imatinib mesylate

Generic: imatinib mesylate

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

imatinib mesylate 400 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-659
Product ID 62135-659_459cd0de-3b95-ca25-e063-6294a90a9854
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208429
Listing Expiration 2026-12-31
Marketing Start 2019-01-17

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 62135659
Hyphenated Format 62135-659

Supplemental Identifiers

RxCUI
403878 403879
UPC
0362135658908 0362135659301
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 ANDA208429 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (62135-659-30)
source: ndc

Packages (1)

62135-659-30 30 TABLET, FILM COATED in 1 BOTTLE (62135-659-30)

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": "459cd0de-3b95-ca25-e063-6294a90a9854", "openfda": {"upc": ["0362135658908", "0362135659301"], "unii": ["8A1O1M485B"], "rxcui": ["403878", "403879"], "spl_set_id": ["65b4d8a6-349d-4fb1-9818-dad6b4ad4fa1"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62135-659-30)", "package_ndc": "62135-659-30", "marketing_start_date": "20240228"}], "brand_name": "Imatinib Mesylate", "product_id": "62135-659_459cd0de-3b95-ca25-e063-6294a90a9854", "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": "62135-659", "generic_name": "Imatinib Mesylate", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imatinib Mesylate", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "400 mg/1"}], "application_number": "ANDA208429", "marketing_category": "ANDA", "marketing_start_date": "20190117", "listing_expiration_date": "20261231"}