Megestrol Acetate 40 mg/mL Suspension
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Progestin class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Megestrol tablets are used to relieve the symptoms and reduce the suffering caused by advanced breast cancer and advanced endometrial cancer (cancer that begins in the lining of the uterus). Megestrol suspension is used to treat loss of appetite, malnutrition, and severe weight loss in patients with acquired immunodeficiency syndrome (AIDS). Megestrol should not be used to prevent loss of appetite and severe weight loss in patients who have not yet developed this condition. Megestrol is a man-made version of the human hormone progesterone. It treats breast cancer and endometrial cancer by affe...
Read the full MedlinePlus article ↗- It depends on the form you have. The liquid suspension is used specifically to treat serious appetite loss and weight loss in people with AIDS — your doctor would have prescribed i...
- What exactly is megestrol acetate used for?
- Yes — the 125 mg/mL suspension can be taken with or without food, so you don't need to worry about timing it around meals. Just make sure to shake the bottle well before each dose....
- Can I take the oral suspension with food?
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Supplement & herbal interactions
Some supplements/herbs that may interact with Megestrol Acetate — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII 1S66E28KXA
Poloxamer 124 is a synthetic polymer that acts as a surfactant and solubilizer in medicines. It helps dissolve and stabilize active ingredients, particularly in liquid formulations and gels.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
8 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1931 | $579.30 / 3000 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Megestrol Acetate 40 mg/mL 64380-0160-01 | Strides | 240 ml | $0.135 | AB | Availability likely | — |
| Megestrol Acetate 40 mg/mL 70954-0896-10 | ANI | 240 ml | $0.135 | AB | Availability likely | — |
| Megestrol Acetate 40 mg/mLthis 00116-4011-30 | Xttrium | 10 cups | — | AB | FDA listed | — |
| Megestrol Acetate 400 mg/10mL 00121-0945-00 | PAI | 10 cups | — | AB | FDA listed | — |
| Megestrol Acetate 400 mg/10mL 00121-1038-00 | PAI | 10 cups | — | AB | FDA listed | — |
| Megestrol Acetate 400 mg/10mL 00904-7577-18 | Major | 10 cups | — | AB | FDA listed | — |
| Megestrol Acetate 40 mg/mL 17856-0060-03 | ATLANTIC | 72 cups | — | AB | FDA listed | — |
| Megestrol Acetate 40 mg/mL 51407-0910-24 | Golden | 240 ml | — | AB | FDA listed | — |
| Megestrol Acetate 40 mg/mL 60687-0916-08 | American | 10 cups | — | AB | FDA listed | — |
| Megestrol Acetate 40 mg/mL 68094-0063-61 | Precision | 10 cups | — | AB | FDA listed | — |
| Megestrol Acetate 40 mg/mL 68094-0174-62 | Precision | 10 cups | — | AB | FDA listed | — |
| Megestrol Acetate 40 mg/mL 68788-8714-02 | Preferred | 240 ml | — | AB | FDA listed | — |
| Megestrol Acetate 40 mg/mL 69339-0160-16 | Natco | 10 cups | — | AB | FDA listed | — |
| Megestrol Acetate 40 mg/mL 81033-0150-43 | Kesin | 30 cups | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00116-4011-08 | 237 mL in 1 BOTTLE, PLASTIC (0116-4011-08) | 2025-03-28 | Active |
| 00116-4011-11 | 10 TRAY in 1 CASE (0116-4011-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10) | 2025-03-28 | Active |
| 00116-4011-16 | 480 mL in 1 BOTTLE, PLASTIC (0116-4011-16) | 2025-03-28 | Active |
| 00116-4011-30 You're viewing this | 30 TRAY in 1 CASE (0116-4011-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10) | 2025-03-28 | Active |
| 00116-4011-40 | 40 TRAY in 1 CASE (0116-4011-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10) | 2025-03-28 | Active |
Pack size FAQ
What quantity is in NDC 00116-4011-30?
What NDC number is used to bill for this package of Megestrol Acetate 40 mg/mL Suspension?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended adult initial dosage of Megestrol Acetate Oral Suspension, USP is 800 mg/day (20 mL/day). Shake container well before using. In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.
⛔ Contraindications ▾
CONTRAINDICATIONS History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.
⚠️ Warnings ▾
WARNINGS Megestrol acetate may cause fetal harm when administered to a pregnant woman. For animal data on fetal effects, see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility . There are no adequate and well-controlled studies in pregnant women.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Megestrol acetate is not intended for prophylactic use to avoid weight loss.
(See also PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility .) The glucocorticoid activity of Megestrol Acetate Oral Suspension, USP has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing's syndrome have been reported in association with the chronic use of Megestrol Acetate Oral Suspension, USP. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megestrol Acetate Oral Suspension, USP therapy in the stressed and non-stressed state.
Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealed the frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic Megestrol Acetate Oral Suspension, USP therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic Megestrol Acetate Oral Suspension, USP therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (eg., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state.
Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death. Finally, in patients who are receiving or being withdrawn from chronic Megestrol Acetate Oral Suspension, USP therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness (eg., surgery, infection).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Clinical Adverse Events Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. These adverse events should be considered by the physician when prescribing Megestrol Acetate Oral Suspension, USP.
