imatinib mesylate

Generic: imatinib mesylate

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imatinib mesylate
Generic Name imatinib mesylate
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

imatinib mesylate 400 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-7630
Product ID 0093-7630_61665dee-61e1-4d1f-bbee-138f3cf37994
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204285
Listing Expiration 2026-12-31
Marketing Start 2016-08-04

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 00937630
Hyphenated Format 0093-7630

Supplemental Identifiers

RxCUI
403878 403879
UPC
0300937629986 0300937630562
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 ANDA204285 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0093-7630-56)
source: ndc

Packages (1)

0093-7630-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7630-56)

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": "61665dee-61e1-4d1f-bbee-138f3cf37994", "openfda": {"upc": ["0300937629986", "0300937630562"], "unii": ["8A1O1M485B"], "rxcui": ["403878", "403879"], "spl_set_id": ["a9cfc301-3c7f-4910-8813-41dcb0b4ca69"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0093-7630-56)", "package_ndc": "0093-7630-56", "marketing_start_date": "20160804"}], "brand_name": "Imatinib Mesylate", "product_id": "0093-7630_61665dee-61e1-4d1f-bbee-138f3cf37994", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bcr-Abl Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "0093-7630", "generic_name": "Imatinib Mesylate", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imatinib Mesylate", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "400 mg/1"}], "application_number": "ANDA204285", "marketing_category": "ANDA", "marketing_start_date": "20160804", "listing_expiration_date": "20261231"}