TAGRISSO (Page 8 of 8)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 40 mg

NDC 0310-1349 -30 30 Tablets

Tagrisso ®

(osimertinib) tablets

40 mg per tablet

Rx only

AstraZeneca

Tagrisso_40_mg_tablet_bottle_label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 80 mg

NDC 0310-1350 -30 30 Tablets

Tagrisso ®

(osimertinib) tablets

80 mg per tablet

Rx only

AstraZeneca

Tagrisso 80 mg tablets bottle label
(click image for full-size original)
TAGRISSO osimertinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-1349
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OSIMERTINIB (OSIMERTINIB) OSIMERTINIB 40
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
SODIUM STEARYL FUMARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Product Characteristics
Color BROWN (beige) Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code AZ;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-1349-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208065 11/13/2015
TAGRISSO osimertinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-1350
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OSIMERTINIB (OSIMERTINIB) OSIMERTINIB 80
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
SODIUM STEARYL FUMARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Product Characteristics
Color BROWN (beige) Score no score
Shape OVAL (biconvex) Size 15mm
Flavor Imprint Code AZ;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-1350-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208065 11/13/2015
Labeler — AstraZeneca Pharmaceuticals LP (054743190)
Registrant — AstraZeneca PLC (230790719)

Revised: 07/2021 AstraZeneca Pharmaceuticals LP

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