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  5. NDC Package Code: 66993-490-36 Ibuprofen Lysine

NDC Package 66993-490-36 Ibuprofen Lysine

Solution Intravenous - 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:
66993-490-36
Package Description:
3 VIAL in 1 CARTON / 2 mL in 1 VIAL
Product Code:
66993-490
Proprietary Name:
Ibuprofen Lysine
Non-Proprietary Name:
Ibuprofen Lysine
Substance Name:
Ibuprofen Lysine
Usage Information:
Ibuprofen Lysine is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.
11-Digit NDC Billing Format:
66993049036
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1747294 - ibuprofen lysine 10 MG/ML in 2 ML Injection
  • RxCUI: 1747294 - 2 ML ibuprofen 10 MG/ML Injection
  • RxCUI: 1747294 - ibuprofen 10 MG/ML (as ibuprofen lysine 17.1 MG/ML) per 2 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Prasco Laboratories
    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):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • IBUPROFEN LYSINE 10 mg/mL
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA021903
    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:
    04-14-2016
    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 66993-490-36?

    The NDC Packaged Code 66993-490-36 is assigned to a package of 3 vial in 1 carton / 2 ml in 1 vial of Ibuprofen Lysine, a human prescription drug labeled by Prasco Laboratories. The product's dosage form is solution and is administered via intravenous form.

    Is NDC 66993-490 included in the NDC Directory?

    Yes, Ibuprofen Lysine with product code 66993-490 is active and included in the NDC Directory. The product was first marketed by Prasco Laboratories on April 14, 2016 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 66993-490-36?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 66993-490-36?

    The 11-digit format is 66993049036. 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
    5-3-266993-490-365-4-266993-0490-36