Norethindrone Acetate And Ethinyl Estradiol Tablet
NDC Package 75834-129-29

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package 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. This formulation utilizes a tablet delivery system. Marketed by Nivagen Pharmaceuticals, Inc., this product is identified by NDC 75834-129 and is authorized under FDA application ANDA203435.

Identification & Billing

NDC Package Code
75834-129-29
Package Description
3 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK (75834-129-84)
Product Code
75834-129
11-Digit Billing Format
75834012929
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
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

Clinical Specifications

Proprietary Name
Norethindrone Acetate And Ethinyl Estradiol
Non-Proprietary Name
Norethindrone Acetate And Ethinyl Estradiol
Substance Name
Ethinyl Estradiol; Norethindrone Acetate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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

Regulatory & Marketing

Labeler Name
Nivagen Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203435
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-25-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (75834-129). Click a package code to view its specific billing and regulatory data.

75834-129-90
90 TABLET in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 75834-129-29 identifies a specific commercial package of 3 blister pack in 1 carton / 28 tablet in 1 blister pack (75834-129-84) of Norethindrone Acetate And Ethinyl Estradiol, a human prescription drug labeled by Nivagen Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains ethinyl estradiol; norethindrone acetate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Nivagen Pharmaceuticals, Inc. on November 25, 2016. The current certification is valid through December 31, 2026.

How is this Nivagen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75834012929. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
75834-129-29
11-Digit CMS (5-4-2)
75834-0129-29

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.