Paxlovid Kit
NDC 0069-5317

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0069-5317?
  5. Paxlovid Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

Paxlovid (nirmatrelvir and ritonavir) is a NDA-approved product labeled by Pfizer Laboratories Div Pfizer Inc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a pink kit. This product entry covers the primary NDC 0069-5317 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0069-5317
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
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

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.

Marketing Timeline

Start Marketing Date: [9]
10-18-2023
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

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 0069-5317?

The NDC code 0069-5317 is assigned by the FDA to the product Paxlovid. It is commonly known by its generic name, nirmatrelvir and ritonavir. This pharmaceutical product is labeled by Pfizer Laboratories Div Pfizer Inc and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0069-5317-20. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 full disclaimer at the bottom of this page.

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 full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".