Mesalamine 4 g/60mL Enema
Other active recalls for Mesalamine (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Aminosalicylate class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Mesalamine works to reduce inflammation directly in the lining of your colon or rectum. Depending on which product you've been prescribed, it can help bring an active flare of ulce...
- What exactly is mesalamine supposed to do for me?
- It really does matter, and they're not interchangeable. The form your doctor chose depends on where in your bowel the inflammation is. Rectal suppositories (like CANASA) treat infl...
- There are so many different forms — pills, enemas, suppositories. Does it matter which one I use?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Mesalamine — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
-
UNII K6MOM3T5YL
A synthetic polymer made from acrylic acid, crosslinked for stability. Used as a thickener and gelling agent to give medicines like creams and gels their texture, and as a binder to hold tablet ingredients together.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
-
UNII M911911U02
Potassium acetate is a salt derived from potassium and acetic acid. It acts as a buffer to help maintain the medicine's pH balance and may also serve as an electrolyte source in liquid formulations.
-
UNII 65OE787Q7W
Potassium metabisulfite is a chemical salt used as a preservative and antioxidant in medicines and foods. It helps prevent spoilage and discoloration by protecting the product from oxidation and microbial growth.
-
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.
-
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.
-
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.
Where does this data come from?
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
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $0.098 | $41.33 / 420 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1148 | $48.22 / 420 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1725 | $72.45 / 420 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mesalamine 4 g/60mL 21922-0045-47 | Encube | 7 bottles | $0.098 | AB | Availability likely | — |
| Mesalamine 4 g/60mLthis 62559-0420-07 | ANI | 7 bottles | $0.098 | AB | Availability likely | — |
| Mesalamine 4 g/60mL 70954-0301-20 | ANI | 7 bottles | $0.098 | AB | Availability likely | — |
| Mesalamine 4 g/60mL 45802-0098-28 | Padagis | 28 bottles | $0.176 | AB | Availability likely | +79% |
| Mesalamine 45802-0923-41 | Padagis | 1 kit | $134.904 | AB | Availability likely | +136956% |
| Mesalamine 45802-0929-49 | Padagis | 1 kit | $134.904 | AB | Availability likely | +136956% |
| sfRowasa Sulfite-Free Formulation 4 g/60mL 00037-0022-07 | Viatris | 7 bottles | — | AB | Discontinued | — |
| Rowasa 4 g/60mL 00037-0066-03 | Viatris | 28 bottles | — | AB | FDA listed | — |
| Mesalamine 63629-8678-01 | Bryant | 1 kit | — | AB | FDA listed | — |
| Mesalamine 63629-8679-01 | Bryant | 1 kit | — | AB | FDA listed | — |
| Mesalamine 4 g/60mL 72162-2302-02 | Bryant | 7 bottles | — | AB | FDA listed | — |
| Mesalamine 4 g/60mL 84725-0002-03 | KLM | 7 bottles | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 7645801 ↗ | Drug substance | — | Jul 24, 2027 |
Is there a generic version of MESALAMINE 4 GM/60 ML ENEMA?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62559-0420-07 You're viewing this | 7 BOTTLE in 1 BOX (62559-420-07) / 60 mL in 1 BOTTLE (62559-420-11) | 2016-05-13 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Mesalamine Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended adult dosage of Mesalamine Rectal Suspension Enema in 60 mL units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. While the effect of Mesalamine Rectal Suspension Enema may be seen within 3 to 21 days, the usual course of therapy would be from 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. Studies available to date have not assessed if Mesalamine Rectal Suspension Enema will modify relapse rates after the 6-week short-term treatment.
Mesalamine Rectal Suspension Enema is for rectal use only. Drink an adequate amount of fluids during treatment. Patients should be instructed to shake the bottle well to make sure the suspension is homogeneous.
The patient should remove the protective sheath from the applicator tip. Holding the bottle at the neck will not cause any of the medication to be discharged. The position most often used is obtained by lying on the left side (to facilitate migration into the sigmoid colon); with the lower leg extended and the upper right leg flexed forward for balance.
An alternative is the knee-chest position. The applicator tip should be gently inserted in the rectum pointing toward the umbilicus. A steady squeezing of the bottle will discharge most of the preparation.
The preparation should be taken at bedtime with the objective of retaining it all night. Patient instructions are included with every seven units.
⛔ Contraindications ▾
CONTRAINDICATIONS Mesalamine Rectal Suspension Enema is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, sulfites or any other component of this medication.
⚠️ Warnings ▾
WARNINGS Hypersensitivity Reactions Sulfite-Related Reactions Mesalamine Rectal Suspension Enema contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but probably low. Sulfite sensitivity is seen more frequently in asthmatic or in atopic nonasthmatic persons.
