Cidofovir Dihydrate Injection, Solution
NDC Package 23155-216-31

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

Package Information

Cidofovir Dihydrate injection is a medication used with probenecid to treat a certain viral eye infection (retinitis due to cytomegalovirus-CMV) in people with AIDS. This formulation utilizes a injection, solution delivery system. Marketed by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc., this product is identified by NDC 23155-216 and is authorized under FDA application ANDA202501.

Identification & Billing

NDC Package Code
23155-216-31
Package Description
5 mL in 1 VIAL, GLASS
Product Code
23155-216
11-Digit Billing Format
23155021631
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cidofovir Dihydrate
Non-Proprietary Name
Cidofovir Dihydrate
Substance Name
Cidofovir
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CIDOFOVIR 375 mg/5mL
Pharmacologic Class
Usage Information
This drug is used with probenecid to treat a certain viral eye infection (retinitis due to cytomegalovirus-CMV) in people with AIDS. It lowers your risk of blindness and other vision problems. Cidofovir belongs to a class of drugs known as antivirals. It works by stopping the growth of the virus. Cidofovir is not a cure for CMV retinitis, and your disease may still worsen during and after treatment.

Regulatory & Marketing

Labeler Name
Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202501
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-06-2012
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 23155-216-31 identifies a specific commercial package of 5 ml in 1 vial, glass of Cidofovir Dihydrate, a human prescription drug labeled by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. This injection, solution is formulated for intravenous use and contains cidofovir 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 Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. on August 06, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This drug is used with probenecid to treat a certain viral eye infection (retinitis due to cytomegalovirus-CMV) in people with AIDS. It lowers your risk of blindness and other vision problems. Cidofovir belongs to a class of drugs known as antivirals. It works by stopping the growth of the virus. Cidofovir is not a cure for CMV retinitis, and your disease may still worsen during and after treatment.

How is this Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 23155021631. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 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)
23155-216-31
11-Digit CMS (5-4-2)
23155-0216-31

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