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  4. NDC Product Code: 40032-920 Oxycodone Hydrochloride

NDC 40032-920 Oxycodone Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 40032-920?
  5. Oxycodone Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

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

Get all the details for National Drug Code (NDC) 40032-920 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
40032-920
Proprietary Name:
Oxycodone Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Novel Laboratories, Inc.
Labeler Code:
40032
Product Label ID:
fb100a73-a655-44e9-9985-d2d7efe5b49b
FDA Application Number: [6]
ANDA204603
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
04-29-2015
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
Flavor(s):
BERRY (C73365)

Code Structure Chart

Product Details

What is NDC 40032-920?

The NDC code 40032-920 is assigned by the FDA to the product Oxycodone Hydrochloride which is product labeled by Novel Laboratories, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 40032-920-60 1 bottle in 1 carton / 30 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Oxycodone Hydrochloride?

Oxycodone hydrochloride oral solution USP, 100 mg per 5 mL (20 mg per mL) an opioid agonist is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients.Oxycodone hydrochloride oral solution USP, 100 mg per 5 mL (20 mg per mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer.

Which are Oxycodone Hydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Oxycodone Hydrochloride Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Oxycodone Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1049615 - oxyCODONE HCl 20 MG in 1 mL Concentrate for Oral Solution
  • RxCUI: 1049615 - oxycodone hydrochloride 20 MG/ML Oral Solution
  • RxCUI: 1049615 - oxycodone hydrochloride 20 MG per 1 ML Concentrate for Oral Solution

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".