Tacrolimus Capsule
NDC Package 65897-0010-2

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

Package Information

Tacrolimus capsules is tacrolimus is used with other medications to prevent rejection of a kidney, heart, or liver transplant. This formulation utilizes a capsule delivery system. Marketed by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, this product is identified by NDC 65897-0010 and is authorized under FDA application ANDA210929.

Identification & Billing

NDC Package Code
65897-0010-2
Package Description
1 BAG in 1 CARTON / 10 BLISTER PACK in 1 BAG / 10 CAPSULE in 1 BLISTER PACK
Product Code
65897-0010
11-Digit Billing Format
65897001002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tacrolimus
Non-Proprietary Name
Tacrolimus
Substance Name
Tacrolimus Anhydrous
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TACROLIMUS ANHYDROUS 1 mg/1
Pharmacologic Class
Usage Information
Tacrolimus is used with other medications to prevent rejection of a kidney, heart, or liver 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
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA210929
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-11-2025
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 65897-0010-2 identifies a specific commercial package of 1 bag in 1 carton / 10 blister pack in 1 bag / 10 capsule in 1 blister pack of Tacrolimus, a human prescription drug labeled by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. This capsule is formulated for oral use and contains tacrolimus anhydrous 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 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd on July 11, 2025. 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, heart, or liver 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 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65897001002. 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)
65897-0010-2
11-Digit CMS (5-4-2)
65897-0010-02

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