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  5. NDC Package Code: 71511-301-16 Qdolo

NDC Package 71511-301-16 Qdolo

Tramadol Hydrochloride Solution 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:
71511-301-16
Package Description:
473 mL in 1 BOTTLE
Product Code:
71511-301
Proprietary Name:
Qdolo
Non-Proprietary Name:
Tramadol Hydrochloride
Substance Name:
Tramadol Hydrochloride
Usage Information:
QDOLO is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
11-Digit NDC Billing Format:
71511030116
NDC to RxNorm Crosswalk:
  • RxCUI: 2395808 - traMADol hydrochloride 5 MG in 1 mL Oral Solution
  • RxCUI: 2395808 - tramadol hydrochloride 5 MG/ML Oral Solution
  • RxCUI: 2395808 - tramadol hydrochloride 5 MG per 1 ML Oral Solution
  • RxCUI: 2395814 - QDOLO 5 MG in 1 mL Oral Solution
  • RxCUI: 2395814 - tramadol hydrochloride 5 MG/ML Oral Solution [Qdolo]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Athena Bioscience, Llc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • TRAMADOL HYDROCHLORIDE 5 mg/mL
    • 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:
    NDA214044
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-11-2020
    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.

    Frequently Asked Questions

    What is NDC 71511-301-16?

    The NDC Packaged Code 71511-301-16 is assigned to a package of 473 ml in 1 bottle of Qdolo, a human prescription drug labeled by Athena Bioscience, Llc. The product's dosage form is solution and is administered via oral form.

    Is NDC 71511-301 included in the NDC Directory?

    Yes, Qdolo with product code 71511-301 is active and included in the NDC Directory. The product was first marketed by Athena Bioscience, Llc on September 11, 2020 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 71511-301-16?

    The 11-digit format is 71511030116. 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
    5-3-271511-301-165-4-271511-0301-16