Focalin (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NOVARTIS NDC 0078-0380-05

Focalin®

dexmethylphenidate
hydrochloride

2.5 mg

100 Tablets

Rx only

Dispense with Medication Guideattached or provided separately.

PRINCIPAL DISPLAY PANEL
									NOVARTIS
									NDC 0078-0380-05
									Focalin®
									dexmethylphenidate hydrochloride
									2.5 mg
									100 tablets
									Rx only
									Dispense with Medication Guide attached or provided separately.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NOVARTIS NDC 0078-0381-05

Focalin®

dexmethylphenidate
hydrochloride

5 mg

100 Tablets

Rx only

Dispense with Medication Guideattached or provided separately.

PRINCIPAL DISPLAY PANEL
									NOVARTIS
									NDC 0078-0381-05
									Focalin®
									dexmethylphenidate hydrochloride
									5 mg
									100 tablets
									Rx only
									Dispense with Medication Guide attached or provided separately.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NOVARTIS NDC 0078-0382-05

Focalin®

dexmethylphenidate
hydrochloride

10 mg

100 Tablets

Rx only

Dispense with Medication Guideattached or provided separately.

PRINCIPAL DISPLAY PANEL
									NOVARTIS
									NDC 0078-0382-05
									Focalin®
									dexmethylphenidate hydrochloride
									10 mg
									100 tablets
									Rx only
									Dispense with Medication Guide attached or provided separately.
(click image for full-size original)
FOCALIN dexmethylphenidate hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0380
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color BLUE (Blue) Score no score
Shape FREEFORM (D-shaped) Size 18mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0380-05 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021278 11/30/2001
FOCALIN dexmethylphenidate hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0381
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
D&C YELLOW NO. 10
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color YELLOW Score no score
Shape FREEFORM (D-shaped) Size 18mm
Flavor Imprint Code D;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0381-05 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021278 11/30/2001
FOCALIN dexmethylphenidate hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0382
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score no score
Shape FREEFORM (D-shaped) Size 18mm
Flavor Imprint Code D;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0382-05 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021278 11/30/2001
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 06/2021 Novartis Pharmaceuticals Corporation

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