Famciclovir
NDC Package 0781-5621-31

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Famciclovir is used to treat infections caused by certain types of viruses. Marketed by Sandoz Inc, this product is identified by NDC 0781-5621 and is authorized under FDA application NDA020363.

Identification & Billing

NDC Package Code
0781-5621-31
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
11-Digit Billing Format
00781562131
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Famciclovir
Dosage Form
-
Usage Information
Famciclovir is used to treat infections caused by certain types of viruses. It treats shingles caused by herpes zoster. It also treats outbreaks of herpes simplex that cause cold sores around the mouth, sores around the anus, and genital herpes. In people with frequent outbreaks of genital herpes, famciclovir is used to help reduce the number of future episodes. Famciclovir is an antiviral drug. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Famciclovir decreases the severity and length of these outbreaks. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain remains after the sores heal. In addition, in people with a weakened immune system, famciclovir can decrease the risk of the virus spreading to other parts of the body and causing serious infections.

Regulatory & Marketing

Labeler Name
Sandoz Inc
FDA Application #
NDA020363
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
03-07-2011
End Marketing Date
01-31-2015
Listing Expiration
01-31-2015
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0781-5621-31 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Famciclovir, labeled by Sandoz Inc. 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 Sandoz Inc on March 07, 2011. The current certification is valid through January 31, 2015.

What are the primary indications for this medication?

Famciclovir is used to treat infections caused by certain types of viruses. It treats shingles caused by herpes zoster. It also treats outbreaks of herpes simplex that cause cold sores around the mouth, sores around the anus, and genital herpes. In people with frequent outbreaks of genital herpes, famciclovir is used to help reduce the number of future episodes. Famciclovir is an antiviral drug. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Famciclovir decreases the severity and length of these outbreaks. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain remains after the sores heal. In addition, in people with a weakened immune system, famciclovir can decrease the risk of the virus spreading to other parts of the body and causing serious infections.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781562131. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (4-4-2)
0781-5621-31
11-Digit CMS (5-4-2)
00781-5621-31

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