Solosec Granule
NDC Package 69751-400-01

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

Package Information

Solosec (secnidazole) granules is a medication used to treat a certain type of vaginal infection (bacterial vaginosis). This formulation utilizes a granule delivery system. Marketed by Evofem Inc., this product is identified by NDC 69751-400 and is authorized under FDA application NDA209363.

Identification & Billing

NDC Package Code
69751-400-01
Package Description
1 PACKET in 1 CARTON / 2 g in 1 PACKET
Product Code
69751-400
11-Digit Billing Format
69751040001
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
Solosec
Non-Proprietary Name
Secnidazole
Substance Name
Secnidazole
Dosage Form
Granule - A small particle or grain.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SECNIDAZOLE 2 g/4.8g
Pharmacologic Class
Usage Information
This medication is used to treat a certain type of vaginal infection (bacterial vaginosis). Secnidazole is an antibiotic that works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Evofem Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA209363
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-31-2018
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 69751-400-01 identifies a specific commercial package of 1 packet in 1 carton / 2 g in 1 packet of Solosec, a human prescription drug labeled by Evofem Inc.. This granule is formulated for oral use and contains secnidazole 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 Evofem Inc. on May 31, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain type of vaginal infection (bacterial vaginosis). Secnidazole is an antibiotic that works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Evofem Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69751040001. 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)
69751-400-01
11-Digit CMS (5-4-2)
69751-0400-01

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