Hydroxyurea Capsule
NDC Package 42291-321-01

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

Package Information

Hydroxyurea capsules is a medication used by people with sickle cell anemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions. This formulation utilizes a capsule delivery system. Marketed by Avkare, this product is identified by NDC 42291-321 and is authorized under FDA application ANDA075143.

Identification & Billing

NDC Package Code
42291-321-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
42291-321
11-Digit Billing Format
42291032101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
RxCUI: 197797 - hydroxyurea 500 MG Oral Capsule

Clinical Specifications

Proprietary Name
Hydroxyurea
Non-Proprietary Name
Hydroxyurea
Substance Name
Hydroxyurea
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)
HYDROXYUREA 500 mg/1
Pharmacologic Class
Usage Information
This medication is used by people with sickle cell anemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions. Some brands are also used to treat certain types of cancer (such as chronic myelogenous leukemia, squamous cell carcinomas).

Regulatory & Marketing

Labeler Name
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA075143
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-23-2013
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 42291-321-01 identifies a specific commercial package of 100 capsule in 1 bottle of Hydroxyurea, a human prescription drug labeled by Avkare. 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 hydroxyurea 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 Avkare on July 23, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used by people with sickle cell anemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions. Some brands are also used to treat certain types of cancer (such as chronic myelogenous leukemia, squamous cell carcinomas).

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291032101. 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)
42291-321-01
11-Digit CMS (5-4-2)
42291-0321-01

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