1. Home
  2. Labeler Index
  3. Bayer Healthcare Pharmaceuticals Inc.
  4. 50419-403
  5. NDC Package Code: 50419-403-70 Safyral

NDC Package 50419-403-70 Safyral

Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
50419-403-70
Package Description:
90 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
Product Code:
50419-403
Proprietary Name:
Safyral
Non-Proprietary Name:
Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium
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).
11-Digit NDC Billing Format:
50419040370
NDC to 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]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bayer Healthcare Pharmaceuticals Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    NDA022574
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-13-2012
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    50419-403-0090 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
    50419-403-033 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-403-01)
    50419-403-7512 PACKAGE in 1 CARTON / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-403-71)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50419-403-70?

    The NDC Packaged Code 50419-403-70 is assigned to a package of 90 blister pack in 1 package / 1 kit in 1 blister pack of Safyral, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 50419-403 included in the NDC Directory?

    Yes, Safyral with product code 50419-403 is active and included in the NDC Directory. The product was first marketed by Bayer Healthcare Pharmaceuticals Inc. on February 13, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 50419-403-70?

    The 11-digit format is 50419040370. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-250419-403-705-4-250419-0403-70