Norethindrone And Ethinyl Estradiol And Ferrous Fumarate Kit
NDC Package 0378-7297-53

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

Package Information

Norethindrone And Ethinyl Estradiol And Ferrous Fumarate kits is a human prescription drug. This formulation utilizes a kit delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-7297 and is authorized under FDA application ANDA202086.

Identification & Billing

NDC Package Code
0378-7297-53
Package Description
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0378-7297-85) / 1 KIT in 1 BLISTER PACK
Product Code
0378-7297
11-Digit Billing Format
00378729753
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: 1095223 - ferrous fumarate 75 MG Chewable Tablet
  • RxCUI: 1095224 - {21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } Pack
  • RxCUI: 1095224 - eth-estra-noreth 0.035-0.4 MG (21) Chewable Tablet / ferr fum 75 MG (7) Chewable Tablet 28 Day Pack
  • RxCUI: 1095224 - {21 (ethinyl estradiol 35 MCG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } Pack
  • RxCUI: 433718 - norethindrone 0.4 MG / ethinyl estradiol 35 MCG Chewable Tablet

Clinical Specifications

Proprietary Name
Norethindrone And Ethinyl Estradiol And Ferrous Fumarate
Non-Proprietary Name
Norethindrone And Ethinyl Estradiol And Ferrous Fumarate
Dosage Form
Kit - A packaged collection of related material.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202086
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-28-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0378-7297-53 identifies a specific commercial package of 3 pouch in 1 carton / 1 blister pack in 1 pouch (0378-7297-85) / 1 kit in 1 blister pack of Norethindrone And Ethinyl Estradiol And Ferrous Fumarate, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This kit is formulated for 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 Mylan Pharmaceuticals Inc. on October 28, 2016. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378729753. 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 (4-4-2)
0378-7297-53
11-Digit CMS (5-4-2)
00378-7297-53

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