Phexxi Gel
NDC Package 69751-100-03

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

Phexxi (lactic acid, l-, citric acid monohydrate, and potassium bitartrate) gel is pHEXXI is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. This formulation utilizes a gel delivery system. Marketed by Evofem, Inc., this product is identified by NDC 69751-100 and is authorized under FDA application NDA208352.

Identification & Billing

NDC Package Code
69751-100-03
Package Description
3 APPLICATOR in 1 BOX / 5 g in 1 APPLICATOR (69751-100-01)
Product Code
69751-100
11-Digit Billing Format
69751010003
RxNorm Crosswalk
  • RxCUI: 2385348 - lactic acid 1.8 % / citric acid 1 % / potassium bitartrate 0.4 % Vaginal Gel
  • RxCUI: 2385348 - citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / potassium bitartrate 0.004 MG/MG Vaginal Gel
  • RxCUI: 2385348 - citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / K+ bitartrate 0.004 MG/MG Vaginal Gel
  • RxCUI: 2385348 - citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / Pot bitartrate 0.004 MG/MG Vaginal Gel
  • RxCUI: 2385353 - PHEXXI 1.8 % / 1 % / 0.4 % Vaginal Gel

Clinical Specifications

Proprietary Name
Phexxi
Non-Proprietary Name
Lactic Acid, L-, Citric Acid Monohydrate, And Potassium Bitartrate
Substance Name
Citric Acid Monohydrate; Lactic Acid, L-; Potassium Bitartrate
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
Pharmacologic Class
Usage Information
PHEXXI is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

Regulatory & Marketing

Labeler Name
Evofem, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208352
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-01-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 (69751-100). Click a package code to view its specific billing and regulatory data.

69751-100-12
12 APPLICATOR in 1 BOX / 5 g in 1 APPLICATOR (69751-100-01)

* 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 69751-100-03 identifies a specific commercial package of 3 applicator in 1 box / 5 g in 1 applicator (69751-100-01) of Phexxi, a human prescription drug labeled by Evofem, Inc.. This gel is formulated for vaginal use and contains citric acid monohydrate; lactic acid, l-; potassium bitartrate 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 August 01, 2020. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69751010003. 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)
69751-100-03
11-Digit CMS (5-4-2)
69751-0100-03

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