gefitinib

Generic: gefitinib

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

Drug Facts

Product Profile

Brand Name gefitinib
Generic Name gefitinib
Labeler natco pharma usa llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gefitinib 250 mg/1

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-168
Product ID 69339-168_210d9dcf-53f2-4dba-9d4e-6a072a153777
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212827
Listing Expiration 2027-12-31
Marketing Start 2023-06-05

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 69339168
Hyphenated Format 69339-168

Supplemental Identifiers

RxCUI
349472
UPC
0369339168035
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 ANDA212827 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03)
source: ndc

Packages (1)

69339-168-03 30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03)

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": "210d9dcf-53f2-4dba-9d4e-6a072a153777", "openfda": {"nui": ["N0000175605", "N0000175076"], "upc": ["0369339168035"], "unii": ["S65743JHBS"], "rxcui": ["349472"], "spl_set_id": ["1a3c0ce7-06a1-4e04-9106-14ddb2a866a5"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Natco Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03)", "package_ndc": "69339-168-03", "marketing_start_date": "20230605"}], "brand_name": "Gefitinib", "product_id": "69339-168_210d9dcf-53f2-4dba-9d4e-6a072a153777", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "69339-168", "generic_name": "Gefitinib", "labeler_name": "Natco Pharma USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gefitinib", "active_ingredients": [{"name": "GEFITINIB", "strength": "250 mg/1"}], "application_number": "ANDA212827", "marketing_category": "ANDA", "marketing_start_date": "20230605", "listing_expiration_date": "20271231"}