Panhematin
NDC Package 55292-701-55

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.

Panhematin is a medication used to treat the symptoms that occur with certain blood disorders (porphyrias). Marketed by Recordati Rare Diseases, Inc., this product is identified by NDC 55292-701 and is authorized under FDA application BLA101246.

Identification & Billing

NDC Package Code
55292-701-55
Package Description
1 VIAL in 1 CARTON / 43 mL in 1 VIAL (55292-701-54)
Product Code
55292-701
11-Digit Billing Format
55292070155
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Panhematin
Dosage Form
-
Usage Information
This medication is used to treat the symptoms that occur with certain blood disorders (porphyrias). Other treatments are recommended for trial before using hemin, also called hematin. Hemin is not a cure for porphyria. In some cases, this medication may relieve symptoms such as pain, high blood pressure, rapid heartbeat, or mental changes that may occur during an acute attack of porphyria. If you have any questions about the use of this medication, consult your doctor.

Regulatory & Marketing

Labeler Name
Recordati Rare Diseases, Inc.
FDA Application #
BLA101246
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-20-1983
End Marketing Date
01-24-2020
Listing Expiration
01-24-2020
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 55292-701-55 identifies a specific commercial package of 1 vial in 1 carton / 43 ml in 1 vial (55292-701-54) of Panhematin, labeled by Recordati Rare Diseases, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Recordati Rare Diseases, Inc. on July 20, 1983. The current certification is valid through January 24, 2020.

What are the primary indications for this medication?

This medication is used to treat the symptoms that occur with certain blood disorders (porphyrias). Other treatments are recommended for trial before using hemin, also called hematin. Hemin is not a cure for porphyria. In some cases, this medication may relieve symptoms such as pain, high blood pressure, rapid heartbeat, or mental changes that may occur during an acute attack of porphyria. If you have any questions about the use of this medication, consult your doctor.

How is this Recordati Rare Diseases, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55292070155. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
55292-701-55
11-Digit CMS (5-4-2)
55292-0701-55

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