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PROGESTERONE 200 mg Capsule, 90-count

by Direct Rx · 90 CAPSULE in 1 BOTTLE (72189-347-90)
NDC 72189-0347-90
🏷️ FDA NDC (as labeled) 72189-347-90 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Progesterone (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 27, 2024 — Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. (Eugia US LLC) · FDA recall D-0186-2025
Class II · Jul 26, 2024 — Presence of Particulate Matter: Complaint received of a glass particle in the vial. (Eugia US LLC) · FDA recall D-0624-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 72189-347-90
Product NDC 72189-347
11-digit billing NDC 72189034790
NCPDP billing unit EA — each (per item)
RxCUI 312641
UNII 4G7DS2Q64Y
Application # ANDA205229
SPL Set ID dc9e2088-e11e-7d32-e053-2a95a90a2995
Established class (EPC) Progesterone
Chemical class Progesterone
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-04-14
Route ORAL
Dosage form CAPSULE
Substance PROGESTERONE
GPI-14 26000040000140
GPI class Progesterone
GCN Seq No 043802
GCN 50786
HICL code 020653
Ingredient (HICL) Progesterone, Micronized
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G2
Therapeutic class — intermediate (HIC2) Progestogens
HIC3 code G2A
Therapeutic class — specific (HIC3) Progestational Agents
AHFS code 68:32.00.00
AHFS class Progestins
FDB label name PROGESTERONE 200 MG CAPSULE
FDB brand name Progesterone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72189-347-90 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72189-0347-90. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Progesterone class.

Pharmacologic class Progesterone
Drug family (ATC) Pregnen (4) derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerDirect Rx
Application holderXIROMED PHARMA ESPANA SL
FDA applicationANDA205229 (ANDA)
Labeler code72189
First marketedApr 2022
Product typeHuman Prescription Drug
Portfolio204 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PROGESTERONE 200 MG CAPSULE Ingredient Progesterone, Micronized
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Progesterone guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer 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 · Q2 2026 $0.4025 $36.23 / 90 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Progesterone 200 mg 00054-0830-25 Hikma 100 capsules $0.404 AB Availability likely —
Progesterone 200 mg 16714-0158-01 Northstar 100 capsules $0.404 AB Availability likely —
Progesterone 200 mg 59651-0153-01 Aurobindo 100 capsules $0.404 AB Availability likely —
Progesterone 200 mg 65162-0808-10 Amneal 100 capsules $0.404 AB Availability likely —
Progesterone 200 mg 69452-0234-20 Bionpharma 100 capsules $0.404 AB Availability likely —
Progesterone 200 mg 70700-0163-01 Xiromed, 100 capsules $0.404 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 $30.395 AB Availability likely —
Progesterone 200 mg 42291-0785-01 AvKARE 100 capsules — AB FDA listed —
Progesterone 200 mg 51407-0981-01 Golden 100 capsules — AB FDA listed —
Progesterone 200 mg 68071-3529-03 NuCare 30 capsules — AB FDA listed —
Progesterone 200 mg 68071-3953-08 NuCare 180 capsules — AB FDA listed —
Progesterone 200 mg 68788-4015-03 Preferred 30 capsules — AB FDA listed —
Progesterone 200 mg 68788-8295-03 Preferred 30 capsules — AB Discontinued —
Progesterone 200 mg 68788-8719-03 Preferred 30 capsules — AB FDA listed —
Progesterone 200 mg 69452-0149-20 Bionpharma 100 capsules — AB FDA listed —
Progesterone 200 mg 71205-0669-30 Proficient 30 capsules — AB FDA listed —
Progesterone 200 mg 71205-0903-11 Proficient 1000 capsules — AB FDA listed —
Progesterone 200 mg 71335-1406-01 Bryant 30 capsules — AB FDA listed —
Progesterone 200 mg 71335-1990-01 Bryant 30 capsules — AB FDA listed —
Progesterone 200 mg 71335-2242-01 Bryant 30 capsules — AB FDA listed —
Progesterone 200 mg 72189-0217-90 direct 90 capsules — AB FDA listed —
Progesterone 200 mgthis 72189-0347-90 Direct 90 capsules — AB FDA listed —
Progesterone 200 mg 73190-0065-01 AvKARE 100 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 76420-0580-10 Asclemed 100 capsules — AB FDA listed —
Progesterone 200 mg 82804-0268-30 Proficient 30 capsules — AB FDA listed —
Progesterone 200 mg 71335-1432-01 Bryant 30 capsules — AB Discontinued —
Progesterone 200 mg 72603-0975-01 NorthStar 100 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
On the market since
Apr 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Progesterone — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Progesterone. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$9.63M
Claims incl. refills
283.5K
Beneficiaries
217.7K
Spend / beneficiary
$44.23
Spend / claim
$33.97
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72189-0347-90 You're viewing this 90 CAPSULE in 1 BOTTLE (72189-347-90) 2022-04-14 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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 — Not published for this NDC No photo available yet for this listing.
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72189-347-90, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72189-0347-90, written without dashes as 72189034790. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72189-0347-90, the first segment (72189) is the labeler code FDA assigned to Direct Rx; the middle segment (0347) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Direct Rx. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Direct Rx is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
⏱️ Dosage and Administration 88 words ▾

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 97 words ▾

Progesterone capsules should not be used in women with any of the following conditions: 1. 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.

2. Undiagnosed abnormal genital bleeding. 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. 7. Known or suspected pregnancy.

⚠️ Warnings ~3 min read ▾

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 most important randomized clinical trial providing information about breast cancer in estrogen plus progestin users is the Women's Health Initiative (WHI) substudy of daily CE (0.625 mg) plus MPA (2.5 mg).

After a mean follow-up of 5.6 years, the estrogen plus progestin substudy reported an increased risk of invasive breast cancer in women who took daily CE plus MP…

🆘 Overdosage 26 words ▾

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 ~3 min read ▾

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 Parameter Progesterone Capsules Daily Dose 100 mg 200 mg 300 mg * Mean ± S.D. Cmax (ng/mL) 17.3 ± 21.9* 38.1 ± 37.8 60.6 ±

72.5Tmax (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 (IC50 < 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 (Cmax 3.68 ng/mL to 4.93 ng/mL) and total equilin concentrations (Cmax 2.27 ng/mL to 3.22 ng/mL) and a decrease in circulating 17β estradiol concentrations (Cmax 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 0.625 mg and Progesterone Caps…

📦 How Supplied / Storage and Handling 76 words ▾

Progesterone capsules, 100 mg are off-white, ovoid, capsules with "PR1" marked. NDC 70700-162-01, Bottle of 100 capsules Progesterone capsules, 200 mg are off-white, ovoid, capsules with "PR2" marked. NDC 70700-163-01, Bottle of 100 capsules Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°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.

📋 Description 125 words ▾

Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C.

The structural formula is: [Chemical Structure] 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 and the following inactive ingredients: peanut oil, gelatin, glycerin, soya lecithin, titanium dioxide, and triglyderides medium chain.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72189-0346-90 · Direct 72189-0348-30 · DirectRx →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.