-1437	Drug product
N021272-003	8653137	2028-09-05	U-1437		2014-02-18
N021272-003	8658694	2028-09-05	U-1437		2014-02-25
N021272-003	11723887	2028-12-15		Drug substance	2023-08-15
N021272-003	9593066	2028-12-15		Drug substance	2017-03-14
N021272-003	7999007	2029-03-29	U-1437	Drug product
N021272-004	8653137	2028-09-05	U-1437		2014-02-18
N021272-004	8658694	2028-09-05	U-1437		2014-02-25
N021272-004	11723887	2028-12-15		Drug substance	2023-08-15
N021272-004	9593066	2028-12-15		Drug substance	2017-03-14
N021272-004	7999007	2029-03-29	U-1437	Drug product
N021272-005	8653137	2028-09-05	U-1437		2021-08-24
N021272-005	8658694	2028-09-05	U-1437		2021-08-24
N021272-005	11723887	2028-12-15		Drug substance	2023-08-15
N021272-005	9593066	2028-12-15		Drug substance	2021-08-24
N021272-005	7999007	2029-03-29	U-1437	Drug product	2021-08-24
N021272-006	8653137	2028-09-05	U-1437		2023-10-20
N021272-006	8658694	2028-09-05	U-1437		2023-10-20
N021272-006	11723887	2028-12-15		Drug substance	2023-10-20
N021272-006	9593066	2028-12-15		Drug substance	2023-10-20
N021272-006	7999007	2029-03-29	U-1437	Drug product	2023-10-20
N021272-007	8653137	2028-09-05	U-1437		2023-10-20
N021272-007	8658694	2028-09-05	U-1437		2023-10-20
N021272-007	11723887	2028-12-15		Drug substance	2023-10-20
N021272-007	9593066	2028-12-15		Drug substance	2023-10-20
N021272-007	7999007	2029-03-29	U-1437	Drug product	2023-10-20
N021272-008	8653137	2028-09-05	U-1437		2023-10-20
N021272-008	8658694	2028-09-05	U-1437		2023-10-20
N021272-008	11723887	2028-12-15		Drug substance	2023-10-20
N021272-008	9593066	2028-12-15		Drug substance	2023-10-20
N021272-008	7999007	2029-03-29	U-1437	Drug product	2023-10-20

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 7 · 262 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
2026-08-18 06:07:40	2026-07	N021272-001	REMODULIN	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	REMODULIN	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	REMODULIN	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	REMODULIN	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	REMODULIN	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2021-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	REMODULIN	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	REMODULIN	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	REMODULIN	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021272-001	REMODULIN	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-002	REMODULIN	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-003	REMODULIN	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-004	REMODULIN	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-005	REMODULIN	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2021-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-006	REMODULIN	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-007	REMODULIN	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-008	REMODULIN	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-001	REMODULIN	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-002	REMODULIN	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-003	REMODULIN	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-004	REMODULIN	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-005	REMODULIN	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2021-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-006	REMODULIN	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-007	REMODULIN	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-008	REMODULIN	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021272-001	REMODULIN	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-002	REMODULIN	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-003	REMODULIN	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-004	REMODULIN	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-005	REMODULIN	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2021-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-006	REMODULIN	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-007	REMODULIN	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-008	REMODULIN	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-001	REMODULIN	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-002	REMODULIN	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-003	REMODULIN	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-004	REMODULIN	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-005	REMODULIN	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2021-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-006	REMODULIN	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-007	REMODULIN	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-008	REMODULIN	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021272-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021272-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021272-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021272-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021272-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021272-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021272-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021272-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021272-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021272-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021272-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021272-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021272-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021272-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021272-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021272-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021272-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021272-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021272-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021272-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021272-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021272-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021272-004	AP	1	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 53 · 2,086 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	N021272-001	8653137	2028-09-05	U-1437		2014-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-001	8658694	2028-09-05	U-1437		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-001	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-001	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-001	7999007	2029-03-29	U-1437	Drug product	2011-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	8653137	2028-09-05	U-1437		2014-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	8658694	2028-09-05	U-1437		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	7999007	2029-03-29	U-1437	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	8653137	2028-09-05	U-1437		2014-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	8658694	2028-09-05	U-1437		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	7999007	2029-03-29	U-1437	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	8653137	2028-09-05	U-1437		2014-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	8658694	2028-09-05	U-1437		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	7999007	2029-03-29	U-1437	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	8653137	2028-09-05	U-1437		2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	8658694	2028-09-05	U-1437		2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	9593066	2028-12-15		Drug substance	2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	7999007	2029-03-29	U-1437	Drug product	2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	8653137	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	8658694	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	11723887	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	9593066	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	7999007	2029-03-29	U-1437	Drug product	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	8653137	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	8658694	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	11723887	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	9593066	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	7999007	2029-03-29	U-1437	Drug product	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	8653137	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	8658694	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	11723887	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	9593066	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	7999007	2029-03-29	U-1437	Drug product	2023-10-20	`caaa826d4ba7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Remodulin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TREPROSTINIL	100 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RUM6K67ESG	Internal UNII lookup
059QF0KO0R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349407	Internal RxNorm lookup
349408	Internal RxNorm lookup
349409	Internal RxNorm lookup
349410	Internal RxNorm lookup
352211	Internal RxNorm lookup
352212	Internal RxNorm lookup
352213	Internal RxNorm lookup
352214	Internal RxNorm lookup
2590175	Internal RxNorm lookup
2590177	Internal RxNorm lookup
2667748	Internal RxNorm lookup
2667750	Internal RxNorm lookup
2667752	Internal RxNorm lookup
2667754	Internal RxNorm lookup
2667756	Internal RxNorm lookup
2667758	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
6c80bb38-e8db-4138-9f0d-dbbf9c673185	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d31d7280-9cbd-4e8c-ad8c-a830d9d6c4bf	Product name	1	20260309
3a764347-294a-401b-979f-44c1c6bb101a	Product name	1	20230126
5e14eefc-ad08-9fbf-a28c-67c518b16369	Product name	5	20210727
799cd7a2-692a-4730-993b-8b702e954a56	Product name	1	20200407
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66302-105-01	Remodulin	1 in 1 BOX	INJECTION, SOLUTION	1		33
66302-105-01	Remodulin	20 mL in 1 VIAL	INJECTION, SOLUTION	20		33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66302-105-01	ML - Milliliter	66302-105	dca1f024-fd77-4fc3-b53c-e5e9b6f13715	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
treprostinil	ACTIVE INGREDIENT	RUM6K67ESG	REMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]	14
treprostinil	ACTIVE MOIETY	RUM6K67ESG	REMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]	14
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	REMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]	14
metacresol	INACTIVE INGREDIENT	GGO4Y809LO	REMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]	14
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	REMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]	14
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	REMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]	14
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	REMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]	14
water	INACTIVE INGREDIENT	059QF0KO0R	REMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66302-105	REMODULIN (TREPROSTINIL) INJECTION, SOLUTION STERILE DILUENT FOR REMODULIN (WATER) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]	31	Current NDC, Legacy NDC, 2 package rows	20241213_6c80bb38-e8db-4138-9f0d-dbbf9c673185.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Remodulin	TREPROSTINIL	United Therapeutics Corporation	6c80bb38-e8db-4138-9f0d-dbbf9c673185	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021272 application number: NDA021272 ndc (product): 66302-105

