PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1047-3

Vardenafil Tablets, 2.5 mg

30 Tablets

Rx only

NDC 70771-1048-3

Vardenafil Tablets, 5 mg

30 Tablets

Rx only

NDC 70771-1049-3

Vardenafil Tablets, 10 mg

30 Tablets

Rx only

NDC 70771-1050-3

Vardenafil Tablets, 20 mg

30 Tablets

Rx only

VARDENAFIL
vardenafil tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1047
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H)	VARDENAFIL	2.5 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	5mm
Flavor		Imprint Code	10;68
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1047-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018
2	NDC:70771-1047-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018
3	NDC:70771-1047-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208960	11/01/2018

VARDENAFIL
vardenafil tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1048
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H)	VARDENAFIL	5 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (LIGHT YELLOW)	Score	no score
Shape	ROUND (ROUND)	Size	5mm
Flavor		Imprint Code	10;69
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1048-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018
2	NDC:70771-1048-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018
3	NDC:70771-1048-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208960	11/01/2018

VARDENAFIL
vardenafil tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1049
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H)	VARDENAFIL	10 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (LIGHT YELLOW TO ORANGE)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	10;70
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1049-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018
2	NDC:70771-1049-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018
3	NDC:70771-1049-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208960	11/01/2018

VARDENAFIL
vardenafil tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1050
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H)	VARDENAFIL	20 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (LIGHT YELLOW TO ORANGE)	Score	no score
Shape	ROUND (ROUND)	Size	8mm
Flavor		Imprint Code	10;71
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1050-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018
2	NDC:70771-1050-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018
3	NDC:70771-1050-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208960	11/01/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (863362789)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1047, 70771-1048, 70771-1049, 70771-1050) , MANUFACTURE(70771-1047, 70771-1048, 70771-1049, 70771-1050)

VARDENAFIL HYDROCHLORIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL