Home DailyMed 2abc0bcb-0d2d-4615-8d38-03221be49fb2 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:24:50 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 TE codes RLD / RS Approval date N202192-001 JAKAFI RUXOLITINIB PHOSPHATE EQ 5MG BASE TABLET / ORAL RLD 2011-11-16 N202192-002 JAKAFI RUXOLITINIB PHOSPHATE EQ 10MG BASE TABLET / ORAL RLD 2011-11-16 N202192-003 JAKAFI RUXOLITINIB PHOSPHATE EQ 15MG BASE TABLET / ORAL RLD 2011-11-16 N202192-004 JAKAFI RUXOLITINIB PHOSPHATE EQ 20MG BASE TABLET / ORAL RLD 2011-11-16 N202192-005 JAKAFI RUXOLITINIB PHOSPHATE EQ 25MG BASE TABLET / ORAL RLD, RS 2011-11-16
Orange Book patents# Current patent rows page 1 of 2 · 145 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202192-001 9079912 2026-12-12 U-3226 2015-08-04 N202192-001 9079912 2026-12-12 U-3227 2015-08-04 N202192-001 9079912 2026-12-12 U-3228 2015-08-04 N202192-001 9079912 2026-12-12 U-3230 2015-08-04 N202192-001 9814722 2026-12-12 U-3226 2019-06-12 N202192-001 9814722 2026-12-12 U-3230 2019-06-12 N202192-001 9079912*PED 2027-06-12 Pediatric extension N202192-001 9814722*PED 2027-06-12 Pediatric extension N202192-001 7598257 2027-12-24 U-3227 Drug substance, Drug product 2011-12-01 N202192-001 7598257 2027-12-24 U-3228 Drug substance, Drug product 2011-12-01 N202192-001 8415362 2027-12-24 Drug substance, Drug product 2013-04-29 N202192-001 10016429 2028-06-12 U-3226 2019-06-12 N202192-001 10016429 2028-06-12 U-3230 2019-06-12 N202192-001 8722693 2028-06-12 Drug substance, Drug product 2014-06-03 N202192-001 8822481 2028-06-12 U-1573 2014-09-24 N202192-001 8822481 2028-06-12 U-3226 2014-09-24 N202192-001 8822481 2028-06-12 U-3227 2014-09-24 N202192-001 8822481 2028-06-12 U-3228 2014-09-24 N202192-001 8822481 2028-06-12 U-3230 2014-09-24 N202192-001 8829013 2028-06-12 U-1201 2014-09-24 N202192-001 8829013 2028-06-12 U-1622 2014-09-24 N202192-001 8829013 2028-06-12 U-3227 2014-09-24 N202192-001 8829013 2028-06-12 U-3228 2014-09-24 N202192-001 7598257*PED 2028-06-24 Pediatric extension N202192-001 8415362*PED 2028-06-24 Pediatric extension N202192-001 10016429*PED 2028-12-12 Pediatric extension N202192-001 8722693*PED 2028-12-12 Pediatric extension N202192-001 8822481*PED 2028-12-12 Pediatric extension N202192-001 8829013*PED 2028-12-12 Pediatric extension N202192-002 9079912 2026-12-12 U-3226 2015-08-04 N202192-002 9079912 2026-12-12 U-3227 2015-08-04 N202192-002 9079912 2026-12-12 U-3228 2015-08-04 N202192-002 9079912 2026-12-12 U-3230 2015-08-04 N202192-002 9814722 2026-12-12 U-3226 2019-06-12 N202192-002 9814722 2026-12-12 U-3230 2019-06-12 N202192-002 9079912*PED 2027-06-12 Pediatric extension N202192-002 9814722*PED 2027-06-12 Pediatric extension N202192-002 7598257 2027-12-24 U-3227 Drug substance, Drug product 2011-12-01 N202192-002 7598257 2027-12-24 U-3228 Drug substance, Drug product 2011-12-01 N202192-002 8415362 2027-12-24 Drug substance, Drug product N202192-002 10016429 2028-06-12 U-3226 2019-06-12 N202192-002 10016429 2028-06-12 U-3230 2019-06-12 N202192-002 8722693 2028-06-12 Drug substance, Drug product 2014-06-03 N202192-002 8822481 2028-06-12 U-1573 2014-09-24 N202192-002 8822481 2028-06-12 U-3226 2014-09-24 N202192-002 8822481 2028-06-12 U-3227 2014-09-24 N202192-002 8822481 2028-06-12 U-3228 2014-09-24 N202192-002 8822481 2028-06-12 U-3230 2014-09-24 N202192-002 8829013 2028-06-12 U-1201 2014-09-24 N202192-002 8829013 2028-06-12 U-1622 2014-09-24 N202192-002 8829013 2028-06-12 U-3227 2014-09-24 N202192-002 8829013 2028-06-12 U-3228 2014-09-24 N202192-002 7598257*PED 2028-06-24 Pediatric extension N202192-002 8415362*PED 2028-06-24 Pediatric extension N202192-002 10016429*PED 2028-12-12 Pediatric extension N202192-002 8722693*PED 2028-12-12 Pediatric extension N202192-002 8822481*PED 2028-12-12 Pediatric extension N202192-002 8829013*PED 2028-12-12 Pediatric extension N202192-003 9079912 2026-12-12 U-3226 2015-08-04 N202192-003 9079912 2026-12-12 U-3227 2015-08-04 N202192-003 9079912 2026-12-12 U-3228 2015-08-04 N202192-003 9079912 2026-12-12 U-3230 2015-08-04 N202192-003 9814722 2026-12-12 U-3226 2019-06-12 N202192-003 9814722 2026-12-12 U-3230 2019-06-12 N202192-003 9079912*PED 2027-06-12 Pediatric extension N202192-003 9814722*PED 2027-06-12 Pediatric extension N202192-003 7598257 2027-12-24 U-3227 Drug substance, Drug product 2011-12-01 N202192-003 7598257 2027-12-24 U-3228 Drug