NDC Code(s) : 61786-868-19
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ATORVASTATIN CALCIUMATORVASTATIN CALCIUM TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-868(NDC:60505-2578)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE(UNII: YRZ789OWMI)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM ACETATE(UNII: Y882YXF34X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SODIUM CARBONATE(UNII: 45P3261C7T)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code APO;A10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-868-1990 in 1 BOTTLE Type 0: Not a Combination Product01/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090548 09/01/2016 12/30/2016

PRINCIPAL DISPLAY PANEL

DRUG: ATORVASTATIN CALCIUM

GENERIC: ATORVASTATIN CALCIUM

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-868-19

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 9 mm

IMPRINT: APO;A10

PACKAGING: 90 in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10mg in 1

INACTIVE INGREDIENT(S):

  • CALCIUM ACETATE
  • HYPROMELLOSES
  • HYDROXYPROPYL CELLULOSE (TYPE H)
  • POLYETHYLENE GLYCOL 8000
  • SILICON DIOXIDE
  • CROSCARMELLOSE SODIUM
  • MAGNESIUM STEARATE
  • SODIUM CARBONATE
  • CELLULOSE, MICROCRYSTALLINE
  • TITANIUM DIOXIDE

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