NDC Code(s) : 50090-0974-0, 50090-0974-1
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

pravastatin sodiumpravastatin sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0974(NDC:68382-071)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM(UNII: 3M8608UQ61)
(PRAVASTATIN - UNII:KXO2KT9N0G) 		PRAVASTATIN SODIUM20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
SODIUM CARBONATE(UNII: 45P3261C7T)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape OVAL (OVAL) Size 11 mm
Flavor Imprint Code ZC45
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-0974-0 30 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
2NDC:50090-0974-1 90 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077751 03/30/2010 11/30/2016

PRINCIPAL DISPLAY PANEL

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