Stavudine
NDC Package 53104-0111-5

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

Stavudine is a medication used with other HIV medications to help control HIV infection. Marketed by Cipla Limited, this product is identified by NDC 53104-0111 and is authorized under FDA application ANDA078030.

Identification & Billing

NDC Package Code
53104-0111-5
Package Description
200 mL in 1 BOTTLE
Product Code
53104-0111
11-Digit Billing Format
53104011105

Clinical Specifications

Proprietary Name
Stavudine
Dosage Form
-
Usage Information
This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Stavudine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTI). Stavudine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Regulatory & Marketing

Labeler Name
Cipla Limited
FDA Application #
ANDA078030
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-20-2009
End Marketing Date
09-01-2021
Listing Expiration
09-01-2021
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 53104-0111-5 identifies a specific commercial package of 200 ml in 1 bottle of Stavudine, labeled by Cipla Limited. 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 Cipla Limited on March 20, 2009. The current certification is valid through September 01, 2021.

What are the primary indications for this medication?

This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Stavudine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTI). Stavudine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

How is this Cipla Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53104011105. 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)
53104-0111-5
11-Digit CMS (5-4-2)
53104-0111-05

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