Venlafaxine (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Venlafaxine Tablets, USP 25 mg

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Venlafaxine Tablets, USP 37.5 mg

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Venlafaxine Tablets, USP 50 mg

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Venlafaxine Tablets, USP 75 mg

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Venlafaxine Tablets, USP 100 mg

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VENLAFAXINE
venlafaxine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-392
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color PINK (peach) Score 2 pieces
Shape PENTAGON (5 sided) (shield-shaped) Size 6mm
Flavor Imprint Code 392
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-392-88 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078627 06/13/2008
VENLAFAXINE
venlafaxine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-393
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 37.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color PINK (peach) Score 2 pieces
Shape PENTAGON (5 sided) (shield-shaped) Size 7mm
Flavor Imprint Code 393
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-393-88 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078627 06/13/2008
VENLAFAXINE
venlafaxine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-394
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 50 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color PINK (peach) Score 2 pieces
Shape PENTAGON (5 sided) (shield-shaped) Size 8mm
Flavor Imprint Code 394
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-394-88 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078627 06/13/2008
VENLAFAXINE
venlafaxine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-395
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 75 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color PINK (peach) Score 2 pieces
Shape PENTAGON (5 sided) (shield-shaped) Size 9mm
Flavor Imprint Code 395
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-395-88 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078627 06/13/2008
VENLAFAXINE
venlafaxine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-396
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color PINK (peach) Score 2 pieces
Shape PENTAGON (5 sided) (shield-shaped) Size 10mm
Flavor Imprint Code 396
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-396-88 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078627 06/13/2008
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
ALKALOIDA chemical company Zrt 643611692 ANALYSIS (57664-392), ANALYSIS (57664-393), ANALYSIS (57664-394), ANALYSIS (57664-395), ANALYSIS (57664-396), MANUFACTURE (57664-392), MANUFACTURE (57664-393), MANUFACTURE (57664-394), MANUFACTURE (57664-395), MANUFACTURE (57664-396), PACK (57664-392), PACK (57664-393), PACK (57664-394), PACK (57664-395), PACK (57664-396)

Revised: 11/2021 Sun Pharmaceutical Industries, Inc.

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