LIPITOR Film-coated tablet Ref.[51699] Active ingredients: Atorvastatin

Source: FDA, National Drug Code (US)  Revision Year: 2022 

Product description

LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Atorvastatin calcium is [R-(R*, R*)]2(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca•3H2O and its molecular weight is 1209.42.

Its structural formula is:

Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol.

LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.

Dosage Forms and Strengths

LIPITOR tablets:

  • 10 mg of atorvastatin: white elliptical, film-coated tablets with “PD 155” on one side and “10” on the other.
  • 20 mg of atorvastatin: white elliptical, film-coated tablets with “PD 156” on one side and “20” on the other.
  • 40 mg of atorvastatin: white elliptical, film-coated tablets with “PD 157” on one side and “40” on the other.
  • 80 mg of atorvastatin: white elliptical, film-coated tablets with “PD 158” on one side and “80” on the other.
How Supplied

LIPITOR tablets are supplied as follows:

Strength How Supplied NDCTablet Description
10 mg of atorvastatin bottles of 90 0071-0155-23 white elliptical, film-coated tablets with “PD 155” on one side and “10” on the other
10 × 10 unit dose blisters 0071-0155-40
20 mg of atorvastatin bottles of 90 0071-0156-23 white elliptical, film-coated tablets with “PD 156” on one side and “20” on the other
10 × 10 unit dose blisters 0071-0156-40
40 mg of atorvastatin bottles of 90 0071-0157-23 white elliptical, film-coated tablets with “PD 157” on one side and “40” on the other
10 × 10 unit dose blisters 0071-0157-40
80 mg of atorvastatin bottles of 90 0071-0158-23 white elliptical, film-coated tablets with “PD 158” on one side and “80” on the other
8 × 8 unit dose blisters 0071-0158-92

Distributed by: Viatris Specialty LLC, Morgantown, WV 26505 U.S.A.

Drugs

Drug Countries
LIPITOR Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Finland, Hong Kong, Ireland, Israel, Japan, Malta, Mexico, Nigeria, Netherlands, New Zealand, Singapore, Turkey, United Kingdom, United States, South Africa
 
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