Atomoxetine (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-216-16 in bottle of 90 Capsules

Atomoxetine Capsules, 18 mg

90 Capsules

ZYDUS

Atomoxetine 18 mg
(click image for full-size original)

NDC 68382-217-16 in bottle of 90 Capsules

Atomoxetine Capsules, 25 mg

90 Capsules

ZYDUS

Atomoxetine 25 mg
(click image for full-size original)

NDC 68382-218-16 in bottle of 90 Capsules

Atomoxetine Capsules, 40 mg

90 Capsules

ZYDUS

Atomoxetine 40 mg
(click image for full-size original)

NDC 68382-219-16 in bottle of 90 Capsules

Atomoxetine Capsules, 60 mg

90 Capsules

ZYDUS

Atomoxetine 60 mg
(click image for full-size original)

NDC 68382-220-16 in bottle of 90 Capsules

Atomoxetine Capsules, 80 mg

90 Capsules

ZYDUS

Atomoxetine 80 mg
(click image for full-size original)

NDC 68382-223-16 in bottle of 90 Capsules

Atomoxetine Capsules, 100 mg

90 Capsules

ZYDUS

Atomoxetine caps 100 mg
(click image for full-size original)
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-216
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
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (GOLDEN) , WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code ZA;68
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-216-06 30 CAPSULE in 1 BOTTLE None
2 NDC:68382-216-14 60 CAPSULE in 1 BOTTLE None
3 NDC:68382-216-16 90 CAPSULE in 1 BOTTLE None
4 NDC:68382-216-10 1000 CAPSULE in 1 BOTTLE None
5 NDC:68382-216-02 2000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079017 12/06/2017
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-217
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
FERROSOFERRIC OXIDE
GELATIN
STARCH, CORN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SILICON DIOXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BLUE (OPAQUE BLUE) , WHITE (OPAQUE WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code ZA69;25mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-217-06 30 CAPSULE in 1 BOTTLE None
2 NDC:68382-217-14 60 CAPSULE in 1 BOTTLE None
3 NDC:68382-217-16 90 CAPSULE in 1 BOTTLE None
4 NDC:68382-217-10 1000 CAPSULE in 1 BOTTLE None
5 NDC:68382-217-02 2000 CAPSULE in 1 BOTTLE None
6 NDC:68382-217-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-217-30)
6 NDC:68382-217-30 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (68382-217-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079017 12/06/2017
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-218
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
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
GELATIN
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (OPAQUE BLUE) , BLUE (OPAQUE BLUE) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code ZA70;40mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-218-06 30 CAPSULE in 1 BOTTLE None
2 NDC:68382-218-14 60 CAPSULE in 1 BOTTLE None
3 NDC:68382-218-16 90 CAPSULE in 1 BOTTLE None
4 NDC:68382-218-10 1000 CAPSULE in 1 BOTTLE None
5 NDC:68382-218-02 2000 CAPSULE in 1 BOTTLE None
6 NDC:68382-218-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-218-30)
6 NDC:68382-218-30 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (68382-218-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079017 12/06/2017
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-219
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
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
GELATIN
STARCH, CORN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SILICON DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BLUE (OPAQUE BLUE) , YELLOW (GOLDEN) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code ZA71;60mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-219-06 30 CAPSULE in 1 BOTTLE None
2 NDC:68382-219-14 60 CAPSULE in 1 BOTTLE None
3 NDC:68382-219-16 90 CAPSULE in 1 BOTTLE None
4 NDC:68382-219-10 1000 CAPSULE in 1 BOTTLE None
5 NDC:68382-219-02 2000 CAPSULE in 1 BOTTLE None
6 NDC:68382-219-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-219-30)
6 NDC:68382-219-30 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (68382-219-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079017 12/06/2017
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-220
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
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
GELATIN
STARCH, CORN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SILICON DIOXIDE
SHELLAC
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color BROWN (OPAQUE BROWN) , WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code ZA72;80mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-220-06 30 CAPSULE in 1 BOTTLE None
2 NDC:68382-220-14 60 CAPSULE in 1 BOTTLE None
3 NDC:68382-220-16 90 CAPSULE in 1 BOTTLE None
4 NDC:68382-220-10 1000 CAPSULE in 1 BOTTLE None
5 NDC:68382-220-02 2000 CAPSULE in 1 BOTTLE None
6 NDC:68382-220-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-220-30)
6 NDC:68382-220-30 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (68382-220-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079017 12/06/2017
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-223
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
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
GELATIN
STARCH, CORN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SILICON DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BROWN (OPAQUE BROWN) , BROWN (OPAQUE BROWN) Score no score
Shape CAPSULE (CAPSULE) Size 21mm
Flavor Imprint Code ZA73;100mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-223-14 60 CAPSULE in 1 BOTTLE None
2 NDC:68382-223-10 1000 CAPSULE in 1 BOTTLE None
3 NDC:68382-223-02 2000 CAPSULE in 1 BOTTLE None
4 NDC:68382-223-06 30 CAPSULE in 1 BOTTLE None
5 NDC:68382-223-16 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079017 12/06/2017
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant — Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (68382-216), ANALYSIS (68382-217), ANALYSIS (68382-218), ANALYSIS (68382-219), ANALYSIS (68382-220), ANALYSIS (68382-223), MANUFACTURE (68382-216), MANUFACTURE (68382-217), MANUFACTURE (68382-218), MANUFACTURE (68382-219), MANUFACTURE (68382-220), MANUFACTURE (68382-223)

Revised: 11/2019 Zydus Pharmaceuticals (USA) Inc.

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