Tyvaso DPI

Product NDC: 66302-716
11-digit product format: 663020716
Labeler code: 66302
Product ID: 66302-716_81912284-3d3a-430e-a55e-df239b084535
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: treprostinil
Dosage form: INHALANT
Route: ORAL
Labeler: United Therapeutics Corporation
Application: NDA214324
Marketing category: NDA
Marketing start: 2022-05-23
Substance: TREPROSTINIL
Active strength: 16 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214324-001	TYVASO DPI	TREPROSTINIL	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-002	TYVASO DPI	TREPROSTINIL	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-003	TYVASO DPI	TREPROSTINIL	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-004	TYVASO DPI	TREPROSTINIL	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-005	TYVASO DPI	TREPROSTINIL	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214324-001	11357782	2027-05-14	U-1849		2025-04-24
N214324-001	11723887	2028-12-15		Drug substance	2023-08-15
N214324-001	9593066	2028-12-15		Drug substance	2022-06-17
N214324-001	10772883	2030-06-11		Drug product	2022-06-17
N214324-001	10421729	2035-04-01		Drug product	2022-06-17
N214324-001	11826327	2042-02-03	U-3749		2023-11-28
N214324-002	11357782	2027-05-14	U-1849		2025-04-24
N214324-002	11723887	2028-12-15		Drug substance	2023-08-15
N214324-002	9593066	2028-12-15		Drug substance	2022-06-17
N214324-002	10772883	2030-06-11		Drug product	2022-06-17
N214324-002	10421729	2035-04-01		Drug product	2022-06-17
N214324-002	11826327	2042-02-03	U-3749		2023-11-28
N214324-003	11357782	2027-05-14	U-1849		2025-04-24
N214324-003	11723887	2028-12-15		Drug substance	2023-08-15
N214324-003	9593066	2028-12-15		Drug substance	2022-06-17
N214324-003	10772883	2030-06-11		Drug product	2022-06-17
N214324-003	10421729	2035-04-01		Drug product	2022-06-17
N214324-003	11826327	2042-02-03	U-3749		2023-11-28
N214324-004	11357782	2027-05-14	U-1849		2025-04-24
N214324-004	11723887	2028-12-15		Drug substance	2023-08-15
N214324-004	9593066	2028-12-15		Drug substance	2022-06-17
N214324-004	10772883	2030-06-11		Drug product	2022-06-17
N214324-004	10421729	2035-04-01		Drug product	2022-06-17
N214324-004	11826327	2042-02-03	U-3749		2023-11-28
N214324-005	11357782	2027-05-14	U-1849		2025-04-24
N214324-005	11723887	2028-12-15		Drug substance	2024-11-18
N214324-005	9593066	2028-12-15		Drug substance	2024-11-18
N214324-005	10772883	2030-06-11		Drug product	2024-11-18
N214324-005	10421729	2035-04-01		Drug product	2024-11-18
N214324-005	11826327	2042-02-03	U-3749		2024-11-18

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 4 · 130 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	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD	2022-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD	2022-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD	2024-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD	2022-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD	2022-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD	2024-10-24	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 864 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	N214324-001	11357782	2027-05-14	U-1849		2025-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-001	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-001	9593066	2028-12-15		Drug substance	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-001	10772883	2030-06-11		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-001	10421729	2035-04-01		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-001	11826327	2042-02-03	U-3749		2023-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	11357782	2027-05-14	U-1849		2025-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	9593066	2028-12-15		Drug substance	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	10772883	2030-06-11		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	10421729	2035-04-01		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	11826327	2042-02-03	U-3749		2023-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	11357782	2027-05-14	U-1849		2025-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	9593066	2028-12-15		Drug substance	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	10772883	2030-06-11		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	10421729	2035-04-01		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	11826327	2042-02-03	U-3749		2023-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	11357782	2027-05-14	U-1849		2025-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	9593066	2028-12-15		Drug substance	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	10772883	2030-06-11		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	10421729	2035-04-01		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	11826327	2042-02-03	U-3749		2023-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	11357782	2027-05-14	U-1849		2025-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	11723887	2028-12-15		Drug substance	2024-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	9593066	2028-12-15		Drug substance	2024-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	10772883	2030-06-11		Drug product	2024-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	10421729	2035-04-01		Drug product	2024-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	11826327	2042-02-03	U-3749		2024-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214324-001	11357782	2027-05-14	U-1849		2025-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-001	11723887	2028-12-15		Drug substance	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-001	9593066	2028-12-15		Drug substance	2022-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-001	10772883	2030-06-11		Drug product	2022-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-001	10421729	2035-04-01		Drug product	2022-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-001	11826327	2042-02-03	U-3749		2023-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-002	11357782	2027-05-14	U-1849		2025-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-002	11723887	2028-12-15		Drug substance	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-002	9593066	2028-12-15		Drug substance	2022-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-002	10772883	2030-06-11		Drug product	2022-06-17	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-001	NP	2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-002	NP	2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-003	