Adverse events which occurred in 1% to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo.
Body as a Whole: abdominal pain, chest pain, infection, moniliasis and sarcoma Cardiovascular System: cardiomyopathy and palpitation Digestive System: constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis Hemic and Lymphatic System: leukopenia Metabolic and Nutritional: LDH increased, edema and peripheral edema Nervous System: paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking Respiratory System: dyspnea, cough, pharyngitis and lung disorder Skin and Appendages: alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder Special Senses: amblyopia Urogenital System : albuminuria, urinary incontinence, urinary tract infection and gynecomastia Postmarketing Postmarketing reports associated with Megestrol Acetate Oral Suspension, USP include thromboembolic phenomena including thrombophlebitis and pulmonary embolism, and glucose intolerance (see WARNINGS and PRECAUTIONS).
To report SUSPECTED ADVERSE REACTIONS, contact Xttrium Laboratories, Inc. at 1-800-587-3721 or FDA at 1-800-FDA-1088. Table Table
🆘 Overdosage ▾
OVERDOSAGE No serious unexpected side effects have resulted from studies involving Megestrol Acetate Oral Suspension, USP administered in dosages as high as 1200 mg/day. In post-marketing experience, limited reports of overdose have been received. Signs and symptoms reported in the context of overdose included diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain.
There is no specific antidote for overdose with Megestrol Acetate Oral Suspension, USP. In case of overdose, appropriate supportive measures should be taken. Megestrol acetate has not been tested for dialyzability; however, due to its low solubility, it is postulated that dialysis would not be an effective means of treating overdose.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The precise mechanism by which megestrol acetate produces effects in anorexia and cachexia is unknown at the present time. There are several analytical methods used to estimate megestrol acetate plasma concentrations, including gas chromatography-mass fragmentography (GC-MF), high pressure liquid chromatography (HPLC) and radioimmunoassay (RIA). The GC-MF and HPLC methods are specific for megestrol acetate and yield equivalent concentrations.
The RIA method reacts to megestrol acetate metabolites and is, therefore, non-specific and indicates higher concentrations than the GC-MF and HPLC methods. Plasma concentrations are dependent, not only on the method used, but also on intestinal and hepatic inactivation of the drug, which may be affected by factors such as intestinal tract motility, intestinal bacteria, antibiotics administered, body weight, diet, and liver function. The major route of drug elimination in humans is urine.
When radiolabeled megestrol acetate was administered to humans in doses of 4 to 90 mg, the urinary excretion within 10 days ranged from 56.5% to 78.4% (mean 66.4%) and fecal excretion ranged from 7.7% to 30.3% (mean 19.8%). The total recovered radioactivity varied between 83.1% and 94.7% (mean 86.2%). Megestrol acetate metabolites which were identified in urine constituted 5% to 8% of the dose administered.
Respiratory excretion as labeled carbon dioxide and fat storage may have accounted for at least part of the readioactivity not found in urine and feces. Plasma steady-state pharmacokinetics of megestrol acetate were evaluated in 10 adult, cachectic male patients with acquired immunodeficiency syndrome (AIDS) and an involuntary weight loss greater than 10% of baseline. Patients received single oral doses of 800 mg/day of Megestrol Acetate Oral Suspension, USP for 21 days.
Plasma concentration data obtained on day 21 were evaluated for up to 48 hours past the last dose. Mean (±1SD) peak plasma concentration (C max ) of megestrol acetate was 753 (±539) ng/mL. Mean area under the concentration time-curve (AUC) was 10476 (±7788) ng × hr/mL.
Median T max value was five hours. Seven of 10 patients gained weight in three weeks. Additionally, 24 adult, asymptomatic HIV seropositive male subjects were dosed once daily with 750 mg of Megestrol Acetate Oral Suspension, USP.
The treatment was administered for 14 days. Mean C max and AUC values were 490 (±238) ng/mL and 6779 (±3048) ng × hr/mL, respectively. The median T max value was three hours.
The mean C min value was 202 (±101) ng/mL. The mean percent of fluctuation value was 107 (±40). The effect of food on the bioavailability of Megestrol Acetate Oral Suspension, USP has not been evaluated.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Megestrol Acetate Oral Suspension, USP 40 mg/mL is available as a creamy-white, lemon-lime flavored oral suspension, for oral administration, containing 40 mg of micronized megestrol acetate per mL. NDC 0116-4011-08 Bottles of 8 fl oz (237 mL) NDC 0116-4011-16 Bottles of 16 fl oz (473 mL) NDC 0116-4011-10 10 mL unit dose cups in trays of 10
📦 Storage and Handling ▾
STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with child-resistant closure. Protect from heat.
📋 Description ▾
DESCRIPTION Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate. Solubility at 37°C in water is 2 µg per mL, solubility in plasma is 24 µg per mL.
Its molecular weight is 384.52. The empirical formula is C 24 H 32 O 4 and the structural formula is represented as follows: Megestrol Acetate Oral Suspension, USP is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol Acetate Oral Suspension, USP contains the following inactive ingredients: alcohol (max.
0.34% v/v from flavor), citric acid anhydrous, lemon-lime flavor, poloxamer 124, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sucrose and xanthan gum. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 4.7.
Megestrol-01