Rosuvastatin Calcium (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

NDC 51407-153-90

Rosuvastatin Calcium Tablets

5 mg

WARNING: As with all medications, keep out of the reach of children.

Rx only

90 Tablets

NDC 51407-154-90

Rosuvastatin Calcium Tablets

10 mg

WARNING: As with all medications, keep out of the reach of children.

Rx only

90 Tablets

NDC 51407-155-90

Rosuvastatin Calcium Tablets

20 mg

WARNING: As with all medications, keep out of the reach of children.

Rx only

90 Tablets

Rosuvastatin Calcium Tablets

40 mg

WARNING: As with all medications, keep out of the reach of children.

Rx only

30 Tablets

ROSUVASTATIN CALCIUM rosuvastatin calcium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-153(NDC:27808-155) 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 ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSPOVIDONE HYPROMELLOSE 2208 (100 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color pink Score no score Shape ROUND (biconvex) Size 7mm Flavor Imprint Code CY;5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51407-153-90 90 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207408 10/31/2016

ROSUVASTATIN CALCIUM rosuvastatin calcium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-154(NDC:27808-156) 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 ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSPOVIDONE HYPROMELLOSE 2208 (100 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code CY;10 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51407-154-90 90 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207408 10/31/2016

ROSUVASTATIN CALCIUM rosuvastatin calcium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-155(NDC:27808-157) 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 ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSPOVIDONE HYPROMELLOSE 2208 (100 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color yellow Score no score Shape ROUND Size 9mm Flavor Imprint Code CY;20 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51407-155-90 90 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207408 10/31/2016

ROSUVASTATIN CALCIUM rosuvastatin calcium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-156(NDC:27808-158) 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 ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSPOVIDONE HYPROMELLOSE 2208 (100 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color pink Score no score Shape ROUND Size 9mm Flavor Imprint Code CY;40 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51407-156-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207408 10/31/2016

Labeler — Golden State Medical Supply, Inc. (603184490)

Establishment
Name	Address	ID/FEI	Operations
Golden State Medical Supply, Inc.		603184490	relabel (51407-153), repack (51407-153), relabel (51407-154), repack (51407-154), relabel (51407-155), repack (51407-155), relabel (51407-156), repack (51407-156)

Revised: 12/2020 Golden State Medical Supply, Inc.