Progesterone 200 mg Capsule, 100-count
Other active recalls for Progesterone (different manufacturers) — 2 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Progesterone class.
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🏭 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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💊 What it looks like
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🧪 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Progesterone 200 mg 00054-0830-25 | Hikma | 100 capsules | $0.417 | AB | Availability likely | — |
| Progesterone 200 mg 69452-0234-20 | Bionpharma | 100 capsules | $0.417 | AB | Availability likely | — |
| Progesterone 200 mg 65162-0808-10 | Amneal | 100 capsules | $0.417 | AB | Availability likely | — |
| Progesterone 200 mg 70700-0163-01 | Xiromed, | 100 capsules | $0.417 | AB | Availability likely | — |
| Progesterone 200 mg 16714-0158-01 | Northstar | 100 capsules | $0.417 | AB | Availability likely | — |
| Progesterone 200 mg 59651-0153-01 | Aurobindo | 100 capsules | $0.417 | AB | Availability likely | — |
| Progesterone 200 mg 43598-0350-01 | Dr. | 100 capsules | $0.425 | AB | FDA listed | — |
| Prometrium 200 mg 72989-0373-30 | Acertis | 30 capsules | $30.417 | AB | Availability likely | — |
| Progesterone 200 mg 69452-0149-20 | Bionpharma | 100 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 71205-0903-11 | Proficient | 1000 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 76420-0059-10 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 76420-0073-10 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 76420-0282-01 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 76420-0574-01 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 68788-8295-03 | Preferred | 30 capsules | — | AB | Discontinued | — |
| Progesterone 200 mg 51407-0981-01 | Golden | 100 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 82804-0268-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 71335-2242-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 73190-0065-01 | AvKARE | 100 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 68071-3953-08 | NuCare | 180 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 71205-0669-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 71335-1432-01 | Bryant | 30 capsules | — | AB | Discontinued | — |
| Progesterone 200 mg 71335-1990-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 42291-0785-01 | AvKARE | 100 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 68071-3529-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 76420-0580-10 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 68788-8719-03 | Preferred | 30 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 72189-0217-90 | direct | 90 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 68788-4015-03 | Preferred | 30 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 71335-1406-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Progesterone 200 mg 72189-0347-90 | Direct | 90 capsules | — | AB | FDA listed | — |
| Progesterone 200 mgthis 72603-0975-01 | NorthStar | 100 capsules | — | AB | FDA listed | — |
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?
📊 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 |
|---|---|---|---|
| 72603-0975-01 You're viewing this | 100 CAPSULE in 1 BOTTLE (72603-975-01) | 2026-08-01 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Cardiovascular Disorders and Probable Dementia Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS , Cardiovascular disorders and Probable dementia .) The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
(See CLINICAL STUDIES and WARNINGS , Cardiovascular disorders .) The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS , Probable dementia and PRECAUTIONS , Geriatric Use .) Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.
(See CLINICAL STUDIES and WARNINGS , Malignant neoplasms , Breast Cancer .) In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Prevention of Endometrial Hyperplasia Progesterone 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 Progesterone capsules may be given as a single daily dose of 400 mg at bedtime for 10 days. Some women may experience difficulty swallowing progesterone capsules.
For these women, progesterone capsules should be taken with a glass of water while in the standing position.
⛔ Contraindications ▾
CONTRAINDICATIONS Progesterone capsules should not be used in women with any of the following conditions: Progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. Undiagnosed abnormal genital bleeding.
Known, suspected, or history of breast cancer. Active deep vein thrombosis, pulmonary embolism or history of these conditions. Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions.
Known liver dysfunction or disease. Known or suspected pregnancy.
⚠️ Warnings ▾
WARNINGS See BOXED WARNING . 1. Cardiovascular disorders An increased risk of pulmonary embolism, deep vein thrombosis (DVT), stroke, and myocardial infarction has been reported with estrogen plus progestin therapy.
