Xromi Solution
NDC Package 62484-0015-5

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

Package Information

Xromi (hydroxyurea) solution 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 solution delivery system. Marketed by Nova Laboratories, Ltd., this product is identified by NDC 62484-0015 and is authorized under FDA application NDA216593.

Identification & Billing

NDC Package Code
62484-0015-5
Package Description
1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE (62484-0015-4)
Product Code
62484-0015
11-Digit Billing Format
62484001505
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xromi
Non-Proprietary Name
Hydroxyurea
Substance Name
Hydroxyurea
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDROXYUREA 100 mg/mL
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
Nova Laboratories, Ltd.
Product Type
Human Prescription Drug
FDA Application #
NDA216593
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-04-2024
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 62484-0015-5 identifies a specific commercial package of 1 bottle in 1 carton / 148 ml in 1 bottle (62484-0015-4) of Xromi, a human prescription drug labeled by Nova Laboratories, Ltd.. This solution 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 Nova Laboratories, Ltd. on April 04, 2024. The current certification is valid through December 31, 2027.

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 Nova Laboratories, Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62484001505. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
62484-0015-5
11-Digit CMS (5-4-2)
62484-0015-05

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