NDC Code(s) : 0003-1427-11, 0003-1427-12, 0003-1427-13, 0003-1427-14, 0003-1427-91, 0003-1428-11, 0003-1428-12, 0003-1428-13, 0003-1428-14, 0003-1428-91
Packager : E.R. Squibb & Sons, L.L.C.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FARXIGADAPAGLIFLOZIN TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0003-1427
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPAGLIFLOZIN PROPANEDIOL(UNII: 887K2391VH)
(dapagliflozin - UNII:1ULL0QJ8UC) 		dapagliflozin5 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline(UNII: OP1R32D61U)
anhydrous lactose(UNII: 3SY5LH9PMK)
crospovidone(UNII: 68401960MK)
silicon dioxide(UNII: ETJ7Z6XBU4)
magnesium stearate(UNII: 70097M6I30)
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 7 mm
Flavor Imprint Code 5;1427
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0003-1427-1130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/01/2014
2NDC:0003-1427-1290 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/01/2014
3NDC:0003-1427-13500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/01/2014
4NDC:0003-1427-1410 in 1 CARTON
410 in 1 BLISTER PACK Type 0: Not a Combination Product08/01/2014
5NDC:0003-1427-911 in 1 CARTON 08/01/2014
57 in 1 BLISTER PACK Type 0: Not a Combination Product08/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202293 01/08/2014 04/30/2017
FARXIGADAPAGLIFLOZIN TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0003-1428
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPAGLIFLOZIN PROPANEDIOL(UNII: 887K2391VH)
(dapagliflozin - UNII:1ULL0QJ8UC) 		dapagliflozin10 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline(UNII: OP1R32D61U)
anhydrous lactose(UNII: 3SY5LH9PMK)
crospovidone(UNII: 68401960MK)
silicon dioxide(UNII: ETJ7Z6XBU4)
magnesium stearate(UNII: 70097M6I30)
Product Characteristics
Color YELLOW Score no score
Shape DIAMOND (biconvenx) Size 11 mm
Flavor Imprint Code 10;1428
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0003-1428-1130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/01/2014
2NDC:0003-1428-1290 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/01/2014
3NDC:0003-1428-13500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/01/2014
4NDC:0003-1428-1410 in 1 CARTON
410 in 1 BLISTER PACK Type 0: Not a Combination Product08/01/2014
5NDC:0003-1428-911 in 1 CARTON 08/01/2014
57 in 1 BLISTER PACK Type 0: Not a Combination Product08/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202293 01/08/2014 08/31/2017

PRINCIPAL DISPLAY PANEL

See How Supplied section for a complete list of available packages of FARXIGA.

30 Tablets
NDC 0003-1427-11
farxiga
(dapagliflozin) tablets
5 mg
Dispense with Medication Guide
Rx only
Bristol-Myers Squibb     AstraZeneca

FARXIGA 5 mg 30s Bottle Label

PRINCIPAL DISPLAY PANEL

30 Tablets
NDC 0003-1428-11
farxiga
(dapagliflozin) tablets
10 mg
Dispense with Medication Guide
Rx only
Bristol-Myers Squibb     AstraZeneca

FARXIGA 10 mg 30s Bottle Label