gleevec

Generic: imatinib mesylate

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gleevec
Generic Name imatinib mesylate
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET
Routes
ORAL
Active Ingredients

imatinib mesylate 400 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0649
Product ID 0078-0649_cbc7561e-5e16-4e05-9c07-52626c43eafc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021588
Listing Expiration 2027-12-31
Marketing Start 2014-12-23

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 00780649
Hyphenated Format 0078-0649

Supplemental Identifiers

RxCUI
403878 403879 404588 404589
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 gleevec (source: ndc)
Generic Name imatinib mesylate (source: ndc)
Application Number NDA021588 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (0078-0649-13) / 10 TABLET in 1 BLISTER PACK (0078-0649-26)
  • 30 TABLET in 1 BOX, UNIT-DOSE (0078-0649-30)
source: ndc

Packages (2)

0078-0649-13 3 BLISTER PACK in 1 CARTON (0078-0649-13) / 10 TABLET in 1 BLISTER PACK (0078-0649-26) 0078-0649-30 30 TABLET in 1 BOX, UNIT-DOSE (0078-0649-30)

Ingredients (1)

imatinib mesylate (400 mg/1)

Linked Drug Pages (1)

Gleevec ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cbc7561e-5e16-4e05-9c07-52626c43eafc", "openfda": {"unii": ["8A1O1M485B"], "rxcui": ["403878", "403879", "404588", "404589"], "spl_set_id": ["211ef2da-2868-4a77-8055-1cb2cd78e24b"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0078-0649-13)  / 10 TABLET in 1 BLISTER PACK (0078-0649-26)", "package_ndc": "0078-0649-13", "marketing_start_date": "20240301"}, {"sample": false, "description": "30 TABLET in 1 BOX, UNIT-DOSE (0078-0649-30)", "package_ndc": "0078-0649-30", "marketing_end_date": "20261231", "marketing_start_date": "20141223"}], "brand_name": "Gleevec", "product_id": "0078-0649_cbc7561e-5e16-4e05-9c07-52626c43eafc", "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": "0078-0649", "generic_name": "imatinib mesylate", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gleevec", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "400 mg/1"}], "application_number": "NDA021588", "marketing_category": "NDA", "marketing_start_date": "20141223", "listing_expiration_date": "20271231"}