Oxycodone Hydrochloride Capsule
NDC Package 40032-950-03

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

Oxycodone Hydrochloride capsules is oxycodone hydrochloride capsule is an opioid analgesic, indicated for the management of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. This formulation utilizes a capsule delivery system. Marketed by Novel Laboratories, Inc., this product is identified by NDC 40032-950 and is authorized under FDA application ANDA204752.

Identification & Billing

NDC Package Code
40032-950-03
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
40032-950
11-Digit Billing Format
40032095003
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxycodone Hydrochloride
Non-Proprietary Name
Oxycodone Hydrochloride
Substance Name
Oxycodone Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OXYCODONE HYDROCHLORIDE 5 mg/1
Pharmacologic Class
Usage Information
Oxycodone hydrochloride capsule is an opioid analgesic, indicated for the management of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Novel Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204752
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-24-2015
Listing Expiration
12-31-2026
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 (40032-950). Click a package code to view its specific billing and regulatory data.

40032-950-01
100 CAPSULE in 1 BOTTLE
40032-950-50
500 CAPSULE 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 40032-950-03 identifies a specific commercial package of 30 capsule in 1 bottle of Oxycodone Hydrochloride, a human prescription drug labeled by Novel Laboratories, Inc.. This capsule 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 Novel Laboratories, Inc. on August 24, 2015. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40032095003. 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)
40032-950-03
11-Digit CMS (5-4-2)
40032-0950-03

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