Home DailyMed 56b4d809-af1d-48e1-a32f-e89ff6ffca8a 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 01:50:24 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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021986-001 SPRYCEL DASATINIB 20MG TABLET / ORAL AB RLD 2006-06-28 N021986-002 SPRYCEL DASATINIB 50MG TABLET / ORAL AB RLD 2006-06-28 N021986-003 SPRYCEL DASATINIB 70MG TABLET / ORAL AB RLD 2006-06-28 N021986-004 SPRYCEL DASATINIB 100MG TABLET / ORAL AB RLD, RS 2008-05-30 N021986-005 SPRYCEL DASATINIB 80MG TABLET / ORAL AB RLD 2010-10-28 N021986-006 SPRYCEL DASATINIB 140MG TABLET / ORAL AB RLD 2010-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021986-001 7491725 2026-03-28 Drug substance, Drug product N021986-001 7491725*PED 2026-09-28 Pediatric extension N021986-002 7491725 2026-03-28 Drug substance, Drug product N021986-002 7491725*PED 2026-09-28 Pediatric extension N021986-003 7491725 2026-03-28 Drug substance, Drug product N021986-003 7491725*PED 2026-09-28 Pediatric extension N021986-004 7491725 2026-03-28 Drug substance, Drug product N021986-004 7491725*PED 2026-09-28 Pediatric extension N021986-005 7491725 2026-03-28 Drug substance, Drug product N021986-005 7491725*PED 2026-09-28 Pediatric extension N021986-006 7491725 2026-03-28 Drug substance, Drug product N021986-006 7491725*PED 2026-09-28 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 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 7 · 258 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 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Observed Orange Book patent history# Patent history page 1 of 32 · 1,272 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 N021986-001 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-001 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-002 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-002 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-003 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-003 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-004 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-004 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-005 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-005 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-006 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-006 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021986-001 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-001 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-002 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-002 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-003 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-003 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-004 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-004 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-005 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-005 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-006 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-006 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021986-001 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-001 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-002 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-002 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-003 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-003 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-004 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-004 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-005 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-005 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-006 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-006 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-001 8680103 2025-02-04 Drug product 2014-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-001 8680103*PED 2025-08-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-001 7491725 2026-03-28 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-001 7491725*PED 2026-09-28 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 31 · 1,236 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.