Estradiol / Norethindrone Acetate Tablet, Film Coated
NDC Package 51991-474-28

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

Package Information

Estradiol / Norethindrone Acetate (estradiol and norethindrone acetate) tablets is 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. This formulation utilizes a tablet, film coated delivery system. Marketed by Breckenridge Pharmaceutical, Inc., this product is identified by NDC 51991-474 and is authorized under FDA application ANDA078324.

Identification & Billing

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
11-Digit Billing Format
51991047428
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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

Clinical Specifications

Proprietary Name
Estradiol / Norethindrone Acetate
Non-Proprietary Name
Estradiol And Norethindrone Acetate
Substance Name
Estradiol; Norethindrone Acetate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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

Regulatory & Marketing

Labeler Name
Breckenridge Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078324
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-17-2008
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51991-474-28 identifies a specific commercial 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.. This tablet, film coated is formulated for oral use and contains 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 Breckenridge Pharmaceutical, Inc. on April 17, 2008. The current certification is valid through December 31, 2026.

How is this Breckenridge Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51991047428. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
51991-474-28
11-Digit CMS (5-4-2)
51991-0474-28

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