Prempro
Product Images NDC 68258-5978

7 FDA label images from Dispensing Solutions, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Prempro (NDC 68258-5978). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

FDA Label Image

Ndc 68258-5978-02 (Ndc 68258 5978 02 Wyeth)

Ndc 68258-5978-02 (Ndc 68258 5978 02      Wyeth)
Prempro 0.3 mg/1.5 mg tablets packaging label from Dispensing Solutions, Inc. The label includes dosage strength, 28 tablets count, NDC 68258-5978-02, and product number 5P0528. It details that each tablet contains 0.3 mg conjugated estrogens and 1.5 mg medroxyprogesterone acetate. The label displays storage instructions, warnings, lot and expiration placeholders, and a barcode.*
FDA Label Image

Ndc 68258-5980-02 (Ndc 68258 5980 02 Wyeth)

Ndc 68258-5980-02 (Ndc 68258 5980 02        Wyeth)
Prempro 0.625 mg/2.5 mg tablet bottle label from Dispensing Solutions, Inc. The label includes 28 tablets, NDC 68258-5980-02, product number 5P0728. Each tablet contains 0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone acetate. Directions state to take one tablet orally once daily at the same time each day as directed by a doctor. The label also warns to keep out of children's reach and store at 68°-77°F.*
FDA Label Image

Chemical Structure (Prempro Premphase 01)

Chemical Structure (Prempro Premphase 01)
Chemical structure diagram showing the molecular structure of the active ingredient in Prempro. The diagram includes carbon rings and various methyl and acetoxy functional groups typical of steroid compounds.*
FDA Label Image

Figure 1 (Prempro Premphase 02)

Figure 1 (Prempro Premphase 02)
A line graph showing the percentage of patients over treatment cycles for Prempro with different dosages labeled as CE/MPA. The x-axis represents the cycle number from 1 to 13, and the y-axis shows the percentage of patients from 10% to 100%. Two lines compare patient percentages for dosages 0.625/2.5 mg and 0.625/5.0 mg across cycles.*
FDA Label Image

Figure 2 (Prempro Premphase 03)

Figure 2 (Prempro Premphase 03)
A line graph depicting the percentage of patients over 13 cycles for different Prempro dosage groups. The x-axis represents cycles from 1 to 13, and the y-axis shows the percentage of patients from 0 to 100. Three dosage groups are plotted, each with a distinct line and markers, showing increasing patient percentages over cycles.*
FDA Label Image

Figure 3 (Prempro Premphase 04)

Figure 3 (Prempro Premphase 04)
A cumulative distribution plot illustrating the percent change from baseline in spine bone mineral density (BMD) among subjects. The graph compares multiple groups, including different dosages labeled as 0.625/2.5, 0.45/1.5, 0.3/1.5, and placebo, with the x-axis representing percent change and the y-axis showing cumulative percent of subjects.*
FDA Label Image

Figure 4 (Prempro Premphase 05)

Figure 4 (Prempro Premphase 05)
A line graph depicting adjusted percent change from baseline over multiple cycles for four groups: three different dosage groups identified by numeric codes and a placebo group. The x-axis represents the cycle number (0, 6, 13, 19, 26), and the y-axis shows adjusted percent change from baseline ranging approximately from -3 to 5. The graph includes markers and error bars for each data point, with distinct styles representing each group.*

* 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.