NDC Package 76420-365-30 Oxycodone Hydrochloride

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

76420-365-30

Package Description:

30 TABLET in 1 BOTTLE, PLASTIC

Product Code:

76420-365

Proprietary Name:

Oxycodone Hydrochloride

Non-Proprietary Name:

Oxycodone Hydrochloride

Substance Name:

Oxycodone Hydrochloride

Usage Information:

Oxycodone hydrochloride 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, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride 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.Oxycodone hydrochloride should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

11-Digit NDC Billing Format:

76420036530

NDC to RxNorm Crosswalk:

RxCUI: 1049611 - oxyCODONE HCl 15 MG Oral Tablet
RxCUI: 1049611 - oxycodone hydrochloride 15 MG Oral Tablet
RxCUI: 1049618 - oxyCODONE HCl 30 MG Oral Tablet
RxCUI: 1049618 - oxycodone hydrochloride 30 MG Oral Tablet
RxCUI: 1049621 - oxyCODONE HCl 5 MG Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Asclemed Usa, Inc.

Dosage Form:

Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

OXYCODONE HYDROCHLORIDE 20 mg/1

Pharmacologic Class(es):

DEA Schedule:

Schedule II (CII) Substances

Sample Package:

FDA Application Number:

ANDA077712

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

09-10-2024

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

76420 - Asclemed Usa, Inc.
- 76420-365 - Oxycodone Hydrochloride
  - 76420-365-30 - 30 TABLET in 1 BOTTLE, PLASTIC

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
76420-365-01	100 TABLET in 1 BOTTLE, PLASTIC
76420-365-60	60 TABLET in 1 BOTTLE, PLASTIC
76420-365-90	90 TABLET in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 76420-365-30?

The NDC Packaged Code 76420-365-30 is assigned to a package of 30 tablet in 1 bottle, plastic of Oxycodone Hydrochloride, a human prescription drug labeled by Asclemed Usa, Inc.. The product's dosage form is tablet and is administered via oral form.

Is NDC 76420-365 included in the NDC Directory?

Yes, Oxycodone Hydrochloride with product code 76420-365 is active and included in the NDC Directory. The product was first marketed by Asclemed Usa, Inc. on September 10, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 76420-365-30?

The 11-digit format is 76420036530. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	76420-365-30	5-4-2	76420-0365-30

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