Home NDC 81749-004-01 Tarpeyo
Product NDC 81749-004
Requested package NDC 81749-004-01
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 43 .
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N215935-001 TARPEYO 4MG CAPSULE, DELAYED RELEASE / ORAL RLD, RS 2021-12-15 84e616aacf4f…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 · 113 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215935-001 8491932 2029-05-07 U-3269 Drug product 2022-01-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215935-001 8491932 2029-05-07 U-3781 Drug product 2022-01-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215935-001 11896719 2043-01-23 U-3810 2024-02-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215935-001 12171882 2043-01-23 U-4085 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215935-001 12171882 2043-01-23 U-4086 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215935-001 12171883 2043-01-23 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215935-001 12311057 2043-01-23 U-4085 Drug product 2025-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215935-001 12311057 2043-01-23 U-4086 Drug product 2025-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215935-001 12311057 2043-01-23 U-4204 Drug product 2025-06-20 84e616aacf4f…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 69 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
DailyMed Product Concepts# 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 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.
DailyMed RxNorm Mappings# 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