Vardenafil Hydrochloride (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

NDC 69238-1151-3

Vardenafil hydrochloride Tablets, 5 mg

Rx only

30 Tablets

Amneal Pharmaceuticals LLC

5 mg
(click image for full-size original)

NDC 69238-1152-3

Vardenafil hydrochloride Tablets, 10 mg

Rx only

30 Tablets

Amneal Pharmaceuticals LLC

10 mg
(click image for full-size original)

NDC 69238-1153-3

Vardenafil hydrochloride Tablets, 20 mg

Rx only

30 Tablets

Amneal Pharmaceuticals LLC

20 mg
(click image for full-size original)

VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1151
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARDENAFIL HYDROCHLORIDE (VARDENAFIL) VARDENAFIL 5 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 5mm
Flavor Imprint Code AC18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1151-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210738 10/31/2018
VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1152
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARDENAFIL HYDROCHLORIDE (VARDENAFIL) VARDENAFIL 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code AC19
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1152-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210738 10/31/2018
VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1153
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARDENAFIL HYDROCHLORIDE (VARDENAFIL) VARDENAFIL 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code AC20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1153-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210738 10/31/2018
Labeler — Amneal Pharmaceuticals NY LLC (123797875)

Revised: 12/2020 Amneal Pharmaceuticals NY LLC

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