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  5. NDC Package Code: 0054-3545-63 Meperidine Hydrochloride

NDC Package 0054-3545-63 Meperidine 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:
0054-3545-63
Package Description:
500 mL in 1 BOTTLE
Product Code:
0054-3545
Proprietary Name:
Meperidine Hydrochloride
Non-Proprietary Name:
Meperidine Hydrochloride
Substance Name:
Meperidine Hydrochloride
Usage Information:
Meperidine Hydrochloride Tablets and Oral Solution is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Meperidine Hydrochloride Tablets and Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:•Have not been tolerated, or are not expected to be tolerated,•Have not provided adequate analgesia, or are not expected to provide adequate analgesia.Meperidine Hydrochloride Tablets or Oral Solution should not be used for treatment of chronic pain. Prolonged meperidine use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine.
11-Digit NDC Billing Format:
00054354563
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
500 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 861455 - meperidine HCl 100 MG Oral Tablet
  • RxCUI: 861455 - meperidine hydrochloride 100 MG Oral Tablet
  • RxCUI: 861455 - pethidine hydrochloride 100 MG Oral Tablet
  • RxCUI: 861467 - meperidine HCl 50 MG Oral Tablet
  • RxCUI: 861467 - meperidine hydrochloride 50 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    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):
  • MEPERIDINE HYDROCHLORIDE 50 mg/5mL
    • Pharmacologic Class(es):
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA088744
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-30-1985
    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 0054-3545-63?

    The NDC Packaged Code 0054-3545-63 is assigned to a package of 500 ml in 1 bottle of Meperidine Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 0054-3545 included in the NDC Directory?

    Yes, Meperidine Hydrochloride with product code 0054-3545 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on January 30, 1985 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 0054-3545-63?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 500.

    What is the 11-digit format for NDC 0054-3545-63?

    The 11-digit format is 00054354563. 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 4-4-2 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
    4-4-20054-3545-635-4-200054-3545-63