Intrarosa Prasterone 6.5 mg Insert, 14-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Androstan derivatives class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Vaginal prasterone is used to treat changes in and around the vagina due to menopause ("change of life," the end of monthly menstrual periods) that can cause painful sexual intercourse. Prasterone is in a class of medications called steroids. It works by replacing hormones that are normally produced in the body.
Read the full MedlinePlus article ↗- Intrarosa is used to treat moderate to severe pain during sex that's caused by vaginal and vulvar tissue changes that happen after menopause. Those changes — thinning, drying, and...
- It's pretty straightforward. You insert one vaginal insert once a day at bedtime, using the applicator that comes in the package. Bedtime is recommended so you can stay lying down...
- How do I use Intrarosa — is it complicated?
- The most common side effect is vaginal discharge — it was reported in a small percentage of women in clinical trials, so it's something to be aware of but not a cause for alarm in...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Prasterone (prescription drug) — tap one for details:
Prasterone (prescription drug) may be associated with lower levels of 5 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 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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UNII XDD37N2GPR
A fat derived from coconut oil that has been chemically treated to make it more stable. It works as a binder and lubricant to help hold the medicine together and improve how it flows during manufacturing.
1 inactive ingredient listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $11.01 | $154.17 / 14 insert |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Intrarosa 6.5 mg 72495-0401-28 | Millicent | 28 inserts | $10.984 | — | Availability likely | — |
| Intrarosa 6.5 mgthis 72495-0501-14 | Millicent | 14 inserts | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
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.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 8957054 ↗ | Method of use | U-1922 | Jan 8, 2030 |
| US 8268806 ↗ | Drug product | — | Mar 19, 2031 |
| US 8629129 ↗ | Drug product | — | Aug 7, 2028 |
Is there a generic version of this drug?
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Why do different websites show different generic release dates?
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What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
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Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72495-0501-14 You're viewing this | 1 BOX in 1 BOX (72495-501-14) / 14 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK | 2020-11-01 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer one INTRAROSA vaginal insert once daily at bedtime, using the provided applicator. One vaginal insert, once daily at bedtime. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Vaginal insert: 6.5 mg of prasterone, smooth, white to off-white solid fat bullet-shaped, measuring 28 mm in length, 9 mm in width at its wider end, and weighing 1.2 gram. Vaginal Insert: 6.5 mg of prasterone. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with INTRAROSA. Undiagnosed abnormal genital bleeding. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Current or Past History of Breast Cancer. ( 5.1 )
5.1Current or Past History of Breast Cancer Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.
5.1Current or Past History of Breast Cancer Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥ 2 percent was vaginal discharge. ( 6.1 ) In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥ 2 percent were vaginal discharge and abnormal Pap smear. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Millicent U.S.
Inc at 1-877-810-2101 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials 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. In four (4) placebo-controlled, 12-week clinical trials [91% - White Caucasian non-Hispanic women, 7% - Black or African American women, and 2% - "Other" women, average age 58.8 years of age (range 40 to 80 years of age)], vaginal discharge is the most frequently reported treatment-emergent adverse reaction in the INTRAROSA treatment group with an incidence of ≥ 2 percent and greater than reported in the placebo treatment group.
There were 38 cases in 665 participating postmenopausal women (5.71 percent) in the INTRAROSA treatment group compared to 17 cases in 464 participating postmenopausal women (3.66 percent) in the placebo treatment group. In a 52-week non-comparative clinical trial [92% - White Caucasian non-Hispanic women, 6% - Black or African American women, and 2% - "Other" women, average age 57.9 years of age (range 43 to 75 years of age)], vaginal discharge and abnormal Pap smear at 52 weeks were the most frequently reported treatment-emergent adverse reaction in women receiving INTRAROSA with an incidence of ≥ 2 percent.
There were 74 cases of vaginal discharge (14.2 percent) and 11 cases of abnormal Pap smear (2.1 percent) in 521 participating postmenopausal women. The eleven (11) cases of abnormal Pap smear at 52 weeks include one (1) case of low-grade squamous intraepithelial lesion (LSIL), and ten (10) cases of atypical cells of undetermined significance (ASCUS).
6.1Clinical Trials 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. In four (4) placebo-controlled, 12-week clinical trials [91% - White Caucasian non-Hispanic women, 7% - Black or African American women, and 2% - "Other" women, average age 58.8 years of age (range 40 to 80 years of age)], vaginal discharge is the most frequently reported treatment-emergent adverse reaction in the INTRAROSA treatment group with an incidence of ≥ 2 percent and greater than reported in the placebo treatment group.
