Hydromorphone Hydrochloride Injection, Solution
NDC Package 0409-2634-01

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

Hydromorphone Hydrochloride injection is hydromorphone hydrochloride is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY) 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. This formulation utilizes a injection, solution delivery system. Marketed by Hospira, Inc., this product is identified by NDC 0409-2634 and is authorized under FDA application ANDA078591.

Identification & Billing

NDC Package Code
0409-2634-01
Package Description
10 VIAL, SINGLE-DOSE in 1 BOX / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2634-10)
Product Code
0409-2634
11-Digit Billing Format
00409263401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydromorphone Hydrochloride
Non-Proprietary Name
Hydromorphone Hydrochloride
Substance Name
Hydromorphone Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
HYDROMORPHONE HYDROCHLORIDE 10 mg/mL
Pharmacologic Class
Usage Information
Hydromorphone hydrochloride is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY) 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, USP (HIGH POTENCY).
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Hospira, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078591
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-31-2008
Listing Expiration
12-31-2027
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 (0409-2634). Click a package code to view its specific billing and regulatory data.

0409-2634-05
10 VIAL, SINGLE-DOSE in 1 BOX / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2634-25)
0409-2634-50
1 VIAL, SINGLE-DOSE in 1 BOX / 50 mL in 1 VIAL, SINGLE-DOSE

* 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 0409-2634-01 identifies a specific commercial package of 10 vial, single-dose in 1 box / 1 ml in 1 vial, single-dose (0409-2634-10) of Hydromorphone Hydrochloride, a human prescription drug labeled by Hospira, Inc.. This injection, solution is formulated for intramuscular; intravenous; subcutaneous use and contains hydromorphone 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 Hospira, Inc. on July 31, 2008. The current certification is valid through December 31, 2027.

How is this Hospira, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00409263401. 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 (4-4-2)
0409-2634-01
11-Digit CMS (5-4-2)
00409-2634-01

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