EZALLOR SPRINKLE (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Carton — 40 mg

NDC 47335-987-64
Ezallor SprinkleTM
(rosuvastatin) Capsules
40 mg
PHARMACIST: Please dispense with Patient Information provided separately to each patient.
Rx only
30 (3 × 10) Unit-Dose Capsules
SUN PHARMA

spl-rosuvastatin-40mg-carton
(click image for full-size original)

EZALLOR SPRINKLE rosuvastatin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-984
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM (ROSUVASTATIN) ROSUVASTATIN 5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
MANNITOL
MAGNESIUM OXIDE
FERRIC OXIDE YELLOW
SODIUM CITRATE, UNSPECIFIED FORM
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FD&C RED NO. 40
FD&C BLUE NO. 1
D&C RED NO. 28
SHELLAC
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color PINK (Pink Cap) , WHITE (Off white Body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 984;984
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-984-83 30 CAPSULE in 1 BOTTLE None
2 NDC:47335-984-81 90 CAPSULE in 1 BOTTLE None
3 NDC:47335-984-64 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (47335-984-60)
3 NDC:47335-984-60 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (47335-984-64)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208647 05/04/2019
EZALLOR SPRINKLE rosuvastatin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-985
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM (ROSUVASTATIN) ROSUVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
MANNITOL
MAGNESIUM OXIDE
FERRIC OXIDE YELLOW
SODIUM CITRATE, UNSPECIFIED FORM
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
D&C RED NO. 28
SHELLAC
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color PURPLE (Purple Cap) , WHITE (Off white Body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 985;985
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-985-83 30 CAPSULE in 1 BOTTLE None
2 NDC:47335-985-81 90 CAPSULE in 1 BOTTLE None
3 NDC:47335-985-64 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (47335-985-60)
3 NDC:47335-985-60 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (47335-985-64)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208647 05/04/2019
EZALLOR SPRINKLE rosuvastatin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-986
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM (ROSUVASTATIN) ROSUVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
MANNITOL
MAGNESIUM OXIDE
FERRIC OXIDE YELLOW
SODIUM CITRATE, UNSPECIFIED FORM
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 3
SHELLAC
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color BLUE (Blue Cap) , WHITE (Off white Body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 986;986
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-986-83 30 CAPSULE in 1 BOTTLE None
2 NDC:47335-986-81 90 CAPSULE in 1 BOTTLE None
3 NDC:47335-986-64 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (47335-986-60)
3 NDC:47335-986-60 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (47335-986-64)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208647 05/04/2019
EZALLOR SPRINKLE rosuvastatin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-987
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM (ROSUVASTATIN) ROSUVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
MANNITOL
MAGNESIUM OXIDE
FERRIC OXIDE YELLOW
SODIUM CITRATE, UNSPECIFIED FORM
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FD&C GREEN NO. 3
SHELLAC
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color GREEN (Green Cap) , WHITE (White Body) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code 987;987
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-987-83 30 CAPSULE in 1 BOTTLE None
2 NDC:47335-987-81 90 CAPSULE in 1 BOTTLE None
3 NDC:47335-987-64 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (47335-987-60)
3 NDC:47335-987-60 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (47335-987-64)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208647 05/04/2019
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS (47335-984), ANALYSIS (47335-985), ANALYSIS (47335-986), ANALYSIS (47335-987), MANUFACTURE (47335-984), MANUFACTURE (47335-985), MANUFACTURE (47335-986), MANUFACTURE (47335-987)

Revised: 09/2020 Sun Pharmaceutical Industries, Inc.

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