imatinib mesylate

Generic: imatinib

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

imatinib mesylate 400 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-2246
Product ID 0378-2246_86b69589-5392-4ffc-9628-86610603c039
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204644
Listing Expiration 2026-12-31
Marketing Start 2017-09-28

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 03782246
Hyphenated Format 0378-2246

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 (source: ndc)
Application Number ANDA204644 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2246-93)
source: ndc

Packages (1)

0378-2246-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2246-93)

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": "86b69589-5392-4ffc-9628-86610603c039", "openfda": {"unii": ["8A1O1M485B"], "rxcui": ["403878", "403879"], "spl_set_id": ["a1787fad-3612-43e1-98fa-ce62361e0b3c"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2246-93)", "package_ndc": "0378-2246-93", "marketing_start_date": "20170928"}], "brand_name": "Imatinib Mesylate", "product_id": "0378-2246_86b69589-5392-4ffc-9628-86610603c039", "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": "0378-2246", "generic_name": "imatinib", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imatinib Mesylate", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "400 mg/1"}], "application_number": "ANDA204644", "marketing_category": "ANDA", "marketing_start_date": "20170928", "listing_expiration_date": "20261231"}