NDC Package 52544-064-31 Layolis Fe

Norethindrone,Ethinyl Estradiol,And Ferrous Fumarate Kit Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

52544-064-31

Package Description:

3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

Product Code:

52544-064

Proprietary Name:

Layolis Fe

Non-Proprietary Name:

Norethindrone, Ethinyl Estradiol, And Ferrous Fumarate

Usage Information:

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: norethindrone (a progestin) and ethinyl estradiol (an estrogen). It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. There is a small amount of iron (ferrous fumarate) in each of the 4 inactive pills taken during the fourth week. The inactive pills do not contain any hormones. These pills are meant to keep you in the habit of taking 1 pill each day and do not have enough iron to treat iron deficiency. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

11-Digit NDC Billing Format:

52544006431

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

3 EA

NDC to RxNorm Crosswalk:

RxCUI: 1095223 - ferrous fumarate 75 MG Chewable Tablet

RxCUI: 1099638 - ethinyl estradiol 0.025 MG / norethindrone 0.8 MG Chewable Tablet

RxCUI: 1099638 - ethinyl estradiol 25 MCG / norethindrone 0.8 MG Chewable Tablet

RxCUI: 1607990 - {24 (ethinyl estradiol 0.025 MG / norethindrone 0.8 MG Chewable Tablet) / 4 (ferrous fumarate 75 MG Chewable Tablet) } Pack

RxCUI: 1607990 - Eth estra-Noreth 0.025-0.8 MG (24) Chewable Tablet / Ferr fum 75 MG (4) Chewable Tablet 28 Day Pack

Product Type:

Human Prescription Drug

Labeler Name:

Actavis Pharma, Inc.

Dosage Form:

Kit - A packaged collection of related material.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Sample Package:

FDA Application Number:

NDA022573

Marketing Category:

NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

Start Marketing Date:

12-23-2011

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

52544 - Actavis Pharma, Inc.
- 52544-064 - Layolis Fe
  - 52544-064-31 - 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

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 disclaimer below.

Frequently Asked Questions

What is NDC 52544-064-31?

The NDC Packaged Code 52544-064-31 is assigned to a package of 3 blister pack in 1 carton / 1 kit in 1 blister pack of Layolis Fe, a human prescription drug labeled by Actavis Pharma, Inc.. The product's dosage form is kit and is administered via oral form.

Is NDC 52544-064 included in the NDC Directory?

Yes, Layolis Fe with product code 52544-064 is active and included in the NDC Directory. The product was first marketed by Actavis Pharma, Inc. on December 23, 2011 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 52544-064-31?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 3.

What is the 11-digit format for NDC 52544-064-31?

The 11-digit format is 52544006431. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	52544-064-31	5-4-2	52544-0064-31

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