imatinib mesylate 400 mg

Generic: imatinib mesylate

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

Drug Facts

Product Profile

Brand Name imatinib mesylate 400 mg
Generic Name imatinib mesylate
Labeler armas pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

imatinib mesylate 400 mg/1

Manufacturer
Armas Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72485-203
Product ID 72485-203_2e636646-af84-4711-84b4-9092bb51ca8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208302
Listing Expiration 2026-12-31
Marketing Start 2019-03-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485203
Hyphenated Format 72485-203

Supplemental Identifiers

RxCUI
403879
UPC
0372485203307
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 400 mg (source: ndc)
Generic Name imatinib mesylate (source: ndc)
Application Number ANDA208302 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72485-203-30)
source: ndc

Packages (1)

72485-203-30 30 TABLET, FILM COATED in 1 BOTTLE (72485-203-30)

Ingredients (1)

imatinib mesylate (400 mg/1)

Linked Drug Pages (1)

Imatinib mesylate 400 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2e636646-af84-4711-84b4-9092bb51ca8a", "openfda": {"upc": ["0372485203307"], "unii": ["8A1O1M485B"], "rxcui": ["403879"], "spl_set_id": ["7b7cc194-29e4-4484-a364-a1ac7d7d6cf5"], "manufacturer_name": ["Armas Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72485-203-30)", "package_ndc": "72485-203-30", "marketing_start_date": "20190315"}], "brand_name": "Imatinib mesylate 400 mg", "product_id": "72485-203_2e636646-af84-4711-84b4-9092bb51ca8a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "72485-203", "generic_name": "imatinib mesylate", "labeler_name": "Armas Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imatinib mesylate", "brand_name_suffix": "400 mg", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "400 mg/1"}], "application_number": "ANDA208302", "marketing_category": "ANDA", "marketing_start_date": "20190315", "listing_expiration_date": "20261231"}