Tacrolimus Ointment
NDC Package 16729-421-01

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

Package Information

Tacrolimus ointment is tacrolimus is used with other medications to prevent rejection of a kidney, heart, or liver transplant. This formulation utilizes a ointment delivery system. Marketed by Accord Healthcare Inc., this product is identified by NDC 16729-421 and is authorized under FDA application ANDA211688.

Identification & Billing

NDC Package Code
16729-421-01
Package Description
1 TUBE in 1 CARTON / 100 g in 1 TUBE
Product Code
16729-421
11-Digit Billing Format
16729042101
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
100 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tacrolimus
Non-Proprietary Name
Tacrolimus
Substance Name
Tacrolimus
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
TACROLIMUS .3 mg/g
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
Accord Healthcare Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211688
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-31-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (16729-421). Click a package code to view its specific billing and regulatory data.

16729-421-10
1 TUBE in 1 CARTON / 30 g in 1 TUBE
16729-421-12
1 TUBE in 1 CARTON / 60 g in 1 TUBE

* 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 16729-421-01 identifies a specific commercial package of 1 tube in 1 carton / 100 g in 1 tube of Tacrolimus, a human prescription drug labeled by Accord Healthcare Inc.. This ointment is formulated for topical 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 Accord Healthcare Inc. on May 31, 2019. 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 Accord Healthcare Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16729042101. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 100 total billable units per package. 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)
16729-421-01
11-Digit CMS (5-4-2)
16729-0421-01

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