Sunitinib Malate (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0093-8199-28

Sunitinib Malate Capsules
12.5 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only28 Capsules

1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0093-8224-28

Sunitinib Malate Capsules
25 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only28 Capsules

1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0093-8229-28

Sunitinib Malate Capsules
37.5 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only28 Capsules

1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0093-8231-28

Sunitinib Malate Capsules
50 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only28 Capsules

1
(click image for full-size original)
SUNITINIB MALATE sunitinib malate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-8199
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUNITINIB MALATE (SUNITINIB) SUNITINIB 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MANNITOL
POVIDONE K30
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C BLUE NO. 2–ALUMINUM LAKE
SHELLAC
PROPYLENE GLYCOL
Product Characteristics
Color red (maroon) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code TEVA;8199;TEVA;8199
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-8199-28 28 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213803 12/22/2021
SUNITINIB MALATE sunitinib malate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-8224
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUNITINIB MALATE (SUNITINIB) SUNITINIB 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MANNITOL
POVIDONE K30
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C BLUE NO. 2–ALUMINUM LAKE
SHELLAC
PROPYLENE GLYCOL
Product Characteristics
Color brown (light brown) , red (maroon) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code TEVA;8224;TEVA;8224
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-8224-28 28 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213803 12/22/2021
SUNITINIB MALATE sunitinib malate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-8229
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUNITINIB MALATE (SUNITINIB) SUNITINIB 37.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MANNITOL
POVIDONE K30
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C BLUE NO. 2–ALUMINUM LAKE
FD&C RED NO. 40
SHELLAC
PROPYLENE GLYCOL
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code TEVA;8229;TEVA;8229
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-8229-28 28 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213803 12/22/2021
SUNITINIB MALATE sunitinib malate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-8231
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUNITINIB MALATE (SUNITINIB) SUNITINIB 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MANNITOL
POVIDONE K30
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C BLUE NO. 2–ALUMINUM LAKE
SHELLAC
PROPYLENE GLYCOL
Product Characteristics
Color brown (light brown) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code TEVA;8231;TEVA;8231
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-8231-28 28 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213803 12/22/2021
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 09/2021 Teva Pharmaceuticals USA, Inc.

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