NDC Package 63323-851-15 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:
63323-851-15
Package Description:
10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (63323-851-07)
Product Code:
Proprietary Name:
Hydromorphone Hydrochloride
Non-Proprietary Name:
Hydromorphone Hydrochloride
Substance 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 Use:Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2)] , reserve Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection [high potency formulation (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 toleratedHave not provided adequate analgesia, or are not expected to provide adequate analgesia
11-Digit NDC Billing Format:
63323085115
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1724276 - HYDROmorphone HCl 2 MG in 1 ML Injection
  • RxCUI: 1724276 - 1 ML hydromorphone hydrochloride 2 MG/ML Injection
  • RxCUI: 1724276 - hydromorphone HCl 2 MG per 1 ML Injection
  • RxCUI: 1724338 - HYDROmorphone HCl 10 MG in 1 ML Injection
  • RxCUI: 1724338 - 1 ML hydromorphone hydrochloride 10 MG/ML Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Fresenius Kabi Usa, Llc
    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:
    NDA019034
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-15-2017
    Listing Expiration Date:
    12-31-2024
    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
    63323-851-1010 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE (63323-851-03)
    63323-851-5050 mL in 1 VIAL, SINGLE-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63323-851-15?

    The NDC Packaged Code 63323-851-15 is assigned to a package of 10 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (63323-851-07) of Hydromorphone Hydrochloride, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection, solution and is administered via intramuscular; intravenous; subcutaneous form.

    Is NDC 63323-851 included in the NDC Directory?

    Yes, Hydromorphone Hydrochloride with product code 63323-851 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on December 15, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63323-851-15?

    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 63323-851-15?

    The 11-digit format is 63323085115. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263323-851-155-4-263323-0851-15