substance, Drug product 2011-12-01 N202192-003 8415362 2027-12-24 Drug substance, Drug product N202192-003 10016429 2028-06-12 U-3226 2019-06-12 N202192-003 10016429 2028-06-12 U-3230 2019-06-12 N202192-003 8722693 2028-06-12 Drug substance, Drug product 2014-06-03 N202192-003 8822481 2028-06-12 U-1573 2014-09-24 N202192-003 8822481 2028-06-12 U-3226 2014-09-24 N202192-003 8822481 2028-06-12 U-3227 2014-09-24 N202192-003 8822481 2028-06-12 U-3228 2014-09-24 N202192-003 8822481 2028-06-12 U-3230 2014-09-24 N202192-003 8829013 2028-06-12 U-1201 2014-09-24 N202192-003 8829013 2028-06-12 U-1622 2014-09-24 N202192-003 8829013 2028-06-12 U-3227 2014-09-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 30 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 6 · 215 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 2026-09-14 22:38:34 2026-08 N202192-001 JAKAFI EQ 5MG BASE TABLET / ORAL RLD 2011-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 JAKAFI EQ 10MG BASE TABLET / ORAL RLD 2011-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-003 JAKAFI EQ 15MG BASE TABLET / ORAL RLD 2011-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-004 JAKAFI EQ 20MG BASE TABLET / ORAL RLD 2011-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-005 JAKAFI EQ 25MG BASE TABLET / ORAL RLD, RS 2011-11-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202192-001 JAKAFI EQ 5MG BASE TABLET / ORAL RLD 2011-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202192-002 JAKAFI EQ 10MG BASE TABLET / ORAL RLD 2011-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202192-003 JAKAFI EQ 15MG BASE TABLET / ORAL RLD 2011-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202192-004 JAKAFI EQ 20MG BASE TABLET / ORAL RLD 2011-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202192-005 JAKAFI EQ 25MG BASE TABLET / ORAL RLD, RS 2011-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202192-001 JAKAFI EQ 5MG BASE TABLET / ORAL RLD 2011-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202192-002 JAKAFI EQ 10MG BASE TABLET / ORAL RLD 2011-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202192-003 JAKAFI EQ 15MG BASE TABLET / ORAL RLD 2011-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202192-004 JAKAFI EQ 20MG BASE TABLET / ORAL RLD 2011-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202192-005 JAKAFI EQ 25MG BASE TABLET / ORAL RLD, RS 2011-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202192-001 JAKAFI EQ 5MG BASE TABLET / ORAL RLD 2011-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202192-002 JAKAFI EQ 10MG BASE TABLET / ORAL RLD 2011-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202192-003 JAKAFI EQ 15MG BASE TABLET / ORAL RLD 2011-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202192-004 JAKAFI EQ 20MG BASE TABLET / ORAL RLD 2011-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202192-005 JAKAFI EQ 25MG BASE TABLET / ORAL RLD, RS 2011-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202192-001 JAKAFI EQ 5MG BASE TABLET / ORAL RLD 2011-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202192-002 JAKAFI EQ 10MG BASE TABLET / ORAL RLD 2011-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202192-003 JAKAFI EQ 15MG BASE TABLET / ORAL RLD 2011-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202192-004 JAKAFI EQ 20MG BASE TABLET / ORAL RLD 2011-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202192-005 JAKAFI EQ 25MG BASE TABLET / ORAL RLD, RS 2011-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202192-001 JAKAFI EQ 5MG BASE TABLET / ORAL RLD 2011-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202192-002 JAKAFI EQ 10MG BASE TABLET / ORAL RLD 2011-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202192-003 JAKAFI EQ 15MG BASE TABLET / ORAL RLD 2011-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202192-004 JAKAFI EQ 20MG BASE TABLET / ORAL RLD 2011-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202192-005 JAKAFI EQ 25MG BASE TABLET / ORAL RLD, RS 2011-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202192-001 JAKAFI EQ 5MG BASE TABLET / ORAL RLD 2011-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202192-002 JAKAFI EQ 10MG BASE TABLET / ORAL RLD 2011-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202192-003 JAKAFI EQ 15MG BASE TABLET / ORAL RLD 2011-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202192-004 