Atorvastatin Calcium (Page 11 of 11)

Rx Only

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

CIA75884G

Rev. 05/2019

10 mg bottle label

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Bottle Label

NDC 62175-890 -46

Atorvastatin
Calcium
Tablets

10 mg*

Pharmacist: please dispense
with patient package insert

Rx Only 90 Tablets

10 mg
(click image for full-size original)

20 mg bottle label

PRINCIPAL DISPLAY PANEL — 20 mg Tablet Bottle Label

NDC 62175-891 -46

Atorvastatin
Calcium
Tablets

20 mg*

Pharmacist: please dispense
with patient package insert

Rx Only 90 Tablets

20 mg
(click image for full-size original)

40 mg bottle label

PRINCIPAL DISPLAY PANEL — 40 mg Tablet Bottle Label

NDC 62175-892 -46

Atorvastatin
Calcium
Tablets

40 mg*

Pharmacist: please dispense
with patient package insert

Rx Only 90 Tablets

40 mg
(click image for full-size original)

80 mg bottle label

PRINCIPAL DISPLAY PANEL — 80 mg Tablet Bottle Label

NDC 62175-897 -46

Atorvastatin
Calcium
Tablets

80 mg*

Pharmacist: please dispense
with patient package insert

Rx Only 90 Tablets

80 mg
(click image for full-size original)
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-890
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
POLYVINYL ALCOHOL (94000 MW)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62175-890-43 1000 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62175-890-45 5000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:62175-890-46 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091624 04/05/2013
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-891
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
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
POLYVINYL ALCOHOL (94000 MW)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62175-891-43 1000 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62175-891-45 5000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:62175-891-46 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091624 04/05/2013
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-892
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
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
POLYVINYL ALCOHOL (94000 MW)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62175-892-41 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62175-892-44 2500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:62175-892-46 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091624 04/05/2013
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-897
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 80 mg
Inactive Ingredients
Ingredient Name Strength
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
POLYVINYL ALCOHOL (94000 MW)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62175-897-41 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62175-897-44 2500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:62175-897-46 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091624 04/05/2013
Labeler — Lannett Company, Inc. (006422406)

Revised: 11/2019 Lannett Company, Inc.

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