imatinib mesylate

Generic: imatinib mesylate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imatinib mesylate
Generic Name imatinib mesylate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

imatinib mesylate 400 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-475
Product ID 47335-475_ad13dbca-474d-4492-9c25-e0e175143d8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078340
Listing Expiration 2026-12-31
Marketing Start 2016-02-01

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 47335475
Hyphenated Format 47335-475

Supplemental Identifiers

RxCUI
403878 403879
UPC
0347335475838 0347335472813
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
  • 400 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (47335-475-13)
  • 3 BLISTER PACK in 1 CARTON (47335-475-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (47335-475-83)
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-475-88)
source: ndc

Packages (4)

47335-475-13 500 TABLET, FILM COATED in 1 BOTTLE (47335-475-13) 47335-475-64 3 BLISTER PACK in 1 CARTON (47335-475-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK 47335-475-83 30 TABLET, FILM COATED in 1 BOTTLE (47335-475-83) 47335-475-88 100 TABLET, FILM COATED in 1 BOTTLE (47335-475-88)

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": "ad13dbca-474d-4492-9c25-e0e175143d8c", "openfda": {"upc": ["0347335475838", "0347335472813"], "unii": ["8A1O1M485B"], "rxcui": ["403878", "403879"], "spl_set_id": ["07764bf9-21b4-4e32-9d7e-e348f8e4291f"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (47335-475-13)", "package_ndc": "47335-475-13", "marketing_start_date": "20160201"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (47335-475-64)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "47335-475-64", "marketing_start_date": "20160201"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (47335-475-83)", "package_ndc": "47335-475-83", "marketing_start_date": "20160201"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-475-88)", "package_ndc": "47335-475-88", "marketing_start_date": "20160201"}], "brand_name": "imatinib mesylate", "product_id": "47335-475_ad13dbca-474d-4492-9c25-e0e175143d8c", "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": "47335-475", "generic_name": "imatinib mesylate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "imatinib mesylate", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "400 mg/1"}], "application_number": "ANDA078340", "marketing_category": "ANDA", "marketing_start_date": "20160201", "listing_expiration_date": "20261231"}