gefitinib

Generic: gefitinib

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

Drug Facts

Product Profile

Brand Name gefitinib
Generic Name gefitinib
Labeler teva pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gefitinib 250 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-4053
Product ID 0480-4053_94ce2dc4-2b69-4c50-b53e-21e24062903d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208913
Listing Expiration 2026-12-31
Marketing Start 2023-06-21

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 04804053
Hyphenated Format 0480-4053

Supplemental Identifiers

RxCUI
349472
UPC
0304804053560
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 ANDA208913 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0480-4053-56)
source: ndc

Packages (1)

0480-4053-56 30 TABLET, FILM COATED in 1 BOTTLE (0480-4053-56)

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": "94ce2dc4-2b69-4c50-b53e-21e24062903d", "openfda": {"nui": ["N0000175605", "N0000175076"], "upc": ["0304804053560"], "unii": ["S65743JHBS"], "rxcui": ["349472"], "spl_set_id": ["3dd135f0-5db1-4236-9756-04533b66dc9d"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0480-4053-56)", "package_ndc": "0480-4053-56", "marketing_start_date": "20230621"}], "brand_name": "Gefitinib", "product_id": "0480-4053_94ce2dc4-2b69-4c50-b53e-21e24062903d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0480-4053", "generic_name": "Gefitinib", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gefitinib", "active_ingredients": [{"name": "GEFITINIB", "strength": "250 mg/1"}], "application_number": "ANDA208913", "marketing_category": "ANDA", "marketing_start_date": "20230621", "listing_expiration_date": "20261231"}