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  5. NDC Package Code: 80425-0501-3 Tramadol Hydrochloride

NDC Package 80425-0501-3 Tramadol Hydrochloride

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
80425-0501-3
Package Description:
60 TABLET, COATED in 1 BOTTLE
Product Code:
80425-0501
Proprietary Name:
Tramadol Hydrochloride
Non-Proprietary Name:
Tramadol Hydrochloride
Substance Name:
Tramadol Hydrochloride
Usage Information:
Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use:Because 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 tramadol 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.Tramadol hydrochloride tablets 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:
80425050103
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Advanced Rx Of Tennessee, Llc
Dosage Form:
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
TRAMADOL HYDROCHLORIDE 50 mg/1
Pharmacologic Class(es):
DEA Schedule:
Schedule IV (CIV) Substances
Sample Package:
No
FDA Application Number:
ANDA076003
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
02-13-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 CodePackage Description
80425-0501-115 TABLET, COATED in 1 BOTTLE
80425-0501-230 TABLET, COATED in 1 BOTTLE
80425-0501-490 TABLET, COATED in 1 BOTTLE
80425-0501-5120 TABLET, COATED in 1 BOTTLE
80425-0501-640 TABLET, COATED in 1 BOTTLE
80425-0501-7180 TABLET, COATED in 1 BOTTLE
80425-0501-8240 TABLET, COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 80425-0501-3?

The NDC Packaged Code 80425-0501-3 is assigned to a package of 60 tablet, coated in 1 bottle of Tramadol Hydrochloride, a human prescription drug labeled by Advanced Rx Of Tennessee, Llc. The product's dosage form is tablet, coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package.

Is NDC 80425-0501 included in the NDC Directory?

Yes, Tramadol Hydrochloride with product code 80425-0501 is active and included in the NDC Directory. The product was first marketed by Advanced Rx Of Tennessee, Llc on February 13, 2025 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 NDC billing unit for package 80425-0501-3?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

What is the 11-digit format for NDC 80425-0501-3?

The 11-digit format is 80425050103. 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 5-4-1 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-180425-0501-35-4-280425-0501-03