Crinone progesterone 45 mg/1.125g Gel, 6 applicators
Other active recalls for Progesterone (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Progesterone class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 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 ↗- During IVF, your ovaries may not produce enough progesterone on their own — especially after egg retrieval. Progesterone vaginal products step in to prepare your uterine lining so...
- What exactly is this medication doing for me during IVF?
- It's best to avoid other vaginal products — including antifungal creams — while using Endometrin or Crinone. Other vaginal products can interfere with how the progesterone is relea...
- Can I use my antifungal cream while I'm on this?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Progesterone — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 Z135WT9208
Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
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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.
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UNII 257THB963H
A solid fat made from palm oil that has been chemically processed to increase stability. It functions as a binder and lubricant in tablets and capsules to help hold ingredients together and improve how the medicine flows during manufacturing.
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UNII N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
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UNII W25LM17A4W
Polycarbophil is a synthetic polymer that absorbs water and swells. It's used as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the digestive system.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII X045WJ989B
Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 inactive ingredients 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
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $16.844 | $113.70 / 6.75 g |
| Medicaid paysCMS SDUD · 12 mo | $17.29 | $116.72 / 6.75 g |
| Medicare drug plans payPart D · Q2 2026 | $17.28 | $116.67 / 6.75 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Crinone 45 mg/1.125gthis 00023-6150-04 | Allergan, | 6 applicators | $16.844 | — | Availability likely | — |
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.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00023-6150-04 You're viewing this | 6 APPLICATOR in 1 CARTON (0023-6150-04) / 1.125 g in 1 APPLICATOR | 1997-05-13 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Assisted Reproductive Technology Crinone 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency. Secondary Amenorrhea Crinone 4% is indicated for the treatment of secondary amenorrhea. Crinone 8% is indicated for use in women who have failed to respond to treatment with Crinone 4%.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Assisted Reproductive Technology Crinone 8% is administered vaginally at a dose of 90 mg once daily in women who require progesterone supplementation. Crinone 8% is administered vaginally at a dose of 90 mg twice daily in women with partial or complete ovarian failure who require progesterone replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10 to 12 weeks.
Secondary Amenorrhea Crinone 4% is administered vaginally every other day up to a total of six doses. For women who fail to respond, a trial of Crinone 8% every other day up to a total of six doses may be instituted. It is important to note that a dosage increase from the 4% gel can only be accomplished by using the 8% gel.
Increasing the volume of gel administered does not increase the amount of progesterone absorbed.
⛔ Contraindications ▾
CONTRAINDICATIONS Crinone should not be used in individuals with any of the following conditions: Known sensitivity to Crinone (progesterone or any of the other ingredients) Undiagnosed vaginal bleeding Liver dysfunction or disease Known or suspected malignancy of the breast or genital organs Missed abortion Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders
⚠️ Warnings ▾
WARNINGS The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses.
No adequate evidence is available to show that they are effective for this purpose.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Assisted Reproductive Technology In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Crinone 8% twice daily, treatment-emergent adverse events occurring in 5% or more of the women are shown in Table 3. TABLE 3 Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Crinone 8% Twice Daily Study COL1620-007US (n = 61) Body as a Whole Bloating 7% Cramps NOS 15% Pain 8% Central and Peripheral Nervous System Dizziness 5% Headache 13% Gastro-Intestinal System Nausea 7% Reproductive, Female Breast Pain 13% Moniliasis Genital 5% Vaginal Discharge 7% Skin and Appendages Pruritus Genital 5% In a second clinical study of 139 women using Crinone 8% once daily for luteal phase support while undergoing an in vitro fertilization procedure, treatment-emergent adverse events reported in ≥ 5% of the women are shown in Table 4.
TABLE 4 Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Crinone 8% Once Daily Study COL1620-F01 (n = 139) Body as a Whole Abdominal Pain 12% Perineal Pain Female 17% Central and Peripheral Nervous System Headache 17% Gastro-Intestinal System Constipation 27% Diarrhea 8% Nausea 22% Vomiting 5% Musculo-Skeletal System Arthralgia 8% Psychiatric Depression 11% Libido Decreased 10% Nervousness 16% Somnolence 27% Reproductive, Female Breast Enlargement 40% Dyspareunia 6% Urinary System Nocturia 13% Secondary Amenorrhea In three studies, 127 women with secondary amenorrhea received estrogen replacement therapy and Crinone 4% or 8% every other day for six doses.
