imatinib mesylate

Generic: imatinib mesylate

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

imatinib mesylate 100 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-490
Product ID 68001-490_05c9d227-d639-916a-e063-6294a90a66a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078340
Listing Expiration 2026-12-31
Marketing Start 2021-03-26

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 68001490
Hyphenated Format 68001-490

Supplemental Identifiers

RxCUI
403878 403879
UPC
0368001490054 0368001491044
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 ANDA078340 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (68001-490-05)
source: ndc

Packages (1)

68001-490-05 90 TABLET, FILM COATED in 1 BOTTLE (68001-490-05)

Ingredients (1)

imatinib mesylate (100 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": "05c9d227-d639-916a-e063-6294a90a66a6", "openfda": {"upc": ["0368001490054", "0368001491044"], "unii": ["8A1O1M485B"], "rxcui": ["403878", "403879"], "spl_set_id": ["be5b9047-155b-59ca-e053-2995a90ad3dc"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68001-490-05)", "package_ndc": "68001-490-05", "marketing_start_date": "20210326"}], "brand_name": "imatinib mesylate", "product_id": "68001-490_05c9d227-d639-916a-e063-6294a90a66a6", "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": "68001-490", "generic_name": "imatinib mesylate", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "imatinib mesylate", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "100 mg/1"}], "application_number": "ANDA078340", "marketing_category": "ANDA", "marketing_start_date": "20210326", "listing_expiration_date": "20261231"}