There were 38 cases in 665 participating postmenopausal women (5.71 percent) in the INTRAROSA treatment group compared to 17 cases in 464 participating postmenopausal women (3.66 percent) in the placebo treatment group. In a 52-week non-comparative clinical trial [92% - White Caucasian non-Hispanic women, 6% - Black or African American women, and 2% - "Other" women, average age 57.9 years of age (range 43 to 75 years of age)], vaginal discharge and abnormal Pap smear at 52 weeks were the most frequently reported treatment-emergent adverse reaction in women receiving INTRAROSA with an incidence of ≥ 2 percent.
There were 74 cases of vaginal discharge (14.2 percent) and 11 cases of abnormal Pap smear (2.1 percent) in 521 participating postmenopausal women. The eleven (11) cases of abnormal Pap smear at 52 weeks include one (1) case of low-grade squamous intraepithelial lesion (LSIL), and ten (10) cases of atypical cells of undetermined significance (ASCUS).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary INTRAROSA is indicated only in postmenopausal women. There are no data with INTRAROSA use in pregnant women regarding any drug-associated risks. Animal reproduction studies have not been conducted with prasterone.
8.2Lactation Risk Summary INTRAROSA is indicated only in postmenopausal women. There is no information on the presence of prasterone in human milk, the effects on the breastfed infant, or the effects on milk production.
8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients.
8.5Geriatric Use Of the 1522 prasterone-treated postmenopausal women enrolled in the four placebo-controlled 12-week and one open-label 52-week clinical trial, 19 and 11 percent, respectively, were 65 years of age or older.
8.6Renal Impairment The effect of renal impairment on the pharmacokinetics of prasterone has not been studied.
8.7Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of prasterone has not been studied.
8.1Pregnancy Risk Summary INTRAROSA is indicated only in postmenopausal women. There are no data with INTRAROSA use in pregnant women regarding any drug-associated risks. Animal reproduction studies have not been conducted with prasterone.
8.2Lactation Risk Summary INTRAROSA is indicated only in postmenopausal women. There is no information on the presence of prasterone in human milk, the effects on the breastfed infant, or the effects on milk production.
8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients.
8.5Geriatric Use Of the 1522 prasterone-treated postmenopausal women enrolled in the four placebo-controlled 12-week and one open-label 52-week clinical trial, 19 and 11 percent, respectively, were 65 years of age or older.
8.6Renal Impairment The effect of renal impairment on the pharmacokinetics of prasterone has not been studied.
8.7Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of prasterone has not been studied.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Prasterone is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of INTRAROSA in postmenopausal women with vulvar and vaginal atrophy is not fully established.
12.3Pharmacokinetics In a study conducted in postmenopausal women, administration of the INTRAROSA vaginal insert once daily for 7 days resulted in a mean prasterone C max and area under the curve from 0 to 24 hours (AUC 0-24 ) at Day 7 of 4.4 ng/mL and 56.2 ng·h/mL, respectively, which were significantly higher than those in the group treated with placebo ( Table 1 ). The C max and AUC 0-24 of the metabolites testosterone and estradiol were also slightly higher in women treated with the INTRAROSA vaginal insert compared to those receiving placebo.
Table 1. C max and AUC 0-24 of Prasterone, Testosterone, and Estradiol on Day 7 Following Daily Administration of Placebo or INTRAROSA (mean ± SD). 1 : N=8 Placebo (N=9) INTRAROSA (N=10) Prasterone C max (ng/mL) 1.60 (±0.95) 4.42 (±1.49) AUC 0-24 (ng·h/mL) 24.82 (±14.31) 56.17 (±28.27) Testosterone C max (ng/mL) 0.12 (±0.04) 1 0.15 (±0.05) AUC 0-24 (ng·h/mL) 2.58 (±0.94) 1 2.79 (±0.94) Estradiol C max (pg/mL) 3.33 (±1.31) 5.04 (±2.68) AUC 0-24 (pg·h/mL) 66.49 (±20.70) 96.93 (±52.06) Figure 1.
Serum Concentrations of Prasterone (A), Testosterone (B), and Estradiol (C) Measured Over a 24h Period on Day 7 Following Daily Administration of Placebo or INTRAROSA (mean ± S.D.). In two primary efficacy trials, daily administration of INTRAROSA vaginal insert for 12 weeks increased mean serum C trough of prasterone and its metabolites testosterone and estradiol by 47%, 21% and 19% from baseline, respectively. This comparison based on C trough may underestimate the magnitude of increase in prasterone and metabolites’ exposure because it does not take into account the overall concentration-time profile following administration of INTRAROSA.
