NDC Code(s) : 49884-374-09, 49884-374-11, 49884-375-09, 49884-375-11
Packager : Par Pharmaceutical Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

KHEDEZLA desvenlafaxine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-374
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESVENLAFAXINE(UNII: NG99554ANW)
(DESVENLAFAXINE - UNII:NG99554ANW) 		DESVENLAFAXINE50 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color pink (PINK) Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code OS;231
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-374-0990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/07/2013
2NDC:49884-374-1130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/07/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204683 07/10/2013 05/31/2015
KHEDEZLA desvenlafaxine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-375
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESVENLAFAXINE(UNII: NG99554ANW)
(DESVENLAFAXINE - UNII:NG99554ANW) 		DESVENLAFAXINE100 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color brown Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code OS;232
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-375-0990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/07/2013
2NDC:49884-375-1130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/07/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204683 07/10/2013 05/31/2015

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 MG LABEL

NDC 49884-374-11

KHEDEZLA

desvenlafaxine

Extended-release Tablets

Note: Give attached Medication Guide when dispensing KHEDEZLA.

Unit of Use 30 Tablets

Rx only

bottle label

bottle label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 MG

NDC 49884-374-09

KHEDEZLA

desvenlafaxine

Extended-release Tablets

Note: Give attached Medication Guide when dispensing KHEDEZLA.

Unit of Use 90 Tablets

Rx only

bottle label

bottle label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 MG LABEL

NDC 49884-375-11

KHEDEZLA

desvenlafaxine

Extended-release Tablets

Note: Give attached Medication Guide when dispensing KHEDEZLA.

Unit of Use 30 Tablets

Rx only

bottle label

bottle label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 MG LABEL

NDC 49884-375-09

KHEDEZLA

desvenlafaxine

Extended-release Tablets

Note: Give attached Medication Guide when dispensing KHEDEZLA.

Unit of Use 90 Tablets

Rx only

bottle label

bottle label