Home NDC 75907-405 Bosutinib
Product NDC 75907-405
11-digit product format 759070405
Labeler code 75907
Product ID 75907-405_cb7a8d1d-07c0-462d-960f-214d44705e76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bosutinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA209624
Marketing category ANDA
Marketing start 2026-06-12
Substance BOSUTINIB
Active strength 400 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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209624-001 BOSUTINIB MONOHYDRATE BOSUTINIB MONOHYDRATE EQ 400MG BASE TABLET / ORAL AB 2026-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209624-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A209624-001 PC 2026-11-23
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 2026-09-14 22:38:34 2026-08 A209624-001 BOSUTINIB MONOHYDRATE EQ 400MG BASE TABLET / ORAL AB 2026-06-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209624-001 BOSUTINIB MONOHYDRATE EQ 400MG BASE TABLET / ORAL AB 2026-06-12 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209624-001 BOSUTINIB MONOHYDRATE EQ 400MG BASE TABLET / ORAL AB 2026-06-12 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A209624-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209624-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209624-001 AB 1 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 A209624-001 PC 2026-11-23 84e616aacf4f…
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 Bosutinib
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BOSUTINIB 400 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1987732 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 75907-405-30 75907040530 30 TABLET, FILM COATED in 1 BOTTLE (75907-405-30) 2026-06-12 No No Current