Quick answers
- What is Progesterone used for?
- The FDA-approved label (Crinone, Allergan, Inc., May 21, 2024) says: “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%.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Progesterone have a boxed warning?
- The label we quote has no boxed warning, but 36 of 55 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Progesterone?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated March 27, 2026). Ask your pharmacist about alternatives.
- Has Progesterone been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started December 27, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Progesterone?
- 27 companies list prescription products of Progesterone in the FDA NDC Directory, including Asclemed USA, Inc., Bryant Ranch Prepack and Proficient Rx LP.
What Progesterone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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%.
— FDA label: Crinone, Allergan, Inc., effective May 21, 2024. Read the full label on DailyMed →
The FDA has 55 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
36 of 55 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Insert · Injection, solution · Gel · Injection |
|---|---|
| Route | Oral · Vaginal · Intramuscular |
| Prescription products | 80 in the FDA NDC Directory |
| Brand names | Crinone, Prometrium, Endometrin, Progesterone Vaginal Insert, Progesterone Vaginal Inserts |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| progesterone 100 mg capsule | Generic | $0.2329 per capsule |
| progesterone 100 mg capsule | Brand: Prometrium | $15.94 per capsule |
| progesterone 100 mg insert | Generic | $8.95 per unit |
| progesterone 100 mg insert | Brand: Endometrin | $15.20 per unit |
| progesterone 200 mg capsule | Generic | $0.4108 per capsule |
| progesterone 200 mg capsule | Brand: Prometrium | $30.39 per capsule |
| progesterone 45 mg/1.125 g gel | Brand: Crinone | $16.84 per gram |
| progesterone 50 mg injection | Generic | $1.33 per mL |
| progesterone 50 mg/mL injection, solution | Generic | $1.33 per mL |
| progesterone 90 mg/1.125 g gel | Brand: Crinone | $27.96 per gram |
NADAC list of November 4, 2026; these prices took effect between January 2, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Asclemed USA, Inc.10 products
- Bryant Ranch Prepack7 products
- Proficient Rx LP5 products
- A-S Medication Solutions4 products
- Bionpharma Inc.4 products
- Direct_Rx4 products
- AvKARE4 products
- Preferred Pharmaceuticals Inc.4 products
- Xiromed, LLC4 products
- NorthStar Rx LLC4 products
- NuCare Pharmaceuticals, Inc.4 products
- Hikma Pharmaceuticals USA Inc.3 products
- Remedyrepack Inc.3 products
- Dr.Reddys Laboratories Inc2 products
- Golden State Medical Supply, Inc.2 products
- Amneal Pharmaceuticals LLC2 products
- Aurobindo Pharma Limited2 products
- Allergan, Inc.2 products
- Acertis Pharmaceuticals, LLC2 products
- Ingenus Pharmaceuticals, LLC1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Northwind Health Company, LLC1 product
- Ferring Pharmaceuticals Inc.1 product
- Eugia US LLC1 product
- Redpharm Drug1 product
- Fresenius Kabi USA, LLC1 product
- Glenmark Pharmaceuticals Inc., USA1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019781 PROMETRIUM | Acertis Pharms | May 14, 1998 | 16, latest February 12, 2026 2026: Labeling · 2024: Labeling · 2020: Manufacturing (CMC) |
| NDA020701 CRINONE | Abbvie | July 31, 1997 | 15, latest September 29, 2015 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
| NDA022057 ENDOMETRIN | Ferring | June 21, 2007 | 9, latest July 15, 2026 2026: Labeling · 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
Generic approvals (13)
- ANDA075906Fresenius Kabi USA · April 25, 2001
- ANDA091033Hikma Farmaceutica · October 28, 2010
- ANDA200456Sofgen Pharms · September 28, 2012
- ANDA200900Bionpharma · August 16, 2013
- ANDA208801DR Reddys · February 28, 2017
- ANDA207724Amneal Pharms Ny · September 7, 2017
- ANDA205229Xiromed · October 20, 2017
- ANDA211285Eugia Pharma · October 26, 2018
- ANDA210965Eugia Pharma · December 6, 2018
- ANDA215634Xiromed · January 5, 2022
- ANDA218391Xiromed · September 19, 2025
- ANDA216363Glenmark Pharms · April 8, 2026
- ANDA219588Novast Labs · October 16, 2026
Shortage status
To be discontinued · updated March 27, 2026 · first posted March 27, 2026
| Product | Crinone, Vaginal Gel, 4% (NDC 0023-6150-04) |
|---|---|
| Company | AbbVie Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 27, 2024 · Class II · Ongoing · D-0186-2025
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10 — Eugia US LLC
-
July 26, 2024 · Class II · Ongoing · D-0624-2024
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, NJ 08520, NDC 55150-306-10. — Eugia US LLC
-
February 26, 2021 · Class II · Terminated · D-0292-2021
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01. — Dr. Reddy's Laboratories, Inc.
-
September 19, 2013 · Class III · Terminated · D-1426-2014
Discoloration; due to prolonged heat exposure.
ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3 — Ferring Pharmaceuticals Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Crinone, Allergan, Inc., effective May 21, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →