Prescription medicine
Progesterone Brand names: Crinone, Prometrium, Endometrin
Progesterone (Prometrium) is a prescription medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 25 generic labelers, and pharmacies paid $0.229 per progesterone 100 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the progesterone FDA label on DailyMed (effective July 23, 2026, Acertis Pharmaceuticals, LLC); the NDA 9238 record on Drugs@FDA; every progesterone label on DailyMed.
Highlights of the record
FDA label of July 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePROMETRIUM ® (progesterone, USP) Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets.
Forms and strengths
- 50 mg
- 100 mg
- 200 mg
- 45 mg/1.125g
- 50 mg/ml
- 90 mg/1.125g
Capsule; insert; injection (solution); gel; injection.
On the market
- Earliest approval on file
- November 1, 1974 Progesterone, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first April 25, 2001; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 29 of which 25 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- January 21, 2030 Milprosa system; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.229 per capsule Progesterone 100 mg capsule
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 7 since 2013 0 Class I among all firms' recalls; latest December 27, 2024; 28 more by firms not listed as its makers
- FAERS reports
- 22,737 through July 30, 2026
What is progesterone used for?
From the label: indications and usagePROMETRIUM ® (progesterone, USP) 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.
FDA pharmacologic class: Progesterone.
Source: FDA drug label (Prometrium), Acertis Pharmaceuticals, LLC, effective July 23, 2026 (SPL set 1cf237ff-c4f8-4faa-a7aa-77599c856889), via openFDA; the full label on DailyMed
Is there a generic for progesterone (Prometrium)?
The FDA approved the first generic progesterone on April 25, 2001. 15 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists progesterone from 25 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Prometrium capsules; a patent listed only for Milprosa system runs to January 21, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1974 earliest approval on file
- 2001 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for progesterone (Prometrium)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.229 per Progesterone 100 mg capsule, down 5% from $0.242 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Progesterone 100 mg capsule (generic)
- Endometrin 100 mg vag insert (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Progesterone 100 mg capsule | Generic | $0.229 per capsule | $6.87 | -5% |
| Progesterone 100 mg vag insert | Generic | $10.88 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | n/a |
| Progesterone 200 mg capsule | Generic | $0.404 per capsule | $12.12 | -2% |
| Progesterone 500 mg/10 mL vial | Generic | $1.36 per mL | $13.61 per vial | -12% |
| Crinone 4% gel | Brand | $16.84 per gram | n/a | +5% |
| Crinone 8% gel | Brand | $27.97 per gram | n/a | +4% |
| Endometrin 100 mg vag insert | Brand | $15.15 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +7% |
| Prometrium 100 mg capsule | Brand | $15.91 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $477.28 | -0.6% |
| Prometrium 200 mg capsule | Brand | $30.39 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $911.84 | +0.5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is progesterone in shortage?
No progesterone presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated March 27, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Crinone, Vaginal Gel, 4% (NDC 0023-6150-04) | AbbVie Inc. | To Be Discontinued | March 27, 2026 |
Every progesterone presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has progesterone been recalled?
The FDA's Enforcement Report lists 35 recalls naming progesterone since 2013: 0 Class I (the most serious), 32 Class II, 3 Class III; 3 still ongoing. 28 of them are by firms that FDA's NDC Directory does not list as a maker of progesterone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 27, 2024 | Class II | Eugia US LLC | Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. |
| July 26, 2024 | Class II | Eugia US LLC | Presence of Particulate Matter: Complaint received of a glass particle in the vial. |
| April 24, 2024 | Class II | Coast Quality Pharmacy, LLC dba Anazao Health not a listed maker | Presence of Foreign Substance; Broken metal piece found embedded in tablet. |
| June 12, 2023 | Class II | Ferring Pharmaceuticals Inc | cGMP deviations: potential for Microbial Contamination of Non-Sterile Products |
| October 12, 2021 | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy not a listed maker | Lack of assurance of sterility |
| August 13, 2021 | Class II | First Royal Care Co. LLC, dba Red Mountain Compounding … not a listed maker | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns |
| February 26, 2021 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing. |
| July 2, 2020 | Class II | MasterPharm LLC not a listed maker | Lack of Processing Controls (lack of assurance of conformity to specifications). |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the progesterone label say about other medicines?
The progesterone label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 16 other medicines name progesterone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Medroxyprogesterone | warnings | … 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. |
Other labels that name progesterone
Source: FDA drug label (Prometrium), Acertis Pharmaceuticals, LLC, effective July 23, 2026 (SPL set 1cf237ff-c4f8-4faa-a7aa-77599c856889), via openFDA; the full label on DailyMed
What do FAERS reports show for progesterone?
The FDA Adverse Event Reporting System holds 22,737 reports that list progesterone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 504 are coded as a death and 3,636 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Progesterone side effects
- the label's list beside FAERS reports
- Progesterone shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other