NDC Code(s) : 69189-0527-1
Packager : Avera McKennan Hospital

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:69189-0527(NDC:65862-527)
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
ETHYLCELLULOSE (20 MPA.S)(UNII: BJG0S321QY)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color GRAY (Opaque Grey), ORANGE (Opaque Peach) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code E;73
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-0527-11 in 1 DOSE PACK Type 0: Not a Combination Product21/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200834 01/21/2016

PRINCIPAL DISPLAY PANEL

Venlafaxine XR 37.5 mg capsule