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  4. NDC Product Code: 0069-5321 Paxlovid

NDC 0069-5321 Paxlovid

Nirmatrelvir And Ritonavir Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0069-5321?
  5. Paxlovid Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
0069-5321
Proprietary Name:
Paxlovid
Non-Proprietary Name: [1]
Nirmatrelvir And Ritonavir
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Pfizer Laboratories Div Pfizer Inc
Labeler Code:
0069
Product Label ID:
8a99d6d6-fd9e-45bb-b1bf-48c7f761232a
FDA Application Number: [6]
NDA217188
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
10-18-2023
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
WHITE (C48325)
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
OVAL (C48345)
Size(s):
18 MM
17 MM
Imprint(s):
PFE;3CL
A;NK
H;R9
NK
Score:
1

Code Structure Chart

Product Details

What is NDC 0069-5321?

The NDC code 0069-5321 is assigned by the FDA to the product Paxlovid which is a human prescription drug product labeled by Pfizer Laboratories Div Pfizer Inc. The generic name of Paxlovid is nirmatrelvir and ritonavir. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0069-5321-30 10 blister pack in 1 carton / 1 kit in 1 blister pack (0069-5321-03) * 2 tablet, film coated in 1 blister pack (0069-2085-02) * 1 tablet, film coated in 1 blister pack (0069-1735-11). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Paxlovid?

PAXLOVID is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

Which are Paxlovid UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Paxlovid Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Paxlovid?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 2587897 - nirmatrelvir 150 MG Oral Tablet
  • RxCUI: 2587898 - {20 (nirmatrelvir 150 MG Oral Tablet) / 10 (ritonavir 100 MG Oral Tablet) } Pack
  • RxCUI: 2587898 - nirmatrelvir 300 MG ; ritonavir 100 MG Daily Dose Pack
  • RxCUI: 2587898 - nirmatrelvir 150 MG Oral Tablet (20) / ritonavir 100 MG Oral Tablet (10) 5-Day Pack
  • RxCUI: 2587899 - {20 (nirmatrelvir 150 MG Oral Tablet) / 10 (ritonavir 100 MG Oral Tablet) } Pack [Paxlovid 5-Day]

* Please review the disclaimer below.

Patient Education

Nirmatrelvir and Ritonavir


The combination of nirmatrelvir and ritonavir is used to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in adults who have mild to moderate symptoms and are at risk of severe disease that could result in hospitalization or death. The FDA has also issued an emergency use authorization (EUA) authorizing use of nirmatrelvir and ritonavir to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in children 12 years of age and older who weigh at least 88 pounds (40 kg). Nirmatrelvir is in a class of medications called antivirals. It works by stopping the virus from spreading in the body. Ritonavir is in a class of medications called pharmacokinetic boosters. It works by increasing the amount of nirmatrelvir available in the body so that the medication will have a greater effect.
[Learn More]


Ritonavir


Ritonavir is used along with other medications to treat human immunodeficiency virus (HIV) infection. Ritonavir is in a class of medications called protease inhibitors. It works by decreasing the amount of HIV in the blood. Although ritonavir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting the HIV virus to other people.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".