imatinib mesylate

Generic: imatinib mesylate

Labeler: archis pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imatinib mesylate
Generic Name imatinib mesylate
Labeler archis pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

imatinib mesylate 100 mg/1

Manufacturer
Archis Pharma LLC

Identifiers & Regulatory

Product NDC 72819-185
Product ID 72819-185_05dbf49e-73b7-3190-e063-6394a90a1a64
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212135
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

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 72819185
Hyphenated Format 72819-185

Supplemental Identifiers

RxCUI
403878 403879
UPC
0372819185095 0372819186030
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 ANDA212135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (72819-185-09)
source: ndc

Packages (1)

72819-185-09 90 TABLET in 1 BOTTLE (72819-185-09)

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": "05dbf49e-73b7-3190-e063-6394a90a1a64", "openfda": {"upc": ["0372819185095", "0372819186030"], "unii": ["8A1O1M485B"], "rxcui": ["403878", "403879"], "spl_set_id": ["9de8d8b9-cf88-4960-82b7-89e5ceb7720e"], "manufacturer_name": ["Archis Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (72819-185-09)", "package_ndc": "72819-185-09", "marketing_start_date": "20220901"}], "brand_name": "imatinib mesylate", "product_id": "72819-185_05dbf49e-73b7-3190-e063-6394a90a1a64", "dosage_form": "TABLET", "pharm_class": ["Bcr-Abl Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "72819-185", "generic_name": "imatinib mesylate", "labeler_name": "Archis Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "imatinib mesylate", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "100 mg/1"}], "application_number": "ANDA212135", "marketing_category": "ANDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}