Femlyv Kit
NDC Package 72495-601-28

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

Femlyv (norethindrone acetate/ethinyl estradiol) kits is fEMLYV is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].Limitations of UseThe efficacy of FEMLYV in females with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated. This formulation utilizes a kit delivery system. Marketed by Millicent Us, Inc., this product is identified by NDC 72495-601 and is authorized under FDA application NDA218718.

Identification & Billing

NDC Package Code
72495-601-28
Package Description
1 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Product Code
72495-601
11-Digit Billing Format
72495060128
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: 2696883 - ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet
  • RxCUI: 2696883 - ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Disintegrating Oral Tablet
  • RxCUI: 2696886 - inert ingredients 1 MG Disintegrating Oral Tablet
  • RxCUI: 2696887 - {24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet) / 4 (inert ingredients 1 MG Disintegrating Oral Tablet) } Pack
  • RxCUI: 2696887 - ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet 28 Day Pack

Clinical Specifications

Proprietary Name
Femlyv
Non-Proprietary Name
Norethindrone Acetate/ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
FEMLYV is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].Limitations of UseThe efficacy of FEMLYV in females with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.

Regulatory & Marketing

Labeler Name
Millicent Us, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA218718
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2024
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 (72495-601). Click a package code to view its specific billing and regulatory data.

72495-601-84
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT 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 72495-601-28 identifies a specific commercial package of 1 pouch in 1 carton / 1 blister pack in 1 pouch / 1 kit in 1 blister pack of Femlyv, a human prescription drug labeled by Millicent Us, 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 Millicent Us, Inc. on November 01, 2024. The current certification is valid through December 31, 2026.

How is this Millicent Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72495060128. 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)
72495-601-28
11-Digit CMS (5-4-2)
72495-0601-28

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