Rosuvastatin Calcium (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rosuvastatin Tablets, USP

5mg

100 Tablets

carton label
(click image for full-size original)

Package/Label Display Panel

Rosuvastatin Tablets, USP

10 mg

100 Tablets

Carton label
(click image for full-size original)

Package/Label Display Panel

Rosuvastatin Tablets, USP

20 mg

100 Tablets

Carton Label
(click image for full-size original)

Package/Label Display Panel

Rosuvastatin Tablets, USP

40 mg

100 Tablets

Carton label
(click image for full-size original)
ROSUVASTATIN CALCIUM rosuvastatin calcium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6778(NDC:13668-179)
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 (120 .MU.M)
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 79
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6778-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6778-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201619 10/31/2016
ROSUVASTATIN CALCIUM rosuvastatin calcium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6779(NDC:13668-180)
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 (120 .MU.M)
FERRIC OXIDE RED
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK (Light Pink) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 1180
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6779-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6779-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201619 10/31/2016
ROSUVASTATIN CALCIUM rosuvastatin calcium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6780(NDC:13668-181)
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 (120 .MU.M)
FERRIC OXIDE RED
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK (Light Pink) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 1181
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6780-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6780-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201619 10/31/2016
ROSUVASTATIN CALCIUM rosuvastatin calcium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6781(NDC:13668-182)
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 (120 .MU.M)
FERRIC OXIDE RED
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK (Light Pink) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code 1182
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6781-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6781-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201619 10/31/2016
Labeler — Major Pharmaceuticals (191427277)

Revised: 02/2023 Major Pharmaceuticals

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