HomeNDC LookupIngredientsProgesterone › 70700-0163-01
Progesterone 200 mg Capsule, 100-count — NDC 70700-0163-01 package photo

Progesterone 200 mg Capsule, 100-count

by Xiromed, LLC · 100 CAPSULE in 1 BOTTLE (70700-163-01)
NDC 70700-0163-01
🏷️ FDA NDC (as labeled) 70700-163-01 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 →
⚠️
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) 70700-163-01
Product NDC 70700-163
11-digit billing NDC 70700016301
NCPDP billing unit EA — each (per item)
RxCUI 260243, 312641
UNII 4G7DS2Q64Y
UPC 0370700162019
Application # ANDA205229
SPL Set ID 0bf317a8-96d6-849d-7850-9084205a5315
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 2021-01-08
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 70700-163-01 — 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 → 70700-0163-01. 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

LabelerXiromed, LLC
Application holderXIROMED PHARMA ESPANA SL
FDA applicationANDA205229 (ANDA)
Labeler code70700
First marketedJan 2021
Product typeHuman Prescription Drug
Portfolio42 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.

💊 What it looks like

Color White
ShapeOval
ImprintPR2
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 5TL50QU0W4
    Peanut oil is a plant-based oil extracted from peanuts. It's used in medicines as a solvent and carrier to dissolve or suspend active ingredients, making them easier to deliver and absorb in the body.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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

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 eaPer package
Retail pharmacies payNADAC · weekly $0.417 $41.70 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.6394 $63.94 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $0.5983 $59.83 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.505 $0.398
▼ Down 13% over the last 24 months.
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 $0.417 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 65162-0808-10 Amneal 100 capsules $0.417 AB Availability likely
Progesterone 200 mg 69452-0234-20 Bionpharma 100 capsules $0.417 AB Availability likely
Progesterone 200 mgthis 70700-0163-01 Xiromed, 100 capsules $0.417 AB Availability likely
Progesterone 200 mg 43598-0350-01 Dr. 100 capsules $0.425 AB FDA listed +2%
Prometrium 200 mg 72989-0373-30 Acertis 30 capsules $30.417 AB Availability likely +7194%
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 mg 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

