Divigel
Product Images NDC 68025-083

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Divigel (NDC 68025-083). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Vertical Pharmaceuticals, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Divigeltable1 (Divigel 1)

A data table showing the number and percentage of subjects with common adverse reactions in a 12-week placebo-controlled study of Divigel. The table lists reactions by system organ class and preferred term, split into Divigel doses (0.25, 0.5, and 1.0 grams/day) and placebo groups, with counts and percentages for infections, infestations, and reproductive system and breast disorders.*

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Figure C (Divigel 10)

An instructional illustration showing a hand applying topical gel to the inner thigh area of a person, likely demonstrating the proper application site for a medication such as DIVIGEL estradiol gel.*

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0.25 mg Carton (Divigel 11)

Packaging label for DIVIGEL 0.25 mg estradiol gel 0.1%, topical use. The label indicates 30 packets per box, each packet providing 0.25 mg estradiol. Distributed by Vertical Pharmaceuticals, LLC, the label also notes the product is made in Finland and includes barcodes, expiration date, lot number areas, and usage warnings.*

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0.5 mg Carton (Divigel 12)

Packaging label for DIVIGEL 0.5 mg estradiol gel, 0.1%. The package contains 30 packets with each 0.5 g gel providing 0.5 mg estradiol. The label shows the manufacturer as Orion Corporation Orion Pharma, Finland, and the distributor as Vertical Pharmaceuticals, LLC, Bridgewater, NJ. The NDC is 68025-066-30 with clear dosage strength and product information displayed.*

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.75 mg Carton (Divigel 13)

Packaging label for DIVIGEL estradiol gel 0.1%, 0.75 mg strength, topical gel with 30 packets per carton. Label shows product name, strength, dosage form, and NDC 68025-083-30. Manufactured by Orion Corporation Orion Pharma in Finland and distributed by Vertical Pharmaceuticals, LLC. The label also includes barcodes and prescription-only status.*

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1 mg Carton (Divigel 14)

Packaging label for DIVIGEL 1 mg topical gel, containing estradiol as the active ingredient. The label indicates the product contains 30 packets, each with 1 g gel providing 1 mg estradiol. The labeler is Vertical Pharmaceuticals, LLC, and the product is manufactured by Orion Corporation Orion Pharma in Finland. The label includes the NDC 68025-067-30 and states Rx only.*

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Divigel 1.25 mg Serialized Trade Carton 152533-2 R1019 (Divigel 15)

Packaging label for Divigel 0.1% (estradiol gel) 1.25 mg strength, topical gel. The label indicates the product contains 30 packets, with each 1.25 g packet providing 1.25 mg estradiol. It is labeled Rx only and distributed by Vertical Pharmaceuticals, LLC. The packaging includes NDC 68025-086-30 and notes manufacturing in Finland by Orion Corporation Orion Pharma.*

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Divigel Chemical Structure (Divigel 2)

Chemical structure of estradiol, the active ingredient in DIVIGEL topical gel. The diagram shows the molecular arrangement and bonds characteristic of estradiol.*

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Divigeltable2 (Divigel 3)

A data table titled 'Mean (%CV) Pharmacokinetic Parameters for Estradiol on Day 14 Following Multiple Daily Doses of Divigel 0.1%.' It presents pharmacokinetic parameters including AUC, Cmax, Cavg, tmax, and E2:E1 ratio for Divigel gel dosages of 0.25 grams, 0.5 grams, and 1.0 gram.*

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Figure 1 (Divigel 4)

A line graph depicting mean serum estradiol concentration (pg/mL) over time (hours) for DIVIGEL topical gel at three strengths: 0.25 mg, 0.5 mg, and 1.0 mg. The x-axis represents time in hours from 0 to 24, and the y-axis shows estradiol concentration from 0 to 100 pg/mL. Data points with error bars illustrate changes in estradiol levels for each strength over the time course.*

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Divigeltable3 (Divigel 5)

A data table titled 'Summary of Change From Baseline in the Median Daily Frequency and Severity of Hot Flushes during Divigel Treatment (ITT Population).' It compares median daily frequency and severity of hot flushes at baseline and at weeks 4, 7, and 12 among groups receiving Divigel at doses of 0.25, 0.5, and 1.0 grams per day, and a placebo group. The table includes median change values and p-values indicating statistical significance.*

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Divigeltable4 (Divigel 6)

A data table titled 'Relative And Absolute Risk Seen In The Estrogen-Alone Substudy Of WHI' showing risk comparisons between CE and Placebo groups. It includes events like CHD events, strokes, breast cancer, fractures, mortality, and others, with relative risks and absolute risk per 10,000 women-years for each group. Footnotes reference WHI publications and study details.*

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Divigeltable5 (Divigel 7)

Table showing relative and absolute risk in the Estrogen Plus Progestin substudy of the WHI over 5.6 years, comparing CE/MPA with placebo across various events such as CHD, strokes, cancers, fractures, mortality, and global index. The table includes relative risks, absolute risks per 10,000 women-years, and confidence intervals for each event.*

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Figure A (Divigel 8)

Illustration showing hands breaking open a single-use packet, demonstrating how to open a unit dose of topical gel.*

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Figure B (Divigel 9)

An instructional line drawing illustrating the method of applying topical gel to the inner thigh area. It depicts hands squeezing gel from a tube onto the upper leg of a seated person wearing underwear.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.