Oxycodone Hydrochloride And Acetaminophen
NDC Package 29033-405-35

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 And Acetaminophen is 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), reserve Oxycodone Hydrochloride and Acetaminophen Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]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 Nostrum Laboratories, Inc., this product is identified by NDC 29033-405 and is authorized under FDA application ANDA201448.

Identification & Billing

NDC Package Code
29033-405-35
Package Description
500 mL in 1 BOTTLE
Product Code
29033-405
11-Digit Billing Format
29033040535
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
500 ML
RxNorm Crosswalk
  • RxCUI: 1049580 - oxyCODONE HCl 5 MG / acetaminophen 325 MG in 5 mL Oral Solution
  • RxCUI: 1049580 - acetaminophen 65 MG/ML / oxycodone hydrochloride 1 MG/ML Oral Solution
  • RxCUI: 1049580 - APAP 325 MG / oxycodone hydrochloride 5 MG per 5 ML Oral Solution
  • RxCUI: 1049580 - APAP 65 MG/ML / Oxycodone Hydrochloride 1 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Oxycodone Hydrochloride And Acetaminophen
Dosage Form
-
Usage Information
Oxycodone Hydrochloride and Acetaminophen 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), reserve Oxycodone Hydrochloride and Acetaminophen Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]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
Nostrum Laboratories, Inc.
FDA Application #
ANDA201448
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2021
Listing Expiration
12-31-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 29033-405-35 identifies a specific commercial package of 500 ml in 1 bottle of Oxycodone Hydrochloride And Acetaminophen, labeled by Nostrum Laboratories, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 500 billable units per package. 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 Nostrum Laboratories, Inc. on December 01, 2021. The current certification is valid through December 31, 2025.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 29033040535. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 500 total billable units per package. 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)
29033-405-35
11-Digit CMS (5-4-2)
29033-0405-35

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