Combivir
NDC Package 49349-683-04

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

Package Information

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

Combivir is this product contains 2 drugs: lamivudine and zidovudine. Marketed by Remedyrepack Inc., this product is identified by NDC 49349-683 and is authorized under FDA application NDA020857.

Identification & Billing

NDC Package Code
49349-683-04
Package Description
14 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
49349-683
11-Digit Billing Format
49349068304

Clinical Specifications

Proprietary Name
Combivir
Dosage Form
-
Usage Information
This product contains 2 drugs: lamivudine and zidovudine. It 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. Both lamivudine and zidovudine belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). Lamivudine/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
Remedyrepack Inc.
FDA Application #
NDA020857
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-17-2011
End Marketing Date
07-25-2012
Listing Expiration
07-25-2012
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49349-683). Click a package code to view its specific billing and regulatory data.

49349-683-12
8 TABLET, FILM COATED in 1 BLISTER PACK
49349-683-21
120 TABLET, FILM COATED in 1 CANISTER

* 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 49349-683-04 identifies a specific commercial package of 14 tablet, film coated in 1 blister pack of Combivir, labeled by Remedyrepack Inc.. 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 Remedyrepack Inc. on February 17, 2011. The current certification is valid through July 25, 2012.

What are the primary indications for this medication?

This product contains 2 drugs: lamivudine and zidovudine. It 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. Both lamivudine and zidovudine belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). Lamivudine/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 Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49349068304. 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)
49349-683-04
11-Digit CMS (5-4-2)
49349-0683-04

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