Home NDC 46708-686 DASATINIB
Product NDC 46708-686
11-digit product format 467080686
Labeler code 46708
Product ID 46708-686_645fcf26-1b2f-40c5-881b-8effe02defbd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DASATINIB
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA216261
Marketing category ANDA
Marketing start 2025-11-11
Substance DASATINIB
Active strength 70 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 A216261-001 DASATINIB DASATINIB 20MG TABLET / ORAL AB 2025-11-06 A216261-002 DASATINIB DASATINIB 50MG TABLET / ORAL AB 2025-11-06 A216261-003 DASATINIB DASATINIB 70MG TABLET / ORAL AB 2025-11-06 A216261-004 DASATINIB DASATINIB 80MG TABLET / ORAL AB 2025-11-06 A216261-005 DASATINIB DASATINIB 100MG TABLET / ORAL AB 2025-11-06 A216261-006 DASATINIB DASATINIB 140MG TABLET / ORAL AB 2025-11-06
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 A216261-001 DASATINIB 20MG TABLET / ORAL AB 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216261-002 DASATINIB 50MG TABLET / ORAL AB 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216261-003 DASATINIB 70MG TABLET / ORAL AB 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216261-004 DASATINIB 80MG TABLET / ORAL AB 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216261-005 DASATINIB 100MG TABLET / ORAL AB 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216261-006 DASATINIB 140MG TABLET / ORAL AB 2025-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216261-001 DASATINIB 20MG TABLET / ORAL AB 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216261-002 DASATINIB 50MG TABLET / ORAL AB 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216261-003 DASATINIB 70MG TABLET / ORAL AB 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216261-004 DASATINIB 80MG TABLET / ORAL AB 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216261-005 DASATINIB 100MG TABLET / ORAL AB 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216261-006 DASATINIB 140MG TABLET / ORAL AB 2025-11-06 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216261-001 DASATINIB 20MG TABLET / ORAL AB 2025-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216261-002 DASATINIB 50MG TABLET / ORAL AB 2025-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216261-003 DASATINIB 70MG TABLET / ORAL AB 2025-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216261-004 DASATINIB 80MG TABLET / ORAL AB 2025-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216261-005 DASATINIB 100MG TABLET / ORAL AB 2025-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216261-006 DASATINIB 140MG TABLET / ORAL AB 2025-11-06 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 70 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 46708-686-60 DASATINIB 60 in 1 BOTTLE TABLET, FILM COATED 60 1
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 46708-686-60 46708068660 60 TABLET, FILM COATED in 1 BOTTLE (46708-686-60) 2025-11-11 No No Current