Cobicistat Powder
NDC Package 57572-0035-1

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Cobicistat powders is a medication used to increase ("boost") the levels of certain HIV protease inhibitors (atazanavir and darunavir). This formulation utilizes a powder delivery system. Marketed by Esteve Quimica, Sa, this product is identified by NDC 57572-0035.

Identification & Billing

NDC Package Code
57572-0035-1
Package Description
35 kg in 1 DRUM
Product Code
57572-0035
11-Digit Billing Format
57572003501

Clinical Specifications

Proprietary Name
Cobicistat
Non-Proprietary Name
Cobicistat
Substance Name
Cobicistat
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
COBICISTAT 1 kg/kg
Usage Information
This drug is used to increase ("boost") the levels of certain HIV protease inhibitors (atazanavir and darunavir). This helps them work better to help control HIV infection. Cobicistat 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
Esteve Quimica, Sa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-01-2012
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57572-0035-1 identifies a specific commercial package of 35 kg in 1 drum of Cobicistat (UNFINISHED drug), a bulk ingredient labeled by Esteve Quimica, Sa. This powder is formulated for use and contains cobicistat 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 Esteve Quimica, Sa on October 01, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This drug is used to increase ("boost") the levels of certain HIV protease inhibitors (atazanavir and darunavir). This helps them work better to help control HIV infection. Cobicistat 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 Esteve Quimica, Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57572003501. 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)
57572-0035-1
11-Digit CMS (5-4-2)
57572-0035-01

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