NDC Code(s) : 0093-3542-56, 0093-3543-56, 0093-3544-56, 0093-3545-56, 0093-3546-56, 0093-3547-56, 0093-3548-56
Packager : Teva Pharmaceuticals USA, Inc.

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:0093-3542
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
STARCH, CORN(UNII: O8232NY3SJ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code TEVA;7590;TEVA;7590
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-3542-5630 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 ANDA079022 05/30/2017
AtomoxetineAtomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3543
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
STARCH, CORN(UNII: O8232NY3SJ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color yellow, white Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code TEVA;7591;TEVA;7591
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-3543-5630 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 ANDA079022 05/30/2017
AtomoxetineAtomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3544
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
STARCH, CORN(UNII: O8232NY3SJ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color blue (aqua blue), white Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code TEVA;7592;TEVA;7592
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-3544-5630 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 ANDA079022 05/30/2017
AtomoxetineAtomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3545
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
STARCH, CORN(UNII: O8232NY3SJ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color blue (aqua blue) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code TEVA;7593;TEVA;7593
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-3545-5630 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 ANDA079022 05/30/2017
AtomoxetineAtomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3546
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
STARCH, CORN(UNII: O8232NY3SJ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color blue (aqua blue), yellow Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code TEVA;7594;TEVA;7594
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-3546-5630 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 ANDA079022 05/30/2017
AtomoxetineAtomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3547
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
STARCH, CORN(UNII: O8232NY3SJ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color brown (brownish-yellow), white Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code TEVA;7588;TEVA;7588
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-3547-5630 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 ANDA079022 05/30/2017
AtomoxetineAtomoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3548
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
STARCH, CORN(UNII: O8232NY3SJ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color brown (brownish-yellow) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code TEVA;7589;TEVA;7589
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-3548-5630 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 ANDA079022 05/30/2017

LABELER - Teva Pharmaceuticals USA, Inc.(001627975)

PRINCIPAL DISPLAY PANEL

NDC 0093-3542-56

Atomoxetine Capsules, USP

10 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Capsules

image

PRINCIPAL DISPLAY PANEL

NDC 0093-3543-56

Atomoxetine Capsules, USP

18 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Capsules

Image

PRINCIPAL DISPLAY PANEL

NDC 0093-3544-56

Atomoxetine Capsules, USP

25 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Capsules

image

PRINCIPAL DISPLAY PANEL

NDC 0093-3545-56

Atomoxetine Capsules, USP

40 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Capsules

image

PRINCIPAL DISPLAY PANEL

NDC 0093-3546-56

Atomoxetine Capsules, USP

60 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Capsules

image

PRINCIPAL DISPLAY PANEL

NDC 0093-3547-56

Atomoxetine Capsules, USP

80 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Capsules

image

PRINCIPAL DISPLAY PANEL

NDC 0093-3548-56

Atomoxetine Capsules, USP

100 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Capsules

image