The Structural Formula Is (Progesterone Capsules 01)
Chemical structure diagram of progesterone, showing its steroid backbone with labeled atoms and bonds.*
Progesterone Capsule
Product Images NDC 0054-0830
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Progesterone (NDC 0054-0830). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Hikma Pharmaceuticals Usa 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.
Product Images & Figures Index
Table 1 (Progesterone Capsules 02)
A table presenting pharmacokinetic parameters of progesterone for daily doses of 100 mg, 200 mg, and 300 mg. Parameters include Cmax (maximum concentration in ng/mL), Tmax (time to reach Cmax in hours), and AUC (area under the curve from 0 to 10 hours in ng·hr/mL) with mean and standard deviation values for each dose.*
Table 2 (Progesterone Capsules 03)
A data table presenting mean pharmacokinetic parameters (Cmax, Tmax, AUC0-24h) for Estradiol, Estrone, and Equilin after coadministration of Conjugated Estrogens 0.625 mg and Progesterone Capsules 200 mg for 12 days to postmenopausal women. The table compares values for conjugated estrogens alone versus conjugated estrogens plus progesterone capsules.*
Table 3 (Progesterone Capsules 04)
Data table titled 'Incidence of Endometrial Hyperplasia in Women Receiving 3 Years of Treatment' comparing endometrial diagnosis outcomes across three treatment groups: Conjugated Estrogens 0.625 mg plus Progesterone Capsules 200 mg (cyclical), Conjugated Estrogens 0.625 mg alone, and Placebo. The table lists patient numbers and percentages for hyperplasia, adenocarcinoma, atypical hyperplasia, complex hyperplasia, and simple hyperplasia for each group in a clinical study setting.*
Figure 1 (Progesterone Capsules 05)
A line graph titled 'Time to Hyperplasia in Women Receiving up to 36 Months of Treatment' showing the probability of hyperplasia over time in months on medication for three groups: Conjugated Estrogens Alone, Conjugated Estrogens Plus Micronized Progesterone (cyclical), and Placebo Only. The graph includes patient counts at each time interval up to 36 months.*
Table 4 (Progesterone Capsules 06)
A data table showing discontinuation rates due to hyperplasia over 36 months of treatment. The table compares the most advanced biopsy results for three treatment groups: Conjugated Estrogens plus Progesterone Capsules (cyclical), Conjugated Estrogens alone, and Placebo. Results are reported as number and percentage of patients with adenocarcinoma, atypical hyperplasia, complex hyperplasia, and simple hyperplasia.*
Table 5 (Progesterone Capsules 07)
A data table titled 'TABLE 5. Relative and Absolute Risk Seen in the Estrogen Plus Progestin Substudy of WHI at an Average of 5.6 Years' presenting various health event risks. Columns compare relative risk and absolute risk per 10,000 women-years for CE/MPA versus placebo groups. Events include CHD, stroke, thrombosis, cancers, fractures, and overall mortality, with confidence intervals and subgroup data where applicable.*
Table 6 (Progesterone Capsules 08)
This data table presents adverse reactions (≥2%) reported in a placebo-controlled trial of postmenopausal women taking progesterone capsules 200 mg with conjugated estrogens 0.625 mg, compared to placebo, over a 3-year period. Reported side effects include headache, breast tenderness, joint pain, depression, and others, with percentage of patients affected listed for each group.*
Table 6 (Progesterone Capsules 09)
A data table listing various side effects or medical events with corresponding frequency counts in two separate columns. Events include chest pain, diarrhea, night sweats, breast pain, swelling of hands and feet, vaginal dryness, constipation, breast carcinoma, breast excisional biopsy, and cholecystectomy.*
Table 7 (Progesterone Capsules 0a)
A data table listing adverse reactions reported by at least 5% of patients using 400 mg/day progesterone capsules or placebo in a controlled trial with estrogen-primed postmenopausal women. It compares the percentage of patients experiencing each adverse effect between the progesterone and placebo groups.*
Ndc 0054-0829-25progesteronecapsules100 mgdo Not Use If Allergic To Peanuts100 Capsules (Progesterone Capsules 0b)
Progesterone 100 mg capsules label from Hikma Pharmaceuticals USA Inc. The label states the product contains 100 mg micronized progesterone per capsule, with a warning not to use if allergic to peanuts. It includes storage instructions, dosage advisory to refer to the package insert, and serialization details. Manufactured in Colombia for Hikma Pharmaceuticals USA Inc.*
Ndc 0054-0830-25progesteronecapsules200 mgdo Not Use If Allergic To Peanuts100 Capsules (Progesterone Capsules 0c)
Label for Progesterone Capsules 200 mg by Hikma Pharmaceuticals USA Inc. The label states the product contains 200 mg micronized progesterone per capsule. It includes warnings such as avoiding use if allergic to peanuts, storage instructions, and note to see the package insert for dosage information. The label also shows the product is dispensed with patient information and is manufactured by Procaps S.A. in Colombia.*
* 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.
