Zidovudine
NDC Package 48792-7809-6

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.

Zidovudine is a medication used with other HIV medications to help control HIV infection. Marketed by Sunshine Lake Pharma Co., Ltd., this product is identified by NDC 48792-7809 and is authorized under FDA application ANDA202058.

Identification & Billing

NDC Package Code
48792-7809-6
Package Description
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
48792780906

Clinical Specifications

Proprietary Name
Zidovudine
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. Zidovudine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors-NRTIs. Zidovudine is used in pregnant women to prevent passing the HIV virus to the unborn baby. This medication is also used in newborns born to mothers infected with HIV to prevent infection in the newborns. Zidovudine 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
Sunshine Lake Pharma Co., Ltd.
FDA Application #
ANDA202058
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2012
End Marketing Date
12-31-2012
Listing Expiration
12-31-2012
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 48792-7809-6 identifies a specific commercial package of 60 tablet, film coated in 1 bottle, plastic of Zidovudine, labeled by Sunshine Lake Pharma Co., Ltd.. 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 Sunshine Lake Pharma Co., Ltd. on September 01, 2012. The current certification is valid through December 31, 2012.

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. Zidovudine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors-NRTIs. Zidovudine is used in pregnant women to prevent passing the HIV virus to the unborn baby. This medication is also used in newborns born to mothers infected with HIV to prevent infection in the newborns. Zidovudine 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 Sunshine Lake Pharma Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48792780906. 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)
48792-7809-6
11-Digit CMS (5-4-2)
48792-7809-06

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