IRESSA (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 250 mg

NDC 0310-0482-30 30 tablets

IRESSA®

(gefitinib) tablets

250 mg

Manufactured for:

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

By: AstraZeneca UK Limited

Macclesfield, Cheshire, England

Product of Belgium

AstraZeneca

Iressa 250 mg Bottle Label
(click image for full-size original)
IRESSA
gefitinib tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-0482
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEFITINIB (GEFITINIB) GEFITINIB 250 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 300
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN Score no score
Shape ROUND (biconvex) Size 11mm
Flavor Imprint Code IRESSA;250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-0482-30 30 TABLET, COATED in 1 BOTTLE None
2 NDC:0310-0482-93 30 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206995 07/13/2015
Labeler — AstraZeneca Pharmaceuticals LP (054743190)
Registrant — AstraZeneca PLC (230790719)

Revised: 05/2021 AstraZeneca Pharmaceuticals LP

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