Oxycodone Hydrochloride
NDC Package 64950-353-51

11-digit billing NDC: 64950035351
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Oxycodone Hydrochloride is oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult 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.Limitations of UseBecause 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 Oxycodone Hydrochloride Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Marketed by Genus Lifesciences Inc., this product is identified by NDC 64950-353 and is authorized under FDA application NDA200535.

Identification & Billing

NDC Package Code
64950-353-51
Package Description
50 POUCH in 1 CASE / 5 SYRINGE, PLASTIC in 1 POUCH (64950-353-91) / .5 mL in 1 SYRINGE, PLASTIC (64950-353-01)
Product Code
64950-353
11-Digit Billing Format
64950035351
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxycodone Hydrochloride
Dosage Form
-
Usage Information
Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult 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.Limitations of UseBecause 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 Oxycodone Hydrochloride Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Regulatory & Marketing

Labeler Name
Genus Lifesciences Inc.
FDA Application #
NDA200535
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-20-2010
End Marketing Date
12-01-2021
Listing Expiration
12-01-2021
Exclude Flag
D
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 (64950-353). Click a package code to view its specific billing and regulatory data.

64950-353-03
1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC
64950-353-52
50 POUCH in 1 CASE / 5 SYRINGE, PLASTIC in 1 POUCH (64950-353-92) / 1 mL in 1 SYRINGE, PLASTIC (64950-353-02)

* 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 64950-353-51 identifies a specific commercial package of 50 pouch in 1 case / 5 syringe, plastic in 1 pouch (64950-353-91) / .5 ml in 1 syringe, plastic (64950-353-01) of Oxycodone Hydrochloride, labeled by Genus Lifesciences Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Genus Lifesciences Inc. on October 20, 2010. The current certification is valid through December 01, 2021.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64950035351. 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)
64950-353-51
11-Digit CMS (5-4-2)
64950-0353-51

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