NP	2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-004	NP	2025-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214324-001	NP	2025-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-002	NP	2025-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-003	NP	2025-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-004	NP	2025-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-001	NP	2025-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-002	NP	2025-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-003	NP	2025-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-004	NP	2025-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-001	NP	2025-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-002	NP	2025-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-003	NP	2025-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-004	NP	2025-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-001	NP	2025-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-002	NP	2025-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-003	NP	2025-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-004	NP	2025-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-001	NP	2025-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-002	NP	2025-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-003	NP	2025-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-004	NP	2025-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214324-001	NP	2025-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214324-002	NP	2025-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214324-003	NP	2025-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214324-004	NP	2025-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214324-001	NP	2025-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214324-002	NP	2025-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214324-003	NP	2025-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214324-004	NP	2025-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214324-001	NP	2025-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214324-002	NP	2025-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214324-003	NP	2025-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214324-004	NP	2025-05-23	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tyvaso DPI
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TREPROSTINIL	16 ug/1

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 2 · 28 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2602751	Internal RxNorm lookup
2602754	Internal RxNorm lookup
2602756	Internal RxNorm lookup
2602758	Internal RxNorm lookup
2602760	Internal RxNorm lookup
2602762	Internal RxNorm lookup
2602764	Internal RxNorm lookup
2602766	Internal RxNorm lookup
2602767	Internal RxNorm lookup
2602768	Internal RxNorm lookup
2602769	Internal RxNorm lookup
2602770	Internal RxNorm lookup
2602771	Internal RxNorm lookup
2602772	Internal RxNorm lookup
2602773	Internal RxNorm lookup
2602774	Internal RxNorm lookup
2641906	Internal RxNorm lookup
2641907	Internal RxNorm lookup
2641911	Internal RxNorm lookup
2641912	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
ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66302-716-04	Tyvaso DPI	1 in 1 KIT	INHALANT	1		14
66302-716-04	Tyvaso DPI	4 in 1 BLISTER PACK	INHALANT	4		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66302-716-04	EA - Each	66302-716	994b0ffc-474b-4953-8069-c116d66d85c5	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66302-716	TYVASO DPI (TREPROSTINIL) INHALANT TYVASO DPI (TREPROSTINIL) KIT [UNITED THERAPEUTICS CORPORATION]	11	Current NDC, Legacy NDC, 2 package rows	20241222_ddc3d400-bcb3-4b09-aae2-0768b10a5b0f.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
Tyvaso DPI	TREPROSTINIL	United Therapeutics Corporation	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214324 application number: NDA214324 ndc (product): 66302-716

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
2602770	{112 (treprostinil 0.016 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 28 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 16-32-48 MCG Titration Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641914	{112 (treprostinil 0.016 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 16-48-64 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602768	{112 (treprostinil 0.016 MG Inhalation Powder [Tyvaso]) / 84 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 16-32 MCG Titration Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602774	{112 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 32-48 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641907	{112 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 32-64 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641912	{112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 48-64 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727471	{112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.08 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 48-80 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727473	{112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.08 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 64-80 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602772	{16 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 16 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 32-48 MCG Institutional Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602769	{112 (treprostinil 0.016 MG Inhalation Powder) / 112 (treprostinil 0.032 MG Inhalation Powder) / 28 (treprostinil 0.048 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641913	{112 (treprostinil 0.016 MG Inhalation Powder) / 112 (treprostinil 0.048 MG Inhalation Powder) / 112 (treprostinil 0.064 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602767	{112 (treprostinil 0.016 MG Inhalation Powder) / 84 (treprostinil 0.032 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602773	{112 (treprostinil 0.032 MG Inhalation Powder) / 112 (treprostinil 0.048 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641906	{112 (treprostinil 0.032 MG Inhalation Powder) / 112 (treprostinil 0.064 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641911	{112 (treprostinil 0.048 MG Inhalation Powder) / 112 (treprostinil 0.064 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727470	{112 (treprostinil 0.048 MG Inhalation Powder) / 112 (treprostinil 0.08 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727472	