imatinib mesylate

Generic: imatinib mesylate

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

Drug Facts

Product Profile

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

imatinib mesylate 100 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-296
Product ID 31722-296_4467e670-2d3a-9832-e063-6394a90a569b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212975
Listing Expiration 2026-12-31
Marketing Start 2025-04-14

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 31722296
Hyphenated Format 31722-296

Supplemental Identifiers

RxCUI
403878 403879
UPC
0331722296908 0331722297301
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 ANDA212975 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (31722-296-90)
source: ndc

Packages (1)

Ingredients (1)

imatinib mesylate (100 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4467e670-2d3a-9832-e063-6394a90a569b", "openfda": {"upc": ["0331722296908", "0331722297301"], "unii": ["8A1O1M485B"], "rxcui": ["403878", "403879"], "spl_set_id": ["e97f0238-b9da-46af-83a3-0826e39893e8"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (31722-296-90)", "package_ndc": "31722-296-90", "marketing_start_date": "20250414"}], "brand_name": "IMATINIB MESYLATE", "product_id": "31722-296_4467e670-2d3a-9832-e063-6394a90a569b", "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": "31722-296", "generic_name": "IMATINIB MESYLATE", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMATINIB MESYLATE", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "100 mg/1"}], "application_number": "ANDA212975", "marketing_category": "ANDA", "marketing_start_date": "20250414", "listing_expiration_date": "20261231"}