NDC Code(s) : 61786-196-19
Packager : REMEDYREPACK INC.

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:61786-196(NDC:68382-072)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM(UNII: 3M8608UQ61)
(PRAVASTATIN - UNII:KXO2KT9N0G) 		PRAVASTATIN SODIUM40 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
SODIUM CARBONATE(UNII: 45P3261C7T)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score no score
Shape OVAL (OVAL) Size 14 mm
Flavor Imprint Code ZC44
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-196-1990 in 1 BOTTLE Type 0: Not a Combination Product20/02/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077751 02/20/2015 04/29/2016

PRINCIPAL DISPLAY PANEL

DRUG: pravastatin sodium

GENERIC: pravastatin sodium

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-196-19

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 14 mm

IMPRINT: ZC44

PACKAGING: 90 in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • PRAVASTATIN SODIUM 40mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • CELLULOSE, MICROCRYSTALLINE
  • SODIUM CARBONATE
  • CROSCARMELLOSE SODIUM
  • MAGNESIUM STEARATE
  • POLYOXYL 35 CASTOR OIL

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