Epinephrine is the preferred treatment for serious allergic or emergency situations even though epinephrine injection contains sodium or potassium metabisulfite with the above-mentioned potential liabilities. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite(s) in epinephrine injection should not deter the administration of the drug for treatment of serious allergic or other emergency situations.
Sulfasalazine-Associated Reactions Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to Mesalamine Rectal Suspension Enema or to other compounds that contain or are converted to mesalamine. As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis and hematologic abnormalities.
Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue Mesalamine Rectal Suspension Enema if an alternative etiology for the signs and symptoms cannot be established. Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure have been reported in patients given products that contain mesalamine or are converted to mesalamine.
In animal studies, the kidney was the principal organ of mesalamine toxicity. Evaluate the risks and benefits of using Mesalamine Rectal Suspension Enema in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs. Mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.
Evaluate renal function in all patients prior to initiation and periodically while on Mesalamine Rectal Suspension Enema therapy. Discontinue Mesalamine Rectal Suspension Enema if renal function deteriorates while on therapy. Mesalamine-Induced Acute Intolerance Syndrome Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease.
Although the exact frequency of occurrence cannot be ascertained, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. Monitor patients for worsening of these symptoms while on treatment.
If acute intolerance syndrome is suspected, promptly discontinue treatment with Mesalamine Rectal Suspension Enema.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Clinical Adverse Experience Mesalamine Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient. ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1%OF MESALAMINE RECTAL SUSPENSION TREATED PATIENTS (COMPARISON TO PLACEBO) SYMPTOM Mesalamine Rectal Suspension Enema N = 815 Placebo N=128 N % N % Abdominal Pain/Cramps/Discomfort 66 8.10 10
7.81Headache 53 6.50 16
12.50Gas/Flatulence 50 6.13 5
3.91Nausea 47 5.77 12
9.38Flu 43 5.28 1
0.78Tired/Weak/Malaise/Fatigue 28 3.44 8
6.25Fever 26 3.19 0
0.00Rash/Spots 23 2.82 4
3.12Cold/Sore Throat 19 2.33 9
7.03Diarrhea 17 2.09 5
3.91Leg/Joint Pain 17 2.09 1
0.78Dizziness 15 1.84 3
2.34Bloating 12 1.47 2
1.56Back Pain 11 1.35 1
0.78Pain on Insertion of Enema Tip 11 1.35 1
0.78Hemorrhoids 11 1.35 0
0.00Itching 10 1.23 1
0.78Rectal Pain 10 1.23 0
0.00Constipation 8 0.98 4
3.12Hair Loss 7 0.86 0
0.00Peripheral Edema 5 0.61 11
8.59UTI/Urinary Burning 5 0.61 4
3.12Rectal Pain/Soreness/Burning 5 0.61 3
2.34Asthenia 1 0.12 4
3.12Insomnia 1 0.12 3
2.34In addition, the following adverse events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice: nephrotoxicity, pancreatitis, fibrosing alveolitis, elevated liver enzymes, nephrogenic diabetes insipidus, intracranial hypertension and nephrolithiasis. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well. Published case reports and/or spontaneous post marketing surveillance have described rare instances of aplastic anemia, agranulocytosis, thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia, and infertility in men.
Anemia, leukocytosis, and thrombocytosis can be part of the clinical presentation of inflammatory bowel disease. Postmarketing cases of severe cutaneous adverse reactions (SJS/TEN, DRESS, and AGEP) and pleurisy/pleuritis have been reported. Hair Loss Mild hair loss characterized by “more hair in the comb” but no withdrawal from clinical trials has been observed in 7 of 815 mesalamine patients but none of the placebo-treated patients.
In the literature there are at least six additional patients with mild hair loss who received either mesalamine or sulfasalazine. Retreatment is not always associated with repeated hair loss. Postmarketing Experience The following adverse reactions have been identified during post-approval use of mesalamine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Renal Disorders • Urine discoloration occurring ex-vivo caused by contact of mesalamine including inactive metabolite, with surfaces or water treated with hypochlorite-containing bleach (see PRECAUTIONS: Information for Patients ).
🤰 Pregnancy ▾
Pregnancy Teratologic studies have been performed in rats and rabbits at oral doses up to five and eight times respectively, the maximum recommended human dose, and have revealed no evidence of harm to the embryo or the fetus. There are, however, no adequate and well-controlled studies in pregnant women for either sulfasalazine or 5-ASA. Because animal reproduction studies are not always predictive of human response, 5-ASA should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical trials of Mesalamine Rectal Suspension Enema did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia and pancytopenia) in patients receiving mesalamine-containing products such as Mesalamine Rectal Suspension Enema who were 65 years or older compared to younger patients, which may also be associated with ulcerative colitis, use of interacting drugs, or reduced renal function.