Should any of these occur or be suspected, estrogen with progestin therapy should be discontinued immediately. Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (for example, personal history or family history of venous thromboembolism [VTE], obesity, and systemic lupus erythematosus) should be managed appropriately. a. Stroke In the Women’s Health Initiative (WHI) estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women in the same age group receiving placebo (33 versus 25 per 10,000 women-years).
The increase in risk was demonstrated after the first year and persisted. (See CLINICAL STUDIES .) Should a stroke occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. b. Coronary Heart Disease In the WHI estrogen plus progestin substudy, there was a statistically non-significant increased risk of coronary heart disease (CHD) events (defined as nonfatal myocardial infarction [MI], silent MI, or CHD death) reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (41 versus 34 per 10,000 women-years).
An increase in relative risk was demonstrated in year 1 and a trend toward decreasing relative risk was reported in years 2 through 5. (See CLINICAL STUDIES .) In postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years), in a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study [HERS]), treatment with daily CE (0.625 mg) plus MPA (2.5 mg) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE plus MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease.
There were more CHD events in the CE plus MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand, three hundred and twenty-one (2,321) women from the original HERS trial agreed to participate in an open-label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall.
Rates of CHD events were comparable among women in the CE plus MPA group and the placebo group in HERS, HERS II, and overall. c. Venous Thromboembolism In the WHI estrogen plus progestin substudy, a statistically significant 2-fold greater rate of VTE (DVT and pulmonary embolism [PE]) was reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (35 versus 17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 versus 13 per 10,000 women-years) and PE (18 versus 8 per 10,000 women-years) were also demonstrated.
The increase in VTE risk was demonstrated during the first year and persisted. (See CLINICAL STUDIES .) Should a VTE occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. If feasible, estrogens with progestins should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.
2. Malignant neoplasms a. Breast Cancer The WHI substudy of daily CE (0.625 mg)-alone provided information about breast cancer in estrogen-alone users.
In the WHI estrogen-alone substudy, after an average of follow-up of 7.1 years, daily CE-alone was not associated with an increased risk of invasive breast cancer [relative risk (RR) 0.80] compared to placebo (see CLINICAL STUD…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS See BOXED WARNING , 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 progesterone capsules on the endometrium was studied in a total of 875 postmenopausal women.
Table 6 lists adverse reactions greater than or equal to 2 percent of women who received cyclic progesterone capsules 200 mg daily (12 days per calendar month cycle) with 0.625 mg conjugated estrogens or placebo. TABLE 6. Adverse Reactions (≥ 2%) Reported in an 875 Patient Placebo-Controlled Trial in Postmenopausal Women Over a 3-Year Period [Percentage (%) of Patients Reporting] Progesterone 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 Amenorrhea In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of progesterone capsules on secondary amenorrhea was studied in 49 estrogen-primed postmenopausal women.
Table 7 lists adverse reactions greater than or equal to 5 percent of women who received progesterone capsules or placebo. TABLE 7. Adverse Reactions (≥ 5%) Reported in Patients Using 400 mg/day in a Placebo-Controlled Trial in Estrogen-Primed Postmenopausal Women Adverse Experience Progesterone Capsules 400 mg Placebo n=25 n=24 Percentage (%) of Patients Fatigue 8 4 Headache 16 8 Dizziness 24 4 Abdominal Distention (Bloating) 8 8 Abdominal Pain (Cramping) 20 13 Diarrhea 8 4 Nausea 8 0 Back Pain 8 8 Musculoskeletal Pain 12 4 Irritability 8 4 Breast Pain 16 8 Infection Viral 12 0 Coughing 8 0 In a multicenter, parallel-group, open label postmarketing dosing study consisting of three consecutive 28-day treatment cycles, 220 premenopausal women with secondary amenorrhea were randomized to receive daily conjugated estrogens therapy (0.625 mg conjugated estrogens) and progesterone capsules, 300 mg per day (n=113) or progesterone capsules, 400 mg per /day (n=107) for 10 days of each treatment cycle.