Treatment-emergent adverse events during estrogen and Crinone treatment that occurred in 5% or more of women are shown in Table 5. TABLE 5 Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Estrogen Treatment and Crinone Every Other Day Studies COL1620-004US, COL1620-005US, COL1620-009US Estrogen + Crinone 4% n = 62 Estrogen + Crinone 8% n = 65 Body as a Whole Abdominal Pain 3 (5%) 6 (9%) Appetite Increased 3 (5%) 5 (8%) Bloating 8 (13%) 8 (12%) Cramps NOS 12 (19%) 17 (26%) Fatigue 13 (21%) 14 (22%) Central and Peripheral Nervous System Headache 12 (19%) 10 (15%) Gastro-Intestinal System Nausea 5 (8%) 4 (6%) Musculo-Skeletal System Back Pain 5 (8%) 2 (3%) Myalgia 5 (8%) 0 (0%) Psychiatric Depression 12 (19%) 10 (15%) Emotional Lability 14 (23%) 14 (22%) Sleep Disorder 11 (18%) 12 (18%) Reproductive, Female Vaginal Discharge 7 (11%) 2 (3%) Resistance Mechanism Upper Respiratory Tract Infection 3 (5%) 5 (8%) Skin and Appendages Pruritus Genital 1 (2%) 4 (6%)
🔄 Drug Interactions ▾
Drug Interactions No drug interactions have been assessed with Crinone.
🤰 Pregnancy ▾
Pregnancy [See CLINICAL STUDIES, Assisted Reproductive Technology ] Crinone 8% has been used to support embryo implantation and maintain pregnancies through its use as part of ART treatment regimens in two clinical studies (studies COL1620-007US and COL1620-F01). In the first study (COL1620-007US), 54 Crinone-treated women had donor oocyte transfer procedures, and clinical pregnancies occurred in 26 women (48%). The outcomes of these 26 pregnancies were as follows: one woman had an elective termination of pregnancy at 19 weeks due to congenital malformations (omphalocele) associated with a chromosomal abnormality; one woman pregnant with triplets had an elective termination of her pregnancy; seven women had spontaneous abortions; and 17 women delivered 25 apparently normal newborns.
In the second study (COL1620-F01), Crinone 8% was used in the luteal phase support of women undergoing in vitro fertilization ("IVF") procedures. In this multi-center, open-label study, 139 women received Crinone 8% once daily beginning within 24 hours of embryo transfer and continuing through Day 30 post-transfer. Clinical pregnancies assessed at Day 90 post-transfer were seen in 36 (26%) of women.
Thirty-two women (23%) delivered newborns and four women (3%) had spontaneous abortions. Of the 47 newborns delivered, one had a teratoma associated with a cleft palate; one had respiratory distress syndrome; 44 were apparently normal and one was lost to follow-up.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use The safety and effectiveness in geriatric patients (over age 65) have not been established.
🆘 Overdosage ▾
OVERDOSAGE There have been no reports of overdosage with Crinone. In the case of overdosage, however, discontinue Crinone, treat the patient symptomatically, and institute supportive measures. As with all prescription drugs, this medicine should be kept out of the reach of children.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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 essential for the development of decidual tissue, and the effect of progesterone on the differentiation of glandular epithelia and stroma has been extensively studied.
Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain the pregnancy. Normal or near-normal endometrial responses to oral estradiol and intramuscular progesterone have been noted in functionally agonadal women through the sixth decade of life.
Progesterone administration decreases the circulatory levels of gonadotropins. Pharmacokinetics Absorption Due to the sustained release properties of Crinone, progesterone absorption is prolonged with an absorption half-life of approximately 25 to 50 hours, and an elimination half-life of 5 to 20 minutes. Therefore, the pharmacokinetics of Crinone are rate-limited by absorption rather than by elimination.
The bioavailability of progesterone in Crinone was determined relative to progesterone administered intramuscularly. In a single dose crossover study, 20 healthy, estrogenized postmenopausal women received 45 mg or 90 mg progesterone vaginally in Crinone 4% or Crinone 8%, or 45 mg or 90 mg progesterone intramuscularly. The pharmacokinetic parameters (mean ± standard deviation) are shown in Table 1.
