Exalgo
NDC Package 23635-412-01

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.

Exalgo is see also Warning section. Marketed by Specgx Llc, this product is identified by NDC 23635-412 and is authorized under FDA application NDA021217.

Identification & Billing

NDC Package Code
23635-412-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
23635-412
11-Digit Billing Format
23635041201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Exalgo
Dosage Form
-
Usage Information
See also Warning section. This medication contains hydromorphone in a long-acting form. It is used to help relieve severe ongoing pain (such as due to cancer). Hydromorphone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the extended-release form of hydromorphone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

Regulatory & Marketing

Labeler Name
Specgx Llc
FDA Application #
NDA021217
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2010
End Marketing Date
03-31-2021
Listing Expiration
03-31-2021
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 23635-412-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Exalgo, labeled by Specgx Llc. 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 Specgx Llc on March 01, 2010. The current certification is valid through March 31, 2021.

What are the primary indications for this medication?

See also Warning section. This medication contains hydromorphone in a long-acting form. It is used to help relieve severe ongoing pain (such as due to cancer). Hydromorphone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the extended-release form of hydromorphone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

How is this Specgx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 23635041201. 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:

10-Digit Format (5-3-2)
23635-412-01
11-Digit CMS (5-4-2)
23635-0412-01

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