Rosuvastatin Calcium (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rosuvastatin Tablets, USP 5mg

Rosuvastatin Tablets, USP 5mg
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Rosuvastatin Tablets, USP 10mg

Rosuvastatin Tablets USP, 10 mg
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Rosuvastatin Tablets, USP 20mg

Rosuvastatin Tablets, USP 20 mg
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Rosuvastatin Tablets, USP 40mg

Rosuvastatin Tablets, USP 40 mg
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ROSUVASTATIN CALCIUM rosuvastatin calcium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE (15 MPA.S AT 5%)
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:13668-179-30 30 TABLET, COATED in 1 BOTTLE None
2 NDC:13668-179-74 100 TABLET, COATED in 1 CARTON None
3 NDC:13668-179-90 90 TABLET, COATED in 1 BOTTLE None
4 NDC:13668-179-05 500 TABLET, COATED in 1 BOTTLE None
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: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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE (15 MPA.S AT 5%)
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:13668-180-90 90 TABLET, COATED in 1 BOTTLE None
2 NDC:13668-180-74 100 TABLET, COATED in 1 CARTON None
3 NDC:13668-180-05 500 TABLET, COATED in 1 BOTTLE None
4 NDC:13668-180-30 30 TABLET, COATED in 1 BOTTLE None
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: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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE (15 MPA.S AT 5%)
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:13668-181-90 90 TABLET, COATED in 1 BOTTLE None
2 NDC:13668-181-30 30 TABLET, COATED in 1 BOTTLE None
3 NDC:13668-181-74 100 TABLET, COATED in 1 CARTON None
4 NDC:13668-181-05 500 TABLET, COATED in 1 BOTTLE None
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: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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE (15 MPA.S AT 5%)
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:13668-182-30 30 TABLET, COATED in 1 BOTTLE None
2 NDC:13668-182-90 90 TABLET, COATED in 1 BOTTLE None
3 NDC:13668-182-05 500 TABLET, COATED in 1 BOTTLE None
4 NDC:13668-182-74 100 TABLET, COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201619 10/31/2016
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 MANUFACTURE (13668-179), MANUFACTURE (13668-180), MANUFACTURE (13668-181), MANUFACTURE (13668-182)

Revised: 01/2019 Torrent Pharmaceuticals Limited

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