NDC Code(s) : 58118-0092-8, 58118-0093-8, 58118-0094-8
Packager : Clinical Solutions Wholesale, LLC

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:58118-0092(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:58118-0092-830 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200834 06/01/2011
Venlafaxine HydrochlorideVenlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0093(NDC:65862-528)
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
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 orange (Opaque Peach) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code E;74
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-0093-830 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200834 06/01/2011
Venlafaxine HydrochlorideVenlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0094(NDC:65862-697)
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
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 orange (Opaque Dark Orange) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code E;89
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-0094-830 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200834 11/23/2011

PRINCIPAL DISPLAY PANEL

NDC 58118-0092-08
Venlafaxine Hydrochloride
Extended-Release Capsules USP
37.5 mg*
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
Rx only                                   30 Capsules

Venlafaxine HCl ER Caps 37.5mg 30 count blister card

PRINCIPAL DISPLAY PANEL

NDC 58118-0093-08
Venlafaxine Hydrochloride
Extended-Release Capsules USP
75 mg*
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
Rx only                                   30 Capsules

Venlafaxine HCl ER Caps 75mg 30 count blister card

PRINCIPAL DISPLAY PANEL

NDC 58118-0094-08
Venlafaxine Hydrochloride
Extended-Release Capsules USP
150 mg*
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
Rx only                                   30 Capsules

Venlafaxine HCl ER Caps 150mg 30 count blister card