Quick answers
- What is Medroxyprogesterone acetate used for?
- The FDA-approved label (Provera, Pharmacia & Upjohn Company LLC, June 29, 2026) says: “PROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Medroxyprogesterone acetate have a boxed warning?
- Yes. The FDA label for Provera has a boxed warning (“WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Medroxyprogesterone acetate?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated August 31, 2026). Ask your pharmacist about alternatives.
- Has Medroxyprogesterone acetate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started December 18, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Medroxyprogesterone acetate?
- 23 companies list prescription products of Medroxyprogesterone acetate in the FDA NDC Directory, including Pharmacia & Upjohn Company LLC, A-S Medication Solutions and Bryant Ranch Prepack.
What Medroxyprogesterone acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
— FDA label: Provera, Pharmacia & Upjohn Company LLC, effective June 29, 2026. Read the full label on DailyMed →
The FDA has 34 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.
This label has a boxed warning. Its heading: WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
. Read it on the full label →
33 of 34 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection, suspension · Injection, suspension, extended release |
|---|---|
| Route | Oral · Intramuscular · Subcutaneous |
| Prescription products | 49 in the FDA NDC Directory |
| Brand names | Provera, Depo-Provera, Depo-Subq Provera |
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 |
|---|---|---|
| medroxyprogesterone acetate 10 mg tablet | Generic | $0.1525 per tablet |
| medroxyprogesterone acetate 104 mg/0.65 mL injection, suspension | Brand: Depo-SubQ Provera | $77.45 per mL |
| medroxyprogesterone acetate 150 mg/mL injection, suspension | Generic | $17.86–$26.90 per mL 13 packages, lowest to highest |
| medroxyprogesterone acetate 150 mg/mL injection, suspension | Brand: Depo-Provera | $50.12–$52.26 per mL 2 packages, lowest to highest |
| medroxyprogesterone acetate 150 mg/mL injection, suspension, extended release | Generic | $17.86–$26.90 per mL 3 packages, lowest to highest |
| medroxyprogesterone acetate 2.5 mg tablet | Generic | $0.1149 per tablet |
| medroxyprogesterone acetate 5 mg tablet | Generic | $0.1395 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- Pharmacia & Upjohn Company LLC6 products
- A-S Medication Solutions5 products
- Bryant Ranch Prepack4 products
- Remedyrepack Inc.4 products
- Teva Pharmaceuticals USA, Inc.3 products
- Mylan Pharmaceuticals Inc.3 products
- PD-Rx Pharmaceuticals, Inc.2 products
- Preferred Pharmaceuticals Inc.2 products
- Amneal Pharmaceuticals LLC2 products
- Amphastar Pharmaceuticals, Inc.2 products
- Prasco Laboratories2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Eugia US LLC2 products
- Hikma Pharmaceuticals USA Inc.1 product
- PharmPak, Inc.1 product
- American Health Packaging1 product
- NuCare Pharmaceuticals, Inc.1 product
- Amneal Pharmaceuticals NY LLC1 product
- Proficient Rx LP1 product
- Mylan Institutional LLC1 product
- Northwind Health Company, LLC1 product
- Coupler LLC1 product
- Xiromed, LLC1 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 |
|---|---|---|---|
| NDA011839 PROVERA | Pfizer | June 18, 1959 | 23, latest February 15, 2024 2024: Labeling · 2023: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
| NDA020246 DEPO-PROVERA | Pfizer | October 29, 1992 | 33, latest December 12, 2025 2025: Labeling · 2024: Labeling · 2020: Efficacy |
| NDA021583 DEPO-SUBQ PROVERA 104 | Pfizer | December 17, 2004 | 20, latest December 12, 2025 2025: Labeling · 2024: Labeling · 2024: Labeling |
Generic approvals (10)
- ANDA040159Barr · August 9, 1996
- ANDA077235Amphastar Pharms Inc · November 28, 2017
- ANDA077334Amphastar Pharms Inc · November 28, 2017
- ANDA210227Xiromed · October 12, 2018
- ANDA210761Sun Pharm · April 24, 2019
- ANDA210760Sun Pharm · May 1, 2019
- ANDA212824Eugia Pharma · August 22, 2022
- ANDA212844Eugia Pharma · August 31, 2022
- ANDA214309Hikma · January 5, 2023
- ANDA215397Amneal · June 7, 2023
Shortage status
To be discontinued · updated August 31, 2026 · first posted August 31, 2026
| Product | PROVERA, Tablet, 10 mg (NDC 0009-0051-01) |
|---|---|
| Company | Pfizer 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 18, 2024 · Class II · Ongoing · D-0185-2025
CGMP Deviations
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspen — Eugia US LLC
-
May 6, 2022 · Class II · Terminated · D-1145-2022
Lack of assurance of sterility
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, Distributed by: — SUN PHARMACEUTICAL INDUSTRIES 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
| RxCUI (RxNorm) | 1000114, 1000124, 1000126, 1000128, 1000135, 1000139, 1000141, 1000145, 1000153, 1000154 … (+2) |
|---|---|
| SPL set ID of the quoted label | a586be28-96af-4fed-a13f-9b94fd4c7405 |
| FDA labels (SPL) | 34 |
| FDA applications | NDA011839, NDA020246, NDA021583, 10 ANDA |
| Active ingredients (FDA) | MEDROXYPROGESTERONE ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Provera, Pharmacia & Upjohn Company LLC, effective June 29, 2026; 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 →