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  5. NDC Package Code: 69238-2548-3 Tasimelteon

NDC Package 69238-2548-3 Tasimelteon

Capsule 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:
69238-2548-3
Package Description:
30 CAPSULE in 1 BOTTLE
Product Code:
69238-2548
Proprietary Name:
Tasimelteon
Non-Proprietary Name:
Tasimelteon
Substance Name:
Tasimelteon
Usage Information:
Tasimelteon is used to treat a certain sleep disorder (non-24-hour sleep-wake disorder). It works like a natural substance called melatonin that your body produces. It helps to control your sleep-wake cycle (circadian rhythm). Tasimelteon may improve your ability to sleep at night and to be more active during the day.
11-Digit NDC Billing Format:
69238254803
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1490473 - tasimelteon 20 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Ny Llc
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • TASIMELTEON 20 mg/1
    • Pharmacologic Class(es):
  • Melatonin Receptor Agonist - [EPC] (Established Pharmacologic Class)
  • Melatonin Receptor Agonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA211654
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-24-2023
    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 69238-2548-3?

    The NDC Packaged Code 69238-2548-3 is assigned to a package of 30 capsule in 1 bottle of Tasimelteon, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 69238-2548 included in the NDC Directory?

    Yes, Tasimelteon with product code 69238-2548 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Ny Llc on February 24, 2023 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 NDC billing unit for package 69238-2548-3?

    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 30.

    What is the 11-digit format for NDC 69238-2548-3?

    The 11-digit format is 69238254803. 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 5-4-1 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
    5-4-169238-2548-35-4-269238-2548-03