Vilazodone Hydrochloride: Package Insert and Label Information (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 0480-2045-56

Vilazodone Hydrochloride Tablets

10 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Tablets

10mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0480-2044-56

Vilazodone Hydrochloride Tablets

20 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Tablets

1
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0480-2043-56

Vilazodone Hydrochloride Tablets

40 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Tablets

40mg
(click image for full-size original)

VILAZODONE HYDROCHLORIDE vilazodone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-2045
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VILAZODONE HYDROCHLORIDE (VILAZODONE) VILAZODONE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color pink Score no score
Shape OVAL Size 9mm
Flavor Imprint Code TV;V7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-2045-56 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208212 06/06/2022
VILAZODONE HYDROCHLORIDE vilazodone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-2044
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VILAZODONE HYDROCHLORIDE (VILAZODONE) VILAZODONE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color brown (beige) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code TV;V71
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-2044-56 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208212 06/06/2022
VILAZODONE HYDROCHLORIDE vilazodone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-2043
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VILAZODONE HYDROCHLORIDE (VILAZODONE) VILAZODONE HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color blue Score no score
Shape OVAL Size 14mm
Flavor Imprint Code TV;V72
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-2043-56 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208212 06/06/2022
Labeler — Teva Pharmaceuticals, Inc. (022629579)

Revised: 01/2022 Teva Pharmaceuticals, Inc.

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