Atomoxetine (Page 12 of 12)

25 mg: Container 30s pack

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

container3
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25 mg: Carton 100s (10×10)

carton3
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40 mg: Container 30s pack

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

container4
(click image for full-size original)

40 mg: Carton 100s(10×10)

carton4
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60 mg: Container 30s pack

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

container5
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60 mg: Carton 100s (10×10)

carton5
(click image for full-size original)

80 mg: Container 30s pack

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

container6
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80 mg: Carton 100s (10×10)

carton6
(click image for full-size original)

100 mg : Container 30s pack

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

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100 mg: Carton 100s (10×10)

carton7
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ATOMOXETINE
atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-519
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
dimethicone
FD&C BLUE NO. 2
gelatin
ferric oxide red
ferric oxide yellow
titanium dioxide
ferrosoferric oxide
butyl alcohol
alcohol
isopropyl alcohol
potassium hydroxide
propylene glycol
Shellac
ammonia
Product Characteristics
Color WHITE (opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RDY;519
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-519-30 30 CAPSULE in 1 BOTTLE None
2 NDC:55111-519-05 500 CAPSULE in 1 BOTTLE None
3 NDC:55111-519-78 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-519-79)
3 NDC:55111-519-79 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (55111-519-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090609 02/23/2018
ATOMOXETINE
atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-520
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
dimethicone
FD&C BLUE NO. 2
gelatin
ferric oxide red
ferric oxide yellow
titanium dioxide
ferrosoferric oxide
butyl alcohol
alcohol
isopropyl alcohol
potassium hydroxide
propylene glycol
Shellac
ammonia
Product Characteristics
Color YELLOW (opaque dark gold) , WHITE (opaque) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code RDY;520
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-520-30 30 CAPSULE in 1 BOTTLE None
2 NDC:55111-520-05 500 CAPSULE in 1 BOTTLE None
3 NDC:55111-520-78 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-520-79)
3 NDC:55111-520-79 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (55111-520-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090609 02/23/2018
ATOMOXETINE
atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-528
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
dimethicone
FD&C BLUE NO. 2
gelatin
ferric oxide red
ferric oxide yellow
titanium dioxide
ferrosoferric oxide
butyl alcohol
alcohol
isopropyl alcohol
potassium hydroxide
propylene glycol
Shellac
ammonia
Product Characteristics
Color BLUE (opaque dark blue) , WHITE (opaque) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code RDY;528
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-528-30 30 CAPSULE in 1 BOTTLE None
2 NDC:55111-528-05 500 CAPSULE in 1 BOTTLE None
3 NDC:55111-528-78 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-528-79)
3 NDC:55111-528-79 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (55111-528-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090609 02/23/2018
ATOMOXETINE
atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-521
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
dimethicone
FD&C BLUE NO. 2
gelatin
ferric oxide red
ferric oxide yellow
titanium dioxide
ferrosoferric oxide
butyl alcohol
alcohol
isopropyl alcohol
potassium hydroxide
propylene glycol
Shellac
ammonia
Product Characteristics
Color BLUE (dark blue) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RDY;521
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-521-30 30 CAPSULE in 1 BOTTLE None
2 NDC:55111-521-05 500 CAPSULE in 1 BOTTLE None
3 NDC:55111-521-78 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-521-79)
3 NDC:55111-521-79 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (55111-521-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090609 02/23/2018
ATOMOXETINE
atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-522
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
dimethicone
FD&C BLUE NO. 2
gelatin
ferric oxide red
ferric oxide yellow
titanium dioxide
ferrosoferric oxide
butyl alcohol
alcohol
isopropyl alcohol
potassium hydroxide
propylene glycol
Shellac
ammonia
Product Characteristics
Color BLUE (opaque dark blue) , YELLOW (opaque dark gold) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RDY;522
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-522-30 30 CAPSULE in 1 BOTTLE None
2 NDC:55111-522-05 500 CAPSULE in 1 BOTTLE None
3 NDC:55111-522-78 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-522-79)
3 NDC:55111-522-79 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (55111-522-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090609 02/23/2018
ATOMOXETINE
atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-563
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
dimethicone
FD&C BLUE NO. 2
gelatin
ferric oxide red
ferric oxide yellow
titanium dioxide
ferrosoferric oxide
butyl alcohol
alcohol
isopropyl alcohol
potassium hydroxide
propylene glycol
Shellac
ammonia
Sodium Lauryl Sulfate
Product Characteristics
Color BROWN (opaque drak brown) , WHITE (opaque white) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RDY;563
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-563-30 30 CAPSULE in 1 BOTTLE None
2 NDC:55111-563-05 500 CAPSULE in 1 BOTTLE None
3 NDC:55111-563-78 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-563-79)
3 NDC:55111-563-79 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (55111-563-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090609 02/23/2018
ATOMOXETINE
atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-564
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
dimethicone
FD&C BLUE NO. 2
gelatin
ferric oxide red
ferric oxide yellow
titanium dioxide
ferrosoferric oxide
butyl alcohol
alcohol
isopropyl alcohol
potassium hydroxide
propylene glycol
Shellac
Sodium Lauryl Sulfate
ammonia
Product Characteristics
Color BROWN (opaque drak brown) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code RDY;564
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-564-30 30 CAPSULE in 1 BOTTLE None
2 NDC:55111-564-05 500 CAPSULE in 1 BOTTLE None
3 NDC:55111-564-78 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-564-79)
3 NDC:55111-564-79 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (55111-564-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090609 02/23/2018
Labeler — Dr. Reddy’s Laboratories Limited (650562841)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited-FTO III 918608162 analysis (55111-519), manufacture (55111-519), analysis (55111-520), manufacture (55111-520), analysis (55111-528), manufacture (55111-528), analysis (55111-521), manufacture (55111-521), analysis (55111-522), manufacture (55111-522), analysis (55111-563), manufacture (55111-563), analysis (55111-564), manufacture (55111-564)

Revised: 01/2022 Dr. Reddy’s Laboratories Limited

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