NDC 0310-0482

IRESSA

Gefitinib

IRESSA is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Gefitinib.

• Product ID: 0310-0482_61b48704-3a33-4daa-8b6c-67cf694d525a
• NDC: 0310-0482
• Product Type: Human Prescription Drug
• Proprietary Name: IRESSA
• Generic Name: Gefitinib
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-07-13
• Marketing Category: NDA / NDA
• Application Number: NDA206995
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: GEFITINIB
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0310-0482-30

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

• Marketing Start Date: 2015-07-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-0482-93 [00310048293]

IRESSA TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA206995
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-25
• Marketing End Date: 2019-08-31

NDC 0310-0482-30 [00310048230]

IRESSA TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA206995
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-13

Drug Details

Active Ingredients

Ingredient	Strength
GEFITINIB	250 mg/1

OpenFDA Data

• SPL SET ID: 827d60e8-7e07-41b7-c28b-49ef1c4a5a41
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • S65743JHBS
• RxNorm Concept Unique ID - RxCUI:
  • 402091
  • 349472

Pharmacological Class

• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]