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  5. NDC Package Code: 31722-568-60 Darunavir

NDC Package 31722-568-60 Darunavir

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
31722-568-60
Package Description:
60 TABLET, FILM COATED in 1 BOTTLE
Product Code:
31722-568
Proprietary Name:
Darunavir
Non-Proprietary Name:
Darunavir
Substance Name:
Darunavir
Usage Information:
Darunavir tablets, co-administered with ritonavir (darunavir tablets/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older  [see  Use in Specific Populations (8.4) and  Clinical Studies (14)] .
11-Digit NDC Billing Format:
31722056860
NDC to RxNorm Crosswalk:
  • RxCUI: 670026 - darunavir 600 MG Oral Tablet
  • RxCUI: 670026 - darunavir (as darunavir ethanolate) 600 MG Oral Tablet
  • RxCUI: 670026 - darunavir (as darunavir hydrate) 600 MG Oral Tablet
  • RxCUI: 824338 - darunavir 400 MG Oral Tablet
  • RxCUI: 824338 - darunavir (as darunavir ethanolate) 400 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Camber Pharmaceuticals, Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DARUNAVIR 600 mg/1
    • Pharmacologic Class(es):
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • HIV Protease Inhibitors - [MoA] (Mechanism of Action)
  • Protease Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA202083
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-14-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 31722-568-60?

    The NDC Packaged Code 31722-568-60 is assigned to a package of 60 tablet, film coated in 1 bottle of Darunavir, a human prescription drug labeled by Camber Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 31722-568 included in the NDC Directory?

    Yes, Darunavir with product code 31722-568 is active and included in the NDC Directory. The product was first marketed by Camber Pharmaceuticals, Inc. on September 14, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 31722-568-60?

    The 11-digit format is 31722056860. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-231722-568-605-4-231722-0568-60