Home NDC 0003-0895 SOTYKTU
Product NDC 0003-0895
11-digit product format 000030895
Labeler code 0003
Product ID 0003-0895_9d2e509f-3c81-45c7-984b-4e3c8b56dbef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name deucravacitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler E.R. Squibb & Sons, L.L.C.
Application NDA214958
Marketing category NDA
Marketing start 2022-09-09
Substance DEUCRAVACITINIB
Active strength 6 mg/1
Pharmacologic classes Tyrosine Kinase 2 Inhibitor [EPC], Tyrosine Kinase 2 Inhibitors [MoA]
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 1 .
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 N214958-001 SOTYKTU DEUCRAVACITINIB 6MG TABLET / ORAL RLD, RS 2022-09-09
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 N214958-001 RE47929 2033-11-07 U-4452 Drug substance, Drug product 2022-10-04 N214958-001 12521390 2043-02-11 U-3434 Drug product 2026-02-09 N214958-001 12521390 2043-02-11 U-4451 Drug product 2026-02-09
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214958-001 NCE 2027-09-09 N214958-001 I-986 2029-03-06
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 2026-02-19 14:30 UTC 2026-02 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214958-001 12521390 2043-02-11 U-3434 Drug product 2026-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 1e350fbaab3a…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base SOTYKTU
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEUCRAVACITINIB 6 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N0A21N6RAU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2612092 Internal RxNorm lookup 2612098 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 0003-0895-11 SOTYKTU 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 0003-0895-91 SOTYKTU 30 in 1 BLISTER PACK TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0003-0895 SOTYKTU (DEUCRAVACITINIB) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.] 1 Current NDC, Legacy NDC, 2 package rows 20220921_ff4d7258-5068-4cdf-9692-8cae04c3198e.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 0003-0895-11 00003089511 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11) 2022-09-09 0000-00-00 No No Current 0003-0895-91 00003089591 30 TABLET, FILM COATED in 1 BLISTER PACK (0003-0895-91) 2022-09-09 0000-00-00 Yes No Current