Atazanavir Capsule
NDC Package 42385-920-60

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

Atazanavir capsules is a medication used with other HIV medications to help control HIV infection. This formulation utilizes a capsule delivery system. Marketed by Laurus Labs Limited, this product is identified by NDC 42385-920 and is authorized under FDA application ANDA212579.

Identification & Billing

NDC Package Code
42385-920-60
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
42385-920
11-Digit Billing Format
42385092060
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Atazanavir
Non-Proprietary Name
Atazanavir
Substance Name
Atazanavir Sulfate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ATAZANAVIR SULFATE 150 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. Atazanavir belongs to a class of drugs known as protease inhibitors. It may be given with certain other medications (such as cobicistat, ritonavir) to increase ("boost") the levels of atazanavir. This helps atazanavir work better. Atazanavir 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
Laurus Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA212579
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2021
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42385-920). Click a package code to view its specific billing and regulatory data.

42385-920-48
10 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK (42385-920-06)

* 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 42385-920-60 identifies a specific commercial package of 60 capsule in 1 bottle of Atazanavir, a human prescription drug labeled by Laurus Labs Limited. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This capsule is formulated for oral use and contains atazanavir sulfate 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 Laurus Labs Limited on April 30, 2021. The current certification is valid through December 31, 2026.

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. Atazanavir belongs to a class of drugs known as protease inhibitors. It may be given with certain other medications (such as cobicistat, ritonavir) to increase ("boost") the levels of atazanavir. This helps atazanavir work better. Atazanavir 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 Laurus Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42385092060. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
42385-920-60
11-Digit CMS (5-4-2)
42385-0920-60

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