Rosuvastatin (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10mg

NDC 68788-7673

Rosuvastatin Calcium Tablets 10mg
(click image for full-size original)

ROSUVASTATIN rosuvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7673(NDC:31722-883)
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
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C BLUE NO. 2
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM BICARBONATE
TALC
TITANIUM DIOXIDE
TRIACETIN
FD&C YELLOW NO. 6
Product Characteristics
Color PINK (Light pink to pink) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code H;R4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7673-2 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68788-7673-3 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68788-7673-6 60 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68788-7673-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207616 02/28/2020
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK (68788-7673)

Revised: 09/2021 Preferred Pharmaceuticals, Inc.

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