Agrylin Capsule
NDC Package 54092-063-01

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

Package Information

Agrylin (anagrelide hydrochloride) capsules is anagrelide is used to treat a certain blood disorder (thrombocythemia), which is caused by your bone marrow making too many platelets. This formulation utilizes a capsule delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 54092-063 and is authorized under FDA application NDA020333.

Identification & Billing

NDC Package Code
54092-063-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
54092-063
11-Digit Billing Format
54092006301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Agrylin
Non-Proprietary Name
Anagrelide Hydrochloride
Substance Name
Anagrelide Hydrochloride 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)
ANAGRELIDE HYDROCHLORIDE ANHYDROUS .5 mg/1
Pharmacologic Class
Usage Information
Anagrelide is used to treat a certain blood disorder (thrombocythemia), which is caused by your bone marrow making too many platelets. Platelets are a blood cell that the body uses to form blood clots. Too many platelets can cause problems with your circulation, including unwanted blood clots and bleeding problems. This drug reduces the number of platelets in the bloodstream by blocking their production.

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020333
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-14-1997
Listing Expiration
12-31-2027
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 54092-063-01 identifies a specific commercial package of 100 capsule in 1 bottle of Agrylin, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This capsule is formulated for oral use and contains anagrelide hydrochloride 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 Takeda Pharmaceuticals America, Inc. on March 14, 1997. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Anagrelide is used to treat a certain blood disorder (thrombocythemia), which is caused by your bone marrow making too many platelets. Platelets are a blood cell that the body uses to form blood clots. Too many platelets can cause problems with your circulation, including unwanted blood clots and bleeding problems. This drug reduces the number of platelets in the bloodstream by blocking their production.

How is this Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54092006301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
54092-063-01
11-Digit CMS (5-4-2)
54092-0063-01

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