Quick answers
- What is Megestrol acetate used for?
- The FDA-approved label (Megestrol Acetate, Atlantic Biologicals Corp., July 9, 2026) says: “Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Megestrol acetate have a boxed warning?
- No. None of the 20 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Megestrol acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Megestrol acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Megestrol acetate?
- 17 companies list prescription products of Megestrol acetate in the FDA NDC Directory, including Strides Pharma Science Limited, Teva Pharmaceuticals USA, Inc. and Major Pharmaceuticals.
What Megestrol acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
— FDA label: Megestrol Acetate, Atlantic Biologicals Corp., effective July 9, 2026. Read the full label on DailyMed →
The FDA has 20 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.
0 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Suspension · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 24 in the FDA NDC Directory |
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 |
|---|---|---|
| megestrol acetate 125 mg/mL suspension | Generic | $1.42 per mL |
| megestrol acetate 20 mg tablet | Generic | $0.1848 per tablet |
| megestrol acetate 40 mg tablet | Generic | $0.2391 per tablet |
| megestrol acetate 40 mg/mL suspension | Generic | $0.1272–$0.1347 per mL 4 packages, lowest to highest |
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.
- Strides Pharma Science Limited3 products
- Teva Pharmaceuticals USA, Inc.2 products
- Major Pharmaceuticals2 products
- PAI Holdings, LLC dba PAI Pharma2 products
- Precision Dose, Inc.2 products
- Bryant Ranch Prepack2 products
- Kesin Pharma Corporation1 product
- American Health Packaging1 product
- Proficient Rx LP1 product
- Remedyrepack Inc.1 product
- Upsher-Smith Laboratories, LLC1 product
- Atlantic Biologicals Corp.1 product
- Preferred Pharmaceuticals Inc.1 product
- Golden State Medical Supply, Inc.1 product
- Xttrium Laboratories, Inc.1 product
- ANI Pharmaceuticals, Inc.1 product
- Natco Pharma USA LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (7)
- ANDA072422Strides Pharma Intl · August 8, 1988
- ANDA072423Strides Pharma Intl · August 8, 1988
- ANDA074621Barr · November 30, 1995
- ANDA075671Strides Pharma Intl · July 25, 2001
- ANDA076721Pharmobedient · November 1, 2004
- ANDA077404Novitium Pharma · February 16, 2006
- ANDA203139Twi Pharms · August 27, 2014
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 577154, 860215, 860221, 860225 |
|---|---|
| SPL set ID of the quoted label | 01119031-9943-4afb-8b45-cb71682f0482 |
| FDA labels (SPL) | 20 |
| FDA applications | 7 ANDA |
| Active ingredients (FDA) | MEGESTROL ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Megestrol Acetate, Atlantic Biologicals Corp., effective July 9, 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 →