NDC Package 0409-2634-05 Hydromorphone Hydrochloride

Injection, Solution Intramuscular; Intravenous; Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Package Information

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:
0409-2634-05
Package Description:
10 VIAL, SINGLE-DOSE in 1 BOX / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2634-25)
Product Code:
Proprietary Name:
Hydromorphone Hydrochloride
Non-Proprietary Name:
Hydromorphone Hydrochloride
Substance Name:
Hydromorphone Hydrochloride
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).
11-Digit NDC Billing Format:
00409263405
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1724338 - HYDROmorphone HCl 10 MG in 1 ML Injection
  • RxCUI: 1724338 - 1 ML hydromorphone hydrochloride 10 MG/ML Injection
  • RxCUI: 1724338 - hydromorphone HCl 10 MG per 1 ML Injection
  • RxCUI: 1724340 - HYDROmorphone HCl 50 MG in 5 ML Injection
  • RxCUI: 1724340 - 5 ML hydromorphone hydrochloride 10 MG/ML Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hospira, Inc.
    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(s):
  • 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.
  • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA078591
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-31-2008
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 CodePackage Description
    0409-2634-0110 VIAL, SINGLE-DOSE in 1 BOX / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2634-10)
    0409-2634-501 VIAL, SINGLE-DOSE in 1 BOX / 50 mL in 1 VIAL, SINGLE-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0409-2634-05?

    The NDC Packaged Code 0409-2634-05 is assigned to a package of 10 vial, single-dose in 1 box / 5 ml in 1 vial, single-dose (0409-2634-25) of Hydromorphone Hydrochloride, a human prescription drug labeled by Hospira, Inc.. The product's dosage form is injection, solution and is administered via intramuscular; intravenous; subcutaneous form.

    Is NDC 0409-2634 included in the NDC Directory?

    Yes, Hydromorphone Hydrochloride with product code 0409-2634 is active and included in the NDC Directory. The product was first marketed by Hospira, Inc. on July 31, 2008 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0409-2634-05?

    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 0409-2634-05?

    The 11-digit format is 00409263405. 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 4-4-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20409-2634-055-4-200409-2634-05