NDC Code(s) : 63629-7161-1, 63629-7161-2, 63629-7161-3
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rosuvastatin CalciumRosuvastatin calcium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-7161(NDC:16252-618)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN - UNII:413KH5ZJ73) 		ROSUVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM CARBONATE MONOHYDRATE(UNII: 2A1Q1Q3557)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3500(UNII: FVS1AZD90Y)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
Product Characteristics
Color PINK Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code RU40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-7161-1 30 in 1 BOTTLE Type 0: Not a Combination Product16/12/2016
2NDC:63629-7161-2 90 in 1 BOTTLE Type 0: Not a Combination Product16/12/2016
3NDC:63629-7161-3 28 in 1 BOTTLE Type 0: Not a Combination Product16/12/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079167 05/02/2016

PRINCIPAL DISPLAY PANEL

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