PAXLOVID Film-coated tablet Ref.[49623] Active ingredients: Nirmatrelvir Nirmatrelvir and Ritonavir Ritonavir

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets. Nirmatrelvir is a SARS-CoV-2 main protease (Mpro) inhibitor, and ritonavir is an HIV-1 protease inhibitor and CYP3A inhibitor.

Nirmatrelvir

The chemical name of active ingredient of nirmatrelvir is (1R,2S,5S)N((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)3((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide]. It has a molecular formula of C23H32F3N5O4 and a molecular weight of 499.54.

Nirmatrelvir has the following structural formula:

Nirmatrelvir is available as immediate-release, film-coated tablets. Each tablet contains 150 mg nirmatrelvir with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, and sodium stearyl fumarate. The following are the ingredients in the film coating: hydroxy propyl methylcellulose, iron oxide red, polyethylene glycol, and titanium dioxide.

Ritonavir

Ritonavir is chemically designated as 10-Hydroxy-2-methyl-5-(1-methylethyl)1 [2-(1 methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)2,4,7,12 tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95.

Ritonavir has the following structural formula:

Ritonavir is available as film-coated tablets. Each tablet contains 100 mg ritonavir with the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate. The following are the ingredients in the film coating: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, talc, and titanium dioxide.

Dosage Forms and Strengths

PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets.

  • Nirmatrelvir is supplied as oval, pink immediate-release, film-coated tablets debossed with “PFE” on one side and “3CL” on the other side. Each tablet contains 150 mg of nirmatrelvir.
  • Ritonavir is supplied as white film-coated ovaloid tablets debossed with the “a” logo and the code NK. Each tablet contains 100 mg of ritonavir.
How Supplied

PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets.

  • Nirmatrelvir tablets, 150 mg are oval, pink immediate-release, film-coated tablets debossed with “PFE” on one side and “3CL” on the other side.
  • Ritonavir tablets, 100 mg are white film-coated ovaloid tablets debossed with the “a” logo and the code NK.

Nirmatrelvir tablets and ritonavir tablets are supplied in separate blister cavities within the same child-resistant blister card.

Each carton contains 30 tablets divided in 5 daily-dose blister cards (NDC number: 0069-1085-30).

Each daily blister card (NDC number: 0069-1085-06) contains 4 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each) and indicates which tablets need to be taken in the morning and evening.

Drugs

Drug Countries
PAXLOVID Austria, Australia, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, New Zealand, Poland, Romania, United Kingdom, United States

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