Metabolism Exogenous prasterone is metabolized in the same manner as endogenous prasterone. Human steroidogenic enzymes such as hydroxysteroid dehydrogenases, 5α-reductases and aromatases transform prasterone into androgens and estrogens. Figure 1
12.1Mechanism of Action Prasterone is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of INTRAROSA in postmenopausal women with vulvar and vaginal atrophy is not fully established.
12.3Pharmacokinetics In a study conducted in postmenopausal women, administration of the INTRAROSA vaginal insert once daily for 7 days resulted in a mean prasterone C max and area under the curve from 0 to 24 hours (AUC 0-24 ) at Day 7 of 4.4 ng/mL and 56.2 ng·h/mL, respectively, which were significantly higher than those in the group treated with placebo ( Table 1 ). The C max and AUC 0-24 of the metabolites testosterone and estradiol were also slightly higher in women treated with the INTRAROSA vaginal insert compared to those receiving placebo.
Table 1. C max and AUC 0-24 of Prasterone, Testosterone, and Estradiol on Day 7 Following Daily Administration of Placebo or INTRAROSA (mean ± SD). 1 : N=8 Placebo (N=9) INTRAROSA (N=10) Prasterone C max (ng/mL) 1.60 (±0.95) 4.42 (±1.49) AUC 0-24 (ng·h/mL) 24.82 (±14.31) 56.17 (±28.27) Testosterone C max (ng/mL) 0.12 (±0.04) 1 0.15 (±0.05) AUC 0-24 (ng·h/mL) 2.58 (±0.94) 1 2.79 (±0.94) Estradiol C max (pg/mL) 3.33 (±1.31) 5.04 (±2.68) AUC 0-24 (pg·h/mL) 66.49 (±20.70) 96.93 (±52.06) Figure 1.
Serum Concentrations of Prasterone (A), Testosterone (B), and Estradiol (C) Measured Over a 24h Period on Day 7 Following Daily Administration of Placebo or INTRAROSA (mean ± S.D.). In two primary efficacy trials, daily administration of INTRAROSA vaginal insert for 12 weeks increased mean serum C trough of prasterone and its metabolites testosterone and estradiol by 47%, 21% and 19% from baseline, respectively. This comparison based on C trough may underestimate the mag…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied INTRAROSA is supplied as white to off-white 1.3 mL solid fat bullet-shaped, smooth vaginal inserts (containing 6.5 mg of prasterone). INTRAROSA is available in small boxes of 4 blister packs containing 7 vaginal inserts (28 vaginal inserts per box). The small box (containing the vaginal inserts) is supplied inside a larger box containing 28 applicators (NDC 72495-401-28).
16.2Storage and Handling Store at 41°F to 86°F (5°C to 30°C). Can be stored at room temperature or in the refrigerator.
16.1How Supplied INTRAROSA is supplied as white to off-white 1.3 mL solid fat bullet-shaped, smooth vaginal inserts (containing 6.5 mg of prasterone). INTRAROSA is available in small boxes of 4 blister packs containing 7 vaginal inserts (28 vaginal inserts per box). The small box (containing the vaginal inserts) is supplied inside a larger box containing 28 applicators (NDC 72495-401-28).
📦 Storage and Handling ▾
16.2Storage and Handling Store at 41°F to 86°F (5°C to 30°C). Can be stored at room temperature or in the refrigerator.
📋 Description ▾
11 DESCRIPTION INTRAROSA (prasterone) vaginal insert is a vaginally administered steroid. Prasterone is identified chemically as 3β-hydroxyandrost-5-en-17-one. It has the empirical formula C 19 H 28 O 2 with a molecular weight of 288.424 g/mol.
Prasterone is a white to off-white crystalline powder insoluble in water and soluble in sodium lauryl sulfate (SLS). The structural formula is: Each INTRAROSA (prasterone) vaginal insert contains 6.5 mg of prasterone in 1.3 ml of off-white hard fat (Witepsol). Prasterone
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read FDA-approved patient labeling (Patient Information and Instructions for Use). Vaginal Discharge Inform postmenopausal women that vaginal discharge may occur with INTRAROSA [see Adverse Reactions ( 6.1 )]. Abnormal Pap Smear Findings Inform postmenopausal women that abnormal Pap smear findings may occur with INTRAROSA [see Adverse Reactions ( 6.1 )].
Manufactured for: Cosette Pharmaceuticals, Inc., Bridgewater, NJ 08807, USA Distributed by: Millicent U.S. Inc, East Hanover, NJ 07936