imatinib mesylate

Generic: imatinib mesylate

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imatinib mesylate
Generic Name imatinib mesylate
Labeler apotex corp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

imatinib mesylate 400 mg/1

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-2901
Product ID 60505-2901_0bbdf523-ac79-a5cf-7e2b-73426c1f268e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079179
Listing Expiration 2027-12-31
Marketing Start 2016-08-05

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 605052901
Hyphenated Format 60505-2901

Supplemental Identifiers

RxCUI
403878 403879
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 ANDA079179 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (60505-2901-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 100 TABLET, FILM COATED in 1 BOTTLE (60505-2901-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (60505-2901-3)
  • 500 TABLET, FILM COATED in 1 BOTTLE (60505-2901-5)
  • 90 TABLET, FILM COATED in 1 BOTTLE (60505-2901-9)
source: ndc

Packages (5)

60505-2901-0 10 BLISTER PACK in 1 CARTON (60505-2901-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK 60505-2901-1 100 TABLET, FILM COATED in 1 BOTTLE (60505-2901-1) 60505-2901-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-2901-3) 60505-2901-5 500 TABLET, FILM COATED in 1 BOTTLE (60505-2901-5) 60505-2901-9 90 TABLET, FILM COATED in 1 BOTTLE (60505-2901-9)

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": "0bbdf523-ac79-a5cf-7e2b-73426c1f268e", "openfda": {"unii": ["8A1O1M485B"], "rxcui": ["403878", "403879"], "spl_set_id": ["0291eca5-7a1d-4a79-30be-252224d96509"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (60505-2901-0)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "60505-2901-0", "marketing_start_date": "20160805"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (60505-2901-1)", "package_ndc": "60505-2901-1", "marketing_start_date": "20160805"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60505-2901-3)", "package_ndc": "60505-2901-3", "marketing_start_date": "20160805"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (60505-2901-5)", "package_ndc": "60505-2901-5", "marketing_start_date": "20160805"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (60505-2901-9)", "package_ndc": "60505-2901-9", "marketing_start_date": "20160805"}], "brand_name": "Imatinib Mesylate", "product_id": "60505-2901_0bbdf523-ac79-a5cf-7e2b-73426c1f268e", "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": "60505-2901", "generic_name": "Imatinib Mesylate", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imatinib Mesylate", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "400 mg/1"}], "application_number": "ANDA079179", "marketing_category": "ANDA", "marketing_start_date": "20160805", "listing_expiration_date": "20271231"}