Tarpeyo

Product NDC: 81749-004
11-digit product format: 817490004
Labeler code: 81749
Product ID: 81749-004_48e9b876-94c8-7c9f-e063-6294a90adcef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: budesonide
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Calliditas Therapeutics AB
Application: NDA215935
Marketing category: NDA
Marketing start: 2021-12-15
Substance: BUDESONIDE
Active strength: 4 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 42.

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
N215935-001	TARPEYO	BUDESONIDE	4MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2021-12-15

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215935-001	8491932	2029-05-07	U-3269	Drug product	2022-01-12
N215935-001	8491932	2029-05-07	U-3781	Drug product	2022-01-12
N215935-001	11896719	2043-01-23	U-3810		2024-02-14
N215935-001	12171882	2043-01-23	U-4085		2025-01-17
N215935-001	12171882	2043-01-23	U-4086		2025-01-17
N215935-001	12171883	2043-01-23		Drug product	2025-01-17
N215935-001	12311057	2043-01-23	U-4085	Drug product	2025-06-20
N215935-001	12311057	2043-01-23	U-4086	Drug product	2025-06-20
N215935-001	12311057	2043-01-23	U-4204	Drug product	2025-06-20

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215935-001	ODE-389	2028-12-15
N215935-001	ODE-464	2030-12-20

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.