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70700-0163-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
113.4K
Units reimbursed last 4 qtrs
4.6M
Gross reimbursed last 4 qtrs
$2.97M
Avg / prescription
$26.18
Avg / unit
$0.6394
Latest quarter Q4 2025
26.6KRx
Medicaid pays / ea
$0.6394
gross reimbursed
vs
NADAC / ea
$0.4170
acquisition cost
=
Spread
+$0.2224
+53% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
37% FFS 63% MCO
Fee-for-service · 42,507 Rx Managed care · 70,871 Rx
State Medicaid map
Alaska: 18,684 units · 2,549 per 100k residents AK Maine: 28,588 units · 2,049 per 100k residents ME Washington: 233,167 units · 2,985 per 100k residents WA Idaho: 35,574 units · 1,811 per 100k residents ID Montana: 17,750 units · 1,568 per 100k residents MT North Dakota: 1,098 units · 140 per 100k residents ND Minnesota: 168,780 units · 2,942 per 100k residents MN Wisconsin: 86,528 units · 1,464 per 100k residents WI Michigan: 167,496 units · 1,669 per 100k residents MI New York: 146,604 units · 749 per 100k residents NY Vermont: 29,039 units · 4,488 per 100k residents VT New Hampshire: 16,182 units · 1,154 per 100k residents NH Oregon: 218,537 units · 5,163 per 100k residents OR Nevada: 30,637 units · 959 per 100k residents NV Wyoming: 7,121 units · 1,219 per 100k residents WY South Dakota: 3,898 units · 424 per 100k residents SD Iowa: 9,855 units · 307 per 100k residents IA Illinois: 134,396 units · 1,071 per 100k residents IL Indiana: 80,340 units · 1,171 per 100k residents IN Ohio: 180,780 units · 1,534 per 100k residents OH Pennsylvania: 72,885 units · 562 per 100k residents PA New Jersey: 41,754 units · 449 per 100k residents NJ Massachusetts: 202,754 units · 2,896 per 100k residents MA California: 423,527 units · 1,087 per 100k residents CA Utah: 72,198 units · 2,113 per 100k residents UT Colorado: 302,735 units · 5,150 per 100k residents CO Nebraska: 28,645 units · 1,448 per 100k residents NE Missouri: 95,130 units · 1,535 per 100k residents MO Kentucky: 155,600 units · 3,438 per 100k residents KY West Virginia: 25,561 units · 1,444 per 100k residents WV Virginia: 168,978 units · 1,939 per 100k residents VA Maryland: 52,036 units · 842 per 100k residents MD Connecticut: 107,875 units · 2,982 per 100k residents CT Rhode Island: 26,428 units · 2,414 per 100k residents RI Arizona: 231,452 units · 3,115 per 100k residents AZ New Mexico: 122,223 units · 5,782 per 100k residents NM Kansas: 23,873 units · 812 per 100k residents KS Arkansas: 13,421 units · 438 per 100k residents AR Tennessee: 147,522 units · 2,070 per 100k residents TN North Carolina: 236,974 units · 2,187 per 100k residents NC South Carolina: 54,042 units · 1,006 per 100k residents SC Delaware: 15,967 units · 1,549 per 100k residents DE Oklahoma: 65,217 units · 1,609 per 100k residents OK Louisiana: 99,458 units · 2,174 per 100k residents LA Mississippi: 11,979 units · 407 per 100k residents MS Alabama: 13,436 units · 263 per 100k residents AL Georgia: 57,302 units · 520 per 100k residents GA D.C.: 5,214 units · 768 per 100k residents DC Hawaii: 10,064 units · 701 per 100k residents HI Texas: 104,080 units · 341 per 100k residents TX Florida: 38,025 units · 168 per 100k residents FL
Units reimbursed · per 100k residents
1405,782
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Mexico 5,782 /100k
2 Oregon 5,163 /100k
3 Colorado 5,150 /100k
4 Vermont 4,488 /100k
5 Kentucky 3,438 /100k
6 Arizona 3,115 /100k
7 Washington 2,985 /100k
8 Connecticut 2,982 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PROGESTERONE — the ingredient across all brands.

Top reported reactions

Headache2,094
Fatigue1,795
Pain1,482
Nausea1,475
Rash984
Dizziness941
Foetal Exposure During Pregnancy899

Age at onset

Neonate238
Infant28
Child10
Adolescent22
Adult3,061
Elderly420

Reporter sex

22,803 reports
Male · 3%
Female · 96%
Unknown · 0%

Serious outcomes

Hospitalization3,651
Life-threatening440
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 2,311 1,358
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70700-0163-01 You're viewing this 100 CAPSULE in 1 BOTTLE (70700-163-01) 2021-01-08 Active

📄 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.
🎯 Indications and Usage 34 words

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 91 words

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 75 words

CONTRAINDICATIONS Progesterone capsules is contraindicated in women with any of the following conditions: Hypersensitivity to its ingredients. Progesterone capsules contain peanut oil and is contraindicated in patients allergic to peanuts. Abnormal genital bleeding of unknown etiology.

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.

⚠️ Warnings ~3 min read

WARNINGS 1. Cardiovascular disorders Progesterone capsules are contraindicated in females with active DVT, PE, arterial thromboembolic disease (e.g., stroke, MI) disease, or a history of these conditions (See CONTRAINDICATIONS ). Immediately discontinue progesterone capsules if a PE, DVT, stroke, or MI occurs or is suspected.

If feasible, discontinue progesterone capsules at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. The safety and efficacy of estrogen plus progestogen for the prevention of cardiovascular disorders has not been established. (See CLINICAL STUDIES ) The Women’s Health Initiative (WHI) estrogen plus progestin trial reported increased risks of PE, DVT, stroke, and MI in postmenopausal women (50 to 79 years of age, average age 63.4 years) 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.