TABLE 1 Single Dose Relative Bioavailability Crinone 4% 45 mg Intramuscular Progesterone Crinone 8% 90 mg Intramuscular Progesterone C max (ng/mL) 13.15 ± 6.49 39.06 ± 13.68 14.87 ± 6.32 53.76 ±
14.9C avg 0-24 (ng/mL) 6.94 ± 4.24 22.41 ± 4.92 6.98 ± 3.21 28.98 ±
8.75AUC 0-96 (ng∙hr/mL) 288.63 ± 273.72 806.26 ± 102.75 296.78 ± 129.90 1378.91 ± 176.39 T max (hr) 5.6 ± 1.84 8.2 ± 6.43 6.8 ± 3.3 9.2 ± 2.7 t 1/2 (hr) 55.13 ± 28.04 28.05 ± 16.87 34.8 ± 11.3 19.6 ±
6.0F (%) 27.6
19.8C max - maximum progesterone serum concentration C avg 0-24 - average progesterone serum concentration over 24 hours AUC 0-96 - area under the drug concentration versus time curve from 0-96 hours post dose T max - time to maximum progesterone concentration t 1/2 - elimination half-life F - relative bioavailability The multiple dose pharmacokinetics of Crinone 4% and Crinone 8% administered every other day and Crinone 8% administered daily or twice daily for 12 days were studied in 10 healthy, estrogenized postmenopausal women in two separate studies.
Steady state was achieved within the first 24 hours after initiation of treatment. The pharmacokinetic parameters (mean ± standard deviation) after the last administration of Crinone 4% or 8% derived from these studies are shown in Table 2. TABLE 2 Multiple Dose Pharmacokinetics Assisted Reproductive Technology Secondary Amenorrhea Daily Dosing 8% Twice Daily Dosing 8% Every Other Day Dosing 4% Every Other Day Dosing 8% C max (ng/mL) 15.97± 5.05 14.57 ± 4.49 13.21± 9.46 13.67 ±
3.58C avg (ng/mL) 8.99 ± 3.53 11.6 ± 3.47 4.05 ± 2.85 6.75 ±
2.83T max (hr) 5.40 ± 0.97 3.55 ± 2.48 6.67 ± 3.16 7.00 ±
2.88AUC 0-t (ng∙hr/mL) 391.98 ±153.28 138.72 ± 41.58 242.15 ± 167.88 438.36 ± 223.36 t 1/2 (hr) 45.00 ± 34.70 25.91 ± 6.15 49.87 ± 31.20 39.08 ±
12.88C max -maximum progesterone serum concentration C avg -average progesterone serum concentration T max -time to maximum progesterone concentration AUC 0-t -area under the drug concentration versus time curve t 1/2 -elimination half-life Distribution Progesterone is extensively bound to serum proteins (~ 96-99%), primarily to serum albumin and corticosteroid binding globulin. Metabolism The major urinary metabolite of oral progesterone is 5β-pregnan-3α, 20α-diol glucuronide which is present in plasma in the conjugated form only.
Plasma metabolites also include 5β-pregnan-3α-ol-20-one (5β-pregnanolone) and 5α-preg…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Crinone is available in the following strengths: 4% gel (45 mg) in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator contains 1.3 g of gel and delivers 1.125 g of gel. NDC 0023-6150-04 : 6 Single-use prefilled applicators.
8% gel (90 mg) in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator contains 1.3 g of gel and delivers 1.125 g of gel. NDC 0023-6151-08 : 15 Single-use prefilled applicators.
Each applicator is wrapped and sealed in a foil overwrap. Store at 20-25ºC (68-77ºF). [See USP controlled room temperature.] Keep out of reach of children. Rx only For all medical inquiries contact: AbbVie Inc.
1-800-678-1605 Distributed by: AbbVie Inc. North Chicago, IL 60064 Content Updated: June 2017 © 2024 AbbVie. All rights reserved.
CRINONE and its design are trademarks of Allergan Sales, LLC, an AbbVie company.
📋 Description ▾
DESCRIPTION Crinone ® (progesterone gel) is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system, which is contained in single use, polypropylene vaginal applicators. The carrier vehicle is an oil in water emulsion containing the water swellable, but insoluble polymer, polycarbophil. The progesterone is partially soluble in both the oil and water phase of the vehicle, with the majority of the progesterone existing as a suspension.
Physically, Crinone has the appearance of a soft, white to off-white gel. The active ingredient, progesterone, is present in either a 4% or an 8% concentration (w/w). The chemical name for progesterone is pregn-4-ene-3,20-dione.
It has an empirical formula of C 21 H 30 O 2 and a molecular weight of 314.5. The structural formula is: Progesterone exists in two polymorphic forms. Form 1, which is the form used in Crinone, exists as white orthorhombic prisms with a melting point of 127-131°C.
Each applicator delivers 1.125 grams of Crinone gel containing either 45 mg (4% gel) or 90 mg (8% gel) of progesterone in a base containing glycerin, light mineral oil, polycarbophil, carbomer homopolymer Type B, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. The structural formula
💬 Information for Patients ▾
Information for Patients The product should not be used concurrently with other local intravaginal therapy. If other local intravaginal therapy is to be used concurrently, there should be at least a 6-hour period before or after Crinone administration. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage.