Atomoxetine Hydrochloride (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 10MG

NDC 47335-814-83

Atomoxetine Hydrochloride Capsules

10 mg

Rx only

30 CAPSULES

SUN PHARMACEUTICAL INDUSTRIES LTD.

PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

atomoxetine-label-10mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 18MG

NDC 47335-815-83

Atomoxetine Hydrochloride Capsules

18 mg

Rx only

30 CAPSULES

SUN PHARMACEUTICAL INDUSTRIES LTD.

PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

atomoxetine-label-18mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 25MG

NDC 47335-816-83

Atomoxetine Hydrochloride Capsules

25 mg

Rx only

30 CAPSULES

SUN PHARMACEUTICAL INDUSTRIES LTD.

PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

atomoxetine-label-25mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 40MG

NDC 47335-817-83

Atomoxetine Hydrochloride Capsules

40 mg

Rx only

30 CAPSULES

SUN PHARMACEUTICAL INDUSTRIES LTD.

PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

atomoxetine-label-40mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 60MG

NDC 47335-818-83

Atomoxetine Hydrochloride Capsules

60 mg

Rx only

30 CAPSULES

SUN PHARMACEUTICAL INDUSTRIES LTD.

PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

atomoxetine-label-60mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 80MG

NDC 47335-819-83

Atomoxetine Hydrochloride Capsules

80 mg

Rx only

30 CAPSULES

SUN PHARMACEUTICAL INDUSTRIES LTD.

PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

atomoxetine-label-80mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 100MG

NDC 47335-820-83

Atomoxetine Hydrochloride Capsules

100 mg

Rx only

30 CAPSULES

SUN PHARMACEUTICAL INDUSTRIES LTD.

PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

atomoxetine-label-100mg
(click image for full-size original)
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-814
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
SILICON DIOXIDE
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (opaque white) , WHITE (opaque white) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code 814
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-814-83 30 CAPSULE (30 CAPSULE) in 1 BOTTLE None
2 NDC:47335-814-88 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
3 NDC:47335-814-08 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
4 NDC:47335-814-18 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079020 10/05/2010
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-815
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
SILICON DIOXIDE
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (opaque yellow) , WHITE (opaque white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 815
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-815-83 30 CAPSULE (30 CAPSULE) in 1 BOTTLE None
2 NDC:47335-815-88 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
3 NDC:47335-815-08 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
4 NDC:47335-815-18 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079020 10/05/2010
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-816
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
SILICON DIOXIDE
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (opaque blue) , WHITE (opaque white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 816
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-816-83 30 CAPSULE (30 CAPSULE) in 1 BOTTLE None
2 NDC:47335-816-88 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
3 NDC:47335-816-08 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
4 NDC:47335-816-18 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079020 10/05/2010
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-817
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
SILICON DIOXIDE
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (opaque blue) , BLUE (opaque blue) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 817
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-817-83 30 CAPSULE (30 CAPSULE) in 1 BOTTLE None
2 NDC:47335-817-88 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
3 NDC:47335-817-08 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
4 NDC:47335-817-18 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079020 10/05/2010
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-818
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
SILICON DIOXIDE
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
Product Characteristics
Color BLUE (opaque blue) , YELLOW (opaque yellow) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code 818
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-818-83 30 CAPSULE (30 CAPSULE) in 1 BOTTLE None
2 NDC:47335-818-88 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
3 NDC:47335-818-08 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
4 NDC:47335-818-18 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079020 10/05/2010
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-819
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
SILICON DIOXIDE
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color BROWN (opaque brown) , WHITE (opaque white) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code 819
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-819-83 30 CAPSULE (30 CAPSULE) in 1 BOTTLE None
2 NDC:47335-819-88 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
3 NDC:47335-819-08 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
4 NDC:47335-819-18 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079020 10/05/2010
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-820
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
SILICON DIOXIDE
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color BROWN (opaque brown) , BROWN (opaque brown) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code 820
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-820-83 30 CAPSULE (30 CAPSULE) in 1 BOTTLE None
2 NDC:47335-820-88 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
3 NDC:47335-820-08 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
4 NDC:47335-820-18 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079020 10/05/2010
Labeler — Sun Pharma Global FZE (864347344)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 MANUFACTURE, ANALYSIS

Revised: 10/2010 Sun Pharma Global FZE

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.