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  5. NDC Package Code: 51991-474-28 Estradiol / Norethindrone Acetate

NDC Package 51991-474-28 Estradiol / Norethindrone Acetate

Estradiol And Norethindrone Acetate Tablet, Film Coated 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:
51991-474-28
Package Description:
1 BLISTER PACK in 1 CARTON / 28 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
51991-474
Proprietary Name:
Estradiol / Norethindrone Acetate
Non-Proprietary Name:
Estradiol And Norethindrone Acetate
Substance Name:
Estradiol; Norethindrone Acetate
Usage Information:
Estradiol/Norethindrone Acetate Tablets are contraindicated in women with any of the following conditions:Undiagnosed abnormal genital bleedingKnown, suspected, or history of breast cancerKnown, past or suspected estrogen-dependent neoplasiaActive DVT, PE, or history of these conditionsActive arterial thromboembolic disease (for example stroke and MI), or a history of these conditionsKnown anaphylactic reaction or angioedema or hypersensitivity to Estradiol/Norethindrone Acetate TabletsKnown liver impairment or diseaseKnown protein C, protein S, or antithrombin deficiency, or other known thrombophilic disordersKnown or suspected pregnancy
11-Digit NDC Billing Format:
51991047428
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1359123 - estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet
  • RxCUI: 1359124 - {28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack
  • RxCUI: 1359124 - Estra-Noreth Ac 0.5-0.1 MG (28) Oral Tablet 28 Day Pack
  • RxCUI: 1359126 - estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet
  • RxCUI: 1359127 - {28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } Pack
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Breckenridge Pharmaceutical, Inc.
    Dosage Form:
    Tablet, Film Coated - 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.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ESTRADIOL 1 mg/1
  • NORETHINDRONE ACETATE .5 mg/1
    • Pharmacologic Class(es):
  • Estradiol Congeners - [CS]
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078324
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-17-2008
    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.

    Frequently Asked Questions

    What is NDC 51991-474-28?

    The NDC Packaged Code 51991-474-28 is assigned to a package of 1 blister pack in 1 carton / 28 tablet, film coated in 1 blister pack of Estradiol / Norethindrone Acetate, a human prescription drug labeled by Breckenridge Pharmaceutical, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 51991-474 included in the NDC Directory?

    Yes, Estradiol / Norethindrone Acetate with product code 51991-474 is active and included in the NDC Directory. The product was first marketed by Breckenridge Pharmaceutical, Inc. on April 17, 2008 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 51991-474-28?

    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 1.

    What is the 11-digit format for NDC 51991-474-28?

    The 11-digit format is 51991047428. 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
    5-3-251991-474-285-4-251991-0474-28