Home NDC 70709-151 PHYRAGO
Product NDC 70709-151
11-digit product format 707090151
Labeler code 70709
Product ID 70709-151_c853d4c8-8373-4603-bc62-41e53130c0aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dasatinib
Dosage form TABLET
Route ORAL
Labeler Cycle Pharmaceuticals Ltd
Application NDA216099
Marketing category NDA
Marketing start 2025-09-22
Substance DASATINIB
Active strength 20 mg/1
Pharmacologic classes Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase 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 44 .
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 N216099-001 PHYRAGO DASATINIB 20MG TABLET / ORAL RLD 2023-12-05 N216099-002 PHYRAGO DASATINIB 50MG TABLET / ORAL RLD 2023-12-05 N216099-003 PHYRAGO DASATINIB 70MG TABLET / ORAL RLD 2023-12-05 N216099-004 PHYRAGO DASATINIB 80MG TABLET / ORAL RLD 2023-12-05 N216099-005 PHYRAGO DASATINIB 100MG TABLET / ORAL RLD, RS 2023-12-05 N216099-006 PHYRAGO DASATINIB 140MG TABLET / ORAL RLD 2023-12-05
Orange Book patents# Current patent rows page 1 of 2 · 120 matching rows.
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 · 120 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 2026-10-15 13:18:30 2026-09 N216099-001 PHYRAGO 20MG TABLET / ORAL RLD 2023-12-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216099-002 PHYRAGO 50MG TABLET / ORAL RLD 2023-12-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216099-003 PHYRAGO 70MG TABLET / ORAL RLD 2023-12-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216099-004 PHYRAGO 80MG TABLET / ORAL RLD 2023-12-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216099-005 PHYRAGO 100MG TABLET / ORAL RLD, RS 2023-12-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216099-006 PHYRAGO 140MG TABLET / ORAL RLD 2023-12-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216099-001 PHYRAGO 20MG TABLET / ORAL RLD 2023-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216099-002 PHYRAGO 50MG TABLET / ORAL RLD 2023-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216099-003 PHYRAGO 70MG TABLET / ORAL RLD 2023-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216099-004 PHYRAGO 80MG TABLET / ORAL RLD 2023-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216099-005 PHYRAGO 100MG TABLET / ORAL RLD, RS 2023-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216099-006 PHYRAGO 140MG TABLET / ORAL RLD 2023-12-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216099-001 PHYRAGO 20MG TABLET / ORAL RLD 2023-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216099-002 PHYRAGO 50MG TABLET / ORAL RLD 2023-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216099-003 PHYRAGO 70MG TABLET / ORAL RLD 2023-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216099-004 PHYRAGO 80MG TABLET / ORAL RLD 2023-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216099-005 PHYRAGO 100MG TABLET / ORAL RLD, RS 2023-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216099-006 PHYRAGO 140MG TABLET / ORAL RLD 2023-12-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216099-001 PHYRAGO 20MG TABLET / ORAL RLD 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216099-002 PHYRAGO 50MG TABLET / ORAL RLD 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216099-003 PHYRAGO 70MG TABLET / ORAL RLD 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216099-004 PHYRAGO 80MG TABLET / ORAL RLD 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216099-005 PHYRAGO 100MG TABLET / ORAL RLD, RS 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216099-006 PHYRAGO 140MG TABLET / ORAL RLD 2023-12-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216099-001 PHYRAGO 20MG TABLET / ORAL RLD 2023-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216099-002 PHYRAGO 50MG TABLET / ORAL RLD 2023-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216099-003 PHYRAGO 70MG TABLET / ORAL RLD 2023-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216099-004 PHYRAGO 80MG TABLET / ORAL RLD 2023-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216099-005 PHYRAGO 100MG TABLET / ORAL RLD, RS 2023-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216099-006 PHYRAGO 140MG TABLET / ORAL RLD 2023-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216099-001 PHYRAGO 20MG TABLET / ORAL RLD 2023-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216099-002 PHYRAGO 50MG TABLET / ORAL RLD 2023-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216099-003 PHYRAGO 70MG TABLET / ORAL RLD 2023-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216099-004 PHYRAGO 80MG TABLET / ORAL RLD 2023-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216099-005 PHYRAGO 100MG TABLET / ORAL RLD, RS 2023-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216099-006 PHYRAGO 140MG TABLET / ORAL RLD 2023-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216099-001 PHYRAGO 20MG TABLET / ORAL RLD 2023-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216099-002 PHYRAGO 50MG TABLET / ORAL RLD 2023-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216099-003 PHYRAGO 70MG TABLET / ORAL RLD 2023-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216099-004 PHYRAGO 80MG TABLET / ORAL RLD 2023-12-05 fd3edfee7708…
Observed Orange Book patent history# Patent history page 1 of 31 · 1,236 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 2 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216099-005 M-307 2026-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216099-006 M-307 2026-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216099-001 M-307 2026-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216099-002 M-307 2026-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216099-003 M-307 2026-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216099-004 M-307 2026-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216099-005 M-307 2026-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216099-006 M-307 2026-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216099-001 M-307 2026-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216099-002 M-307 2026-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216099-003 M-307 2026-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216099-004 M-307 2026-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216099-005 M-307 2026-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216099-006 M-307 2026-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216099-001 M-307 2026-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216099-002 M-307 2026-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216099-003 M-307 2026-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216099-004 M-307 2026-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216099-005 M-307 2026-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216099-006 M-307 2026-12-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216099-001 M-307 2026-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216099-002 M-307 2026-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216099-003 M-307 2026-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216099-004 M-307 2026-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216099-005 M-307 2026-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216099-006 M-307 2026-12-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216099-001 M-307 2026-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216099-002 M-307 2026-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216099-003 M-307 2026-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216099-004 M-307 2026-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216099-005 M-307 2026-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216099-006 M-307 2026-12-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216099-001 M-307 2026-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216099-002 M-307 2026-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216099-003 M-307 2026-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216099-004 M-307 2026-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216099-005 M-307 2026-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216099-006 M-307 2026-12-05 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216099-001 M-307 2026-12-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216099-002 M-307 2026-12-05 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PHYRAGO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DASATINIB 20 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 · 12 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 2691837 Internal RxNorm lookup 2691839 Internal RxNorm lookup 2691841 Internal RxNorm lookup 2691843 Internal RxNorm lookup 2691845 Internal RxNorm lookup 2691847 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 70709-151-20 PHYRAGO 60 in 1 BOTTLE TABLET 60 3
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 Units Marketing start Sample Exclude flag Status 70709-151-20 70709015120 60 TABLET in 1 BOTTLE (70709-151-20) 60 tablet 2025-09-22 No No Current