Home NDC 70771-1901 dasatinib
Product NDC 70771-1901
11-digit product format 707711901
Labeler code 70771
Product ID 70771-1901_571889d7-845d-4fed-8d7d-6470d4d36fa1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dasatinib
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA218719
Marketing category ANDA
Marketing start 2025-03-03
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 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 A218719-001 DASATINIB DASATINIB 20MG TABLET / ORAL AB 2025-03-03 A218719-002 DASATINIB DASATINIB 50MG TABLET / ORAL AB 2025-03-03 A218719-003 DASATINIB DASATINIB 70MG TABLET / ORAL AB 2025-03-03 A218719-004 DASATINIB DASATINIB 80MG TABLET / ORAL AB 2025-03-03 A218719-005 DASATINIB DASATINIB 100MG TABLET / ORAL AB 2025-03-03 A218719-006 DASATINIB DASATINIB 140MG TABLET / ORAL AB 2025-03-03
Therapeutic equivalence codes# Current TE-code 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.
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 A218719-001 DASATINIB 20MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218719-002 DASATINIB 50MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218719-003 DASATINIB 70MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218719-004 DASATINIB 80MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218719-005 DASATINIB 100MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218719-006 DASATINIB 140MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218719-001 DASATINIB 20MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218719-002 DASATINIB 50MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218719-003 DASATINIB 70MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218719-004 DASATINIB 80MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218719-005 DASATINIB 100MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218719-006 DASATINIB 140MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218719-001 DASATINIB 20MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218719-002 DASATINIB 50MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218719-003 DASATINIB 70MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218719-004 DASATINIB 80MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218719-005 DASATINIB 100MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218719-006 DASATINIB 140MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218719-001 DASATINIB 20MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218719-002 DASATINIB 50MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218719-003 DASATINIB 70MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218719-004 DASATINIB 80MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218719-005 DASATINIB 100MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218719-006 DASATINIB 140MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218719-001 DASATINIB 20MG TABLET / ORAL AB 2025-03-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218719-002 DASATINIB 50MG TABLET / ORAL AB 2025-03-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218719-003 DASATINIB 70MG TABLET / ORAL AB 2025-03-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218719-004 DASATINIB 80MG TABLET / ORAL AB 2025-03-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218719-005 DASATINIB 100MG TABLET / ORAL AB 2025-03-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218719-006 DASATINIB 140MG TABLET / ORAL AB 2025-03-03 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base dasatinib
Listing expiration 2026-12-31 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 · 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 70771-1901-6 dasatinib 60 in 1 BOTTLE TABLET 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1901 DASATINIB TABLET [ZYDUS LIFESCIENCES LIMITED] 1 Current NDC, 1 package rows 20250309_4eed6b7b-a09d-4d2e-a345-968dd68323bc.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 70771-1901-6 70771190106 60 TABLET in 1 BOTTLE (70771-1901-6) 60 tablet 2025-03-03 No No Current