Analyses were also conducted in women aged 50-59 years, a group of women more likely to present with new onset of moderate to severe VMS compared to women in other age groups in the trial. (See CLINICAL STUDIES. ) Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin trial of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known.

Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. a. Venous Thromboembolism In women aged 50 to 59 years, the WHI estrogen plus progestin trial reported a relative risk for PE of 2.05 (95% confidence interval [CI], 0.89, 4.71) for CE/MPA compared to placebo, with a risk difference of 6 per 10,000 women- years (WYs; 11 versus 5). The relative risk for DVT was 3.01 (95% CI, 1.36, 6.66) in those receiving CE/MPA compared to placebo, with a risk difference of 10 per 10,000 WYs (15 versus 5).

(See CLINICAL STUDIES ). In the overall study population of women aged 50 to 79 years (average 63.4 years), the trial reported a relative risk for PE of 1.98 (95% CI, 1.36, 2.87) for CE/MPA compared to placebo, with a risk difference of 9 per 10,000 WYs (18 versus 9). The relative risk for DVT was 1.87 (95% CI, 1.37, 2.54) for CE/MPA compared to placebo, with a risk difference of 12 per 10,000 WYs (25 versus 14).

(See CLINICAL STUDIES ). b. Stroke In women aged 50 to 59 years, the WHI estrogen plus progestin trial reported a relative risk for stroke of 1.51 (95% CI, 0.81, 2.82) for CE/MPA compared to placebo, with a risk difference of 5 per 10,000 WYs (15 versus 10). (See CLINICAL STUDIES ).

In the overall study population of women aged 50 to 79 years (average 63.4 years), the WHI estrogen plus progestin trial reported relative risk for stroke of 1.37 (95% CI, 1.07, 1.76) for CE/MPA compared to placebo, with a risk difference of 9 per 10,000 WYs (33 versus 24). (See CLINICAL STUDIES ). c. Coronary Heart Disease In women 50 to 59 years of age, the WHI estrogen plus progestin trial reported a relative risk for coronary heart disease (CHD) events (defined as nonfatal MI, silent MI, or CHD death) of 1.34 (95% CI, 0.82, 2.19) for CE/MPA compared placebo, with a risk difference of 5 per 10,000 WYs (23 versus 17).

In the overall study population of women aged 50 to 79 years (average 63.4 years), the trial reported a relative risk of CHD of 1.18 (95% CI, 0.95, 1.45) for CE/MPA compared to placebo, with a risk difference of 6 per 10,000 WYs (41 versus 35). (See CLINICAL STUDIES ). In the Heart and Estrogen/Progestin Replacement Study (HERS) and open label extension (HERS II), postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years) received daily CE (0.625 mg) plus MPA or placebo.

In Year 1, there were more CHD event…

🤒 Adverse Reactions ~3 min read

ADVERSE REACTIONS 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 progesterone 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 progesterone 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] 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 8 lists adverse reactions greater than or equal to 5 percent of women who received progesterone capsules or placebo. TABLE 8. 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. Eyes: blurred v…

🔄 Drug / Laboratory Test Interactions 57 words

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 105 words

E. Pregnancy Progesterone capsules should not be used during pregnancy. 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 20 words

G. Pediatric Use Progesterone capsules are not indicated in children. Clinical studies have not been conducted in the pediatric population.

🧓 Geriatric Use 143 words

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 .)

🆘 Overdosage 27 words

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 ~3 min read

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 Parameter Progesterone Capsules Daily Dose 100 mg 200 mg 300 mg C max (ng/mL) 17.3 ± 21.9 a 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 a Mean ± S.D. 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 17β 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 68 words

HOW SUPPLIED 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 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. Keep out of reach of children.

📦 Storage and Handling 32 words

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. Keep out of reach of children.

📋 Description 126 words

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, 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: Progesterone is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Each progesterone capsule for oral administration contains 100 mg or 200 mg of micronized progesterone and the following inactive ingredients: peanut oil, gelatin, glycerin, soya lecithin, titanium dioxide, and triglycerides medium chain.

Chemical Structure

💬 Information for Patients 40 words

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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.