Oxycodone Hydrochloride Solution
NDC Package 64950-354-45

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Oxycodone Hydrochloride solution is oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see Warnings and Precautions (5.2)], reserve Oxycodone Hydrochloride Oral Solution 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. This formulation utilizes a solution delivery system. Marketed by Genus Lifesciences Inc., this product is identified by NDC 64950-354 and is authorized under FDA application NDA200535.

Identification & Billing

NDC Package Code
64950-354-45
Package Description
40 CUP, UNIT-DOSE in 1 CASE / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)
Product Code
64950-354
11-Digit Billing Format
64950035445
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxycodone Hydrochloride
Non-Proprietary Name
Oxycodone Hydrochloride
Substance Name
Oxycodone Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OXYCODONE HYDROCHLORIDE 5 mg/5mL
Pharmacologic Class
Usage Information
Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see Warnings and Precautions (5.2)], reserve Oxycodone Hydrochloride Oral Solution 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
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Genus Lifesciences Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA200535
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-09-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (64950-354). Click a package code to view its specific billing and regulatory data.

64950-354-10
1 BOTTLE, PLASTIC in 1 CARTON / 100 mL in 1 BOTTLE, PLASTIC
64950-354-50
1 BOTTLE, PLASTIC in 1 CARTON / 500 mL in 1 BOTTLE, PLASTIC
64950-354-55
50 CUP, UNIT-DOSE in 1 CASE / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)

* 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 64950-354-45 identifies a specific commercial package of 40 cup, unit-dose in 1 case / 5 ml in 1 cup, unit-dose (64950-354-05) of Oxycodone Hydrochloride, a human prescription drug labeled by Genus Lifesciences Inc.. This solution is formulated for oral use and contains oxycodone 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 Genus Lifesciences Inc. on September 09, 2013. The current certification is valid through December 31, 2027.

How is this Genus Lifesciences Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64950035445. 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:

10-Digit Format (5-3-2)
64950-354-45
11-Digit CMS (5-4-2)
64950-0354-45

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