Safyral Kit
NDC Package 50419-403-75

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

Safyral (drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium) kits is this combination hormone medication is used to prevent pregnancy. This formulation utilizes a kit delivery system. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-403 and is authorized under FDA application NDA022574.

Identification & Billing

NDC Package Code
50419-403-75
Package Description
12 PACKAGE in 1 CARTON / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-403-71)
Product Code
50419-403
11-Digit Billing Format
50419040375
RxNorm Crosswalk
  • RxCUI: 1013628 - levomefolate calcium 0.451 MG Oral Tablet
  • RxCUI: 1050492 - drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet
  • RxCUI: 1050493 - {21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet) / 7 (levomefolate calcium 0.451 MG Oral Tablet) } Pack
  • RxCUI: 1050493 - Drospiren-Eth estra-Levomefol Ca 3-0.03-0.451 MG (21) Oral Tablet / Levomefol Ca 0.451 MG (7) Oral Tablet 28 Day Pack
  • RxCUI: 1050494 - {21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet) / 7 (levomefolate calcium 0.451 MG Oral Tablet) } Pack [Safyral 28 Day]

Clinical Specifications

Proprietary Name
Safyral
Non-Proprietary Name
Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone). 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. This product also contains a folate supplement (such as l-methylfolate, levomefolate). Folate is a B-vitamin that women of childbearing age use to help prevent spinal cord defects in an unborn baby. The folate supplement in this medication, along with a diet rich in folate, lowers this risk if you become pregnant while taking this drug or soon after you stop taking it. Besides preventing pregnancy, birth control pills may make your periods more regular, and may decrease blood loss, painful periods, and the risk of ovarian cysts. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Regulatory & Marketing

Labeler Name
Bayer Healthcare Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022574
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-13-2012
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 (50419-403). Click a package code to view its specific billing and regulatory data.

50419-403-00
90 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
50419-403-03
3 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-403-01)
50419-403-70
90 BLISTER PACK in 1 PACKAGE / 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 50419-403-75 identifies a specific commercial package of 12 package in 1 carton / 5 blister pack in 1 package / 1 kit in 1 blister pack (50419-403-71) of Safyral, a human prescription drug labeled by Bayer Healthcare 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 Bayer Healthcare Pharmaceuticals Inc. on February 13, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone). 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. This product also contains a folate supplement (such as l-methylfolate, levomefolate). Folate is a B-vitamin that women of childbearing age use to help prevent spinal cord defects in an unborn baby. The folate supplement in this medication, along with a diet rich in folate, lowers this risk if you become pregnant while taking this drug or soon after you stop taking it. Besides preventing pregnancy, birth control pills may make your periods more regular, and may decrease blood loss, painful periods, and the risk of ovarian cysts. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50419040375. 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)
50419-403-75
11-Digit CMS (5-4-2)
50419-0403-75

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