iressa

Generic: gefitinib

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name iressa
Generic Name gefitinib
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

gefitinib 250 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-0482
Product ID 0310-0482_508019dd-61d5-4459-9476-3f5897143f0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206995
Listing Expiration 2026-12-31
Marketing Start 2015-07-13

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 03100482
Hyphenated Format 0310-0482

Supplemental Identifiers

RxCUI
349472 402091
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 iressa (source: ndc)
Generic Name gefitinib (source: ndc)
Application Number NDA206995 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (0310-0482-30)
source: ndc

Packages (1)

0310-0482-30 30 TABLET, COATED in 1 BOTTLE (0310-0482-30)

Ingredients (1)

gefitinib (250 mg/1)

Linked Drug Pages (1)

IRESSA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "508019dd-61d5-4459-9476-3f5897143f0c", "openfda": {"nui": ["N0000175605", "N0000175076"], "unii": ["S65743JHBS"], "rxcui": ["349472", "402091"], "spl_set_id": ["827d60e8-7e07-41b7-c28b-49ef1c4a5a41"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (0310-0482-30)", "package_ndc": "0310-0482-30", "marketing_start_date": "20150713"}], "brand_name": "IRESSA", "product_id": "0310-0482_508019dd-61d5-4459-9476-3f5897143f0c", "dosage_form": "TABLET, COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0310-0482", "generic_name": "Gefitinib", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IRESSA", "active_ingredients": [{"name": "GEFITINIB", "strength": "250 mg/1"}], "application_number": "NDA206995", "marketing_category": "NDA", "marketing_start_date": "20150713", "listing_expiration_date": "20261231"}