Progesterone 50 mg/mL Injection, Solution, 10 mL
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Progesterone class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- When you still have your uterus and you're taking estrogen, estrogen can cause the lining of your uterus to grow too thick — a condition called endometrial hyperplasia, which can i...
- Why do I need to take progesterone if I'm already on estrogen?
- Yes, and it's important to be honest about this. Large studies have shown that taking estrogen combined with progestin — including progesterone — is associated with a higher risk o...
- Is it true that taking progesterone with estrogen can raise my risk of breast cancer or stroke?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Progesterone — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII QX10HYY4QV
Sesame oil is a plant-derived oil from sesame seeds. It's used in medicines as a solvent or carrier to dissolve or suspend active ingredients, helping them mix evenly throughout the formulation.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.435 | $14.35 / 10 ml |
| Medicaid paysCMS SDUD · 12 mo | $1.75 | $17.46 / 10 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J2675 | $0.559 / J2675 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Progesterone 50 mg 00143-9725-01 | Hikma | 10 injections | $1.435 | AO | Availability likely | — |
| Progesterone 50 mg/mL 00591-3128-79 | Actavis | 10 ml | $1.435 | — | Availability likely | — |
| Progesterone 50 mg/mLthis 55150-0306-10 | Eugia | 10 ml | $1.435 | AO | Availability likely | — |
| Progesterone 50 mg/mL 63323-0261-10 | Fresenius | 1 vial | $1.435 | AO | Availability likely | — |
| Progesterone 50 mg/mL 70700-0286-22 | XIROMED, | 10 ml | $1.435 | AO | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55150-0306-10 You're viewing this | 10 mL in 1 VIAL, MULTI-DOSE (55150-306-10) | 2018-12-06 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Progesterone is administered by intramuscular injection. It differs from other commonly used steroids in that it is irritating at the place of injection. Amenorrhea: Five to 10 mg are given for six to eight consecutive days.
If there has been sufficient ovarian activity to produce a proliferative endometrium, one can expect withdrawal bleeding forty-eight to seventy-two hours after the last injection. This may be followed by spontaneous normal cycles. Functional Uterine Bleeding: Five to 10 mg are given daily for six doses.
Bleeding may be expected to cease within six days. When estrogen is given as well, the administration of progesterone is begun after two weeks of estrogen therapy. If menstrual flow begins during the course of injections of progesterone, they are discontinued.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.
⛔ Contraindications ▾
CONTRAINDICATIONS Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy. Liver dysfunction or disease. Known or suspected malignancy of breast or genital organs. Undiagnosed vaginal bleeding. Missed abortion. Known sensitivity to progesterone injection. Known sensitivity to sesame oil/seeds.
⚠️ Warnings ▾
WARNINGS The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. Medication should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine.
If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn. Acute eosinophilic pneumonia has been reported in patients receiving progesterone in sesame oil. In reported cases associated with progesterone in sesame oil, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates.
In general, patients developed eosinophilic pneumonia 2 to 4 weeks after starting progesterone in sesame oil and improved when progesterone in sesame oil was discontinued and a different formulation of progesterone and/or steroid therapy was initiated. Patients who develop these signs and symptoms while receiving progesterone in sesame oil should undergo prompt medical evaluation, and progesterone in sesame oil should be discontinued immediately.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; edema; change in weight (increase or decrease); changes in cervical erosion and cervical secretions; cholestatic jaundice; breast tenderness and galactorrhea; pain, irritation, and/or redness at the injection area; skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash; acne, alopecia and hirsutism; rash (allergic) with and without pruritus; anaphylactoid reactions (including eosinophilic pneumonia); mental depression; pyrexia; insomnia; nausea; and somnolence.
A statistically significant association has been demonstrated between use of estrogen-progestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. There is also evidence suggestive of an association with neuro-ocular lesions, e.g., retinal thrombosis and optic neuritis.
The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: rise in blood pressure in susceptible individual, premenstrual syndrome, changes in libido, changes in appetite, cystitis-like syndrome, headache, nervousness, fatigue, backache, hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, hemorrhagic eruption, itching, and dizziness. The following laboratory results may be altered by the use of estrogen-progestin combination drugs: increased sulfobromophthalein retention and other hepatic function tests; coagulation tests: increase in prothrombin factors VII, VIII, IX, and X; metyrapone test; pregnanediol determinations; thyroid function: increase in PBI and butanol extractable protein bound iodine, and decrease in T 3 uptake values.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use: The safety and effectiveness in geriatric patients (over age 65) have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Transforms proliferative endometrium into secretory endometrium. Inhibits (at the usual dose range) the secretion of pituitary gonadotropins, which in turn prevents follicular maturation and ovulation. Pharmacokinetics and Metabolism: Absorption: After intramuscular administration of 10 mg of progesterone in oil, maximum plasma concentrations (geometric mean of 7 ng/mL) were reached within approximately 8 hours after injection and plasma concentrations remained above baseline for about 24 hours after injection.
Injection of 10, 25, and 50 mg resulted in geometric mean values for maximum plasma concentration (C MAX ) of 7, 28, and 50 ng/mL, respectively. Distribution: Progesterone is extensively bound to plasma proteins, primarily albumin (50 to 54%) and cortisol-binding protein (43 to 48%). Metabolism: Progesterone is metabolized primarily in the liver by reduction to pregnanediol, pregnanetriol, and pregnanolone.
Subsequent conjugation results in the formation of glucuronide and sulfate metabolites. The mean plasma metabolic clearance rate in cycling women is 2510 ± 135 (SEM) L/day. Excretion: The glucuronide and sulfate conjugates of pregnanediol and pregnanolone are excreted in the urine and bile.
Progesterone metabolites which are excreted in the bile may undergo enterohepatic recycling or may be excreted in the feces. The pharmacokinetic data was determined in a small number of patients, limiting the precision in which population values may be estimated. Special Populations: Renal Insufficiency: The safety and effectiveness in patients with renal insufficiency have not been established.
Since progesterone metabolites are excreted mainly by the kidneys, progesterone should be administered with caution and careful monitoring in this patient population (see PRECAUTIONS ). Hepatic Insufficiency: The safety and effectiveness in patients with hepatic insufficiency have not been established. Since progesterone is metabolized by the liver, use in patients with liver dysfunction or disease is contraindicated (see CONTRAINDICATIONS ).
Drug Interactions: The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (IC 50 < 01 µM). Ketoconazole is a known inhibitor of cytochrome P450 3A4 and these data suggest that ketoconazole or other known inhibitors of this enzyme may increase the bioavailability of progesterone. The clinical relevance of the in vitro findings is unknown.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Progesterone injection USP, 500 mg per 10 mL (50 mg/mL) is a sterile, clear, colorless to yellowish oily solution and is supplied as follows: 10 mL Multiple-Dose Vial packaged individually NDC 55150-306-10 Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]. The vial stopper is not made with natural rubber latex. For all medical inquiries contact: Eugia US LLC 279 Princeton-Hightstown Rd.
E. Windsor, NJ 08520 1-866-850-2876 Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E.Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: June 2023
📋 Description ▾
DESCRIPTION Progesterone injection USP, a progestin, is a sterile solution of progesterone in a suitable vegetable oil available for intramuscular use. Progesterone occurs as a white or creamy white, crystalline powder or colourless crystals. It is soluble in alcohol, in acetone, and in dioxane; sparingly soluble in vegetable oils; practically insoluble in water.
It has the following structural formula: Pregn-4-ene-3, 20-dione Each mL contains: Progesterone 50 mg, Benzyl Alcohol 10% as preservative in Sesame Oil q.s. chemical-structure