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  5. NDC Package Code: 13811-689-30 Tramadol Hydrochloride Extended-release

NDC Package 13811-689-30 Tramadol Hydrochloride Extended-release

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
13811-689-30
Package Description:
30 CAPSULE in 1 BOTTLE, PLASTIC
Product Code:
13811-689
Proprietary Name:
Tramadol Hydrochloride Extended-release
Non-Proprietary Name:
Tramadol Hydrochloride
Substance Name:
Tramadol Hydrochloride
Usage Information:
Tramadol Hydrochloride Extended-Release Capsules are indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate.Limitation of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions ( 5.1)] , reserve Tramadol Hydrochloride Extended-Release Capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Tramadol Hydrochloride Extended-Release Capsules are not indicated as an as-needed (prn) analgesic.
11-Digit NDC Billing Format:
13811068930
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1148478 - traMADol HCl 100 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1148478 - 24 HR tramadol hydrochloride 100 MG Extended Release Oral Capsule
  • RxCUI: 1148485 - traMADol HCl 200 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1148485 - 24 HR tramadol hydrochloride 200 MG Extended Release Oral Capsule
  • RxCUI: 1148485 - tramadol hydrochloride 200 MG 24 HR Extended Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Trigen Laboratories, Llc
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • TRAMADOL HYDROCHLORIDE 100 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:
    NDA022370
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    06-22-2015
    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.

    Frequently Asked Questions

    What is NDC 13811-689-30?

    The NDC Packaged Code 13811-689-30 is assigned to a package of 30 capsule in 1 bottle, plastic of Tramadol Hydrochloride Extended-release, a human prescription drug labeled by Trigen Laboratories, Llc. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 13811-689 included in the NDC Directory?

    Yes, Tramadol Hydrochloride Extended-release with product code 13811-689 is active and included in the NDC Directory. The product was first marketed by Trigen Laboratories, Llc on June 22, 2015 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 13811-689-30?

    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 30.

    What is the 11-digit format for NDC 13811-689-30?

    The 11-digit format is 13811068930. 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
    5-3-213811-689-305-4-213811-0689-30