Dilaudid Injection, Solution
NDC Package 76045-010-11

11-digit billing NDC: 76045001011 · Billing unit: ML · 10 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Dilaudid (hydromorphone hydrochloride) injection is dILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.Limitations of Use:•Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including DILAUDID INJECTION for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 76045-010 and is authorized under FDA application NDA019034.

Identification & Billing

NDC Package Code
76045-010-11
Package Description
10 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (76045-010-01)
Product Code
76045-010
11-Digit Billing Format
76045001011
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk
  • RxCUI: 1433251 - HYDROmorphone HCl 0.5 MG in 0.5 ML Prefilled Syringe
  • RxCUI: 1433251 - 0.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe
  • RxCUI: 1433251 - hydromorphone HCl 0.5 MG per 0.5 ML Prefilled Syringe
  • RxCUI: 1872265 - Dilaudid 1 MG in 1 ML Prefilled Syringe
  • RxCUI: 1872265 - 1 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe [Dilaudid]

Clinical Specifications

Proprietary Name
Dilaudid
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 2 mg/mL
Pharmacologic Class
Usage Information
DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.Limitations of Use:•Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including DILAUDID INJECTION for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA019034
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-16-2016
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1171
Source: ASP
Inj, hydromorphone, 0.1 mg
HCPCS Dosage 0.1 MG
Units / Pkg 200

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (76045-010). Click a package code to view its specific billing and regulatory data.

76045-010-10
24 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (76045-010-00)

* 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 76045-010-11 identifies a specific commercial package of 10 syringe in 1 carton / 1 ml in 1 syringe (76045-010-01) of Dilaudid, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 10 billable units per package. 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 Fresenius Kabi Usa, Llc on December 16, 2016. The current certification is valid through December 31, 2027.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76045001011. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 total billable units per package. 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 (5-3-2)
76045-010-11
11-Digit CMS (5-4-2)
76045-0010-11

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