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  5. NDC Package Code: 59385-055-22 Elyxyb - Celecoxib

NDC Package 59385-055-22 Elyxyb - Celecoxib

Celecoxib Liquid 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:
59385-055-22
Package Description:
1 BOTTLE in 1 CARTON / 4.8 mL in 1 BOTTLE (59385-055-02)
Product Code:
59385-055
Proprietary Name:
Elyxyb - Celecoxib
Non-Proprietary Name:
Celecoxib
Substance Name:
Celecoxib
Usage Information:
This medication is a nonsteroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor, which relieves pain and swelling (inflammation). It is used to treat arthritis, acute pain, and menstrual pain and discomfort. The pain and swelling relief provided by this medication helps you perform more of your normal daily activities. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. This drug works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.
11-Digit NDC Billing Format:
59385005522
NDC to RxNorm Crosswalk:
  • RxCUI: 2373454 - celecoxib 120 MG in 4.8 mL Oral Solution
  • RxCUI: 2373454 - celecoxib 25 MG/ML Oral Solution
  • RxCUI: 2373460 - Elyxyb 120 MG in 4.8 mL Oral Solution
  • RxCUI: 2373460 - celecoxib 25 MG/ML Oral Solution [Elyxyb]
  • RxCUI: 2373460 - Elyxyb 120 MG per 4.8 mL Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Biodelivery Sciences International Inc
    Dosage Form:
    Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CELECOXIB 120 mg/4.8mL
    • 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:
    Yes
    FDA Application Number:
    NDA212157
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-01-2022
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    59385-055-066 BOTTLE in 1 CARTON / 4.8 mL in 1 BOTTLE (59385-055-01)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 59385-055-22?

    The NDC Packaged Code 59385-055-22 is assigned to a package of 1 bottle in 1 carton / 4.8 ml in 1 bottle (59385-055-02) of Elyxyb - Celecoxib, a human prescription drug labeled by Biodelivery Sciences International Inc. The product's dosage form is liquid and is administered via oral form.

    Is NDC 59385-055 included in the NDC Directory?

    Yes, Elyxyb - Celecoxib with product code 59385-055 is active and included in the NDC Directory. The product was first marketed by Biodelivery Sciences International Inc on January 01, 2022 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 59385-055-22?

    The 11-digit format is 59385005522. 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
    5-3-259385-055-225-4-259385-0055-22