imatinib mesylate

Generic: imatinib mesylate

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

imatinib mesylate 100 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-633
Product ID 67877-633_7579620e-3748-46fa-8295-f9b47d0aa5b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208302
Listing Expiration 2026-12-31
Marketing Start 2019-02-01

Pharmacologic Class

Classes
kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877633
Hyphenated Format 67877-633

Supplemental Identifiers

RxCUI
403878 403879
UPC
0367877634302
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 ANDA208302 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (67877-633-90)
source: ndc

Packages (1)

67877-633-90 90 TABLET, FILM COATED in 1 BOTTLE (67877-633-90)

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": "7579620e-3748-46fa-8295-f9b47d0aa5b8", "openfda": {"upc": ["0367877634302"], "unii": ["8A1O1M485B"], "rxcui": ["403878", "403879"], "spl_set_id": ["7579620e-3748-46fa-8295-f9b47d0aa5b8"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (67877-633-90)", "package_ndc": "67877-633-90", "marketing_start_date": "20190201"}], "brand_name": "Imatinib mesylate", "product_id": "67877-633_7579620e-3748-46fa-8295-f9b47d0aa5b8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "67877-633", "generic_name": "imatinib mesylate", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imatinib mesylate", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "100 mg/1"}], "application_number": "ANDA208302", "marketing_category": "ANDA", "marketing_start_date": "20190201", "listing_expiration_date": "20261231"}