Consider monitoring complete blood cell counts and platelet counts in elderly patients during treatment with Mesalamine Rectal Suspension Enema, especially if used concomitantly with anticoagulants. In general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concurrent disease or other drug therapy in elderly patients when prescribing Mesalamine Rectal Suspension Enema. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
🆘 Overdosage ▾
OVERDOSAGE Mesalamine absorption from the colon is limited; however, Mesalamine Rectal Suspension Enema is an aminosalicylate, and symptoms of salicylate toxicity include nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) involvement. There is no specific antidote for mesalamine overdose.
Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Each Mesalamine Rectal Suspension Enema delivers up to 4 g of mesalamine to the left side of the colon. The mechanism of action of mesalamine (and sulfasalazine) is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid (AA) metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes (LTs) and hydroxyeicosatetraenoic acids (HETEs) is increased in patients with ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin (PG) production in the colon.
Preclinical Toxicology Preclinical studies have shown the kidney to be the major target organ for mesalamine toxicity. Adverse renal function changes were observed in rats after a single 600 mg/kg oral dose, but not after a 200 mg/kg dose. Gross kidney lesions, including papillary necrosis, were observed after a single oral > 900 mg/kg dose, and after I.V. doses of > 214 mg/kg.
Mice responded similarly. In a 13-week oral (gavage) dose study in rats, the high dose of 640 mg/kg/day mesalamine caused deaths, probably due to renal failure, and dose-related renal lesions (papillary necrosis and/or multifocal tubular injury) were seen in most rats given the high dose (males and females) as well as in males receiving lower doses 160 mg/kg/day. Renal lesions were not observed in the 160 mg/kg/day female rats.
Minimal tubular epithelial damage was seen in the 40 mg/kg/day males and was reversible. In a six-month oral study in dogs, the no-observable dose level of mesalamine was 40 mg/kg/day and doses of 80 mg/kg/day and higher caused renal pathology similar to that described for the rat. In a combined 52-week toxicity and 127-week carcinogenicity study in rats, degeneration in kidneys was observed at doses of 100 mg/kg/day and above admixed with diet for 52 weeks, and at 127 weeks increased incidence of kidney degeneration and hyalinization of basement membranes and Bowman’s capsule were seen at 100 mg/kg/day and above.
In the 12-month eye toxicity study in dogs, Keratoconjunctivitis Sicca (KCS) occurred at oral doses of 40 mg/kg/day and above. The oral preclinical studies were done with a highly bioavailable suspension where absorption throughout the gastrointestinal tract occurred. The human dose of 4 grams represents approximately 80 mg/kg but when mesalamine is given rectally as a suspension, absorption is poor and limited to the distal colon (see Pharmacokinetics ).
Overt renal toxicity has not been observed (see ADVERSE REACTIONS and PRECAUTIONS ), but the potential must be considered. Pharmacokinetics Mesalamine administered rectally as Mesalamine Rectal Suspension Enema is poorly absorbed from the colon and is excreted principally in the feces during subsequent bowel movements. The extent of absorption is dependent upon the retention time of the drug product, and there is considerable individual variation.
At steady state, approximately 10 to 30% of the daily 4-gram dose can be recovered in cumulative 24-hour urine collections. Other than the kidney, the organ distribution and other bioavailability characteristics of absorbed mesalamine in man are not known. It is known that the compound undergoes acetylation but whether this process takes place at colonic or systemic sites has not been elucidated.
Whatever the metabolic site, most of the absorbed mesalamine is excreted in the urine as the N-acetyl-5-ASA metabolite. The poor colonic absorption of rectally administered mesalamine is substantiated by the low serum concentration of 5-ASA and N-acetyl-5-ASA seen in ulcerative colitis patients after dosage with mesalamine. Under clinical conditions patients demonstrated plasma levels 10 to 12 hours post mesalamine administration of 2 μg/mL, about two-thirds of which was the N-acetyl metabolite.
While the elimination half-life of mesalam…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Mesalamine Rectal Suspension Enema for rectal administration is an off-white to tan colored suspension. Each disposable enema bottle contains 4 grams of mesalamine in 60 mL aqueous suspension. Enema bottles are supplied in boxed, foil-wrapped trays as follows: Carton of 7 Bottles: NDC 62559-420-07 Mesalamine Rectal Suspension Enemas are for rectal use only.
KEEP OUT OF REACH OF CHILDREN Patient instructions are included. Storage Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted, please refer to current USP. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your physician.
Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded. NOTE: Mesalamine Rectal Suspension Enema will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel.
Take care in choosing a suitable location for administration of this product. Rx only Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9819 Rev 10/23 For Medical Inquiries, Call Toll Free: 1-800-308-6755 ani
📋 Description ▾
DESCRIPTION The active ingredient in Mesalamine Rectal Suspension Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14.
The structural formula is: Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative.
The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product. structure