NDC Code(s) : 65580-301-03, 65580-301-09, 65580-302-03, 65580-302-09, 65580-303-03, 65580-303-09, 65580-304-03, 65580-304-09
Packager : Upstate Pharma, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

venlafaxine hydrochloridevenlafaxine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65580-301
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
venlafaxine hydrochloride(UNII: 7D7RX5A8MO)
(venlafaxine - UNII:GRZ5RCB1QG) 		venlafaxine37.5 mg
Inactive Ingredients
Ingredient Name Strength
mannitol(UNII: 3OWL53L36A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
silicon dioxide(UNII: ETJ7Z6XBU4)
magnesium stearate(UNII: 70097M6I30)
cellulose acetate(UNII: 3J2P07GVB6)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
titanium dioxide(UNII: 15FIX9V2JP)
triacetin(UNII: XHX3C3X673)
ferrosoferric oxide(UNII: XM0M87F357)
propylene glycol(UNII: 6DC9Q167V3)
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 8 mm
Flavor Imprint Code OS301
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65580-301-0330 in 1 BOTTLE Type 0: Not a Combination Product30/09/2008
2NDC:65580-301-0990 in 1 BOTTLE Type 0: Not a Combination Product30/09/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022104 09/30/2008 12/31/2017
venlafaxine hydrochloridevenlafaxine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65580-302
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
venlafaxine hydrochloride(UNII: 7D7RX5A8MO)
(venlafaxine - UNII:GRZ5RCB1QG) 		venlafaxine75 mg
Inactive Ingredients
Ingredient Name Strength
mannitol(UNII: 3OWL53L36A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
silicon dioxide(UNII: ETJ7Z6XBU4)
magnesium stearate(UNII: 70097M6I30)
cellulose acetate(UNII: 3J2P07GVB6)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
titanium dioxide(UNII: 15FIX9V2JP)
triacetin(UNII: XHX3C3X673)
ferrosoferric oxide(UNII: XM0M87F357)
propylene glycol(UNII: 6DC9Q167V3)
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 8 mm
Flavor Imprint Code OS302
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65580-302-0330 in 1 BOTTLE Type 0: Not a Combination Product30/09/2008
2NDC:65580-302-0990 in 1 BOTTLE Type 0: Not a Combination Product30/09/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022104 09/30/2008 12/31/2017
venlafaxine hydrochloridevenlafaxine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65580-303
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
venlafaxine hydrochloride(UNII: 7D7RX5A8MO)
(venlafaxine - UNII:GRZ5RCB1QG) 		venlafaxine150 mg
Inactive Ingredients
Ingredient Name Strength
mannitol(UNII: 3OWL53L36A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
silicon dioxide(UNII: ETJ7Z6XBU4)
magnesium stearate(UNII: 70097M6I30)
cellulose acetate(UNII: 3J2P07GVB6)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
titanium dioxide(UNII: 15FIX9V2JP)
triacetin(UNII: XHX3C3X673)
ferrosoferric oxide(UNII: XM0M87F357)
propylene glycol(UNII: 6DC9Q167V3)
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 10 mm
Flavor Imprint Code OS303
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65580-303-0330 in 1 BOTTLE Type 0: Not a Combination Product30/09/2008
2NDC:65580-303-0990 in 1 BOTTLE Type 0: Not a Combination Product30/09/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022104 09/30/2008 01/31/2018
venlafaxine hydrochloridevenlafaxine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65580-304
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
venlafaxine hydrochloride(UNII: 7D7RX5A8MO)
(venlafaxine - UNII:GRZ5RCB1QG) 		venlafaxine225 mg
Inactive Ingredients
Ingredient Name Strength
mannitol(UNII: 3OWL53L36A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
silicon dioxide(UNII: ETJ7Z6XBU4)
magnesium stearate(UNII: 70097M6I30)
cellulose acetate(UNII: 3J2P07GVB6)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
titanium dioxide(UNII: 15FIX9V2JP)
triacetin(UNII: XHX3C3X673)
ferrosoferric oxide(UNII: XM0M87F357)
propylene glycol(UNII: 6DC9Q167V3)
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 11 mm
Flavor Imprint Code OS304
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65580-304-0330 in 1 BOTTLE Type 0: Not a Combination Product30/09/2008
2NDC:65580-304-0990 in 1 BOTTLE Type 0: Not a Combination Product30/09/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022104 09/30/2008 07/31/2018

PRINCIPAL DISPLAY PANEL

NDC 65580-301-03
Rx Only

Venlafaxine
Extended Release
Tablets
(VENLAFAXINE
HYDROCHLORIDE)

37.5 mg*
*present as venlafaxine hydrochloride

Note to authorized dispenser:
Each time Venlafaxine
Extended Release Tablets are
dispensed, give the patient the
attached Medication Guide.

Unit of Use
30
Tablets

PRINCIPAL DISPLAY PANEL - 37.5 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 65580-302-03
Rx Only

Venlafaxine
Extended Release
Tablets
(VENLAFAXINE
HYDROCHLORIDE)

75 mg*
*present as venlafaxine hydrochloride

Note to authorized dispenser:
Each time Venlafaxine
Extended Release Tablets are
dispensed, give the patient the
attached Medication Guide.

Unit of Use
30
Tablets

Principal Display Panel - 75 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 65580-303-03
Rx Only

Venlafaxine
Extended Release
Tablets
(VENLAFAXINE
HYDROCHLORIDE)

150 mg*
*present as venlafaxine hydrochloride

Note to authorized dispenser:
Each time Venlafaxine
Extended Release Tablets are
dispensed, give the patient the
attached Medication Guide.

Unit of Use
30
Tablets

Principal Display Panel - 150 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 65580-304-03
Rx Only

Venlafaxine
Extended Release
Tablets
(VENLAFAXINE
HYDROCHLORIDE)

225 mg*
*present as venlafaxine hydrochloride

Note to authorized dispenser:
Each time Venlafaxine
Extended Release Tablets are
dispensed, give the patient the
attached Medication Guide.

Unit of Use
30
Tablets

Principal Display Panel - 225 mg Tablet Bottle Label