Home NDC 46708-311-35 Bosutinib
Product NDC 46708-311
Requested package NDC 46708-311-35
11-digit product format 467080311
Labeler code 46708
Product ID 46708-311_17a3b455-b49a-492d-b6dc-47e96e6037ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bosutinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA209543
Marketing category ANDA
Marketing start 2026-05-19
Substance BOSUTINIB
Active strength 100 mg/1
Pharmacologic classes Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209543-001 BOSUTINIB MONOHYDRATE BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 A209543-002 BOSUTINIB MONOHYDRATE BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A209543-001 PC 2026-12-08 A209543-002 PC 2026-12-08
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 2026-08-18 06:07:40 2026-07 A209543-001 BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209543-002 BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209543-001 BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209543-002 BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209543-001 BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209543-002 BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209543-001 BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209543-002 BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209543-001 BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209543-002 BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 A209543-001 PC 2026-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209543-002 PC 2026-12-08 caaa826d4ba7…
Additional Listing Data#
Finished product Yes
Brand name base Bosutinib
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BOSUTINIB 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5018V4AEZ0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1307624 Internal RxNorm lookup 1307633 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 46708-311-35 Bosutinib 120 in 1 BOTTLE TABLET, FILM COATED 120 2
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 Marketing start Sample Exclude flag Status 46708-311-35 46708031135 120 TABLET, FILM COATED in 1 BOTTLE (46708-311-35) 2026-05-19 No No Current