Divigel
NDC Package 68025-083-07

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

Divigel (estradiol) gel is a medication a female hormone (estrogen). This formulation utilizes a gel delivery system. Marketed by Vertical Pharmaceuticals, Llc, this product is identified by NDC 68025-083 and is authorized under FDA application NDA022038.

Identification & Billing

NDC Package Code
68025-083-07
Package Description
7 PACKET in 1 CARTON / .75 g in 1 PACKET
Product Code
68025-083
11-Digit Billing Format
68025008307
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Divigel
Non-Proprietary Name
Estradiol
Substance Name
Estradiol
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
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
ESTRADIOL .75 mg/.75g
Pharmacologic Class
Usage Information
This medication is a female hormone (estrogen). It is absorbed through the skin and enters into the bloodstream. It is used by women to help reduce a certain symptom of menopause (hot flashes). Symptoms of menopause are caused by the body making less estrogen. If you are using estrogens to treat only vaginal symptoms of menopause (such as vaginal dryness/burning/itching), products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.

Regulatory & Marketing

Labeler Name
Vertical Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022038
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-18-2019
Listing Expiration
12-31-2027
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 (68025-083). Click a package code to view its specific billing and regulatory data.

68025-083-30
30 PACKET in 1 CARTON / .75 g in 1 PACKET

* 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 68025-083-07 identifies a specific commercial package of 7 packet in 1 carton / .75 g in 1 packet of Divigel, a human prescription drug labeled by Vertical Pharmaceuticals, Llc. This gel is formulated for topical use and contains estradiol 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 Vertical Pharmaceuticals, Llc on January 18, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is a female hormone (estrogen). It is absorbed through the skin and enters into the bloodstream. It is used by women to help reduce a certain symptom of menopause (hot flashes). Symptoms of menopause are caused by the body making less estrogen. If you are using estrogens to treat only vaginal symptoms of menopause (such as vaginal dryness/burning/itching), products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.

How is this Vertical Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68025008307. 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)
68025-083-07
11-Digit CMS (5-4-2)
68025-0083-07

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