FARXIGA (Page 13 of 13)

PRINCIPAL DISPLAY PANEL – 5 mg tablets

30 Tablets NDC 0310-6205-30
farxiga®
(dapagliflozin) tablets
5 mg
Dispense with
Medication Guide
Rx only AstraZeneca

Farxiga 5 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 10 mg tablets

30 Tablets NDC 0310-6210-30
farxiga®
(dapagliflozin) tablets
10 mg
Dispense with
Medication Guide
Rx only AstraZeneca

Farxiga 10 mg Bottle Label
(click image for full-size original)
FARXIGA dapagliflozin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-6205
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPAGLIFLOZIN PROPANEDIOL (dapagliflozin) dapagliflozin 5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
anhydrous lactose
CROSPOVIDONE, UNSPECIFIED
silicon dioxide
magnesium stearate
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 7mm
Flavor Imprint Code 5;1427
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-6205-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0310-6205-95 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 7 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0310-6205-95)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202293 01/14/2008
FARXIGA dapagliflozin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-6210
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPAGLIFLOZIN PROPANEDIOL (dapagliflozin) dapagliflozin 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
anhydrous lactose
CROSPOVIDONE, UNSPECIFIED
silicon dioxide
magnesium stearate
Product Characteristics
Color YELLOW Score no score
Shape DIAMOND (biconvenx) Size 11mm
Flavor Imprint Code 10;1428
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-6210-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0310-6210-95 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 7 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0310-6210-95)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202293 01/14/2008
Labeler — AstraZeneca Pharmaceuticals LP (054743190)
Registrant — AstraZeneca PLC (230790719)

Revised: 05/2021 AstraZeneca Pharmaceuticals LP

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