Norgestimate And Ethinyl Estradiol
NDC Package 50090-3733-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Norgestimate And Ethinyl Estradiol is do not prescribe norgestimate and ethinyl estradiol tablets to women who are known to have the following conditions:•A high risk of arterial or venous thrombotic diseases. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-3733 and is authorized under FDA application ANDA204057.

Identification & Billing

NDC Package Code
50090-3733-0
Package Description
1 KIT in 1 KIT
Product Code
50090-3733
11-Digit Billing Format
50090373300
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Norgestimate And Ethinyl Estradiol
Dosage Form
-
Usage Information
Do not prescribe norgestimate and ethinyl estradiol tablets to women who are known to have the following conditions:•A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:∘Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]∘Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]∘Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]∘Have cerebrovascular disease [see Warnings and Precautions (5.1)]∘Have coronary artery disease [see Warnings and Precautions (5.1)]∘Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]∘Have uncontrolled hypertension [see Warnings and Precautions (5.4)]∘Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)]∘Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.7)]▪Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]•Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)]•Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]•Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)]•Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.11)] •Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)]

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
FDA Application #
ANDA204057
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-23-2016
Listing Expiration
12-31-2022
Exclude Flag
I
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 50090-3733-0 identifies a specific commercial package of 1 kit in 1 kit of Norgestimate And Ethinyl Estradiol, labeled by A-s Medication Solutions. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by A-s Medication Solutions on February 23, 2016. The current certification is valid through December 31, 2022.

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: 50090373300. 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)
50090-3733-0
11-Digit CMS (5-4-2)
50090-3733-00

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