Sirolimus Powder
NDC Package 85694-003-01

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.

Sirolimus powders is sirolimus is used with other medications to prevent rejection of a kidney transplant. This formulation utilizes a powder delivery system. Marketed by Suresource Pharma Llc, this product is identified by NDC 85694-003.

Identification & Billing

NDC Package Code
85694-003-01
Package Description
5 g in 1 BAG
Product Code
85694-003
11-Digit Billing Format
85694000301

Clinical Specifications

Proprietary Name
Sirolimus
Non-Proprietary Name
Sirolimus
Substance Name
Sirolimus
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)
SIROLIMUS 1 g/g
Usage Information
Sirolimus is used with other medications to prevent rejection of a kidney transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own. Sirolimus may also be used to treat a certain lung disease (lymphangioleiomyomatosis-LAM).

Regulatory & Marketing

Labeler Name
Suresource Pharma Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
08-01-2025
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 85694-003-01 identifies a specific commercial package of 5 g in 1 bag of Sirolimus (UNFINISHED drug), a bulk ingredient labeled by Suresource Pharma Llc. This powder is formulated for use and contains sirolimus 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 Suresource Pharma Llc on August 01, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Sirolimus is used with other medications to prevent rejection of a kidney transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own. Sirolimus may also be used to treat a certain lung disease (lymphangioleiomyomatosis-LAM).

How is this Suresource Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85694000301. 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)
85694-003-01
11-Digit CMS (5-4-2)
85694-0003-01

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