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	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215935-001	TARPEYO	4MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2021-12-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 104 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	N215935-001	8491932	2029-05-07	U-3269	Drug product	2022-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215935-001	8491932	2029-05-07	U-3781	Drug product	2022-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215935-001	11896719	2043-01-23	U-3810		2024-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215935-001	12171882	2043-01-23	U-4085		2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215935-001	12171882	2043-01-23	U-4086		2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215935-001	12171883	2043-01-23		Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215935-001	12311057	2043-01-23	U-4085	Drug product	2025-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215935-001	12311057	2043-01-23	U-4086	Drug product	2025-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215935-001	12311057	2043-01-23	U-4204	Drug product	2025-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215935-001	8491932	2029-05-07	U-3269	Drug product	2022-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215935-001	8491932	2029-05-07	U-3781	Drug product	2022-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215935-001	11896719	2043-01-23	U-3810		2024-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215935-001	12171882	2043-01-23	U-4085		2025-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215935-001	12171882	2043-01-23	U-4086		2025-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215935-001	12171883	2043-01-23		Drug product	2025-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215935-001	12311057	2043-01-23	U-4085	Drug product	2025-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215935-001	12311057	2043-01-23	U-4086	Drug product	2025-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215935-001	12311057	2043-01-23	U-4204	Drug product	2025-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	8491932	2029-05-07	U-3269	Drug product	2022-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	8491932	2029-05-07	U-3781	Drug product	2022-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	11896719	2043-01-23	U-3810		2024-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	12171882	2043-01-23	U-4085		2025-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	12171882	2043-01-23	U-4086		2025-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	12171883	2043-01-23		Drug product	2025-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	12311057	2043-01-23	U-4085	Drug product	2025-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	12311057	2043-01-23	U-4086	Drug product	2025-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	12311057	2043-01-23	U-4204	Drug product	2025-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215935-001	8491932	2029-05-07	U-3269	Drug product	2022-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215935-001	8491932	2029-05-07	U-3781	Drug product	2022-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215935-001	11896719	2043-01-23	U-3810		2024-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215935-001	12171882	2043-01-23	U-4085		2025-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215935-001	12171882	2043-01-23	U-4086		2025-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215935-001	12171883	2043-01-23		Drug product	2025-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215935-001	12311057	2043-01-23	U-4085	Drug product	2025-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215935-001	12311057	2043-01-23	U-4086	Drug product	2025-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215935-001	12311057	2043-01-23	U-4204	Drug product	2025-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215935-001	8491932	2029-05-07	U-3269	Drug product	2022-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215935-001	8491932	2029-05-07	U-3781	Drug product	2022-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215935-001	11896719	2043-01-23	U-3810		2024-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215935-001	12171882	2043-01-23	U-4085		2025-01-17	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 67 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	N215935-001	ODE-389	2028-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215935-001	ODE-464	2030-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215935-001	ODE-389	2028-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215935-001	ODE-464	2030-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	ODE-389	2028-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215935-001	ODE-464	2030-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215935-001	ODE-389	2028-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215935-001	ODE-464	2030-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215935-001	ODE-389	2028-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215935-001	ODE-464	2030-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215935-001	ODE-389	2028-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215935-001	ODE-464	2030-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215935-001	NP	2024-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215935-001	ODE-389	2028-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215935-001	ODE-464	2030-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215935-001	NP	2024-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215935-001	ODE-389	2028-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215935-001	ODE-464	2030-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215935-001	NP	2024-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215935-001	ODE-389	2028-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215935-001	ODE-464	2030-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215935-001	NP	2024-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215935-001	ODE-389	2028-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215935-001	ODE-464	2030-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215935-001	NP	2024-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215935-001	ODE-389	2028-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215935-001	ODE-464	2030-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215935-001	NP	2024-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215935-001	ODE-389	2028-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215935-001	ODE-464	2030-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215935-001	NP	2024-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215935-001	ODE-389	2028-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215935-001	ODE-464	2030-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215935-001	NP	2024-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215935-001	ODE-389	2028-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215935-001	ODE-464	2030-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215935-001	NP	2024-12-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215935-001	ODE-389	2028-12-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215935-001	ODE-464	2030-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215935-001	NP	2024-12-15	`5c6f7cd8ea54…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3OKS62Q6X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2587883	Internal RxNorm lookup
2587889	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
938cada4-d6bf-4252-836f-dd40f9eadb4d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7816cdf6-b925-4282-bedd-11ae25d518a1	Product name	1	20250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4d	Product name	2	20240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6	Product name	1	20231006
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
a03aea00-1d8b-bfad-a82e-f52f68676f63	Product name	2	20221216
54a29484-7dde-4771-9547-005149321621	Product name	1	20220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743	Product name	5	20211018
218c043e-94e5-4e66-a363-d0d446485bc6	Product name	2	20210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a	Product name	1	20210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7	Product name	9	20210127
da63bc8c-2e89-4044-89d6-1facbff5474e	Product name	1	20200121
899766bc-33ce-8154-910d-12cb0889fb56	Product name	2	20150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81749-004-01	Tarpeyo	120 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	120		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81749-004-01	EA - Each	81749-004	db4d8749-212b-41b0-a3bf-ecdbbf88e6e7	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81749-004	TARPEYO (BUDESONIDE) CAPSULE, DELAYED RELEASE [CALLIDITAS THERAPEUTICS AB]	4	Current NDC, Legacy NDC, 1 package rows	20240619_938cada4-d6bf-4252-836f-dd40f9eadb4d.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
Tarpeyo	BUDESONIDE	Calliditas Therapeutics AB	938cada4-d6bf-4252-836f-dd40f9eadb4d	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215935 application number: NDA215935 ndc (product): 81749-004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3OKS62Q6X	BUDESONIDE	51333-22-3	BUDESONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2587883	budesonide 4 MG Delayed Release Oral Capsule	PSN	938cada4-d6bf-4252-836f-dd40f9eadb4d	5
2587889	TARPEYO 4 MG Delayed Release Oral Capsule	PSN	938cada4-d6bf-4252-836f-dd40f9eadb4d	5
2587889	budesonide 4 MG Delayed Release Oral Capsule [Tarpeyo]	SBD	938cada4-d6bf-4252-836f-dd40f9eadb4d	5
2587883	budesonide 4 MG Delayed Release Oral Capsule	SCD	938cada4-d6bf-4252-836f-dd40f9eadb4d	5
2587889	Tarpeyo 4 MG Delayed Release Oral Capsule	SY	938cada4-d6bf-4252-836f-dd40f9eadb4d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
81749-004-01	81749000401	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (81749-004-01)	2021-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tarpeyo	Calliditas Therapeutics AB \| Micro-Macinazione S.A. \| Minakem Dunkerque Production S.A.S \| Patheon Pharmaceuticals Inc. \| Sicor Società Italiana Corticosteroidi S.r.l	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	5