Tacrolimus Granule, For Suspension
NDC Package 12838-1330-9

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.

Tacrolimus granules is tacrolimus is used with other medications to prevent rejection of a kidney transplant. This formulation utilizes a granule, for suspension delivery system. Marketed by Astellas Pharma Inc., this product is identified by NDC 12838-1330.

Identification & Billing

NDC Package Code
12838-1330-9
Package Description
3000 GRANULE, FOR SUSPENSION in 1 BOX
Product Code
12838-1330
11-Digit Billing Format
12838133009

Clinical Specifications

Proprietary Name
Tacrolimus
Non-Proprietary Name
Tacrolimus
Substance Name
Tacrolimus
Dosage Form
Granule, For Suspension - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Active Ingredient(s)
TACROLIMUS 1 mg/1
Usage Information
Tacrolimus 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.

Regulatory & Marketing

Labeler Name
Astellas Pharma Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
05-24-2018
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 12838-1330-9 identifies a specific commercial package of 3000 granule, for suspension in 1 box of Tacrolimus (UNFINISHED drug), drug for further processing labeled by Astellas Pharma Inc.. This granule, for suspension is formulated for use and contains tacrolimus 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 Astellas Pharma Inc. on May 24, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tacrolimus 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.

How is this Astellas Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12838133009. 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)
12838-1330-9
11-Digit CMS (5-4-2)
12838-1330-09

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