NDC Code(s) : 70518-1322-0, 70518-1322-1, 70518-1322-2, 70518-1322-3, 70518-1322-4
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:70518-1322(NDC:60505-2580)
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) 		ATORVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM ACETATE(UNII: Y882YXF34X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SODIUM CARBONATE(UNII: 45P3261C7T)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code APO;ATV40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70518-1322-030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/07/2018
2NDC:70518-1322-190 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/07/2018
3NDC:70518-1322-230 in 1 BLISTER PACK Type 0: Not a Combination Product25/07/2018
4NDC:70518-1322-345 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/09/2018
5NDC:70518-1322-428 in 1 BLISTER PACK Type 0: Not a Combination Product08/02/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090548 07/25/2018

LABELER - REMEDYREPACK INC.(829572556)

PRINCIPAL DISPLAY PANEL

DRUG: ATORVASTATIN CALCIUM

GENERIC: ATORVASTATIN CALCIUM

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-1322-0

NDC: 70518-1322-1

NDC: 70518-1322-2

NDC: 70518-1322-3

NDC: 70518-1322-4

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 14 mm

IMPRINT: APO;ATV40

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 45 in 1 BOTTLE PLASTIC

PACKAGING: 28 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40mg in 1

INACTIVE INGREDIENT(S):

  • CALCIUM ACETATE
  • CROSCARMELLOSE SODIUM
  • SODIUM CARBONATE
  • MICROCRYSTALLINE CELLULOSE
  • MAGNESIUM STEARATE
  • SILICON DIOXIDE
  • HYPROMELLOSE, UNSPECIFIED
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW)
  • POLYETHYLENE GLYCOL 8000
  • TITANIUM DIOXIDE

/xml/303989c9-823e-4bcb-a7b3-7024fd0d3a38/Remedy_Label.jpg

/xml/303989c9-823e-4bcb-a7b3-7024fd0d3a38/Remedy_Label.jpg