Oxycodone Hydrochloride
NDC Package 40032-430-03

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Oxycodone Hydrochloride is tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.   (1)Limitations of Use (1)Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets 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. Marketed by Novel Laboratories, Inc., this product is identified by NDC 40032-430 and is authorized under FDA application ANDA204021.

Identification & Billing

NDC Package Code
40032-430-03
Package Description
30 TABLET in 1 BOTTLE
Product Code
40032-430
11-Digit Billing Format
40032043003
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxycodone Hydrochloride
Dosage Form
-
Usage Information
Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.   (1)Limitations of Use (1)Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets 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.

Regulatory & Marketing

Labeler Name
Novel Laboratories, Inc.
FDA Application #
ANDA204021
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-12-2017
Listing Expiration
12-31-2019
Exclude Flag
I
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 (40032-430). Click a package code to view its specific billing and regulatory data.

40032-430-01
100 TABLET in 1 BOTTLE
40032-430-05
500 TABLET in 1 BOTTLE

* 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 40032-430-03 identifies a specific commercial package of 30 tablet in 1 bottle of Oxycodone Hydrochloride, labeled by Novel Laboratories, 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 Novel Laboratories, Inc. on June 12, 2017. The current certification is valid through December 31, 2019.

How is this Novel Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40032043003. 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)
40032-430-03
11-Digit CMS (5-4-2)
40032-0430-03

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