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  5. NDC Package Code: 0642-7471-01 Tyblume

NDC Package 0642-7471-01 Tyblume

Levonorgestrel And Ethinyl Estradiol Kit - 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:
0642-7471-01
Package Description:
1 BLISTER PACK in 1 BOX / 1 KIT in 1 BLISTER PACK
Product Code:
0642-7471
Proprietary Name:
Tyblume
Non-Proprietary Name:
Levonorgestrel And Ethinyl Estradiol
Usage Information:
Levonorgestrel and Ethinyl Estradiol Tablets (LNG/EE Tablets) is indicated for use by females of reproductive potential to prevent pregnancy.
11-Digit NDC Billing Format:
00642747101
NDC to RxNorm Crosswalk:
  • RxCUI: 242297 - levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet
  • RxCUI: 242297 - ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet
  • RxCUI: 2465331 - {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Chewable Tablet) / 7 (inert ingredients 1 MG Chewable Tablet) } Pack [Tyblume 28 Day]
  • RxCUI: 2465331 - Tyblume Chewable 28 Day Pack
  • RxCUI: 2539224 - ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Chewable Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Exeltis Usa, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    NDA209405
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-26-2020
    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
    0642-7471-021 BLISTER PACK in 1 BOX / 1 KIT in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0642-7471-01?

    The NDC Packaged Code 0642-7471-01 is assigned to a package of 1 blister pack in 1 box / 1 kit in 1 blister pack of Tyblume, a human prescription drug labeled by Exeltis Usa, Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 0642-7471 included in the NDC Directory?

    Yes, Tyblume with product code 0642-7471 is active and included in the NDC Directory. The product was first marketed by Exeltis Usa, Inc. on October 26, 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 0642-7471-01?

    The 11-digit format is 00642747101. 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 4-4-2 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
    4-4-20642-7471-015-4-200642-7471-01