Sirolimus
NDC Package 0904-7147-07

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Sirolimus is used with other medications to prevent rejection of a kidney transplant. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-7147 and is authorized under FDA application ANDA208691.

Identification & Billing

NDC Package Code
0904-7147-07
Package Description
30 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
0904-7147
11-Digit Billing Format
00904714707

Clinical Specifications

Proprietary Name
Sirolimus
Dosage Form
-
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
Major Pharmaceuticals
FDA Application #
ANDA208691
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-16-2020
End Marketing Date
11-30-2022
Listing Expiration
11-30-2022
Exclude Flag
D
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 0904-7147-07 identifies a specific commercial package of 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack of Sirolimus, labeled by Major Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Major Pharmaceuticals on October 16, 2020. The current certification is valid through November 30, 2022.

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 Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904714707. 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 (4-4-2)
0904-7147-07
11-Digit CMS (5-4-2)
00904-7147-07

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