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  5. NDC Package Code: 75834-129-90 Norethindrone Acetate And Ethinyl Estradiol

NDC Package 75834-129-90 Norethindrone Acetate And Ethinyl Estradiol

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:
75834-129-90
Package Description:
90 TABLET in 1 BOTTLE
Product Code:
75834-129
Proprietary Name:
Norethindrone Acetate And Ethinyl Estradiol
Non-Proprietary Name:
Norethindrone Acetate And Ethinyl Estradiol
Substance Name:
Ethinyl Estradiol; Norethindrone Acetate
Usage Information:
Norethindrone acetate and ethinyl estradiol tablets are contraindicated in women with any of the following conditions:Undiagnosed abnormal genital bleedingKnown, suspected, or history of breast cancerKnown or suspected estrogen-dependent neoplasiaActive DVT, PE or a history of these conditionsActive arterial thromboembolic disease (for example, stroke and MI), or a history of these conditionsKnown anaphylactic reaction or angioedema to Norethindrone acetate and Ethinyl estradiol tablets.Known liver impairment or diseaseKnown protein C, protein S, or antithrombin deficiency, or other known thrombophilic disordersKnown or suspected pregnancy
11-Digit NDC Billing Format:
75834012990
NDC to RxNorm Crosswalk:
  • RxCUI: 1090992 - norethindrone acetate 1 MG / ethinyl estradiol 5 MCG Oral Tablet
  • RxCUI: 1090992 - ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1090992 - ethinyl estradiol 5 MCG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1251323 - norethindrone acetate 0.5 MG / ethinyl estradiol 2.5 MCG Oral Tablet
  • RxCUI: 1251323 - ethinyl estradiol 0.0025 MG / norethindrone acetate 0.5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Nivagen 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):
  • ETHINYL ESTRADIOL .0025 mg/1
  • NORETHINDRONE ACETATE .5 mg/1
    • Pharmacologic Class(es):
  • 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:
    ANDA203435
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-25-2016
    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
    75834-129-293 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK (75834-129-84)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 75834-129-90?

    The NDC Packaged Code 75834-129-90 is assigned to a package of 90 tablet in 1 bottle of Norethindrone Acetate And Ethinyl Estradiol, a human prescription drug labeled by Nivagen Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 75834-129 included in the NDC Directory?

    Yes, Norethindrone Acetate And Ethinyl Estradiol with product code 75834-129 is active and included in the NDC Directory. The product was first marketed by Nivagen Pharmaceuticals, Inc. on November 25, 2016 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 75834-129-90?

    The 11-digit format is 75834012990. 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
    5-3-275834-129-905-4-275834-0129-90