gefitinib

Generic: gefitinib

Labeler: qilu pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gefitinib
Generic Name gefitinib
Labeler qilu pharmaceutical co., ltd.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

gefitinib 250 mg/1

Manufacturer
Qilu Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 67184-0531
Product ID 67184-0531_8aa73f33-2813-4dfa-939f-e4291081449a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211591
Listing Expiration 2026-12-31
Marketing Start 2023-02-13

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 671840531
Hyphenated Format 67184-0531

Supplemental Identifiers

RxCUI
349472
UPC
0367184053124
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 (67184-0531-1)
  • 500 TABLET, COATED in 1 BOTTLE (67184-0531-2)
  • 3 BLISTER PACK in 1 CARTON (67184-0531-3) / 10 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (3)

67184-0531-1 30 TABLET, COATED in 1 BOTTLE (67184-0531-1) 67184-0531-2 500 TABLET, COATED in 1 BOTTLE (67184-0531-2) 67184-0531-3 3 BLISTER PACK in 1 CARTON (67184-0531-3) / 10 TABLET, COATED in 1 BLISTER PACK

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": "8aa73f33-2813-4dfa-939f-e4291081449a", "openfda": {"nui": ["N0000175605", "N0000175076"], "upc": ["0367184053124"], "unii": ["S65743JHBS"], "rxcui": ["349472"], "spl_set_id": ["0afc12dd-12f8-4def-9027-f38412a862b9"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Qilu Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (67184-0531-1)", "package_ndc": "67184-0531-1", "marketing_start_date": "20230213"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (67184-0531-2)", "package_ndc": "67184-0531-2", "marketing_start_date": "20230213"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (67184-0531-3)  / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "67184-0531-3", "marketing_start_date": "20230213"}], "brand_name": "Gefitinib", "product_id": "67184-0531_8aa73f33-2813-4dfa-939f-e4291081449a", "dosage_form": "TABLET, COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "67184-0531", "generic_name": "Gefitinib", "labeler_name": "Qilu Pharmaceutical Co., Ltd.", "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": "20230213", "listing_expiration_date": "20261231"}