Progesterone is a progesterone sold in the U.S. under 5 brand and generic names, for amenorrhea, endometrial hyperplasia and female infertility. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Prometrium (application NDA019781). Other progesterone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Prevention of Endometrial Hyperplasia PROMETRIUM Capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to a postmenopausal woman with a uterus who is receiving daily conjugated estrogens tablets. Treatment of Secondary Amenorrhea PROMETRIUM Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days. Some women may experience difficulty swallowing PROMETRIUM Capsules. For these women, PROMETRIUM Capsules should be taken with a glass of water while in the standing position.
See WARNINGS and PRECAUTIONS . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of PROMETRIUM Capsules on the endometrium was studied in a total of 875 postmenopausal women. Table 7 lists adverse reactions greater than or equal to 2 percent of women who received cyclic PROMETRIUM Capsules 200 mg daily (12 days per calendar month cycle) with 0.625 mg conjugated estrogens or placebo. TABLE 7. Adverse Reactions (≥ 2%) Reported in an 875 Patient Placebo-Controlled Trial in Postmenopausal Women Over a 3-Year Period [Percentage (%) of Patients Reporting] PROMETRIUM Capsules 200 mg with Conjugated Estrogens 0.625 mg Placebo (n=178) (n=174) Headache 31 27 Breast Tenderness 27 6 Joint Pain 20 29 Depression 19 12 Dizziness 15 9 Abdominal Bloating 12 5 Hot Flashes 11 35 Urinary Problems 11 9 Abdominal Pain 10 10 Vaginal Discharge 10 3 Nausea / Vomiting 8 7 Worry 8 4 Chest Pain 7 5 Diarrhea 7 4 Night Sweats 7 17 Breast Pain 6 2 Swelling of Hands and Feet 6 9 Vaginal Dryness 6 10 Constipation 3 2 Breast Carcinoma 2 <1 Breast Excisional Biopsy 2 <1 Cholecystectomy 2 <1 Effects on Secondary…
PROMETRIUM is contraindicated in women with any of the following conditions: 1. Hypersensitivity to its ingredients. PROMETRIUM Capsules contain peanut oil and is contraindicated in patients allergic to peanuts. 2. Abnormal genital bleeding of unknown etiology. 3. Known, suspected, or history of breast cancer. 4. Active deep vein thrombosis, pulmonary embolism or history of these conditions. 5. Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. 6. Known liver dysfunction or disease.
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Topical | Generic | $12 | View → | |
| 2 | 70/100 | Prescription | System | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 555;873;b | 5 mg | white | round | — |
| P1 | 100 mg | white | round | — |
| PREMPRO;0625;25 | 0.625 mg / 2.5 mg | orange | oval | — |
| PREMPRO;0625;25 | 0.625 mg / 2.5 mg | orange | oval | — |
| PREMPRO;03;15 | 0.3 mg / 1.5 mg | yellow | oval | — |
| PREMPRO;0625;25 |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Medroxyprogesterone Acetate Injectable Suspension
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Mckesson Medical-Surgical Inc. Corporate Office · Apr 25, 2025
Progesterone Injection USP
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Eugia US LLC · Dec 27, 2024
medroxyPROGESTERone Acetate Injectable Suspension
CGMP Deviations
Eugia US LLC · Dec 18, 2024
Progesterone Injection
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Eugia US LLC · Jul 26, 2024
Progesterone 200 mg
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Coast Quality Pharmacy, LLC dba Anazao Health · Apr 24, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
| $12 |
| View → |
| 3 | Not yet rated | Prescription | Insert | Generic | $12 | View → |
| 4 | Not yet rated | Prescription | Capsule | Generic | $12 | View → |
| 5 | Not yet rated | Prescription | Capsule | Generic | $12 | View → |
| 0.625 mg / 2.5 mg |
| orange |
| oval |
| — |
| PREMPRO;03;15 | 0.3 mg / 1.5 mg | yellow | oval | — |
|---|
| PREMPRO;045;15 | 0.45 mg / 1.5 mg | yellow | oval | — |
|---|
| PREMPRO;0625;25 | 0.625 mg / 2.5 mg | orange | oval | — |
|---|
| PREMPRO;0625;5 | 0.625 mg / 5 mg | blue | oval | — |
|---|
| PREMPRO;045;15 | 0.45 mg / 1.5 mg | yellow | oval | — |
|---|
| PREMPRO | 0.625 mg / 2.5 mg | orange | oval | — |
|---|