NDC Code(s) : 49349-452-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-452(NDC:0093-7386)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE(UNII: 7D7RX5A8MO)
(VENLAFAXINE - UNII:GRZ5RCB1QG) 		VENLAFAXINE HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE (7 MPA.S)(UNII: H3UP11403C)
GELATIN(UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POVIDONE K30(UNII: U725QWY32X)
SHELLAC(UNII: 46N107B71O)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color orange Score no score
Shape CAPSULE (CAPSULE, EXTENDED RELEASE) Size 24 mm
Flavor Imprint Code 93;7386
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-452-0230 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076565 08/04/2011

PRINCIPAL DISPLAY PANEL

DRUG: Venlafaxine Hydrochloride
GENERIC: Venlafaxine Hydrochloride
DOSAGE: CAPSULE, EXTENDED RELEASE
ADMINSTRATION: ORAL
NDC: 49349-452-02
STRENGTH:150 mg
COLOR: orange
SHAPE: CAPSULE
SCORE: No score
SIZE: 24 mm
IMPRINT: 30
QTY: 30

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