Source: FDA, National Drug Code (US) Revision Year: 2021
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.
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 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 |
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PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets.
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How Supplied |
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PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets.
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. |
Drug | Countries | |
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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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