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  5. NDC Package Code: 66869-564-90 Seglentis

NDC Package 66869-564-90 Seglentis

Celecoxib And Tramadol Hydrochloride Tablet 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:
66869-564-90
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 90 TABLET in 1 BOTTLE, PLASTIC
Product Code:
66869-564
Proprietary Name:
Seglentis
Non-Proprietary Name:
Celecoxib And Tramadol Hydrochloride
Substance Name:
Celecoxib; Tramadol Hydrochloride
Usage Information:
SEGLENTIS is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve SEGLENTIS for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated, or are not expected to be tolerated.Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
11-Digit NDC Billing Format:
66869056490
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2588478 - celecoxib 56 MG / traMADol hydrochloride 44 MG Oral Tablet
  • RxCUI: 2588478 - celecoxib 56 MG / tramadol hydrochloride 44 MG Oral Tablet
  • RxCUI: 2588478 - celecoxib 56 MG / tramadol hydrochloride 44 MG (equivalent to tramadol 39 MG) Oral Tablet
  • RxCUI: 2588484 - Seglentis 56 MG / 44 MG Oral Tablet
  • RxCUI: 2588484 - celecoxib 56 MG / tramadol hydrochloride 44 MG Oral Tablet [Seglentis]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Kowa Pharmaceuticals America, Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CELECOXIB 56 mg/1
  • TRAMADOL HYDROCHLORIDE 44 mg/1
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA213426
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-01-2022
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    66869-564-301 BOTTLE, PLASTIC in 1 CARTON / 30 TABLET in 1 BOTTLE, PLASTIC
    66869-564-3535 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 66869-564-90?

    The NDC Packaged Code 66869-564-90 is assigned to a package of 1 bottle, plastic in 1 carton / 90 tablet in 1 bottle, plastic of Seglentis, a human prescription drug labeled by Kowa Pharmaceuticals America, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 66869-564 included in the NDC Directory?

    Yes, Seglentis with product code 66869-564 is active and included in the NDC Directory. The product was first marketed by Kowa Pharmaceuticals America, Inc. on January 01, 2022 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 66869-564-90?

    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 1.

    What is the 11-digit format for NDC 66869-564-90?

    The 11-digit format is 66869056490. 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
    5-3-266869-564-905-4-266869-0564-90