Home NDC 66993-238 Dasatinib
Product NDC 66993-238
11-digit product format 669930238
Labeler code 66993
Product ID 66993-238_19048218-75dd-45fc-8e6e-fc660d861fb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dasatinib
Dosage form TABLET
Route ORAL
Labeler Prasco Laboratories
Application NDA021986
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2024-09-03
Substance DASATINIB
Active strength 140 mg/1
Pharmacologic classes Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase 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 · 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 · 246 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 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…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Observed Orange Book patent history# Patent history page 1 of 32 · 1,248 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 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…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-002 8680103 2025-02-04 Drug product 2014-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-002 8680103*PED 2025-08-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-002 7491725 2026-03-28 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-002 7491725*PED 2026-09-28 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-003 8680103 2025-02-04 Drug product 2014-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-003 8680103*PED 2025-08-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-003 7491725 2026-03-28 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-003 7491725*PED 2026-09-28 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-004 8680103 2025-02-04 Drug product 2014-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-004 8680103*PED 2025-08-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-004 7491725 2026-03-28 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-004 7491725*PED 2026-09-28 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-005 8680103 2025-02-04 Drug product 2014-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-005 8680103*PED 2025-08-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-005 7491725 2026-03-28 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-005 7491725*PED 2026-09-28 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-006 8680103 2025-02-04 Drug product 2014-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-006 8680103*PED 2025-08-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-006 7491725 2026-03-28 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-006 7491725*PED 2026-09-28 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021986-001 8680103 2025-02-04 Drug product 2014-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-001 8680103*PED 2025-08-04 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-001 7491725 2026-03-28 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-001 7491725*PED 2026-09-28 Pediatric extension 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 31 · 1,212 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dasatinib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DASATINIB 140 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RBZ1571X5H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 643105 Internal RxNorm lookup 643107 Internal RxNorm lookup 643109 Internal RxNorm lookup 799047 Internal RxNorm lookup 1045402 Internal RxNorm lookup 1045406 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 66993-238-30 Dasatinib 1 in 1 CARTON TABLET 1 10 66993-238-30 Dasatinib 30 in 1 BOTTLE TABLET 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66993-238 DASATINIB TABLET [PRASCO LABORATORIES] 10 Current NDC, 2 package rows 20240910_1931e73f-918c-4d69-9543-de9643513d05.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 Units Marketing start Sample Exclude flag Status 66993-238-30 66993023830 1 BOTTLE in 1 CARTON (66993-238-30) / 30 TABLET in 1 BOTTLE 1 bottle 2024-09-03 No No Current