gefitinib

Generic: gefitinib

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gefitinib
Generic Name gefitinib
Labeler ingenus pharmaceuticals, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

gefitinib 250 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-366
Product ID 50742-366_932e3701-75ae-438f-bb6a-2c2662c73ee5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211591
Listing Expiration 2026-12-31
Marketing Start 2023-04-27

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742366
Hyphenated Format 50742-366

Supplemental Identifiers

RxCUI
349472
UNII
S65743JHBS
NUI
N0000175605 N0000175076

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 gefitinib (source: ndc)
Generic Name gefitinib (source: ndc)
Application Number ANDA211591 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (50742-366-30)
source: ndc

Packages (1)

50742-366-30 30 TABLET, COATED in 1 BOTTLE (50742-366-30)

Ingredients (1)

gefitinib (250 mg/1)

Linked Drug Pages (1)

Gefitinib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "932e3701-75ae-438f-bb6a-2c2662c73ee5", "openfda": {"nui": ["N0000175605", "N0000175076"], "unii": ["S65743JHBS"], "rxcui": ["349472"], "spl_set_id": ["6402435f-9f6a-4f02-91a2-6267d783fa78"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (50742-366-30)", "package_ndc": "50742-366-30", "marketing_start_date": "20230427"}], "brand_name": "Gefitinib", "product_id": "50742-366_932e3701-75ae-438f-bb6a-2c2662c73ee5", "dosage_form": "TABLET, COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "50742-366", "generic_name": "Gefitinib", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gefitinib", "active_ingredients": [{"name": "GEFITINIB", "strength": "250 mg/1"}], "application_number": "ANDA211591", "marketing_category": "ANDA", "marketing_start_date": "20230427", "listing_expiration_date": "20261231"}