DAPAGLIFLOZIN tablet

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dapagliflozin Tablets, 5 mg

NDC: 70771-1714-3

Bottles of 30 tablets

Rx only

Dapagliflozin Tablets, 10 mg

NDC: 70771-1715-3

Bottles of 30 tablets

Rx only

INGREDIENTS AND APPEARANCE

DAPAGLIFLOZIN 
dapagliflozin tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1714
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DAPAGLIFLOZIN (UNII: 1ULL0QJ8UC) (DAPAGLIFLOZIN - UNII:1ULL0QJ8UC)	DAPAGLIFLOZIN	5 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	1380
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1714-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2026
2	NDC: 70771-1714-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211582	04/06/2026

DAPAGLIFLOZIN 
dapagliflozin tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1715
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DAPAGLIFLOZIN (UNII: 1ULL0QJ8UC) (DAPAGLIFLOZIN - UNII:1ULL0QJ8UC)	DAPAGLIFLOZIN	10 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	1381
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1715-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2026
2	NDC: 70771-1715-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211582	04/06/2026

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1714, 70771-1715) , MANUFACTURE(70771-1714, 70771-1715)