Tacrolimus Capsule, Gelatin Coated
NDC Package 43817-421-01

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, gelatin coated delivery system. Marketed by Panacea Biotec Limited, this product is identified by NDC 43817-421 and is authorized under FDA application ANDA090802.

Identification & Billing

NDC Package Code
43817-421-01
Package Description
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
43817-421
11-Digit Billing Format
43817042101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tacrolimus
Non-Proprietary Name
Tacrolimus
Substance Name
Tacrolimus
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TACROLIMUS .5 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
Panacea Biotec Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA090802
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-26-2016
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 43817-421-01 identifies a specific commercial package of 100 capsule, gelatin coated in 1 bottle of Tacrolimus, a human prescription drug labeled by Panacea Biotec Limited. This capsule, gelatin coated is formulated for oral 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 Panacea Biotec Limited on February 26, 2016. 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 Panacea Biotec Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43817042101. 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)
43817-421-01
11-Digit CMS (5-4-2)
43817-0421-01

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