Dilaudid Injection, Solution
NDC Package 76045-009-10
Package Information
Dilaudid (hydromorphone hydrochloride) injection is a medication used to help relieve moderate to severe pain. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 76045-009 and is authorized under FDA application NDA019034.
Identification & Billing
- 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
- 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.
Regulatory & Marketing
Hierarchy Structure
- 76045 - Fresenius Kabi Usa, Llc
- 76045-009 - Dilaudid
- 76045-009-10 - 24 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (76045-009-00)
- 76045-009 - Dilaudid
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 (76045-009). Click a package code to view its specific billing and regulatory data.
* 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 76045-009-10 identifies a specific commercial package of 24 syringe in 1 carton / 1 ml in 1 syringe (76045-009-00) of Dilaudid, a human prescription drug labeled by Fresenius Kabi Usa, Llc. 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 04, 2018. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
This medication is used to help relieve moderate to severe pain. Hydromorphone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain.
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: 76045000910. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
