Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate Kit
NDC Package 69238-1686-3

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

Package Information

Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate kits is norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. This formulation utilizes a kit delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-1686 and is authorized under FDA application ANDA214292.

Identification & Billing

NDC Package Code
69238-1686-3
Package Description
5 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON (69238-1686-6) / 1 KIT in 1 BLISTER PACK
Product Code
69238-1686
11-Digit Billing Format
69238168603
RxNorm Crosswalk
  • RxCUI: 1421459 - ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Capsule
  • RxCUI: 1421459 - ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Capsule
  • RxCUI: 1421460 - ferrous fumarate 75 MG Oral Capsule
  • RxCUI: 1421461 - {24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Capsule) / 4 (ferrous fumarate 75 MG Oral Capsule) } Pack
  • RxCUI: 1421461 - Eth estra-Noreth Ac 0.02-1 MG (24) Oral Capsule / Ferr fum 75 MG (4) Oral Capsule 28 Day Pack

Clinical Specifications

Proprietary Name
Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate
Non-Proprietary Name
Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA214292
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-26-2021
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 69238-1686-3 identifies a specific commercial package of 5 carton in 1 tray / 1 blister pack in 1 carton (69238-1686-6) / 1 kit in 1 blister pack of Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. This kit is formulated for oral use and contains 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 Amneal Pharmaceuticals Ny Llc on July 26, 2021. The current certification is valid through December 31, 2026.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238168603. 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 (5-4-1)
69238-1686-3
11-Digit CMS (5-4-2)
69238-1686-03

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