Zortress (Page 12 of 12)

PRINCIPAL DISPLAY PANEL

NDC 0078-0417-20

Rx only

ZORTRESS®

(everolimus) Tablets

0.25 mg per tablet

Contents:
6 blister cards of
10 tablets each

DISPENSE WITH MEDICATION GUIDEENCLOSED OR PROVIDED SEPARATELY.

NOVARTIS

PRINCIPAL DISPLAY PANEL
								NDC 0078-0417-20
								Rx only
								ZORTRESS®
								(everolimus) Tablets
								0.25 mg per tablet
								Contents: 6 blister cards of 10 tablets each
								DISPENSE WITH MEDICATION GUIDE ENCLOSED OR PROVIDED SEPARATELY.
								NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0414-20

Rx only

ZORTRESS®

(everolimus) Tablets

0.5 mg per tablet

Contents:
6 blister cards of
10 tablets each

DISPENSE WITH MEDICATION GUIDEENCLOSED OR PROVIDED SEPARATELY.

NOVARTIS

PRINCIPAL DISPLAY PANEL
								NDC 0078-0414-20
								Rx only
								ZORTRESS®
								(everolimus) Tablets
								0.5 mg per tablet
								Contents: 6 blister cards of 10 tablets each
								DISPENSE WITH MEDICATION GUIDE ENCLOSED OR PROVIDED SEPARATELY.
								NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0415-20

Rx only

ZORTRESS®

(everolimus) Tablets

0.75 mg per tablet

Contents:
6 blister cards of
10 tablets each

DISPENSE WITH MEDICATION GUIDEENCLOSED OR PROVIDED SEPARATELY.

NOVARTIS

PRINCIPAL DISPLAY PANEL
								NDC 0078-0415-20
								Rx only
								ZORTRESS®
								(everolimus) Tablets
								0.75 mg per tablet
								Contents: 6 blister cards of 10 tablets each
								DISPENSE WITH MEDICATION GUIDE ENCLOSED OR PROVIDED SEPARATELY.
								NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0422-20

Rx only

ZORTRESS®

(everolimus) Tablets

1 mg per tablet

Contents:
6 blister cards of
10 tablets each

DISPENSE WITH MEDICATION GUIDEENCLOSED OR PROVIDED SEPARATELY.

NOVARTIS

PRINCIPAL DISPLAY PANEL
								NDC 0078-0422-20
								Rx only
								ZORTRESS®
								(everolimus) Tablets
								1 mg per tablet
								Contents: 6 blister cards of 10 tablets each
								DISPENSE WITH MEDICATION GUIDE ENCLOSED OR PROVIDED SEPARATELY.
								NOVARTIS
(click image for full-size original)
ZORTRESS everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0417
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (EVEROLIMUS) EVEROLIMUS 0.25 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CROSPOVIDONE
HYPROMELLOSES
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to yellowish) Score no score
Shape ROUND (round) Size 6mm
Flavor Imprint Code C;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0417-20 60 BLISTER PACK in 1 BOX contains a BLISTER PACK (0078-0417-61)
1 NDC:0078-0417-61 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (0078-0417-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021560 04/22/2010
ZORTRESS everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0414
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (EVEROLIMUS) EVEROLIMUS 0.5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CROSPOVIDONE
HYPROMELLOSES
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to yellowish) Score no score
Shape ROUND (round) Size 7mm
Flavor Imprint Code CH;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0414-20 60 BLISTER PACK in 1 BOX contains a BLISTER PACK (0078-0414-61)
1 NDC:0078-0414-61 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (0078-0414-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021560 04/22/2010
ZORTRESS everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0415
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (EVEROLIMUS) EVEROLIMUS 0.75 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CROSPOVIDONE
HYPROMELLOSES
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to yellowish) Score no score
Shape ROUND (round) Size 9mm
Flavor Imprint Code CL;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0415-20 60 BLISTER PACK in 1 BOX contains a BLISTER PACK (0078-0415-61)
1 NDC:0078-0415-61 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (0078-0415-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021560 04/22/2010
ZORTRESS everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0422
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (EVEROLIMUS) EVEROLIMUS 1 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CROSPOVIDONE
HYPROMELLOSES
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to yellowish) Score no score
Shape ROUND (round) Size 9mm
Flavor Imprint Code CU;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0422-20 60 BLISTER PACK in 1 BOX contains a BLISTER PACK (0078-0422-61)
1 NDC:0078-0422-61 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (0078-0422-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021560 04/22/2010
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 05/2021 Novartis Pharmaceuticals Corporation

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