Estradiol And Norethindrone Acetate Tablet
NDC Package 50742-657-68

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

Estradiol And Norethindrone Acetate tablets is classified as a

administered via oral route. This formulation utilizes a tablet delivery system. Marketed by Ingenus Pharmaceuticals, Llc, this product is identified by NDC 50742-657 and is authorized under FDA application ANDA210612.

Identification & Billing

NDC Package Code
50742-657-68
Package Description
6 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK
Product Code
50742-657
11-Digit Billing Format
50742065768
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 And Norethindrone Acetate
Non-Proprietary Name
Estradiol And Norethindrone Acetate
Substance Name
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

Regulatory & Marketing

Labeler Name
Ingenus Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA210612
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-03-2019
Listing Expiration
12-31-2027
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 (50742-657). Click a package code to view its specific billing and regulatory data.

50742-657-28
1 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK
50742-657-84
3 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK

* 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 50742-657-68 identifies a specific commercial package of 6 blister pack in 1 carton / 28 tablet in 1 blister pack of Estradiol And Norethindrone Acetate, a human prescription drug labeled by Ingenus Pharmaceuticals, Llc. This tablet 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 Ingenus Pharmaceuticals, Llc on April 03, 2019. The current certification is valid through December 31, 2027.

How is this Ingenus Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50742065768. 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)
50742-657-68
11-Digit CMS (5-4-2)
50742-0657-68

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