Home NDC 63539-236 CIBINQO
Product NDC 63539-236
11-digit product format 635390236
Labeler code 63539
Product ID 63539-236_0043f6db-decd-4d53-a301-35f2f7a63664
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abrocitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler U.S. Pharmaceuticals
Application NDA213871
Marketing category NDA
Marketing start 2022-02-24
Substance ABROCITINIB
Active strength 50 mg/1
Pharmacologic classes Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213871-001 CIBINQO ABROCITINIB 50MG TABLET / ORAL RLD 2022-01-14 N213871-002 CIBINQO ABROCITINIB 100MG TABLET / ORAL RLD 2022-01-14 N213871-003 CIBINQO ABROCITINIB 200MG TABLET / ORAL RLD, RS 2022-01-14
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 N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 N213871-001 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 N213871-002 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 N213871-002 9549929 2034-02-19 U-3195 2022-02-11 N213871-002 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 N213871-003 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 N213871-003 9549929 2034-02-19 U-3195 2022-02-11 N213871-003 9035074 2036-01-14 Drug substance, Drug product 2022-02-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 3 · 96 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 2026-02-19 14:30 UTC 2026-02 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 7 · 279 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 N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-001 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-002 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-002 9549929 2034-02-19 U-3195 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-002 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-003 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-003 9549929 2034-02-19 U-3195 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-003 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-001 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-002 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-002 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-002 9549929 2034-02-19 U-3195 2022-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-003 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-003 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-003 9549929 2034-02-19 U-3195 2022-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213871-001 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-002 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-002 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-002 9549929 2034-02-19 U-3195 2022-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-003 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-003 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-003 9549929 2034-02-19 U-3195 2022-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-001 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-002 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-002 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-002 9549929 2034-02-19 U-3195 2022-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-003 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-003 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-003 9549929 2034-02-19 U-3195 2022-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213871-001 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213871-002 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 162 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CIBINQO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ABROCITINIB 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 73SM5SF3OR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2591481 Internal RxNorm lookup 2591487 Internal RxNorm lookup 2591489 Internal RxNorm lookup 2591491 Internal RxNorm lookup 2591493 Internal RxNorm lookup 2591495 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 63539-236-14 CIBINQO 14 in 1 BOTTLE TABLET, FILM COATED 14 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63539-236 CIBINQO (ABROCITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 4 Current NDC, Legacy NDC, 1 package rows 20250322_16c12a56-4550-414b-ac9d-b785b41fea6b.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 · 2 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 63539-236-14 63539023614 14 TABLET, FILM COATED in 1 BOTTLE (63539-236-14) 2022-02-24 0000-00-00 Yes No Current