Norgestimate And Ethinyl Estradiol Kit
NDC Package 42291-565-84

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

Package Information

Norgestimate And Ethinyl Estradiol kits is do not prescribe norgestimate and ethinyl estradiol to women who are known to have the following conditions:A high risk of arterial or venous thrombotic diseases. This formulation utilizes a kit delivery system. Marketed by Avkare, this product is identified by NDC 42291-565 and is authorized under FDA application ANDA091232.

Identification & Billing

NDC Package Code
42291-565-84
Package Description
1 CARTON in 1 CARTON / 3 BLISTER PACK in 1 CARTON (42291-565-28) / 1 KIT in 1 BLISTER PACK
Product Code
42291-565
11-Digit Billing Format
42291056584
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
Norgestimate And Ethinyl Estradiol
Non-Proprietary Name
Norgestimate And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Do not prescribe norgestimate and ethinyl estradiol 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
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA091232
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-20-2020
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 42291-565-84 identifies a specific commercial package of 1 carton in 1 carton / 3 blister pack in 1 carton (42291-565-28) / 1 kit in 1 blister pack of Norgestimate And Ethinyl Estradiol, a human prescription drug labeled by Avkare. 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 Avkare on April 20, 2020. The current certification is valid through December 31, 2026.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291056584. 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 (5-3-2)
42291-565-84
11-Digit CMS (5-4-2)
42291-0565-84

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