imatinib mesylate

Generic: imatinib mesylate

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imatinib mesylate
Generic Name imatinib mesylate
Labeler upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

imatinib mesylate 400 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-0533
Product ID 0832-0533_47f6137e-e0ea-4ada-e063-6394a90a37b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212135
Marketing Start 2024-05-17
Marketing End 2027-01-31

Pharmacologic Class

Classes
bcr-abl tyrosine kinase inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] kinase inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08320533
Hyphenated Format 0832-0533

Supplemental Identifiers

RxCUI
403878 403879
UPC
0308320533032
UNII
8A1O1M485B

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name imatinib mesylate (source: ndc)
Generic Name imatinib mesylate (source: ndc)
Application Number ANDA212135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0832-0533-03)
source: ndc

Packages (1)

0832-0533-03 30 TABLET in 1 BOTTLE (0832-0533-03)

Ingredients (1)

imatinib mesylate (400 mg/1)

Linked Drug Pages (1)

imatinib mesylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47f6137e-e0ea-4ada-e063-6394a90a37b5", "openfda": {"upc": ["0308320533032"], "unii": ["8A1O1M485B"], "rxcui": ["403878", "403879"], "spl_set_id": ["5d07ac08-962e-41a8-8a3c-50febc8c5f34"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0832-0533-03)", "package_ndc": "0832-0533-03", "marketing_end_date": "20270131", "marketing_start_date": "20240517"}], "brand_name": "imatinib mesylate", "product_id": "0832-0533_47f6137e-e0ea-4ada-e063-6394a90a37b5", "dosage_form": "TABLET", "pharm_class": ["Bcr-Abl Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "0832-0533", "generic_name": "imatinib mesylate", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "imatinib mesylate", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "400 mg/1"}], "application_number": "ANDA212135", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "20240517"}