NDC Package 65841-758-10 Tramadol Hydrochloride And Acetaminophen

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

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:
65841-758-10
Package Description:
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Tramadol Hydrochloride And Acetaminophen
Non-Proprietary Name:
Tramadol Hydrochloride And Acetaminophen
Substance Name:
Acetaminophen; Tramadol Hydrochloride
Usage Information:
Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseTramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less.Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride and acetaminophen tablets 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:
65841075810
NDC to RxNorm Crosswalk:
  • RxCUI: 836395 - traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 836395 - acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet
  • RxCUI: 836395 - APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Lifesciences Limited
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA090460
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-15-2012
    Listing Expiration Date:
    12-31-2024
    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
    65841-758-01100 TABLET, FILM COATED in 1 BOTTLE
    65841-758-05500 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65841-758-10?

    The NDC Packaged Code 65841-758-10 is assigned to a package of 1000 tablet, film coated in 1 bottle of Tramadol Hydrochloride And Acetaminophen, a human prescription drug labeled by Zydus Lifesciences Limited. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 65841-758 included in the NDC Directory?

    Yes, Tramadol Hydrochloride And Acetaminophen with product code 65841-758 is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on October 15, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65841-758-10?

    The 11-digit format is 65841075810. 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
    5-3-265841-758-105-4-265841-0758-10