Atomoxetine (Page 12 of 12)

10 mg: Carton 100s (10×10)

18 mg: Container 30s pack

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

18 mg: Carton 100s(10×10)

25 mg: Container 30s pack

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

25 mg: Carton 100s (10×10)

40 mg: Container 30s pack

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

40 mg: Carton 100s(10×10)

60 mg: Container 30s pack

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

60 mg: Carton 100s (10×10)

80 mg: Container 30s pack

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

80 mg: Carton 100s (10×10)

100 mg : Container 30s pack

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

100 mg: Carton 100s (10×10)

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: 04/2020 Dr. Reddy’s Laboratories Limited