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  5. NDC Package Code: 71335-1319-1 Tramadol Hydrochloride

NDC Package 71335-1319-1 Tramadol Hydrochloride

Tablet 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:
71335-1319-1
Package Description:
8 TABLET in 1 BOTTLE
Product Code:
71335-1319
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:
71335131901
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
8 EA
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:
    Bryant Ranch Prepack
    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):
  • 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:
    ANDA075964
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-22-2002
    Listing Expiration Date:
    12-31-2025
    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
    71335-1319-284 TABLET in 1 BOTTLE
    71335-1319-356 TABLET in 1 BOTTLE
    71335-1319-410 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71335-1319-1?

    The NDC Packaged Code 71335-1319-1 is assigned to a package of 8 tablet in 1 bottle of Tramadol Hydrochloride, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 8 billable units per package.

    Is NDC 71335-1319 included in the NDC Directory?

    Yes, Tramadol Hydrochloride with product code 71335-1319 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on June 22, 2002 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 71335-1319-1?

    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 8.

    What is the 11-digit format for NDC 71335-1319-1?

    The 11-digit format is 71335131901. 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
    5-4-171335-1319-15-4-271335-1319-01