NDC Code(s) : 60429-121-30, 60429-121-90, 60429-122-30, 60429-122-90, 60429-123-30, 60429-123-90
Packager : Golden State Medical Supply, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Venlafaxine Hydrochloridevenlafaxine hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-121(NDC:68382-034)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSES(UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color GRAY (GRAY), WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 16 mm
Flavor Imprint Code ZA;35;37;5;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-121-3030 in 1 BOTTLE
2NDC:60429-121-9090 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090174 06/12/2013
Venlafaxine Hydrochloridevenlafaxine hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-122(NDC:68382-035)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSES(UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color ORANGE (PEACH), WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 20 mm
Flavor Imprint Code ZA;36;75;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-122-3030 in 1 BOTTLE
2NDC:60429-122-9090 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090174 06/12/2013
Venlafaxine Hydrochloridevenlafaxine hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-123(NDC:68382-036)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSES(UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color ORANGE (Dark Orange), WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 22 mm
Flavor Imprint Code ZA;37;150;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-123-3030 in 1 BOTTLE
2NDC:60429-123-9090 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090174 06/12/2013

PRINCIPAL DISPLAY PANEL

NDC 60429-121-30 in bottle of 30 capsules

Venlafaxine Hydrochloride Extended-release Capsules, 37.5 mg

Rx only

30 capsules

GSMS

Label Grphic-Venlafaxine HCl ER 37.5mg 30s

PRINCIPAL DISPLAY PANEL

NDC 60429-122-30 in bottle of 30 capsules

Venlafaxine Hydrochloride Extended-release Capsules, 75 mg

Rx only

30 capsules

GSMS

Label Graphic-Venlafaxine HCl ER 75mg 30s

PRINCIPAL DISPLAY PANEL

NDC 60429-123-30 in bottle of 30 capsules

Venlafaxine Hydrochloride Extended-release Capsules, 150 mg

Rx only

30 capsules

GSMS

Label Graphic-Venlafaxine HCl ER 150mg 30s