Ganciclovir
NDC Package 63304-636-28

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ganciclovir is capsules are indicated for the prevention of CMV disease in solid organ transplant recipients and in individuals with advanced HIV infection at risk for developing CMV disease. Marketed by Ranbaxy Pharmaceuticals Inc., this product is identified by NDC 63304-636 and is authorized under FDA application ANDA076457.

Identification & Billing

NDC Package Code
63304-636-28
Package Description
180 CAPSULE in 1 BOTTLE
Product Code
63304-636
11-Digit Billing Format
63304063628
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
180 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ganciclovir
Dosage Form
-
Usage Information
Ganciclovir capsules are indicated for the prevention of CMV disease in solid organ transplant recipients and in individuals with advanced HIV infection at risk for developing CMV disease. Ganciclovir capsules are also indicated as an alternative to the intravenous formulation for maintenance treatment of CMV retinitis in immunocompromised patients, including patients with AIDS, in whom retinitis is stable following appropriate induction therapy and for whom the risk of more rapid progression is balanced by the benefit associated with avoiding daily IV infusions (see CLINICAL TRIALS).SAFETY AND EFFICACY OF GANCICLOVIR HAVE NOT BEEN ESTABLISHED FOR CONGENITAL OR NEONATAL CMV DISEASE; NOT FOR THE TREATMENT OF ESTABLISHED CMV DISEASE OTHER THAN RETINITIS; NOR FOR USE IN NON-IMMUNOCOMPROMISED INDIVIDUALS. THE SAFETY AND EFFICACY OF GANCICLOVIR CAPSULES HAVE NOT BEEN ESTABLISHED FOR TREATING ANY MANIFESTATION OF CMV DISEASE OTHER THAN MAINTENANCE TREATMENT OF CMV RETINITIS.

Regulatory & Marketing

Labeler Name
Ranbaxy Pharmaceuticals Inc.
FDA Application #
ANDA076457
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-27-2003
Listing Expiration
12-31-2017
Exclude Flag
I
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 (63304-636). Click a package code to view its specific billing and regulatory data.

63304-636-10
1000 CAPSULE in 1 BOTTLE
63304-636-60
60 CAPSULE in 1 BOTTLE
63304-636-90
90 CAPSULE 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 63304-636-28 identifies a specific commercial package of 180 capsule in 1 bottle of Ganciclovir, labeled by Ranbaxy Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 180 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Ranbaxy Pharmaceuticals Inc. on August 27, 2003. The current certification is valid through December 31, 2017.

How is this Ranbaxy Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304063628. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 180 total billable units per package. 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)
63304-636-28
11-Digit CMS (5-4-2)
63304-0636-28

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