Cryselle Kit
NDC Package 50090-2183-0

11-digit billing NDC: 50090218300 · Billing unit: EA · 1 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cryselle (norgestrel and ethinyl estradiol) kits is cryselle is indicated for use by females of reproductive potential to prevent pregnancy.In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use. This formulation utilizes a kit delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-2183 and is authorized under FDA application ANDA075840.

Identification & Billing

NDC Package Code
50090-2183-0
Package Description
1 KIT in 1 KIT
Product Code
50090-2183
11-Digit Billing Format
50090218300
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cryselle
Non-Proprietary Name
Norgestrel And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Cryselle is indicated for use by females of reproductive potential to prevent pregnancy.In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
Product Type
Human Prescription Drug
FDA Application #
ANDA075840
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-24-2002
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 50090-2183-0 identifies a specific commercial package of 1 kit in 1 kit of Cryselle, a human prescription drug labeled by A-s Medication Solutions. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 A-s Medication Solutions on July 24, 2002. The current certification is valid through December 31, 2026.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090218300. 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 (5-4-1)
50090-2183-0
11-Digit CMS (5-4-2)
50090-2183-00

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