Sunitinib Malate (Page 10 of 10)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 63304-091-27

Sunitinib Malate Capsules

12.5 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

28 Capsules SUN PHARMA
spl-sunitinib-capsules-label1
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 63304-092-27

Sunitinib Malate Capsules

25 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

28 Capsules SUN PHARMA
spl-sunitinib-25mg-label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 63304-093-27

Sunitinib Malate Capsules

37.5 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

28 Capsules SUN PHARMA
spl-sunitinib-capsules-label3
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 63304-094-27

Sunitinib Malate Capsules

50 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

28 Capsules SUN PHARMA
spl-sunitinib-50mg-label
(click image for full-size original)
SUNITINIB MALATE sunitinib malate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-091
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
FERRIC OXIDE RED
TITANIUM DIOXIDE
POTASSIUM HYDROXIDE
SHELLAC
GELATIN, UNSPECIFIED
Product Characteristics
Color BROWN (opaque reddish brown cap) , BROWN (opaque reddish brown body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RM53;RM53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-091-27 28 CAPSULE in 1 BOTTLE None
2 NDC:63304-091-86 4 BLISTER PACK in 1 BOX contains a BLISTER PACK (63304-091-11)
2 NDC:63304-091-11 7 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (63304-091-86)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213914 12/25/2019
SUNITINIB MALATE sunitinib malate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-092
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
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
POTASSIUM HYDROXIDE
SHELLAC
GELATIN, UNSPECIFIED
Product Characteristics
Color ORANGE (opaque caramel cap) , BROWN (opaque reddish brown body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code RM54;RM54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-092-27 28 CAPSULE in 1 BOTTLE None
2 NDC:63304-092-86 4 BLISTER PACK in 1 BOX contains a BLISTER PACK (63304-092-11)
2 NDC:63304-092-11 7 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (63304-092-86)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213914 12/25/2019
SUNITINIB MALATE sunitinib malate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-093
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
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
GELATIN, UNSPECIFIED
Product Characteristics
Color YELLOW (opaque yellow cap) , YELLOW (opaque yellow body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code RM55;RM55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-093-27 28 CAPSULE in 1 BOTTLE None
2 NDC:63304-093-86 4 BLISTER PACK in 1 BOX contains a BLISTER PACK (63304-093-11)
2 NDC:63304-093-11 7 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (63304-093-86)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213914 12/25/2019
SUNITINIB MALATE sunitinib malate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-094
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
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
POTASSIUM HYDROXIDE
SHELLAC
GELATIN, UNSPECIFIED
Product Characteristics
Color ORANGE (opaque caramel cap) , ORANGE (opaque caramel body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RM56;RM56
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-094-27 28 CAPSULE in 1 BOTTLE None
2 NDC:63304-094-86 4 BLISTER PACK in 1 BOX contains a BLISTER PACK (63304-094-11)
2 NDC:63304-094-11 7 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (63304-094-86)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213914 12/25/2019
Labeler — Sun Pharmaceutical Industries Inc. (146974886)
Registrant — Sun Pharmaceutical Industries Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 650445203 MANUFACTURE (63304-091), MANUFACTURE (63304-092), MANUFACTURE (63304-093), MANUFACTURE (63304-094)

Revised: 09/2021 Sun Pharmaceutical Industries Inc.

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