NDC Code(s) : 64980-373-03, 64980-374-03, 64980-375-03, 64980-376-03, 64980-376-10, 64980-377-03, 64980-377-10, 64980-378-03, 64980-379-03
Packager : Rising Pharma Holdings, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Atomoxetine Atomoxetine CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:64980-373
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0)
(ATOMOXETINE - UNII:ASW034S0B8) 		ATOMOXETINE10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color WHITE (Off-white Opaque) Score no score
Shape CAPSULE Size 11 mm
Flavor Imprint Code F;41
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64980-373-0330 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079016 05/30/2017
Atomoxetine Atomoxetine CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:64980-374
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0)
(ATOMOXETINE - UNII:ASW034S0B8) 		ATOMOXETINE18 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color YELLOW (Golden Opaque), WHITE (Off-white Opaque) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code F;42
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64980-374-0330 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079016 05/30/2017
Atomoxetine Atomoxetine CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:64980-375
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0)
(ATOMOXETINE - UNII:ASW034S0B8) 		ATOMOXETINE25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BLUE (Blue Opaque), WHITE (Off-white Opaque) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code F;43
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64980-375-0330 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079016 05/30/2017
Atomoxetine Atomoxetine CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:64980-376
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0)
(ATOMOXETINE - UNII:ASW034S0B8) 		ATOMOXETINE40 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BLUE (Blue Opaque) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code F;45
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64980-376-0330 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
2NDC:64980-376-101000 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079016 05/30/2017
Atomoxetine Atomoxetine CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:64980-377
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0)
(ATOMOXETINE - UNII:ASW034S0B8) 		ATOMOXETINE60 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BLUE (Blue Opaque), YELLOW (Golden Opaque) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code F;46
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64980-377-0330 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
2NDC:64980-377-101000 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079016 05/30/2017
Atomoxetine Atomoxetine CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:64980-378
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0)
(ATOMOXETINE - UNII:ASW034S0B8) 		ATOMOXETINE80 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BROWN (Brown Opaque), WHITE (Off-white Opaque) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code F;47
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64980-378-0330 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079016 05/30/2017
Atomoxetine Atomoxetine CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:64980-379
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0)
(ATOMOXETINE - UNII:ASW034S0B8) 		ATOMOXETINE100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BROWN (Brown Opaque) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code Y;04
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64980-379-0330 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079016 05/30/2017

LABELER - Rising Pharma Holdings, Inc.(116880195)

REGISTRANT - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917642 ANALYSIS(64980-373, 64980-374, 64980-375, 64980-376, 64980-377, 64980-378, 64980-379), MANUFACTURE(64980-373, 64980-374, 64980-375, 64980-376, 64980-377, 64980-378, 64980-379)

PRINCIPAL DISPLAY PANEL


Rising Pharmaceuticals, Inc.                     NDC 64980-373-03
Atomoxetine
Capsules, USP
1 0 mg
 PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY
 30 Capsules                     Rx only 



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Capsules Bottle)

PRINCIPAL DISPLAY PANEL


Rising Pharmaceuticals, Inc.           NDC 64980-374-03
Atomoxetine
Capsules, USP
 18 mg
 PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY
 30 Capsules                        Rx only
                             


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 18 mg (30 Capsules Bottle)

PRINCIPAL DISPLAY PANEL


Rising Pharmaceuticals, Inc.              NDC 64980-375-03

Atomoxetine
Capsules, USP
 25 mg
 PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY
 30 Capsules                        Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg (30 Capsules Bottle)

PRINCIPAL DISPLAY PANEL


Rising Pharmaceuticals, Inc.                 NDC 64980-376-03 
Atomoxetine
Capsules, USP
 40 mg
 PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY
 30 Capsules                     Rx only                   


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg (30 Capsules Bottle)

PRINCIPAL DISPLAY PANEL


Rising Pharmaceuticals, Inc.                 NDC 64980-377-03
Atomoxetine
Capsules, USP
 60 mg
 PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY
 30 Capsules                          Rx only                       


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 60 mg (30 Capsules Bottle)

PRINCIPAL DISPLAY PANEL


Rising Pharmaceuticals, Inc.                     NDC 64980-378-03
Atomoxetine
Capsules, USP
 80 mg
 PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY
 30 Capsules                           Rx only                      


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 80 mg (30 Capsules Bottle)

PRINCIPAL DISPLAY PANEL


Rising Pharmaceuticals, Inc.                       NDC 64980-379-03
Atomoxetine
Capsules, USP
 100 mg
 PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY
 30 Capsules                                Rx only                       


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (30 Capsules Bottle)