Sirolimus Solution
NDC Package 72603-409-01

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

Package Information

Sirolimus solution is sirolimus is used with other medications to prevent rejection of a kidney transplant. This formulation utilizes a solution delivery system. Marketed by Northstar Rx Llc, this product is identified by NDC 72603-409 and is authorized under FDA application ANDA216728.

Identification & Billing

NDC Package Code
72603-409-01
Package Description
1 BOTTLE, GLASS in 1 CARTON / 60 mL in 1 BOTTLE, GLASS
Product Code
72603-409
11-Digit Billing Format
72603040901
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sirolimus
Non-Proprietary Name
Sirolimus
Substance Name
Sirolimus
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SIROLIMUS 1 mg/mL
Pharmacologic Class
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
Northstar Rx Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216728
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-19-2023
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J7520
Source: ASP
Sirolimus, oral
HCPCS Dosage 1 MG
Units / Pkg 60

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 72603-409-01 identifies a specific commercial package of 1 bottle, glass in 1 carton / 60 ml in 1 bottle, glass of Sirolimus, a human prescription drug labeled by Northstar Rx Llc. This solution is formulated for oral 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 Northstar Rx Llc on January 19, 2023. 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 Northstar Rx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72603040901. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
72603-409-01
11-Digit CMS (5-4-2)
72603-0409-01

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