Hydromorphone Hydrochloride
NDC Package 17478-540-01

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Hydromorphone Hydrochloride is injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Marketed by Akorn, this product is identified by NDC 17478-540 and is authorized under FDA application ANDA078228.

Identification & Billing

NDC Package Code
17478-540-01
Package Description
10 AMPULE in 1 CARTON / 1 mL in 1 AMPULE
Product Code
17478-540
11-Digit Billing Format
17478054001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Hydromorphone Hydrochloride
Dosage Form
-
Usage Information
Hydromorphone hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Hydromorphone hydrochloride injection [high potency formulation (HPF)] is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg oral morphine per day, or at least 25 mcg transdermal fentanyl per hour, or at least 30 mg oral oxycodone per day, or at least 8 g oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid for one week or longer. Patients must remain on around-the-clock opioids while administering hydromorphone hydrochloride injection (HPF). Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve hydromorphone hydrochloride injection (HPF) for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated Have not provided adequate analgesia, or are not expected to provide adequate analgesia

Regulatory & Marketing

Labeler Name
Akorn
FDA Application #
ANDA078228
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-15-2010
Listing Expiration
12-31-2023
Exclude Flag
I
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 (17478-540). Click a package code to view its specific billing and regulatory data.

17478-540-05
10 AMPULE in 1 CARTON / 5 mL in 1 AMPULE
17478-540-50
1 VIAL in 1 CARTON / 50 mL in 1 VIAL

* 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 17478-540-01 identifies a specific commercial package of 10 ampule in 1 carton / 1 ml in 1 ampule of Hydromorphone Hydrochloride, labeled by Akorn. 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 Akorn on May 15, 2010. The current certification is valid through December 31, 2023.

How is this Akorn product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17478054001. 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)
17478-540-01
11-Digit CMS (5-4-2)
17478-0540-01

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