Overall, the most frequently reported treatment-emergent adverse reactions, reported in greater than or equal to 5 percent of subjects, were nausea, fatigue, vaginal mycosis, nasopharyngitis, upper respiratory tract infection, headache, dizziness, breast tenderness, abdominal distension, acne, dysmenorrhea, mood swing, and urinary tract infection. Postmarketing Experience: The following additional adverse reactions have been reported with progesterone capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Genitourinary System: endometrial carcinoma, hypospadia, intra-uterine death, menorrhagia, menstrual disorder, metrorrhagia, ovarian cyst, spontaneous abortion. Cardiovascular: circulatory collapse, congenital heart disease (including ventricular septal defect and patent ductus arteriosus), hypertension, hypotension, tachycardia. Gastrointestinal: acute pancreatitis, cholestasis, cholestatic hepatitis, dysphagia, hepatic failure, hepatic necrosis, hepatitis, increased liver function tests (including alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased), jaundice, swollen tongue.
Skin: alopecia, pruritus, urticaria…
🔄 Drug / Laboratory Test Interactions ▾
C. Drug-Laboratory Test Interactions The following laboratory results may be altered by the use of estrogen plus progestin therapy: Increased sulfobromophthalein retention and other hepatic function tests. Coagulation tests: increase in prothrombin factors VII, VIII, IX and X. Pregnanediol determination. Thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values.
🤰 Pregnancy ▾
E. Pregnancy Progesterone capsules should not be used during pregnancy. (See CONTRAINDICATIONS ).
Pregnancy Category B: Reproductive studies have been performed in mice at doses up to 9 times the human oral dose, in rats at doses up to 44 times the human oral dose, in rabbits at a dose of 10 mcg/day delivered locally within the uterus by an implanted device, in guinea pigs at doses of approximately one-half the human oral dose and in rhesus monkeys at doses approximately the human dose, all based on body surface area, and have revealed little or no evidence of impaired fertility or harm to the fetus due to progesterone.
🧒 Pediatric Use ▾
G. Pediatric Use Progesterone capsules are not indicated in children. Clinical studies have not been conducted in the pediatric population.
🧓 Geriatric Use ▾
H. Geriatric Use There have not been sufficient numbers of geriatric women involved in clinical studies utilizing progesterone capsules to determine whether those over 65 years of age differ from younger subjects in their response to progesterone capsules. The Women’s Health Initiative Study In the Women’s Health Initiative (WHI) estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age.
(See CLINICAL STUDIES and WARNINGS , Cardiovascular disorders and Malignant neoplasms .) The Women’s Health Initiative Memory Study In the Women’s Health Initiative Memory Study (WHIMS) of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in the estrogen plus progestin ancillary study when compared to placebo. (See CLINICAL STUDIES and WARNINGS , Probable dementia .)
🆘 Overdosage ▾
OVERDOSAGE No studies on overdosage have been conducted in humans. In the case of overdosage, progesterone capsules should be discontinued and the patient should be treated symptomatically.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Progesterone capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization. Pharmacokinetics A.
Absorption After oral administration of progesterone as a micronized soft-gelatin capsule formulation, maximum serum concentrations were attained within 3 hours. The absolute bioavailability of micronized progesterone is not known. Table 1 summarizes the mean pharmacokinetic parameters in postmenopausal women after five oral daily doses of progesterone capsules 100 mg as a micronized soft-gelatin capsule formulation.
TABLE 1. Pharmacokinetic Parameters of Progesterone Capsules 1. Mean ± S.D.
