NDC Code(s) : 68462-265-30, 68462-265-23, 68462-266-30, 68462-266-23, 68462-267-30, 68462-267-23, 68462-268-30, 68462-268-23, 68462-269-30, 68462-269-23, 68462-270-30, 68462-270-23, 68462-271-30, 68462-271-51
Packager : Glenmark Pharmaceuticals Inc., USA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

atomoxetineatomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-265
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)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
METHYL ALCOHOL(UNII: Y4S76JWI15)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color WHITE (Opaque White), WHITE (Opaque White) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code 265;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-265-3030 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
2NDC:68462-265-232000 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 ANDA079019 05/30/2017
atomoxetineatomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-266
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)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
AMMONIA(UNII: 5138Q19F1X)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color YELLOW (Opaque Yellow), WHITE (Opaque White) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code 266;18
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-266-3030 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
2NDC:68462-266-232000 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 ANDA079019 05/30/2017
atomoxetineatomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-267
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)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
METHYL ALCOHOL(UNII: Y4S76JWI15)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BLUE (Opaque Blue), WHITE (Opaque White) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code 267;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-267-3030 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
2NDC:68462-267-232000 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 ANDA079019 05/30/2017
atomoxetineatomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-268
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)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
METHYL ALCOHOL(UNII: Y4S76JWI15)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BLUE (Opaque Blue), BLUE (Opaque Blue) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code 268;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-268-3030 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
2NDC:68462-268-232000 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 ANDA079019 05/30/2017
atomoxetineatomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-269
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)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
AMMONIA(UNII: 5138Q19F1X)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BLUE (Opaque Blue), YELLOW (Opaque Yellow) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code 269;60
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-269-3030 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
2NDC:68462-269-232000 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 ANDA079019 05/30/2017
atomoxetineatomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-270
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)
D&C RED NO. 28(UNII: 767IP0Y5NH)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
METHYL ALCOHOL(UNII: Y4S76JWI15)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BROWN (Opaque Reddish Brown), WHITE (Opaque White) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code 270;80
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-270-3030 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
2NDC:68462-270-232000 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 ANDA079019 05/30/2017
atomoxetineatomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-271
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)
D&C RED NO. 28(UNII: 767IP0Y5NH)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
METHYL ALCOHOL(UNII: Y4S76JWI15)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BROWN (Opaque Reddish Brown), BROWN (Opaque Reddish Brown) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code 271;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-271-3030 in 1 BOTTLE Type 0: Not a Combination Product30/05/2017
2NDC:68462-271-511500 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 ANDA079019 05/30/2017

LABELER - Glenmark Pharmaceuticals Inc., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 677318665 MANUFACTURE(68462-265, 68462-266, 68462-267, 68462-268, 68462-269, 68462-270, 68462-271), ANALYSIS(68462-265, 68462-266, 68462-267, 68462-268, 68462-269, 68462-270, 68462-271)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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