NDC Code(s) : 0591-4060-30, 0591-3659-30, 0591-3660-30
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DesvenlafaxineDesvenlafaxine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-4060
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESVENLAFAXINE SUCCINATE(UNII: ZB22ENF0XR)
(DESVENLAFAXINE - UNII:NG99554ANW) 		DESVENLAFAXINE25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE OXIDE 100000(UNII: V46Y6OJ5QB)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color pink (light pink) Score no score
Shape SQUARE (square pyramid) Size 9 mm
Flavor Imprint Code A112
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-4060-3030 in 1 BOTTLE Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204065 03/01/2017
DesvenlafaxineDesvenlafaxine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3659
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESVENLAFAXINE SUCCINATE(UNII: ZB22ENF0XR)
(DESVENLAFAXINE - UNII:NG99554ANW) 		DESVENLAFAXINE50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE OXIDE 100000(UNII: V46Y6OJ5QB)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color pink (light pink) Score no score
Shape SQUARE (square pyramid) Size 12 mm
Flavor Imprint Code WPI;3659
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3659-3030 in 1 BOTTLE Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204065 03/01/2017
DesvenlafaxineDesvenlafaxine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3660
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESVENLAFAXINE SUCCINATE(UNII: ZB22ENF0XR)
(DESVENLAFAXINE - UNII:NG99554ANW) 		DESVENLAFAXINE100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE OXIDE 100000(UNII: V46Y6OJ5QB)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color red (reddish-orange) Score no score
Shape SQUARE (square pyramid) Size 12 mm
Flavor Imprint Code WPI;3660
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3660-3030 in 1 BOTTLE Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204065 03/01/2017

LABELER - Actavis Pharma, Inc.(119723554)

PRINCIPAL DISPLAY PANEL

NDC 0591-4060-30
Desvenlafaxine
Extended-Release
Tablets
25 mg
PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.
Rx only
30 Tablets

label-25mg-30s

PRINCIPAL DISPLAY PANEL

NDC 0591-3659-30
Desvenlafaxine
Extended-Release
Tablets
50 mg
PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.
Rx only
30 Tablets

label-50mg-30s

PRINCIPAL DISPLAY PANEL

NDC 0591-3660-30
Desvenlafaxine
Extended-Release
Tablets
100 mg
PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.
Rx only
30 Tablets

label-100mg-30s