Zidovudine Syrup
NDC Package 65862-048-24

11-digit billing NDC: 65862004824 · Billing unit: ML · 240 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Zidovudine syrups is zidovudine oral solution is contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulation. This formulation utilizes a syrup delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-048 and is authorized under FDA application ANDA077268.

Identification & Billing

NDC Package Code
65862-048-24
Package Description
240 mL in 1 BOTTLE
Product Code
65862-048
11-Digit Billing Format
65862004824
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
240 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zidovudine
Non-Proprietary Name
Zidovudine
Substance Name
Zidovudine
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZIDOVUDINE 10 mg/mL
Pharmacologic Class
Usage Information
Zidovudine oral solution is contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulation.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA077268
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-19-2005
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65862-048-24 identifies a specific commercial package of 240 ml in 1 bottle of Zidovudine, a human prescription drug labeled by Aurobindo Pharma Limited. This syrup is formulated for oral use and contains zidovudine 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 Aurobindo Pharma Limited on September 19, 2005. The current certification is valid through December 31, 2027.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862004824. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 240 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)
65862-048-24
11-Digit CMS (5-4-2)
65862-0048-24

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