{112 (treprostinil 0.064 MG Inhalation Powder) / 112 (treprostinil 0.08 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602771	{16 (treprostinil 0.032 MG Inhalation Powder) / 16 (treprostinil 0.048 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602751	treprostinil 16 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602767	treprostinil 16-32 MCG Titration Pack, 112 (16 MCG), 84 (32 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602769	treprostinil 16-32-48 MCG Titration Pack, 112 (16 MCG), 112 (32 MCG), 28 (48 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641913	treprostinil 16-48-64 MCG Maintenance Pack, 112 (16 MCG), 112 (48 MCG), 112 (64 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602756	treprostinil 32 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602771	treprostinil 32-48 MCG Institutional Pack, 16 (32 MCG), 16 (48 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602773	treprostinil 32-48 MCG Maintenance Pack, 112 (32 MCG), 112 (48 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641906	treprostinil 32-64 MCG Maintenance Pack, 112 (32 MCG), 112 (64 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602760	treprostinil 48 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641911	treprostinil 48-64 MCG Maintenance Pack, 112 (48 MCG), 112 (64 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727470	treprostinil 48-80 MCG Titration Pack, 112 (48 MCG), 112 (80 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602764	treprostinil 64 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727472	treprostinil 64-80 MCG Titration Pack, 112 (64 MCG), 112 (80 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697737	treprostinil 80 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602754	TYVASO DPI 16 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602768	Tyvaso DPI 16-32 MCG Titration Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602770	Tyvaso DPI 16-32-48 MCG Titration Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641914	Tyvaso DPI 16-48-64 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602758	TYVASO DPI 32 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602772	Tyvaso DPI 32-48 MCG Institutional Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602774	Tyvaso DPI 32-48 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641907	Tyvaso DPI 32-64 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602762	TYVASO DPI 48 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641912	Tyvaso DPI 48-64 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727471	Tyvaso DPI 48-80 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602766	TYVASO DPI 64 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727473	Tyvaso DPI 64-80 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697739	TYVASO DPI 80 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602754	treprostinil 0.016 MG Inhalation Powder [Tyvaso]	SBD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602758	treprostinil 0.032 MG Inhalation Powder [Tyvaso]	SBD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602762	treprostinil 0.048 MG Inhalation Powder [Tyvaso]	SBD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602766	treprostinil 0.064 MG Inhalation Powder [Tyvaso]	SBD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697739	treprostinil 0.08 MG Inhalation Powder [Tyvaso]	SBD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602751	treprostinil 0.016 MG Inhalation Powder	SCD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602756	treprostinil 0.032 MG Inhalation Powder	SCD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602760	treprostinil 0.048 MG Inhalation Powder	SCD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602764	treprostinil 0.064 MG Inhalation Powder	SCD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697737	treprostinil 0.08 MG Inhalation Powder	SCD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602751	treprostinil 16 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602767	treprostinil 16-32 MCG Titration Pack, 112 (16 MCG), 84 (32 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602769	treprostinil 16-32-48 MCG Titration Pack, 112 (16 MCG), 112 (32 MCG), 28 (48 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641913	treprostinil 16-48-64 MCG Maintenance Pack, 112 (16 MCG), 112 (48 MCG), 112 (64 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602756	treprostinil 32 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602771	treprostinil 32-48 MCG Institutional Pack, 16 (32 MCG), 16 (48 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602773	treprostinil 32-48 MCG Maintenance Pack, 112 (32 MCG), 112 (48 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641906	treprostinil 32-64 MCG Maintenance Pack, 112 (32 MCG), 112 (64 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602760	treprostinil 48 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641911	treprostinil 48-64 MCG Maintenance Pack, 112 (48 MCG), 112 (64 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727470	treprostinil 48-80 MCG Titration Pack, 112 (48 MCG), 112 (80 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602764	treprostinil 64 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727472	treprostinil 64-80 MCG Titration Pack, 112 (64 MCG), 112 (80 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697737	treprostinil 80 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602754	Tyvaso 0.016 MG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602758	Tyvaso 0.032 MG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602762	Tyvaso 0.048 MG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602766	Tyvaso 0.064 MG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697739	Tyvaso 0.08 MG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602754	Tyvaso 16 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602758	Tyvaso 32 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602762	Tyvaso 48 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602766	Tyvaso 64 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697739	Tyvaso 80 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66302-716-04	66302071604	1 BLISTER PACK in 1 KIT (66302-716-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK	1 blister pack	2022-05-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tyvaso DPI - United Therapeutics Corporation	United Therapeutics Corporation	2025-11-20	HUMAN PRESCRIPTION DRUG LABEL	14