Atorvastatin Calcium (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Atorvastatin Calcium Tablets, 10 mg — Container Label

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

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Atorvastatin Calcium Tablets, 20 mg — Container Label

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

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Atorvastatin Calcium Tablets, 40 mg — Container Label

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

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ATORVASTATIN CALCIUM atorvastatin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-121
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
CROSPOVIDONE
Hydroxypropyl Cellulose, Unspecified
lactose monohydrate
magnesium stearate
methyl alcohol
cellulose, microcrystalline
sodium bicarbonate
sodium lauryl sulfate
isopropyl alcohol
methylene chloride
Polyethylene Glycol, Unspecified
titanium dioxide
hypromelloses
Product Characteristics
Color WHITE (white to off white) Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code RDY;121
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-121-30 30 TABLET in 1 BOTTLE None
2 NDC:55111-121-60 60 TABLET in 1 BOTTLE None
3 NDC:55111-121-90 90 TABLET in 1 BOTTLE None
4 NDC:55111-121-05 500 TABLET in 1 BOTTLE None
5 NDC:55111-121-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091650 07/17/2012
ATORVASTATIN CALCIUM atorvastatin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-122
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
CROSPOVIDONE
Hydroxypropyl Cellulose, Unspecified
lactose monohydrate
magnesium stearate
methyl alcohol
cellulose, microcrystalline
sodium bicarbonate
sodium lauryl sulfate
isopropyl alcohol
methylene chloride
Polyethylene Glycol, Unspecified
titanium dioxide
hypromelloses
Product Characteristics
Color WHITE (white to off white) Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code RDY;122
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-122-30 30 TABLET in 1 BOTTLE None
2 NDC:55111-122-60 60 TABLET in 1 BOTTLE None
3 NDC:55111-122-90 90 TABLET in 1 BOTTLE None
4 NDC:55111-122-05 500 TABLET in 1 BOTTLE None
5 NDC:55111-122-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091650 07/17/2012
ATORVASTATIN CALCIUM atorvastatin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-123
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
CROSPOVIDONE
Dimethylaminoethyl Methacrylate — Butyl Methacrylate — Methyl Methacrylate Copolymer
Hydroxypropyl Cellulose, Unspecified
lactose monohydrate
magnesium stearate
methyl alcohol
cellulose, microcrystalline
sodium bicarbonate
sodium lauryl sulfate
isopropyl alcohol
methylene chloride
Polyethylene Glycol, Unspecified
titanium dioxide
hypromelloses
Product Characteristics
Color WHITE (white to off white) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code RDY;123
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-123-30 30 TABLET in 1 BOTTLE None
2 NDC:55111-123-60 60 TABLET in 1 BOTTLE None
3 NDC:55111-123-90 90 TABLET in 1 BOTTLE None
4 NDC:55111-123-05 500 TABLET in 1 BOTTLE None
5 NDC:55111-123-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091650 07/17/2012
Labeler — Dr. Reddy’s Laboratories Limited (650562841)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited — FTO III 918608162 analysis (55111-121), analysis (55111-122), analysis (55111-123), manufacture (55111-121), manufacture (55111-122), manufacture (55111-123)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited FTO-Sez-Process Unit-01 860037244 analysis (55111-121), manufacture (55111-121), analysis (55111-122), manufacture (55111-122), analysis (55111-123), manufacture (55111-123)

Revised: 06/2021 Dr. Reddy’s Laboratories Limited

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