Hemangeol Solution
NDC Package 64370-375-01

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

Package Information

Hemangeol (propranolol hydrochloride) solution is this formulation of propranolol is used for infants and children to treat a certain benign tumor (proliferating infantile hemangioma). This formulation utilizes a solution delivery system. Marketed by Pierre Fabre Pharmaceuticals, Inc., this product is identified by NDC 64370-375 and is authorized under FDA application NDA205410.

Identification & Billing

NDC Package Code
64370-375-01
Package Description
1 BOTTLE, GLASS in 1 CARTON / 120 mL in 1 BOTTLE, GLASS
Product Code
64370-375
11-Digit Billing Format
64370037501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hemangeol
Non-Proprietary Name
Propranolol Hydrochloride
Substance Name
Propranolol Hydrochloride
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)
PROPRANOLOL HYDROCHLORIDE 4.28 mg/mL
Pharmacologic Class
Usage Information
This formulation of propranolol is used for infants and children to treat a certain benign tumor (proliferating infantile hemangioma). It helps to shrink the tumor. Propranolol belongs to a class of drugs known as beta blockers.

Regulatory & Marketing

Labeler Name
Pierre Fabre Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA205410
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-14-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (64370-375). Click a package code to view its specific billing and regulatory data.

64370-375-50
1 BOTTLE, GLASS in 1 CARTON / 50 mL in 1 BOTTLE, GLASS

* 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 64370-375-01 identifies a specific commercial package of 1 bottle, glass in 1 carton / 120 ml in 1 bottle, glass of Hemangeol, a human prescription drug labeled by Pierre Fabre Pharmaceuticals, Inc.. This solution is formulated for oral use and contains propranolol hydrochloride 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 Pierre Fabre Pharmaceuticals, Inc. on April 14, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This formulation of propranolol is used for infants and children to treat a certain benign tumor (proliferating infantile hemangioma). It helps to shrink the tumor. Propranolol belongs to a class of drugs known as beta blockers.

How is this Pierre Fabre Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64370037501. 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 (5-3-2)
64370-375-01
11-Digit CMS (5-4-2)
64370-0375-01

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