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Molecule

Progesterone

Progesterone
Available on request
Presentations
12
Brands
5
Manufacturers
5
Available from stock
0

Progesterone is a progesterone indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency, among other approved uses. MedsAcross supplies Progesterone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Progesterone
ATC classification
G03DA04 Progesterone · Sex hormones and fertility medicines, subgroup G03D, subgroup G03DA
US FDA first approval
1 November 1974
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral, Vaginal, Intramuscular
Dosage forms
Capsule, Vaginal insert, Injection, Vaginal gel
Identifiers
UNII 4G7DS2Q64YRxCUI 8727CAS 57-83-0DrugBank DB00396Q26963

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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%.

Source: US FDA prescribing information

Dosing overview

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.

Source: US FDA prescribing information

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

Source: US FDA prescribing information

Warnings and precautions

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.

Source: US FDA prescribing information

Side effects

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.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

12 presentations of Progesterone, sorted by availability.

MedicineManufacturerRegisterAvailability
Progesterone 100 mg capsuleOralGeneric name—US FDAAvailable on request
Progesterone 200 mg capsuleOralGeneric name—US FDAAvailable on request
Progesterone 500 mg/10 mL injectionIntramuscularGeneric name—US FDAAvailable on request
Progesterone 100 mg vaginal insertVaginalGeneric name—US FDAAvailable on request
Crinone 4% vaginal gelVaginalAllerganUS FDAAvailable on request
Crinone 8% vaginal gelVaginalAllerganUS FDAAvailable on request
Endometrin 100 mg vaginal insertVaginalFerring PharmaceuticalsUS FDAAvailable on request
Progesterone 50 mg injectionIntramuscularGeneric name—US FDAAvailable on request
Progesterone vaginal insert 100 mg vaginal insertVaginalXiromedUS FDAAvailable on request
Progesterone Vaginal Inserts 100 mg vaginal insertVaginalGlenmark PharmaceuticalsIndiaUS FDAAvailable on request
Prometrium 100 mg capsuleOralAcertis PharmaceuticalsUS FDAAvailable on request
Prometrium 200 mg capsuleOralAcertis PharmaceuticalsUS FDAAvailable on request

Brands by market

5 brand names across 1 markets.

Brand names by country

Manufacturers

Indian manufacturers are highlighted.

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 1 November 1974Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Progesterone in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Progesterone available for export from India?

Yes, on request. MedsAcross lists 12 presentations of Progesterone and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Glenmark Pharmaceuticals.

What brand names does Progesterone have?

The catalogue lists 5 brand names for Progesterone, including Crinone, Endometrin, Progesterone vaginal insert, Progesterone Vaginal Inserts, Prometrium.

Is Progesterone approved by the US FDA?

Yes. The US FDA first approved Progesterone on 1 November 1974, according to Drugs@FDA.

Does Progesterone need cold chain shipping?

No listed presentation of Progesterone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Progesterone in?

Progesterone is classified under ATC code G03DA04 (Progesterone).

References

  1. Crinone prescribing information (Allergan). U.S. National Library of Medicine, DailyMed. Retrieved 21 May 2024

Request Progesterone for export supply

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