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RUM6K67ESG	TREPROSTINIL	81846-19-7	TREPROSTINIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2667750	Remodulin 0.1 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667754	Remodulin 0.2 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667758	Remodulin 0.4 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352211	Remodulin 1 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352214	Remodulin 10 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352212	Remodulin 2.5 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2590177	Remodulin 20 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352213	Remodulin 5 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667748	treprostinil 0.1 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667752	treprostinil 0.2 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667756	treprostinil 0.4 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
349407	treprostinil 1 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
349408	treprostinil 10 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
349409	treprostinil 2.5 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2590175	treprostinil 20 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
349410	treprostinil 5 MG/ML Injectable Solution	PSN	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667750	treprostinil 0.1 MG/ML Injectable Solution [Remodulin]	SBD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667754	treprostinil 0.2 MG/ML Injectable Solution [Remodulin]	SBD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667758	treprostinil 0.4 MG/ML Injectable Solution [Remodulin]	SBD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352211	treprostinil 1 MG/ML Injectable Solution [Remodulin]	SBD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352214	treprostinil 10 MG/ML Injectable Solution [Remodulin]	SBD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352212	treprostinil 2.5 MG/ML Injectable Solution [Remodulin]	SBD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2590177	treprostinil 20 MG/ML Injectable Solution [Remodulin]	SBD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352213	treprostinil 5 MG/ML Injectable Solution [Remodulin]	SBD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667748	treprostinil 0.1 MG/ML Injectable Solution	SCD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667752	treprostinil 0.2 MG/ML Injectable Solution	SCD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667756	treprostinil 0.4 MG/ML Injectable Solution	SCD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
349407	treprostinil 1 MG/ML Injectable Solution	SCD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
349408	treprostinil 10 MG/ML Injectable Solution	SCD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
349409	treprostinil 2.5 MG/ML Injectable Solution	SCD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2590175	treprostinil 20 MG/ML Injectable Solution	SCD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
349410	treprostinil 5 MG/ML Injectable Solution	SCD	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667750	Remodulin 0.1 MG/ML Injectable Solution	SY	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667754	Remodulin 0.2 MG/ML Injectable Solution	SY	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2667758	Remodulin 0.4 MG/ML Injectable Solution	SY	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352211	Remodulin 1 MG/ML Injectable Solution	SY	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352214	Remodulin 10 MG/ML Injectable Solution	SY	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352212	Remodulin 2.5 MG/ML Injectable Solution	SY	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
2590177	Remodulin 20 MG/ML Injectable Solution	SY	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33
352213	Remodulin 5 MG/ML Injectable Solution	SY	6c80bb38-e8db-4138-9f0d-dbbf9c673185	33

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66302-105-01	66302010501	1 VIAL in 1 BOX (66302-105-01) / 20 mL in 1 VIAL	1 vial	2002-05-22	0000-00-00	No	No	Current