Prograf Capsule, Gelatin Coated
NDC Package 0469-0607-73

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

Package Information

Prograf (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 Astellas Pharma Us, Inc., this product is identified by NDC 0469-0607 and is authorized under FDA application NDA050708.

Identification & Billing

NDC Package Code
0469-0607-73
Package Description
1 BOTTLE in 1 CARTON / 100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
0469-0607
11-Digit Billing Format
00469060773
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prograf
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
Astellas Pharma Us, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA050708
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-24-1998
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J7507
Source: ASP
Tacrolimus imme rel oral 1mg
HCPCS Dosage 1 MG
Units / Pkg 50

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0469-0607-73 identifies a specific commercial package of 1 bottle in 1 carton / 100 capsule, gelatin coated in 1 bottle of Prograf, a human prescription drug labeled by Astellas Pharma Us, Inc.. 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 Astellas Pharma Us, Inc. on August 24, 1998. 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 Astellas Pharma Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00469060773. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (4-4-2)
0469-0607-73
11-Digit CMS (5-4-2)
00469-0607-73

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