Focalin XR (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 0078-0430-05 Rx only

Focalin XR®

(dexmethylphenidate HCl)

extended-release capsules

5 mg

100 capsules

Dispense with Medication
Guide attached or providedseparately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
									NDC 0078-0430-05
									Rx only
									Focalin XR®
									(dexmethylphenidate HCl)
									extended-release capsules
									5 mg
									100 capsules
									Dispense with Medication Guide attached or provided separately.
									NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0431-05 Rx only

Focalin XR®

(dexmethylphenidate HCl)

extended-release capsules

10 mg

100 capsules

Dispense with Medication
Guide attached or providedseparately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
									NDC 0078-0431-05
									Rx only
									Focalin XR®
									(dexmethylphenidate HCl)
									extended-release capsules
									10 mg
									100 capsules
									Dispense with Medication Guide attached or provided separately.
									NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0493-05 Rx only

Focalin XR®

(dexmethylphenidate HCl)

extended-release capsules

15 mg

100 capsules

Dispense with Medication
Guide attached or providedseparately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
									NDC 0078-0493-05
									Rx only
									Focalin XR®
									(dexmethylphenidate HCl)
									extended-release capsules
									15 mg
									100 capsules
									Dispense with Medication Guide attached or provided separately.
									NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0432-05 Rx only

Focalin XR®

(dexmethylphenidate HCl)

extended-release capsules

20 mg

100 capsules

Dispense with Medication
Guide attached or providedseparately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
									NDC 0078-0432-05
									Rx only
									Focalin XR®
									(dexmethylphenidate HCl)
									extended-release capsules
									20 mg
									100 capsules
									Dispense with Medication Guide attached or provided separately.
									NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0608-05 Rx only

Focalin XR®

(dexmethylphenidate HCl)

extended-release capsules

25 mg

100 capsules

Dispense in tight container (USP).

Dispense with Medication Guideattached or provided separately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
									NDC 0078-0608-05
									Rx only
									Focalin XR®
									(dexmethylphenidate HCl)
									extended-release capsules
									25 mg
									100 capsules
									Dispense in tight container (USP).
									Dispense with Medication Guide attached or provided separately.
									NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0433-05 Rx only

Focalin XR®

(dexmethylphenidate HCl)

extended-release capsules

30 mg

100 capsules

Dispense in tight container (USP).

Dispense with
Medication Guide attachedor provided separately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
									NDC 0078-0433-05
									Rx only
									Focalin XR®
									(dexmethylphenidate HCl)
									extended-release capsules
									30 mg
									100 capsules
									Dispense in tight container (USP).
									Dispense with Medication Guide attached or provided separately.
									NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0609-05 Rx only

Focalin XR®

(dexmethylphenidate HCl)

extended-release capsules

35 mg

100 capsules

Dispense in tight container (USP).

Dispense with
Medication Guide attachedor provided separately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
									NDC 0078-0609-05
									Rx only
									Focalin XR®
									(dexmethylphenidate HCl)
									extended-release capsules
									35 mg
									100 capsules
									Dispense in tight container (USP).
									Dispense with Medication Guide attached or provided separately.
									NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0434-05 Rx only

Focalin XR®

(dexmethylphenidate HCl)

extended-release capsules

40 mg

100 capsules

Dispense in tight container (USP).

Dispense with
Medication Guide attachedor provided separately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
									NDC 0078-0434-05
									Rx only
									Focalin XR®
									(dexmethylphenidate HCl)
									extended-release capsules
									40 mg
									100 capsules
									Dispense in tight container (USP).
									Dispense with Medication Guide attached or provided separately.
									NOVARTIS
(click image for full-size original)
FOCALIN XR dexmethylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0433
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
GELATIN
POLYETHYLENE GLYCOL
DEXTROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color BROWN, WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code NVR;D30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0433-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021802 05/31/2005
FOCALIN XR dexmethylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0608
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
POLYETHYLENE GLYCOL
DEXTROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (light blue) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code NVR;D25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0608-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021802 05/31/2005
FOCALIN XR dexmethylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0609
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 35 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
GELATIN
POLYETHYLENE GLYCOL
DEXTROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color BLUE (light blue) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code NVR;D35
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0609-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021802 05/31/2005
FOCALIN XR dexmethylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0434
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
GELATIN
POLYETHYLENE GLYCOL
DEXTROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color GREEN, WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code NVR;D40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0434-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021802 05/31/2005
FOCALIN XR dexmethylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0493
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
GELATIN
POLYETHYLENE GLYCOL
DEXTROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code NVR;D15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0493-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021802 05/31/2005
FOCALIN XR dexmethylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0430
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
GELATIN
POLYETHYLENE GLYCOL
DEXTROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code NVR;D5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0430-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021802 05/31/2005
FOCALIN XR dexmethylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0431
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
GELATIN
POLYETHYLENE GLYCOL
DEXTROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code NVR;D10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0431-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021802 05/31/2005
FOCALIN XR dexmethylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0432
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
POLYETHYLENE GLYCOL
DEXTROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code NVR;D20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0432-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021802 05/31/2005
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 06/2020 Novartis Pharmaceuticals Corporation

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