Afinitor (Page 12 of 12)

PRINCIPAL DISPLAY PANEL

NDC 0078-0594-51

Rx only

28 Tablets

Carton contains 4 individual blister cards of 7 tablets.

AFINITOR® (everolimus) tablets

Each tablet contains

2.5 mg

everolimus

NOVARTIS


							PRINCIPAL DISPLAY PANEL
							NDC 0078-0594-51
							Rx only
							28 Tablets
							Carton contains 4 individual blister cards of 7 tablets.
							AFINITOR®
							(everolimus) tablets
							Each tablet contains 2.5 mg everolimus
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0566-51

Rx only

28 Tablets

Carton contains 4 individual blister cards of 7 tablets.

AFINITOR® (everolimus) tablets

Each tablet contains

5 mg

everolimus

NOVARTIS


							PRINCIPAL DISPLAY PANEL
							NDC 0078-0566-51
							Rx only
							28 Tablets
							Carton contains 4 individual blister cards of 7 tablets.
							AFINITOR®
							(everolimus) tablets
							Each tablet contains 5 mg everolimus
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0620-51

Rx only

28 Tablets

Carton contains 4 individual blister cards of 7 tablets.

AFINITOR® (everolimus) tablets

Each tablet contains

7.5 mg

everolimus

NOVARTIS


							PRINCIPAL DISPLAY PANEL
							NDC 0078-0620-51
							Rx only
							28 Tablets
							Carton contains 4 individual blister cards of 7 tablets.
							AFINITOR®
							(everolimus) tablets
							Each tablet contains 7.5 mg everolimus
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0567-51

Rx only

28 Tablets

Carton contains 4 individual blister cards of 7 tablets.

AFINITOR® (everolimus) tablets

Each tablet contains

10 mg

everolimus

NOVARTIS


							PRINCIPAL DISPLAY PANEL
							NDC 0078-0567-51
							Rx only
							28 Tablets
							Carton contains 4 individual blister cards of 7 tablets.
							AFINITOR®
							(everolimus) tablets
							Each tablet contains 10 mg everolimus
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0626-51

Rx only

28 Tablets for Oral Suspension

Carton contains 4 individual blister cards of 7 tablets.

AFINITOR DISPERZ® (everolimus tablets for oral suspension)

2 mg

TABLETS MUST BE DISPERSED IN WATER.

TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.

Each tablet contains 2 mg everolimus

NOVARTIS


							PRINCIPAL DISPLAY PANEL
							NDC 0078-0626-51
							Rx only
							28 Tablets for Oral Suspension
							Carton contains 4 individual blister cards of 7 tablets.
							AFINITOR DISPERZ®
							(everolimus tablets for oral suspension)
							2 mg	
							TABLETS MUST BE DISPERSED IN WATER.
							TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.
							Each tablet contains 2 mg everolimus
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0627-51

Rx only

28 Tablets for Oral Suspension

Carton contains 4 individual blister cards of 7 tablets.

AFINITOR DISPERZ® (everolimus tablets for oral suspension)

3 mg

TABLETS MUST BE DISPERSED IN WATER.

TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.

Each tablet contains 3 mg everolimus

NOVARTIS


							PRINCIPAL DISPLAY PANEL
							NDC 0078-0627-51
							Rx only
							28 Tablets for Oral Suspension
							Carton contains 4 individual blister cards of 7 tablets.
							AFINITOR DISPERZ®
							(everolimus tablets for oral suspension)
							3 mg	
							TABLETS MUST BE DISPERSED IN WATER.
							TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.
							Each tablet contains 3 mg everolimus
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0628-51

Rx only

28 Tablets for Oral Suspension

Carton contains 4 individual blister cards of 7 tablets.

AFINITOR DISPERZ® (everolimus tablets for oral suspension)

5 mg

TABLETS MUST BE DISPERSED IN WATER.

TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.

Each tablet contains 5 mg everolimus

NOVARTIS


							PRINCIPAL DISPLAY PANEL
							NDC 0078-0628-51
							Rx only
							28 Tablets for Oral Suspension
							Carton contains 4 individual blister cards of 7 tablets.
							AFINITOR DISPERZ®
							(everolimus tablets for oral suspension)
							5 mg	
							TABLETS MUST BE DISPERSED IN WATER.
							TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.
							Each tablet contains 5 mg everolimus
							NOVARTIS
(click image for full-size original)
AFINITOR everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0566
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (EVEROLIMUS) EVEROLIMUS 5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CROSPOVIDONE
HYPROMELLOSES
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to slightly yellow) Score no score
Shape OVAL (elongated with a bevelled edge) Size 12mm
Flavor Imprint Code 5;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0566-51 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0078-0566-61)
1 NDC:0078-0566-61 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0078-0566-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022334 03/31/2009
AFINITOR everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0567
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (EVEROLIMUS) EVEROLIMUS 10 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CROSPOVIDONE
HYPROMELLOSES
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to slightly yellow) Score no score
Shape OVAL (elongated with a bevelled edge) Size 15mm
Flavor Imprint Code UHE;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0567-51 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0078-0567-61)
1 NDC:0078-0567-61 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0078-0567-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022334 03/31/2009
AFINITOR everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0594
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (EVEROLIMUS) EVEROLIMUS 2.5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CROSPOVIDONE
HYPROMELLOSES
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to slightly yellow) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code LCL;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0594-51 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0078-0594-61)
1 NDC:0078-0594-61 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0078-0594-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022334 07/09/2010
AFINITOR everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0620
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (EVEROLIMUS) EVEROLIMUS 7.5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CROSPOVIDONE
HYPROMELLOSES
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to slightly yellow) Score no score
Shape OVAL (elongated tablets with a bevelled edge) Size 15mm
Flavor Imprint Code 7P5;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0620-51 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0078-0620-61)
1 NDC:0078-0620-61 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0078-0620-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022334 07/29/2011
AFINITOR DISPERZ everolimus tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0626
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (EVEROLIMUS) EVEROLIMUS 2 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
HYPROMELLOSES
CROSPOVIDONE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
Product Characteristics
Color WHITE (white to slightly yellowish) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code D2;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0626-51 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0078-0626-61)
1 NDC:0078-0626-61 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK This package is contained within the CARTON (0078-0626-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203985 08/29/2012
AFINITOR DISPERZ everolimus tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0627
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (EVEROLIMUS) EVEROLIMUS 3 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
HYPROMELLOSES
CROSPOVIDONE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
Product Characteristics
Color WHITE (white to slightly yellowish) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code D3;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0627-51 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0078-0627-61)
1 NDC:0078-0627-61 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK This package is contained within the CARTON (0078-0627-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203985 08/29/2012
AFINITOR DISPERZ everolimus tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0628
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (EVEROLIMUS) EVEROLIMUS 5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
HYPROMELLOSES
CROSPOVIDONE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code D5;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0628-51 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0078-0628-61)
1 NDC:0078-0628-61 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK This package is contained within the CARTON (0078-0628-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203985 08/29/2012
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 04/2021 Novartis Pharmaceuticals Corporation

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