1. Home
  2. Labeler Index
  3. Aphena Pharma Solutions - Tennessee, Llc
  4. 71610-398
  5. NDC Package Code: 71610-398-67 Tramadol Hydrochloride

NDC Package 71610-398-67 Tramadol Hydrochloride

Tablet, Film 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:
71610-398-67
Package Description:
168 TABLET, FILM COATED in 1 BOTTLE
Product Code:
71610-398
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 UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride 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:
71610039867
NDC to RxNorm Crosswalk:
  • RxCUI: 835603 - traMADol HCl 50 MG Oral Tablet
  • RxCUI: 835603 - tramadol hydrochloride 50 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aphena Pharma Solutions - Tennessee, Llc
    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.
    • Active Ingredient(s):
  • TRAMADOL HYDROCHLORIDE 50 mg/1
    • Pharmacologic Class(es):
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA091498
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-22-2015
    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
    71610-398-1515 TABLET, FILM COATED in 1 BOTTLE
    71610-398-2020 TABLET, FILM COATED in 1 BOTTLE
    71610-398-24224 TABLET, FILM COATED in 1 BOTTLE
    71610-398-2828 TABLET, FILM COATED in 1 BOTTLE
    71610-398-3030 TABLET, FILM COATED in 1 BOTTLE
    71610-398-4040 TABLET, FILM COATED in 1 BOTTLE
    71610-398-4545 TABLET, FILM COATED in 1 BOTTLE
    71610-398-4656 TABLET, FILM COATED in 1 BOTTLE
    71610-398-5050 TABLET, FILM COATED in 1 BOTTLE
    71610-398-5360 TABLET, FILM COATED in 1 BOTTLE
    71610-398-5484 TABLET, FILM COATED in 1 BOTTLE
    71610-398-5780 TABLET, FILM COATED in 1 BOTTLE
    71610-398-6090 TABLET, FILM COATED in 1 BOTTLE
    71610-398-65100 TABLET, FILM COATED in 1 BOTTLE
    71610-398-70120 TABLET, FILM COATED in 1 BOTTLE
    71610-398-72112 TABLET, FILM COATED in 1 BOTTLE
    71610-398-73135 TABLET, FILM COATED in 1 BOTTLE
    71610-398-75150 TABLET, FILM COATED in 1 BOTTLE
    71610-398-80180 TABLET, FILM COATED in 1 BOTTLE
    71610-398-85200 TABLET, FILM COATED in 1 BOTTLE
    71610-398-90240 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71610-398-67?

    The NDC Packaged Code 71610-398-67 is assigned to a package of 168 tablet, film coated in 1 bottle of Tramadol Hydrochloride, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 71610-398 included in the NDC Directory?

    Yes, Tramadol Hydrochloride with product code 71610-398 is active and included in the NDC Directory. The product was first marketed by Aphena Pharma Solutions - Tennessee, Llc on May 22, 2015 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 71610-398-67?

    The 11-digit format is 71610039867. 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
    5-3-271610-398-675-4-271610-0398-67