Atorvastatin Calcium: Package Insert and Label Information (Page 7 of 7)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL- 20 mg Tablet Bottle Label

NDC 68645-591-54

30 Tablets

Rx only

Atorvastatin Calcium Tablets, USP

20 mg

Atorvastatin Calcium Tablets, USP 20 mg
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL- 40 mg Tablet Bottle Label

NDC 68645-592-54

30 Tablets

Rx only

Atorvastatin Calcium Tablets, USP

40 mg

Atorvastatin Calcium Tablets, USP 40 mg
(click image for full-size original)
ATORVASTATIN CALCIUM atorvastatin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-591(NDC:70377-028)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (90000 WAMW)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off White Oval Shaped Tablet) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 114
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68645-591-54 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209912 06/18/2018 06/30/2021
ATORVASTATIN CALCIUM atorvastatin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-592(NDC:70377-029)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (90000 WAMW)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off White Oval Shaped Tablet) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 115
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68645-592-54 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209912 06/18/2018 06/30/2021
Labeler — Legacy Pharmaceutical Packaging, LLC (143213275)

Revised: 10/2020 Legacy Pharmaceutical Packaging, LLC

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