NDC Code(s) : 68788-9425-2, 68788-9425-3, 68788-9425-6, 68788-9425-9, 68788-9425-1, 68788-9425-8
Packager : Preferred Pharmaceuticals, 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:68788-9425(NDC:60505-3778)
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
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
GELATIN(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
Product Characteristics
Color ORANGE (PEACH), GRAY (GRAY) Score no score
Shape CAPSULE (CAPSULE) Size 16 mm
Flavor Imprint Code EffexorXR;375
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-9425-220 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:68788-9425-330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:68788-9425-660 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
4NDC:68788-9425-990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
5NDC:68788-9425-1100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
6NDC:68788-9425-8120 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020699 04/18/2014

PRINCIPAL DISPLAY PANEL

NDC 68788-9425

Venlafaxine Hydrochloride
Extended-Release Capsules

37.5 mg*

SEALED FOR YOUR PROTECTION

DISPENSE WITH ATTACHED
MEDICATION GUIDE

Rx Only

APOTEX CORP.
Capsules

Repackaged By: Preferred Pharmaceuticals Inc.

Venlafaxine HCl Extended-Release Capsules 37.5mg