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  5. NDC Package Code: 75834-245-05 Levetiracetam Extended Release

NDC Package 75834-245-05 Levetiracetam Extended Release

Levetiracetam Tablet, Film Coated, Extended Release 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:
75834-245-05
Package Description:
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
75834-245
Proprietary Name:
Levetiracetam Extended Release
Non-Proprietary Name:
Levetiracetam
Substance Name:
Levetiracetam
Usage Information:
Levetiracetam is used to treat seizures (epilepsy). It belongs to a class of drugs known as anticonvulsants. Levetiracetam may decrease the number of seizures you have.
11-Digit NDC Billing Format:
75834024505
NDC to RxNorm Crosswalk:
  • RxCUI: 807832 - levETIRAcetam 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 807832 - 24 HR levetiracetam 500 MG Extended Release Oral Tablet
  • RxCUI: 807832 - levetiracetam 500 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 846378 - levETIRAcetam 750 MG 24HR Extended Release Oral Tablet
  • RxCUI: 846378 - 24 HR levetiracetam 750 MG Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Nivagen Pharmaceuticals, Inc.
    Dosage Form:
    Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LEVETIRACETAM 500 mg/1
  • LEVETIRACETAM 500 mg/1
    • Pharmacologic Class(es):
  • Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA201464
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-16-2020
    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
    75834-245-6060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
    75834-245-99180000 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 75834-245-05?

    The NDC Packaged Code 75834-245-05 is assigned to a package of 500 tablet, film coated, extended release in 1 bottle of Levetiracetam Extended Release, a human prescription drug labeled by Nivagen Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 75834-245 included in the NDC Directory?

    Yes, Levetiracetam Extended Release with product code 75834-245 is active and included in the NDC Directory. The product was first marketed by Nivagen Pharmaceuticals, Inc. on September 16, 2020 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 75834-245-05?

    The 11-digit format is 75834024505. 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
    5-3-275834-245-055-4-275834-0245-05