Parameter Progesterone Capsules Daily Dose 100 mg 200 mg 300 mg C max (ng/mL) 17.3 ± 21.9 1 38.1 ± 37.8 60.6 ±
72.5T max (hr) 1.5 ± 0.8 2.3 ± 1.4 1.7 ±
0.6AUC (0-10) (ng × hr/mL) 43.3 ± 30.8 101.2 ± 66.0 175.7 ± 170.3 Serum progesterone concentrations appeared linear and dose proportional following multiple dose administration of progesterone capsules 100 mg over the dose range 100 mg per day to 300 mg per day in postmenopausal women. Although doses greater than 300 mg per day were not studied in females, serum concentrations from a study in male volunteers appeared linear and dose proportional between 100 mg per day and 400 mg per day. The pharmacokinetic parameters in male volunteers were generally consistent with those seen in postmenopausal women.
B. Distribution Progesterone is approximately 96 percent to 99 percent bound to serum proteins, primarily to serum albumin (50 to 54 percent) and transcortin (43 to 48 percent). C.
Metabolism Progesterone is metabolized primarily by the liver largely to pregnanediols and pregnanolones. Pregnanediols and pregnanolones are conjugated in the liver to glucuronide and sulfate metabolites. Progesterone metabolites which are excreted in the bile may be deconjugated and may be further metabolized in the intestine via reduction, dehydroxylation, and epimerization.
D. Excretion The glucuronide and sulfate conjugates of pregnanediol and pregnanolone are excreted in the bile and urine. Progesterone metabolites are eliminated mainly by the kidneys.
Progesterone metabolites which are excreted in the bile may undergo enterohepatic recycling or may be excreted in the feces. E. Special Populations The pharmacokinetics of progesterone capsules have not been assessed in low body weight or obese patients.
Hepatic Insufficiency: The effect of hepatic impairment on the pharmacokinetics of progesterone capsules has not been studied. Renal Insufficiency: The effect of renal impairment on the pharmacokinetics of progesterone capsules has not been studied. F.
Food–Drug Interaction Concomitant food ingestion increased the bioavailability of progesterone capsules relative to a fasting state when administered to postmenopausal women at a dose of 200 mg. G. Drug Interactions The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (IC 50 < 0.1 µM).
Ketoconazole is a known inhibitor of cytochrome P450 3A4, hence 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. Coadministration of conjugated estrogens and progesterone capsules to 29 postmenopausal women over a 12-day period resulted in an increase in total estrone concentrations (C max 3.68 ng/mL to 4.93 ng/mL) and total equilin concentrations (C max 2.27 ng/mL to 3.22 ng/mL) and a decrease in circulating 17 estradiol concentrations (C max 0.037 ng/mL to 0.030 ng/mL).
The half-life of the conjugated estrogens was similar with coadministration of progesterone capsules. Table 2 summarizes the pharmacokinetic parameters. TABLE 2.
Mean (± S.D.) Pharmacokinetic Parameters for Estradiol, Estrone, and Equilin Following Coadministration of Conjugated Estrogens 0…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Progesterone Capsules 100 mg are white to off white, round shaped soft gelatin capsules imprinted with “P1” using black ink and containing white to off white suspension. Bottles of 100 NDC 72603-974-01 Progesterone Capsules 200 mg are white to off white, oval shaped soft gelatin capsules imprinted with “P2” using black ink and containing white to off white suspension. Bottles of 100 NDC 72603-975-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from excessive moisture. Dispense in tight, light-resistant container as defined in USP/NF, accompanied by a Patient Insert. Keep out of reach of children.
Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Eugia Pharma Specialities Limited Medchal-Malkajgiri District - 500101 India Issued: June 2026
📋 Description ▾
DESCRIPTION Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C 21 H 30 O 2 . Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, crystalline powder or colorless crystals practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, melting between 126º and 131ºC.
The structural formula is: Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain 100 mg or 200 mg micronized progesterone USP.
The inactive ingredients for progesterone capsules include: gelatin, glycerin, hypromellose, iron oxide black, lecithin, peanut oil, propylene glycol, titanium dioxide. chemical-structure
💬 Information for Patients ▾
B. Patient Information General: This product contains peanut oil and should not be used if you are allergic to peanuts. Physicians are advised to discuss the contents of the Patient Information leaflet with patients for whom they prescribe progesterone capsules.