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  5. NDC Package Code: 0378-7272-53 Norethindrone

NDC Package 0378-7272-53 Norethindrone

Tablet 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:
0378-7272-53
Package Description:
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0378-7272-85) / 28 TABLET in 1 BLISTER PACK
Product Code:
0378-7272
Proprietary Name:
Norethindrone
Non-Proprietary Name:
Norethindrone
Substance Name:
Norethindrone
Usage Information:
This medication is used to prevent pregnancy. It is often referred to as the "mini-pill" because it does not contain any estrogen. Norethindrone (a form of progestin) is a hormone that prevents pregnancy by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changing the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. This medication also stops the release of an egg (ovulation) in about half of a woman's menstrual cycles. While the "mini-pill" is more effective than certain other methods of birth control (such as condoms, cervical cap, diaphragm), it is less effective than combination hormone (estrogen and progestin) birth control because it does not consistently prevent ovulation. It is usually used by women who cannot take estrogen. To reduce the risk of pregnancy, it is very important to take this medication exactly as prescribed. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
11-Digit NDC Billing Format:
00378727253
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 198042 - norethindrone 0.35 MG Oral Tablet
  • RxCUI: 748961 - {28 (norethindrone 0.35 MG Oral Tablet) } Pack
  • RxCUI: 748961 - Noreth 0.35 MG (28) Oral Tablet 28 Day Pack
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals 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):
  • NORETHINDRONE .35 mg/1
    • Pharmacologic Class(es):
  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA200980
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-24-2013
    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 0378-7272-53?

    The NDC Packaged Code 0378-7272-53 is assigned to a package of 3 pouch in 1 carton / 1 blister pack in 1 pouch (0378-7272-85) / 28 tablet in 1 blister pack of Norethindrone, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0378-7272 included in the NDC Directory?

    Yes, Norethindrone with product code 0378-7272 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on June 24, 2013 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 0378-7272-53?

    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 3.

    What is the 11-digit format for NDC 0378-7272-53?

    The 11-digit format is 00378727253. 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
    4-4-20378-7272-535-4-200378-7272-53