Home NDC 0832-0533-03 imatinib mesylate
Product NDC 0832-0533
Requested package NDC 0832-0533-03
11-digit product format 008320533
Labeler code 0832
Product ID 0832-0533_47f6137e-e0ea-4ada-e063-6394a90a37b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name imatinib mesylate
Dosage form TABLET
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA212135
Marketing category ANDA
Marketing start 2024-05-17
Marketing end 2027-01-31
Substance IMATINIB MESYLATE
Active strength 400 mg/1
Pharmacologic classes Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]
NDC exclude flag No
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212135-001 IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 A212135-002 IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-08-01 22:54:32 2026-06 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A212135-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A212135-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base imatinib mesylate Active Ingredients# Ingredient, Strength table Ingredient Strength IMATINIB MESYLATE 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8A1O1M485B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403878 Internal RxNorm lookup 403879 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 0832-0533-03 imatinib mesylate 30 in 1 BOTTLE TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-0533 IMATINIB MESYLATE TABLET [UPSHER-SMITH LABORATORIES, LLC] 2 Current NDC, 1 package rows 20241207_5d07ac08-962e-41a8-8a3c-50febc8c5f34.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0832-0533-03 00832053303 30 TABLET in 1 BOTTLE (0832-0533-03) 30 tablet 2024-05-17 2027-01-31 No No Historical