Hydroxyurea
NDC Package 70518-4302-0

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Hydroxyurea 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. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4302 and is authorized under FDA application ANDA218021.

Identification & Billing

NDC Package Code
70518-4302-0
Package Description
30 CAPSULE in 1 BLISTER PACK
Product Code
70518-4302
11-Digit Billing Format
70518430200

Clinical Specifications

Proprietary Name
Hydroxyurea
Dosage Form
-
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
Remedyrepack Inc.
FDA Application #
ANDA218021
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-04-2025
End Marketing Date
07-16-2025
Listing Expiration
07-16-2025
Exclude Flag
D
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 70518-4302-0 identifies a specific commercial package of 30 capsule in 1 blister pack of Hydroxyurea, labeled by Remedyrepack Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Remedyrepack Inc. on March 04, 2025. The current certification is valid through July 16, 2025.

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 Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518430200. 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 (5-4-1)
70518-4302-0
11-Digit CMS (5-4-2)
70518-4302-00

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