NDC 17478-540-01 Hydromorphone Hydrochloride
Injection Intramuscular; Intravenous; Subcutaneous

Package Information

The table below has 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 17478-540-01
Package Description 10 AMPULE in 1 CARTON / 1 mL in 1 AMPULE
Product Code 17478-540
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Hydromorphone Hydrochloride
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Hydromorphone Hydrochloride
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Hydromorphone Hydrochloride
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
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 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
17478054001
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 What kind of product is this?
    Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
    Human Prescription Drug
    Labeler Name Akorn
    Dosage Form Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    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.
    Active Ingredient(s)
    Pharmacologic Class(es)
    DEA Schedule Schedule II (CII) Substances What is the Drug Enforcement Administration (DEA) CII Schedule?
    The controlled substances in the CII schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the United States. Schedule CII controlled substances include certain narcotic, stimulant, and depressant drugs.
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category What is the Marketing Category?
    Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    FDA Application Number What is the FDA Application Number?
    This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
    ANDA078228
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    05-15-2010
    Listing Expiration Date What is the Listing Expiration Date?
    This is the date when the listing record will expire if not updated or certified by the product labeler.
    12-31-2023
    Exclude Flag What is the NDC Exclude Flag?
    This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
    N
    NDC 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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 17478-540-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    17478054001J1170Hydromorphone injection4 MG1102.525

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for Hydromorphone Hydrochloride with product NDC 17478-540.

    NDC Package CodePackage Description
    17478-540-0510 AMPULE in 1 CARTON / 5 mL in 1 AMPULE
    17478-540-501 VIAL in 1 CARTON / 50 mL in 1 VIAL

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 17478-540-01?

    The NDC Packaged Code 17478-540-01 is assigned to a package of 10 ampule in 1 carton / 1 ml in 1 ampule of Hydromorphone Hydrochloride, a human prescription drug labeled by Akorn. The product's dosage form is injection and is administered via intramuscular; intravenous; subcutaneous form.

    Is NDC 17478-540 included in the NDC Directory?

    Yes, Hydromorphone Hydrochloride with product code 17478-540 is active and included in the NDC Directory. 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 17478-540-01?

    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 17478-540-01?

    The 11-digit format is 17478054001. 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 Package Format10-Digit Original Package Code11-Digit Package Format11-Digit Conversion Package Code
    5-3-217478-540-015-4-217478-0540-01