NDC Code(s) : 55111-608-60, 55111-608-10, 55111-608-79, 55111-608-81, 55111-609-30, 55111-609-90, 55111-609-10, 55111-609-79, 55111-609-81, 55111-610-30, 55111-610-90, 55111-610-10, 55111-610-79, 55111-610-81
Packager : Dr. Reddy's Laboratories Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DuloxetineDuloxetine CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-608
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE(UNII: 9044SC542W)
(DULOXETINE - UNII:O5TNM5N07U) 		DULOXETINE20 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin(UNII: 2G86QN327L)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Glycine(UNII: TE7660XO1C)
Sucrose(UNII: C151H8M554)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Propylene glycol(UNII: 6DC9Q167V3)
Talc(UNII: 7SEV7J4R1U)
Titanium dioxide(UNII: 15FIX9V2JP)
Shellac(UNII: 46N107B71O)
Triethyl citrate(UNII: 8Z96QXD6UM)
Ferrosoferric Oxide(UNII: XM0M87F357)
Potassium hydroxide(UNII: WZH3C48M4T)
Sodium lauryl sulfate(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 15 mm
Flavor Imprint Code RDY608;20mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55111-608-6060 in 1 BOTTLE
2NDC:55111-608-101000 in 1 BOTTLE
3NDC:55111-608-813 in 1 CARTON
3NDC:55111-608-7910 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090723 06/18/2014
DuloxetineDuloxetine CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-609
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE(UNII: 9044SC542W)
(DULOXETINE - UNII:O5TNM5N07U) 		DULOXETINE30 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin(UNII: 2G86QN327L)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Glycine(UNII: TE7660XO1C)
Sucrose(UNII: C151H8M554)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Propylene glycol(UNII: 6DC9Q167V3)
Talc(UNII: 7SEV7J4R1U)
Titanium dioxide(UNII: 15FIX9V2JP)
Shellac(UNII: 46N107B71O)
Triethyl citrate(UNII: 8Z96QXD6UM)
Sodium lauryl sulfate(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code RDY609;30mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55111-609-3030 in 1 BOTTLE
2NDC:55111-609-9090 in 1 BOTTLE
3NDC:55111-609-101000 in 1 BOTTLE
4NDC:55111-609-813 in 1 CARTON
4NDC:55111-609-7910 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090723 06/18/2014
DuloxetineDuloxetine CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-610
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE(UNII: 9044SC542W)
(DULOXETINE - UNII:O5TNM5N07U) 		DULOXETINE60 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin(UNII: 2G86QN327L)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Glycine(UNII: TE7660XO1C)
Sucrose(UNII: C151H8M554)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Propylene glycol(UNII: 6DC9Q167V3)
Talc(UNII: 7SEV7J4R1U)
Titanium dioxide(UNII: 15FIX9V2JP)
Shellac(UNII: 46N107B71O)
Potassium hydroxide(UNII: WZH3C48M4T)
Triethyl citrate(UNII: 8Z96QXD6UM)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 20 mm
Flavor Imprint Code RDY610;60mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55111-610-3030 in 1 BOTTLE
2NDC:55111-610-9090 in 1 BOTTLE
3NDC:55111-610-101000 in 1 BOTTLE
4NDC:55111-610-813 in 1 CARTON
4NDC:55111-610-7910 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090723 06/18/2014

PRINCIPAL DISPLAY PANEL

Container : 20 mg 60's count

PRINCIPAL DISPLAY PANEL

Carton: 20 mg 30's (3x10)

PRINCIPAL DISPLAY PANEL

Container: 30 mg 30's count

PRINCIPAL DISPLAY PANEL

Carton: 30 mg 30's (3x10)

PRINCIPAL DISPLAY PANEL

Container: 60 mg 30's count

PRINCIPAL DISPLAY PANEL

Carton: 60 mg 30's (3x10)