Levonorgestrel And Ethinyl Estradiol Kit
NDC Package 42192-623-28

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

Package Information

Levonorgestrel And Ethinyl Estradiol kits is levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy. This formulation utilizes a kit delivery system. Marketed by Acella Pharmaceuticals, this product is identified by NDC 42192-623 and is authorized under FDA application NDA208612.

Identification & Billing

NDC Package Code
42192-623-28
Package Description
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
42192-623
11-Digit Billing Format
42192062328
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • 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: 2672922 - ferrous bisglycinate 36.5 MG Oral Tablet
  • RxCUI: 2672923 - {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack
  • RxCUI: 2672923 - Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day Pack

Clinical Specifications

Proprietary Name
Levonorgestrel And Ethinyl Estradiol
Non-Proprietary Name
Levonorgestrel And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy.

Regulatory & Marketing

Labeler Name
Acella Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA208612
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-21-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42192-623). Click a package code to view its specific billing and regulatory data.

42192-623-03
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

* 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 42192-623-28 identifies a specific commercial package of 1 blister pack in 1 carton / 1 kit in 1 blister pack of Levonorgestrel And Ethinyl Estradiol, a human prescription drug labeled by Acella Pharmaceuticals. 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 Acella Pharmaceuticals on August 21, 2023. The current certification is valid through December 31, 2026.

How is this Acella Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42192062328. 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)
42192-623-28
11-Digit CMS (5-4-2)
42192-0623-28

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