Atazanavir Sulfate Capsule
NDC Package 65862-710-39

11-digit billing NDC: 65862071039
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Atazanavir Sulfate (atazanavir) capsules is atazanavir capsule  is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg.Limitations of Use:Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]. Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)]. This formulation utilizes a capsule delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-710 and is authorized under FDA application ANDA204806.

Identification & Billing

NDC Package Code
65862-710-39
Package Description
3000 CAPSULE in 1 BAG
Product Code
65862-710
11-Digit Billing Format
65862071039
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Atazanavir Sulfate
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)
Pharmacologic Class
Usage Information
Atazanavir capsule  is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg.Limitations of Use:Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]. Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA204806
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-25-2018
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
N/A

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 (65862-710). Click a package code to view its specific billing and regulatory data.

65862-710-03
3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK (65862-710-10)
65862-710-05
500 CAPSULE in 1 BOTTLE
65862-710-60
60 CAPSULE in 1 BOTTLE

* 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 65862-710-39 identifies a specific commercial package of 3000 capsule in 1 bag of Atazanavir Sulfate, a human prescription drug labeled by Aurobindo Pharma Limited. 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 Aurobindo Pharma Limited on June 25, 2018. The current certification is valid through December 31, 2027.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862071039. 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)
65862-710-39
11-Digit CMS (5-4-2)
65862-0710-39

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