NDC Package 17478-540-05 Hydromorphone Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

17478-540-05

Package Description:

10 AMPULE in 1 CARTON / 5 mL in 1 AMPULE

Product Code:

17478-540

Proprietary Name:

Hydromorphone Hydrochloride

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

11-Digit NDC Billing Format:

17478054005

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Labeler Name:

Akorn

Sample Package:

Start Marketing Date:

05-15-2010

Listing Expiration Date:

12-31-2023

Exclude Flag:

Code Structure:

17478 - Akorn
- 17478-540 - Hydromorphone Hydrochloride
  - 17478-540-05 - 10 AMPULE in 1 CARTON / 5 mL in 1 AMPULE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
17478-540-01	10 AMPULE in 1 CARTON / 1 mL in 1 AMPULE
17478-540-50	1 VIAL in 1 CARTON / 50 mL in 1 VIAL

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 17478-540-05?

The NDC Packaged Code 17478-540-05 is assigned to a package of 10 ampule in 1 carton / 5 ml in 1 ampule of Hydromorphone Hydrochloride, labeled by Akorn. The product's dosage form is and is administered via form.

Is NDC 17478-540 included in the NDC Directory?

No, Hydromorphone Hydrochloride with product code 17478-540 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Akorn on May 15, 2010 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 17478-540-05?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 17478-540-05?

The 11-digit format is 17478054005. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	17478-540-05	5-4-2	17478-0540-05

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