Lo Simpesse Kit
NDC Package 65862-866-95

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

Package Information

Lo Simpesse (levonorgestrel and ethinyl estradiol and ethinyl estradiol) kits is lo SimpesseTM (Levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) is indicated for use by women to prevent pregnancy. This formulation utilizes a kit delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-866 and is authorized under FDA application ANDA206852.

Identification & Billing

NDC Package Code
65862-866-95
Package Description
2 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (65862-866-94) / 1 KIT in 1 BLISTER PACK
Product Code
65862-866
11-Digit Billing Format
65862086695
RxNorm Crosswalk
  • RxCUI: 1921723 - {7 (ethinyl estradiol 0.01 MG Oral Tablet) / 84 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) } Pack [Lo Simpesse 91 Day]
  • RxCUI: 1921723 - Lo Simpesse 91 Day Pack
  • RxCUI: 242297 - levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet
  • RxCUI: 242297 - ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet
  • RxCUI: 248310 - ethinyl estradiol 0.01 MG Oral Tablet

Clinical Specifications

Proprietary Name
Lo Simpesse
Non-Proprietary Name
Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Lo SimpesseTM (Levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) is indicated for use by women to prevent pregnancy.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA206852
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-28-2017
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 65862-866-95 identifies a specific commercial package of 2 pouch in 1 carton / 1 blister pack in 1 pouch (65862-866-94) / 1 kit in 1 blister pack of Lo Simpesse, a human prescription drug labeled by Aurobindo Pharma Limited. 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 Aurobindo Pharma Limited on April 28, 2017. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862086695. 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)
65862-866-95
11-Digit CMS (5-4-2)
65862-0866-95

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