NDC Code(s) : 13668-109-05, 13668-109-01, 13668-109-30, 13668-109-60, 13668-110-30, 13668-110-01, 13668-110-05, 13668-111-30, 13668-111-01, 13668-111-05
Packager : Torrent Pharmaceuticals Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Duloxetine hydrochlorideDuloxetin hydrochloride CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-109
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
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color blue (light blue cap and body) Score no score
Shape CAPSULE Size 15 mm
Flavor Imprint Code 20;1109
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13668-109-05500 in 1 BOTTLE Type 0: Not a Combination Product12/11/2013
2NDC:13668-109-01100 in 1 BOTTLE Type 0: Not a Combination Product12/11/2013
3NDC:13668-109-3030 in 1 BOTTLE Type 0: Not a Combination Product12/11/2013
4NDC:13668-109-6060 in 1 BOTTLE Type 0: Not a Combination Product12/11/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090774 12/11/2013
Duloxetine hydrochlorideDuloxetin hydrochloride CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-110
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
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color blue (blue cap and milky white body) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code 30;1110
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13668-110-3030 in 1 BOTTLE Type 0: Not a Combination Product12/11/2013
2NDC:13668-110-01100 in 1 BOTTLE Type 0: Not a Combination Product12/11/2013
3NDC:13668-110-05500 in 1 BOTTLE Type 0: Not a Combination Product12/11/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090774 12/11/2013
Duloxetine hydrochlorideDuloxetin hydrochloride CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-111
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
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color blue (opaque blue cap and yellow body) Score no score
Shape CAPSULE Size 20 mm
Flavor Imprint Code 60;1111
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13668-111-3030 in 1 BOTTLE Type 0: Not a Combination Product12/11/2013
2NDC:13668-111-01100 in 1 BOTTLE Type 0: Not a Combination Product12/11/2013
3NDC:13668-111-05500 in 1 BOTTLE Type 0: Not a Combination Product12/11/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090774 12/11/2013

LABELER - Torrent Pharmaceuticals Limited(916488547)

REGISTRANT - Torrent Pharma, Inc.(790033935)

Establishment
Name Address ID/FEI Business Operations
Torrent Pharmaceuticals Limited 916488547 manufacture(13668-109, 13668-110, 13668-111)

PRINCIPAL DISPLAY PANEL

Duloxetine Delayed-Release Capsules, USP 20mg

Label-20 mg

Duloxetine Delayed-Release Capsules, USP 30 mg

Label-20 mg

Duloxetine Delayed-Release Capsules, USP 60 mg

Label-20 mg