JAKAFI EQ 20MG BASE TABLET / ORAL RLD 2011-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202192-005 JAKAFI EQ 25MG BASE TABLET / ORAL RLD, RS 2011-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202192-001 JAKAFI EQ 5MG BASE TABLET / ORAL RLD 2011-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202192-002 JAKAFI EQ 10MG BASE TABLET / ORAL RLD 2011-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202192-003 JAKAFI EQ 15MG BASE TABLET / ORAL RLD 2011-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202192-004 JAKAFI EQ 20MG BASE TABLET / ORAL RLD 2011-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202192-005 JAKAFI EQ 25MG BASE TABLET / ORAL RLD, RS 2011-11-16 03ed91905a0d…
Observed Orange Book patent history# Patent history page 1 of 129 · 5,155 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 N202192-001 9079912 2026-12-12 U-3226 2015-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 9079912 2026-12-12 U-3228 2015-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 9079912 2026-12-12 U-3227 2015-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 9079912 2026-12-12 U-3230 2015-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 9814722 2026-12-12 U-3226 2019-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 9814722 2026-12-12 U-3230 2019-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 9079912*PED 2027-06-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 9814722*PED 2027-06-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 7598257 2027-12-24 U-3228 Drug substance, Drug product 2011-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 7598257 2027-12-24 U-3227 Drug substance, Drug product 2011-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8415362 2027-12-24 Drug substance, Drug product 2013-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 10016429 2028-06-12 U-3226 2019-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 10016429 2028-06-12 U-3230 2019-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8722693 2028-06-12 Drug substance, Drug product 2014-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8822481 2028-06-12 U-1573 2014-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8822481 2028-06-12 U-3226 2014-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8822481 2028-06-12 U-3228 2014-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8822481 2028-06-12 U-3227 2014-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8822481 2028-06-12 U-3230 2014-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8829013 2028-06-12 U-1622 2014-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8829013 2028-06-12 U-1201 2014-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8829013 2028-06-12 U-3227 2014-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8829013 2028-06-12 U-3228 2014-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 7598257*PED 2028-06-24 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8415362*PED 2028-06-24 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 10016429*PED 2028-12-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8722693*PED 2028-12-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8822481*PED 2028-12-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-001 8829013*PED 2028-12-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 9079912 2026-12-12 U-3227 2015-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 9079912 2026-12-12 U-3226 2015-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 9079912 2026-12-12 U-3228 2015-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 9079912 2026-12-12 U-3230 2015-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 9814722 2026-12-12 U-3226 2019-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 9814722 2026-12-12 U-3230 2019-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 9079912*PED 2027-06-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 9814722*PED 2027-06-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 7598257 2027-12-24 U-3228 Drug substance, Drug product 2011-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 7598257 2027-12-24 U-3227 Drug substance, Drug product 2011-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202192-002 8415362 2027-12-24 Drug substance, Drug product 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 29 · 1,136 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.