Hydroxyurea
NDC Package 10135-702-01
Package Information
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 Marlex Pharmaceuticals, Inc., this product is identified by NDC 10135-702 and is authorized under FDA application ANDA213438.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 10135 - Marlex Pharmaceuticals, Inc.
- 10135-702 - Hydroxyurea
- 10135-702-01 - 100 CAPSULE in 1 BOTTLE, PLASTIC
- 10135-702 - Hydroxyurea
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.
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 10135-702-01 identifies a specific commercial package of 100 capsule in 1 bottle, plastic of Hydroxyurea, labeled by Marlex Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. 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 Marlex Pharmaceuticals, Inc. on January 28, 2022. The current certification is valid through December 31, 2024.
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 Marlex Pharmaceuticals, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135070201. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
