Fosamprenavir Calcium Tablet, Coated
NDC Package 63304-583-01

11-digit billing NDC: 63304058301
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fosamprenavir Calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.The following points should be considered when initiating therapy with fosamprenavir calcium tablets plus ritonavir in protease inhibitor-experienced patients:The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that fosamprenavir calcium tablets plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2)]. This formulation utilizes a tablet, coated delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 63304-583 and is authorized under FDA application ANDA204024.

Identification & Billing

NDC Package Code
63304-583-01
Package Description
100 TABLET, COATED in 1 BOTTLE
Product Code
63304-583
11-Digit Billing Format
63304058301
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

Clinical Specifications

Proprietary Name
Fosamprenavir Calcium
Non-Proprietary Name
Fosamprenavir Calcium
Substance Name
Fosamprenavir Calcium
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FOSAMPRENAVIR CALCIUM 700 mg/1
Pharmacologic Class
Usage Information
Fosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.The following points should be considered when initiating therapy with fosamprenavir calcium tablets plus ritonavir in protease inhibitor-experienced patients:The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that fosamprenavir calcium tablets plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2)]. Once-daily administration of fosamprenavir calcium tablets plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients [see Dosage and Administration (2.2,2.3), Clinical Studies (14.2, 14.3)]. Dosing of fosamprenavir calcium tablets plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months [see Clinical Pharmacology (12.3)].

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204024
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-28-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63304-583). Click a package code to view its specific billing and regulatory data.

63304-583-30
30 TABLET, COATED in 1 BOTTLE
63304-583-60
60 TABLET, COATED in 1 BOTTLE

* 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 63304-583-01 identifies a specific commercial package of 100 tablet, coated in 1 bottle of Fosamprenavir Calcium, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This tablet, coated is formulated for oral use and contains fosamprenavir calcium 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 Sun Pharmaceutical Industries, Inc. on November 28, 2019. The current certification is valid through December 31, 2027.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304058301. 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 (5-3-2)
63304-583-01
11-Digit CMS (5-4-2)
63304-0583-01

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