NDC 49884-375-11
API & Excipient Details

Desvenlafaxine Succinate marketed by Par Pharmaceutical Inc. under NDC Code 49884-375-11

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DESVENLAFAXINE(UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW)	DESVENLAFAXINE	50 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49884-374-09	90 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	10/07/2013
2	NDC:49884-374-11	30 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	10/07/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DESVENLAFAXINE(UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW)	DESVENLAFAXINE	100 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49884-375-09	90 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	10/07/2013
2	NDC:49884-375-11	30 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	10/07/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA204683	07/10/2013	05/31/2015

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL