Progesterone vaginal insert 100 mg Insert, 21-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
Vaginal progesterone is used as part of assisted reproductive technology (ART; fertility treatment) in women experiencing infertility (not getting pregnant despite having carefully timed, unprotected sex). Vaginal progesterone is also used to bring on menstruation (periods) in women of childbearing age experiencing absence of menstruation who have had normal periods and then stopped. Progesterone is in a class of medications called progestins (female hormones). It works as a part of ART by increase embryo implantation and decrease the risk of miscarriage. It works to bring on menstruation by...
Read the full MedlinePlus article ↗- 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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Adipic acid is an organic compound used in medicines as a buffer and pH regulator. It helps maintain the proper acidity level in the product to keep it stable and improve how the body absorbs the active ingredient.
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Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
8 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $11.981 | $251.60 / 21 insert |
| Medicaid paysCMS SDUD · 12 mo | $12.07 | $253.50 / 21 insert |
| 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 Vaginal Inserts 100 mg 68462-0175-33 | Glenmark | 21 inserts | $11.981 | AB | Availability likely | — |
| Progesterone 100 mg 70095-0136-03 | Sun | 21 inserts | $11.981 | AB | Availability likely | — |
| Progesterone vaginal insert 100 mgthis 70700-0201-70 | XIROMED, | 21 inserts | $11.981 | AB | Availability likely | — |
| Endometrin 100 mg 55566-6500-03 | Ferring | 21 inserts | $15.152 | AB | Availability likely | +26% |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Code | What it grants | Expires |
|---|---|---|
| CGT | FDA-granted marketing exclusivity | Mar 22, 2026 |
Is there a generic version of PROGESTERONE 100 MG VAG INSERT?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
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What does a patent or protection date mean here?
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70700-0201-70 You're viewing this | 1 CARTON in 1 CARTON (70700-201-70) / 21 BLISTER PACK in 1 CARTON (70700-201-69) / 1 INSERT in 1 BLISTER PACK (70700-201-68) | 2025-09-23 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women. Progesterone vaginal insert is a progesterone indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The dose of progesterone vaginal insert is 100 mg administered vaginally two or three times daily starting the day after oocyte retrieval and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose of progesterone vaginal insert in this age group has not been determined. ( 2.1 )
2.1General Dosing Information The dose of progesterone vaginal insert is 100 mg administered vaginally two or three times daily starting the day after oocyte retrieval and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose of progesterone vaginal insert in this age group has not been determined.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 100 mg progesterone vaginal insert is a yellowish-white oblong-shaped tablet debossed with "201" on one side and "XI" on the other side. 100 mg vaginal insert ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Progesterone vaginal insert should not be used in individuals with any of the following conditions: Previous allergic reactions to progesterone or any of the ingredients of progesterone vaginal insert [ see Description (11) ] Known missed abortion or ectopic pregnancy Liver disease Known or suspected breast cancer Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events Previous allergic reactions to progesterone or any of the ingredients of progesterone vaginal insert ( 4 ) Known missed abortion or ectopic pregnancy ( 4 ) Liver disease ( 4 ) Known or suspected breast cancer ( 4 ) Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Life-threatening arterial or venous thromboembolic disorders may occur during hormone treatment, including treatment with progesterone vaginal insert. Discontinue progesterone vaginal insert if any of these are suspected. ( 5.1 ) Observe patients with a history of depression closely.
Consider discontinuation if symptoms worsen. ( 5.2 ) Progesterone vaginal insert is not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert. ( 5.3 )
5.1Cardiovascular or Cerebrovascular Disorders The physician should be alert to earliest signs of myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis. Progesterone vaginal insert should be discontinued if any of these are suspected.
5.2Depression Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.
5.3Use of Other Vaginal Products Progesterone vaginal insert is not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert [ see Drug Interactions (7) ].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions reported (greater than 2%) were post-oocyte retrieval pain, abdominal pain, nausea, and ovarian hyperstimulation syndrome. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC at 1-844-XIROMED (1-844-947-6633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Studies Experience 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. The safety data reflect exposure to progesterone vaginal insert in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5% Asian, and 4.6% Other) in a single Assisted Reproductive Technology 10 week clinical study conducted in the U.S.
Progesterone vaginal insert was studied at doses of 100 mg twice daily and 100 mg three times daily. The adverse reactions that occurred at a rate greater than or equal to 2% in either progesterone vaginal insert group are summarized in Table 1. Table 1: Number and Frequency of Reported Adverse Reactions in Women Treated with Progesterone Vaginal Insert in an Assisted Reproductive Technology Study Body System Progesterone vaginal insert 100 mg twice daily (N=404) Progesterone vaginal insert 100 mg three times daily (N=404) Preferred Term Gastrointestinal Disorders Abdominal pain 50 (12%) 50 (12%) Nausea 32 (8%) 29 (7%) Abdominal distension 18 (4%) 17 (4%) Constipation 9 (2%) 14 (3%) Vomiting 13 (3%) 9 (2%) General Disorders and Administration Site Conditions Fatigue 7 (2%) 12 (3%) Infections and Infestations Urinary tract infection 9 (2%) 4 (1%) Injury, Poisoning and Procedural Complications Post-oocyte retrieval pain 115 (28%) 102 (25%) Nervous System Disorders Headache 15 (4%) 13 (3%) Reproductive System and Breast Disorders Ovarian hyperstimulation syndrome 30 (7%) 27 (7%) Uterine spasm 15 (4%) 11 (3%) Vaginal bleeding 13 (3%) 14 (3%) Other less common reported adverse reactions included vaginal irritation, itching, burning, discomfort, urticaria, and peripheral edema.
6.2Expected Adverse Reaction Profile Seen with Progesterone Progesterone vaginal insert is also expected to have adverse reactions similar to other drugs containing progesterone that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No formal drug-drug interaction studies have been conducted for progesterone vaginal insert. Drugs known to induce the hepatic cytochrome-P450-3A4 system (such as rifampin, carbamazepine) may increase the elimination of progesterone. The effect of concomitant vaginal products on the exposure of progesterone from progesterone vaginal insert has not been assessed.
Progesterone vaginal insert is not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert [ see Warnings and Precautions (5.3) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Progesterone vaginal insert has been used to support embryo implantation and maintain clinical pregnancy in one clinical study. The live birth outcomes of these pregnancies were as follows: Among the 404 subjects treated with progesterone vaginal insert twice daily, 143 subjects had live births consisting of 85 singletons, 56 twins, and 2 triplets. In this treatment group, 13 subjects had a spontaneous abortion, 1 subject had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.4% based on 203 livebirths).
Among the 404 subjects treated with progesterone vaginal insert three times daily, 155 subjects had livebirths consisting of 91 singletons, 60 twins, and 4 triplets. In this treatment group, 22 subjects had a spontaneous abortion, 4 subjects had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.1% based on 223 livebirths). Birth defects reported in the progesterone vaginal insert twice daily group included: one fetus with a cleft palate and intrauterine growth retardation, one fetus with spina bifida, three fetuses with congenital heart defects, one fetus with an umbilical hernia, and one fetus with an intestinal anomaly.
Birth defects reported in the progesterone vaginal insert three times daily group included: one fetus with an esophageal fistula, one fetus with hypospadias and an underdeveloped right ear, one fetus with Down Syndrome and an atrial septal defect, one fetus with congenital heart anomalies, one fetus with DiGeorge's syndrome, one fetus with a hand deformity, and one fetus with cleft palate. For additional information on the pharmacology of progesterone vaginal insert and pregnancy outcome information [ see Clinical Pharmacology (12) and Clinical Studies Sections (14) ].
8.3Nursing Mothers Detectable amounts of progesterone have been identified in the milk of nursing mothers. The effect of this on the nursing infant has not been determined.
8.4Pediatric Use This drug is not intended for pediatric use and no clinical data have been collected in children. Therefore, the safety and effectiveness of progesterone vaginal insert in pediatric patients have not been established.
8.5Geriatric Use No clinical data have been collected in patients over age 65.
🤰 Pregnancy ▾
8.1Pregnancy Progesterone vaginal insert has been used to support embryo implantation and maintain clinical pregnancy in one clinical study. The live birth outcomes of these pregnancies were as follows: Among the 404 subjects treated with progesterone vaginal insert twice daily, 143 subjects had live births consisting of 85 singletons, 56 twins, and 2 triplets. In this treatment group, 13 subjects had a spontaneous abortion, 1 subject had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.4% based on 203 livebirths).
Among the 404 subjects treated with progesterone vaginal insert three times daily, 155 subjects had livebirths consisting of 91 singletons, 60 twins, and 4 triplets. In this treatment group, 22 subjects had a spontaneous abortion, 4 subjects had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.1% based on 223 livebirths). Birth defects reported in the progesterone vaginal insert twice daily group included: one fetus with a cleft palate and intrauterine growth retardation, one fetus with spina bifida, three fetuses with congenital heart defects, one fetus with an umbilical hernia, and one fetus with an intestinal anomaly.
Birth defects reported in the progesterone vaginal insert three times daily group included: one fetus with an esophageal fistula, one fetus with hypospadias and an underdeveloped right ear, one fetus with Down Syndrome and an atrial septal defect, one fetus with congenital heart anomalies, one fetus with DiGeorge's syndrome, one fetus with a hand deformity, and one fetus with cleft palate. For additional information on the pharmacology of progesterone vaginal insert and pregnancy outcome information [ see Clinical Pharmacology (12) and Clinical Studies Sections (14) ].
🧒 Pediatric Use ▾
8.4Pediatric Use This drug is not intended for pediatric use and no clinical data have been collected in children. Therefore, the safety and effectiveness of progesterone vaginal insert in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No clinical data have been collected in patients over age 65.
🆘 Overdosage ▾
10 OVERDOSAGE Treatment of overdosage consists of discontinuation of progesterone vaginal insert together with institution of appropriate symptomatic and supportive care.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain a pregnancy.
12.3Pharmacokinetics Absorption Progesterone serum concentrations increased following the administration of the progesterone vaginal insert in 12 healthy pre-menopausal females. On single dosing, the mean C max was 17.0 ng/mL in the progesterone vaginal insert twice daily group and 19.8 ng/mL in the progesterone vaginal insert three times daily group. On multiple dosing, steady-state concentrations were attained within approximately 1 day after initiation of treatment with progesterone vaginal insert.
Both progesterone vaginal insert regimens provided average serum concentrations of progesterone exceeding 10 ng/mL on Day 5. The pharmacokinetic results are summarized in Table 2. Table 2: Mean (±Standard Deviation) Serum Progesterone Pharmacokinetic Parameters Pharmacokinetic Parameter (unit) Progesterone vaginal insert 100 mg twice daily (N=6) Progesterone vaginal insert 100 mg three times daily (N=6) Single Dosing C max (ng/mL) 17.0 ± 6.5 19.8 ±
7.2T max (hr) 24.0 ± 0.0 17.3 ±
7.4AUC 0-24 (ng∙hr/mL) 217 ± 113 284 ± 143 Day 5 of Multiple Dosing C max (ng/mL) 18.5 ± 5.5 24.1 ±
5.6T max (hr) 18.0 ± 9.4 18.0 ±
9.4C min (ng/mL) 8.9 ± 4.5 10.9 ±
6.7C avg (ng/ml) 14.0 ± 4.8 15.9 ±
4.3AUC 0-24 (ng∙hr/mL) 327 ± 127 436 ± 106 C max Maximum progesterone serum concentration. T max Time to maximum progesterone serum concentration. C avg Average progesterone serum concentration.
AUC 0-24 Area under the drug concentration versus time curve from 0 to 24 hours post dose. C min Minimum progesterone serum concentration. Distribution Progesterone is approximately 96% to 99% bound to serum proteins, primarily to serum albumin and corticosteroid binding globulin.
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 that are excreted in the bile may be deconjugated and may be further metabolized in the gut via reduction, dehydroxylation, and epimerization.
Excretion Progesterone undergoes renal and biliary elimination. Following injection of labeled progesterone, 50 to 60% of the excretion of metabolites occurs via the kidney; approximately 10% occurs via the bile and feces. Overall recovery of the labeled material accounts for 70% of an administered dose.
Only a small portion of unchanged progesterone is excreted in the bile .
🧬 Mechanism of Action ▾
12.1Mechanism of Action Progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain a pregnancy.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each progesterone vaginal insert is a yellowish-white oblong-shaped insert debossed with "201" on one side and "XI" on the other side. Each progesterone vaginal insert, 100 mg, is packed individually in a sealed foil pouch. These pouches are available in cartons packed: 21 vaginal inserts with 21 disposable vaginal applicators (NDC 70700-201-70) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Progesterone vaginal insert contains micronized progesterone. Progesterone vaginal insert is supplied with polyethylene vaginal applicators. The active ingredient, progesterone, is present in 100 mg amount along with other excipients.
The chemical name for progesterone is pregn-4-ene-3,20-dione. It has a molecular formula of C 21 H 30 O 2 and a molecular weight of 314.5. Progesterone exists in two polymorphic forms.
The form used in progesterone vaginal insert, the alpha-form, has a melting point of 127 to 131°C. The structural formula is: Each progesterone vaginal insert delivers 100 mg of progesterone in a base containing adipic acid, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, polyvinylpyrrolidone, pregelatinized starch, sodium bicarbonate, and sodium lauryl sulfate. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (17.4) .
17.1Vaginal Bleeding Inform patients of the importance of reporting irregular vaginal bleeding to their doctor as soon as possible.
17.2Common Adverse Reactions with Progesterone Inform patients of the possible side effects of progesterone therapy such as headaches, breast tenderness, bloating, mood swings, irritability, and drowsiness.
17.3Coadministration of Vaginal Products Inform patients that progesterone vaginal insert is not recommended for use with other vaginal products.