Acyclovir Sodium Powder
NDC Package 46014-1019-1

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Acyclovir Sodium powders is a medication used in certain people to treat outbreaks of herpes simplex infection of the skin (such as on the genitals), mucous membrane areas (such as the mouth, nose), or brain. This formulation utilizes a powder delivery system. Marketed by Excella Gmbh &co.kg, this product is identified by NDC 46014-1019.

Identification & Billing

NDC Package Code
46014-1019-1
Package Description
50 kg in 1 DRUM
Product Code
46014-1019
11-Digit Billing Format
46014101901

Clinical Specifications

Proprietary Name
Acyclovir Sodium
Non-Proprietary Name
Acyclovir Sodium
Substance Name
Acyclovir Sodium
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ACYCLOVIR SODIUM 1 kg/kg
Usage Information
This medication is used in certain people to treat outbreaks of herpes simplex infection of the skin (such as on the genitals), mucous membrane areas (such as the mouth, nose), or brain. It is also used in certain people to treat shingles infection. The viruses that cause these infections live in the body quietly until an outbreak occurs. Acyclovir does not cure these infections, but can speed healing of the sores, decrease pain/itching/formation of new sores, and lower the risk of other problems from the virus (e.g., infection spreading to other parts of the body/organs, persistent pain after sores heal).

Regulatory & Marketing

Labeler Name
Excella Gmbh &co.kg
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
12-16-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 46014-1019-1 identifies a specific commercial package of 50 kg in 1 drum of Acyclovir Sodium (UNFINISHED drug), a bulk ingredient labeled by Excella Gmbh &co.kg. This powder is formulated for use and contains acyclovir sodium 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 Excella Gmbh &co.kg on December 16, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used in certain people to treat outbreaks of herpes simplex infection of the skin (such as on the genitals), mucous membrane areas (such as the mouth, nose), or brain. It is also used in certain people to treat shingles infection. The viruses that cause these infections live in the body quietly until an outbreak occurs. Acyclovir does not cure these infections, but can speed healing of the sores, decrease pain/itching/formation of new sores, and lower the risk of other problems from the virus (e.g., infection spreading to other parts of the body/organs, persistent pain after sores heal).

How is this Excella Gmbh &co.kg product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46014101901. 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 (5-4-1)
46014-1019-1
11-Digit CMS (5-4-2)
46014-1019-01

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