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)

This is a table showing the percentage of subjects who experienced adverse reactions during a 12-week placebo-controlled study of Divigel, a medication available in three different dosages. The table lists the number of individuals who experienced each adverse reaction, broken down by dosage. Adverse reactions include nasopharyngitis, upper respiratory tract infections, vaginal mycosis, breast tenderness, and metrorrhagia. "Adverse reactions reported by >5 percent of patients in any treatment group."*

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Figure C (Divigel 10)

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0.25 mg Carton (Divigel 11)

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0.5 mg Carton (Divigel 12)

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.75 mg Carton (Divigel 13)

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1 mg Carton (Divigel 14)

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

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Divigel Chemical Structure (Divigel 2)

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Divigeltable2 (Divigel 3)

This is a table showing the pharmacokinetic parameters of Estradiol after multiple daily doses of Divigel 0.1% in different amounts (0.25g, 0.5g, and 1.0g). The parameters listed include AUCo-24, Crmax, Cayg, tmax, and E2:E1 ratio. The values are given as mean (%CV) and in some cases as median (Min, Max).*

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Figure 1 (Divigel 4)

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Divigeltable3 (Divigel 5)

The text presents a summary of the change from baseline in the median daily frequency and severity of hot flushes during Divigel treatment in an ITT population. It shows the results for different doses of Divigel and a placebo group, including the evaluation population and median changes at weeks 4, 7, and 12. It also includes p-values for the van Elteren's test, stratified by pooled center, to determine if the difference in median change was significant.*

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Divigeltable4 (Divigel 6)

This is a table presenting the relative and absolute risks observed in the estrogen-alone substudy of WHI. The risks are expressed in percentage and absolute risk per 10,000 women-years. The risks include CHD events, CHD death, strokes, deep venous thrombosis, pulmonary embolism, breast cancer, colorectal cancer, hip fracture, vertebral fracture, lower arm/wrist fracture, and overall mortality. The results are based on an average follow-up of 7.1 years and are not adjusted for multiple comparisons. The source and detailed terms of the study can be viewed at www.nhlbi.nih.gov/whi.*

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Divigeltable5 (Divigel 7)

The text is a table displaying relative and absolute risks associated with the use of estrogen plus progestin as reported in the Estrogen Plus Progestin Substudy of Women's Health Initiative for an average of 5.6 years. The risks are listed for various events such as CHD, stroke, breast cancer, fractures, and mortality with comparison to those taking placebo. The table also notes that the results are based on centrally adjudicated data, and a subset of events was combined in the "Global Index."*

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Figure A (Divigel 8)

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Figure B (Divigel 9)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.