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  5. NDC Package Code: 76282-738-30 Darunavir

NDC Package 76282-738-30 Darunavir

Darunavir 800 Mg Tablet 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:
76282-738-30
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
76282-738
Proprietary Name:
Darunavir
Non-Proprietary Name:
Darunavir 800 Mg
Substance Name:
Darunavir Hydrate
Usage Information:
Darunavir tablets, co-administered with ritonavir (darunavir/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:
76282073830
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1359269 - darunavir 800 MG Oral Tablet
  • RxCUI: 1359269 - darunavir (as darunavir ethanolate) 800 MG Oral Tablet
  • 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Exelan Pharmaceuticals Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DARUNAVIR HYDRATE 800 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:
    ANDA206288
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-19-2024
    Listing Expiration Date:
    12-31-2025
    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 76282-738-30?

    The NDC Packaged Code 76282-738-30 is assigned to a package of 30 tablet in 1 bottle of Darunavir, a human prescription drug labeled by Exelan Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 76282-738 included in the NDC Directory?

    Yes, Darunavir with product code 76282-738 is active and included in the NDC Directory. The product was first marketed by Exelan Pharmaceuticals Inc. on January 19, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 76282-738-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 76282-738-30?

    The 11-digit format is 76282073830. 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
    5-3-276282-738-305-4-276282-0738-30