Paxlovid Kit
NDC Package 0069-5321-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Paxlovid (nirmatrelvir and ritonavir) kits is 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. This formulation utilizes a kit delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0069-5321 and is authorized under FDA application NDA217188.

Identification & Billing

NDC Package Code
0069-5321-30
Package Description
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)
Product Code
0069-5321
11-Digit Billing Format
00069532130
RxNorm Crosswalk
  • 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]

Clinical Specifications

Proprietary Name
Paxlovid
Non-Proprietary Name
Nirmatrelvir And Ritonavir
Dosage Form
Kit - A packaged collection of related material.
Usage Information
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.

Regulatory & Marketing

Labeler Name
Pfizer Laboratories Div Pfizer Inc
Product Type
Human Prescription Drug
FDA Application #
NDA217188
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-18-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0069-5321-30 identifies a specific commercial package of 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) of Paxlovid, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Pfizer Laboratories Div Pfizer Inc on October 18, 2023. The current certification is valid through December 31, 2027.

How is this Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00069532130. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0069-5321-30
11-Digit CMS (5-4-2)
00069-5321-30

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.