Atomoxetine (Page 9 of 9)

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ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-755
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C BLUE NO. 1
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color WHITE (Opaque White) , WHITE (Opaque White) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 265;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-755-01 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079019 06/01/2018
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-756
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 18 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
AMMONIA
SHELLAC
Product Characteristics
Color YELLOW (Opaque Yellow) , WHITE (Opaque White) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 266;18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-756-01 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079019 06/01/2018
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-757
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C RED NO. 28
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BLUE (Opaque Blue) , WHITE (Opaque White) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 267;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-757-01 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079019 06/01/2018
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-758
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 40 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C RED NO. 28
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BLUE (Opaque Blue) , BLUE (Opaque Blue) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 268;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-758-01 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079019 06/01/2018
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-759
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 60 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 3
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
AMMONIA
SHELLAC
Product Characteristics
Color BLUE (Opaque Blue) , YELLOW (Opaque Yellow) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 269;60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-759-01 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079019 06/01/2018
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-760
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 80 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BROWN (Opaque Reddish Brown) , WHITE (Opaque White) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 270;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-760-01 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079019 06/01/2018
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-761
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BROWN (Opaque Reddish Brown) , BROWN (Opaque Reddish Brown) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 271;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-761-01 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079019 06/01/2018
Labeler — Northstar Rx LLC (830546433)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 MANUFACTURE (16714-755), MANUFACTURE (16714-756), MANUFACTURE (16714-757), MANUFACTURE (16714-758), MANUFACTURE (16714-759), MANUFACTURE (16714-760), MANUFACTURE (16714-761), ANALYSIS (16714-755), ANALYSIS (16714-756), ANALYSIS (16714-757), ANALYSIS (16714-758), ANALYSIS (16714-759), ANALYSIS (16714-760), ANALYSIS (16714-761)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited 650435873 API MANUFACTURE (16714-755), API MANUFACTURE (16714-756), API MANUFACTURE (16714-757), API MANUFACTURE (16714-758), API MANUFACTURE (16714-759), API MANUFACTURE (16714-760), API MANUFACTURE (16714-761)

Revised: 03/2020 Northstar Rx LLC

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