Zidovudine Tablet
NDC Package 67046-1613-3

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

Package Information

Zidovudine tablets is a medication used with other HIV medications to help control HIV infection. This formulation utilizes a tablet delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-1613 and is authorized under FDA application ANDA090092.

Identification & Billing

NDC Package Code
67046-1613-3
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
67046-1613
11-Digit Billing Format
67046161303
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zidovudine
Non-Proprietary Name
Zidovudine
Substance Name
Zidovudine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZIDOVUDINE 300 mg/1
Pharmacologic Class
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
Coupler Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090092
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-13-2025
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 67046-1613-3 identifies a specific commercial package of 30 tablet in 1 blister pack of Zidovudine, a human prescription drug labeled by Coupler Llc. This tablet 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 Coupler Llc on November 13, 2025. The current certification is valid through December 31, 2027.

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 Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046161303. 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)
67046-1613-3
11-Digit CMS (5-4-2)
67046-1613-03

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