Sirolimus Tablet, Film Coated
NDC Package 70518-4449-0

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

Package Information

Sirolimus tablets is sirolimus is used with other medications to prevent rejection of a kidney transplant. This formulation utilizes a tablet, film coated delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4449 and is authorized under FDA application ANDA208691.

Identification & Billing

NDC Package Code
70518-4449-0
Package Description
100 POUCH in 1 BOX / 1 TABLET, FILM COATED in 1 POUCH (70518-4449-1)
Product Code
70518-4449
11-Digit Billing Format
70518444900
RxNorm Crosswalk
RxCUI: 905158 - sirolimus 0.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Sirolimus
Non-Proprietary Name
Sirolimus
Substance Name
Sirolimus
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SIROLIMUS .5 mg/1
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
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208691
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-19-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-4449-0 identifies a specific commercial package of 100 pouch in 1 box / 1 tablet, film coated in 1 pouch (70518-4449-1) of Sirolimus, a human prescription drug labeled by Remedyrepack Inc.. This tablet, film coated 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 Remedyrepack Inc. on August 19, 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 Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518444900. 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)
70518-4449-0
11-Digit CMS (5-4-2)
70518-4449-00

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