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  5. NDC Package Code: 52605-010-10 Tramadol Hydrochloride

NDC Package 52605-010-10 Tramadol Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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

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:
52605-010-10
Package Description:
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code:
52605-010
Proprietary Name:
Tramadol Hydrochloride
Usage Information:
Tramadol hydrochloride is 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, even at recommended doses [see  Warnings  and  Precautions  (5.1)],  reserve  tramadol hydrochloride  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.
11-Digit NDC Billing Format:
52605001010
NDC to RxNorm Crosswalk:
  • RxCUI: 835603 - traMADol HCl 50 MG Oral Tablet
  • RxCUI: 835603 - tramadol hydrochloride 50 MG Oral Tablet
    • Labeler Name:
    Polygen Pharmaceuticals Inc.
    Sample Package:
    No
    Start Marketing Date:
    06-01-2020
    Listing Expiration Date:
    12-31-2020
    Exclude Flag:
    I
    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
    52605-010-01100 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 52605-010-10?

    The NDC Packaged Code 52605-010-10 is assigned to a package of 1000 tablet, film coated in 1 bottle of Tramadol Hydrochloride, labeled by Polygen Pharmaceuticals Inc.. The product's dosage form is and is administered via form.

    Is NDC 52605-010 included in the NDC Directory?

    No, Tramadol Hydrochloride with product code 52605-010 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Polygen Pharmaceuticals Inc. on June 01, 2020 and its listing in the NDC Directory is set to expire on December 31, 2020 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 52605-010-10?

    The 11-digit format is 52605001010. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-252605-010-105-4-252605-0010-10