0069-0345 NDC - PAXLOVID (NIRMATRELVIR AND RITONAVIR)

Drug Information

Product NDC: 0069-0345

Proprietary Name: Paxlovid

Non Proprietary Name: nirmatrelvir and ritonavir

Active Ingredient(s):


Administration Route(s):

Dosage Form(s): KIT

Labeler Information

Labeler Name: Pfizer Laboratories Div Pfizer Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: EMERGENCY USE AUTHORIZATION
Start Marketing Date:4/18/2022

Package Information

No. Package Code Package Description Billing Unit
10069-0345-305 BLISTER PACK in 1 CARTON (0069-0345-30) / 1 KIT in 1 BLISTER PACK (0069-0345-06) * 4 TABLET, FILM COATED in 1 BLISTER PACK (0069-2085-01) * 2 TABLET, FILM COATED in 1 BLISTER PACK (0069-1345-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0069-0345The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMEPaxlovidThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEnirmatrelvir and ritonavirThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEKITThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE4/18/2022This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEEMERGENCY USE AUTHORIZATIONProduct 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.
LABELER NAMEPfizer Laboratories Div Pfizer IncName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 2/1/2023