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  5. NDC Package Code: 68462-304-50 Norethindrone Acetate

NDC Package 68462-304-50 Norethindrone Acetate

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:
68462-304-50
Package Description:
50 TABLET in 1 BOTTLE
Product Code:
68462-304
Proprietary Name:
Norethindrone Acetate
Non-Proprietary Name:
Norethindrone Acetate
Substance Name:
Norethindrone Acetate
Usage Information:
This medication is used to treat women with abnormal bleeding from the uterus. It is also used to treat women who have stopped having menstrual periods for several months (amenorrhea) but who are not pregnant or going through menopause. In addition, this medication is used to treat a condition (endometriosis) in which tissue that normally lines the inside of the uterus is found outside the uterus in the abdomen/pelvic area, causing painful/irregular periods. Norethindrone is a type of female hormone (progestin). It is like the hormone progesterone that your body makes naturally. This medication works by stopping the normal growth of the uterus lining during the menstrual cycle and signaling hormone changes in the uterus to restore normal menstrual periods. This medication must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.
11-Digit NDC Billing Format:
68462030450
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
50 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1000405 - norethindrone acetate 5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Glenmark Pharmaceuticals Inc., Usa
    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):
  • NORETHINDRONE ACETATE 5 mg/1
    • Pharmacologic Class(es):
  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA091090
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-21-2010
    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
    68462-304-05500 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68462-304-50?

    The NDC Packaged Code 68462-304-50 is assigned to a package of 50 tablet in 1 bottle of Norethindrone Acetate, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. The product's dosage form is tablet and is administered via oral form.

    Is NDC 68462-304 included in the NDC Directory?

    Yes, Norethindrone Acetate with product code 68462-304 is active and included in the NDC Directory. The product was first marketed by Glenmark Pharmaceuticals Inc., Usa on July 21, 2010 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 68462-304-50?

    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 50.

    What is the 11-digit format for NDC 68462-304-50?

    The 11-digit format is 68462030450. 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
    5-3-268462-304-505-4-268462-0304-50