Nextstellis Kit
NDC Package 51862-258-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Nextstellis (drospirenone and estetrol) kits is nEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy. This formulation utilizes a kit delivery system. Marketed by Mayne Pharma, this product is identified by NDC 51862-258 and is authorized under FDA application NDA214154.

Identification & Billing

NDC Package Code
51862-258-01
Package Description
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)
Product Code
11-Digit Billing Format
51862025801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
  • RxCUI: 2539032 - {24 (drospirenone 3 MG / estetrol 14.2 MG Oral Tablet) / 4 (inert ingredients 1 MG Oral Tablet) } Pack [Nextstellis 28 Day]
  • RxCUI: 2539032 - Nextstellis 28 Day Pack
  • RxCUI: 2539033 - drospirenone 3 MG / estetrol 14.2 MG Oral Tablet
  • RxCUI: 2539036 - {24 (drospirenone 3 MG / estetrol 14.2 MG Oral Tablet) / 4 (inert ingredients 1 MG Oral Tablet) } Pack
  • RxCUI: 2539036 - drospiren-estetrol 3-14.2 MG (24) Oral Tablet / Inert 1 MG (4) Oral Tablet 28 Day Pack

Clinical Specifications

Proprietary Name
Nextstellis
Non-Proprietary Name
Drospirenone And Estetrol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy.

Regulatory & Marketing

Labeler Name
Mayne Pharma
Product Type
Human Prescription Drug
FDA Application #
NDA214154
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-16-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage
  • 51862 - Mayne Pharma
    • 51862-258 - Nextstellis
      • 51862-258-01 - 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)

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 (51862-258). Click a package code to view its specific billing and regulatory data.

1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)

* 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 51862-258-01 identifies a specific commercial package of 1 blister pack in 1 carton / 1 kit in 1 blister pack * 24 tablet, film coated in 1 blister pack (51862-259-24) * 4 tablet, film coated in 1 blister pack (51862-261-04) of Nextstellis, a human prescription drug labeled by Mayne Pharma. 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 Mayne Pharma on April 16, 2021. The current certification is valid through December 31, 2026.

How is this Mayne Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51862025801. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
51862-258-01
11-Digit CMS (5-4-2)
51862-0258-01

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