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  5. NDC Package Code: 63304-583-01 Fosamprenavir Calcium

NDC Package 63304-583-01 Fosamprenavir Calcium

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
63304-583-01
Package Description:
100 TABLET, COATED in 1 BOTTLE
Product Code:
63304-583
Proprietary Name:
Fosamprenavir Calcium
Non-Proprietary Name:
Fosamprenavir Calcium
Substance Name:
Fosamprenavir Calcium
Usage Information:
This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Fosamprenavir belongs to a class of drugs known as protease inhibitors. It may be given with ritonavir, another protease inhibitor, to increase ("boost") the levels of fosamprenavir. This helps fosamprenavir work better. Fosamprenavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
11-Digit NDC Billing Format:
63304058301
NDC to RxNorm Crosswalk:
  • RxCUI: 402109 - fosamprenavir calcium 700 MG Oral Tablet
  • RxCUI: 402109 - fosamprenavir 700 MG Oral Tablet
  • RxCUI: 402109 - fosamprenavir (as fosamprenavir calcium) 700 MG (amprenavir 600 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    Dosage Form:
    Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FOSAMPRENAVIR CALCIUM 700 mg/1
    • Pharmacologic Class(es):
  • Cytochrome P450 3A4 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • HIV Protease Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inducers - [MoA] (Mechanism of Action)
  • Protease Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA204024
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-28-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    63304-583-3030 TABLET, COATED in 1 BOTTLE
    63304-583-6060 TABLET, COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63304-583-01?

    The NDC Packaged Code 63304-583-01 is assigned to a package of 100 tablet, coated in 1 bottle of Fosamprenavir Calcium, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet, coated and is administered via oral form.

    Is NDC 63304-583 included in the NDC Directory?

    Yes, Fosamprenavir Calcium with product code 63304-583 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on November 28, 2019 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 63304-583-01?

    The 11-digit format is 63304058301. 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
    5-3-263304-583-015-4-263304-0583-01