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sfRowasa Sulfite-Free Formulation mesalamine 4 g/60mL Suspension — NDC 0037-0022-07 (Billing 00037-0022-07)

by Viatris Specialty LLC · 7 BOTTLE, WITH APPLICATOR in 1 CARTON / 60 mL in 1 BOTTLE, WITH APPLICATOR

This is a package of sfRowasa Sulfite-Free Formulation mesalamine 4 g/60mL Suspension from Viatris Specialty LLC, no longer marketed (first marketed Mar 2016), no longer in the FDA NDC Directory, this package's marketing ended Jul 2026. It is the main listing for this product, which comes in 2 package sizes.

NDC 00037-0022-07
🏷️ FDA NDC (as labeled) 0037-0022-07 billing pads the labeler segment with a zero
This package
Contains60 mL in 1 bottle, with applicator Medicaid pays$1.04 / unit · 12 mo Per package$435.37 / 420 ml · Medicaid Pack sizes2 compare ↓
Main listing for product 0037-0022 · Also comes in: 28 bottles 0037-0022-28
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0037-0022-07 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0037 labeler · 0022 product · 07 package
Package marketed since
Mar 24, 2016
Package marketing ended
Jul 31, 2026
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 0037002207 8
Medicaid fills, this package
110 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Mesalamine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 5, 2024 — Failed Dissolution Specifications: Out of specification for dissolution. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0350-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0037-0022-07
Product NDC 0037-0022
11-digit billing NDC 00037002207
NCPDP billing unit ML — per mL (volume)
RxCUI 206798, 238151
UNII 4Q81I59GXC
Application # NDA019618
SPL Set ID aa273fdc-f7c4-4901-8f71-59ae03b8cdb1
Established class (EPC) Aminosalicylate
Chemical class Aminosalicylic Acids
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2016-03-24
Marketing end 2026-07-31
Route RECTAL
Dosage form SUSPENSION
Substance MESALAMINE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 52500030005110
GPI class SfRowasa
GCN Seq No 004444
GCN 47270
HICL code 001848
Ingredient (HICL) Mesalamine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q3
Therapeutic class — intermediate (HIC2) Anal-Rectal Preparations
HIC3 code Q3E
Therapeutic class — specific (HIC3) Chronic Inflam. Colon Dx, 5-A-Salicylat,Rectal Tx
AHFS code 56:36.00.00
AHFS class Anti-Inflammatory Agents (Gi Drugs)
FDB label name SFROWASA 4 GM/60 ML ENEMA
FDB brand name Sfrowasa
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004444
  • GCN: 47270
  • GPI-14 (Medi-Span): 52500030005110
  • HICL (First Databank): 001848
  • AHFS class code: 56:36.00.00
  • RxCUI (RxNorm): 206798
Why two NDCs? The FDA registers this code as 0037-0022-07 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00037-0022-07. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Aminosalicylate class.

Pharmacologic class Aminosalicylate
Drug family (ATC) Aminosalicylic acid and similar agents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name SFROWASA 4 GM/60 ML ENEMA Ingredient Mesalamine
📖 What it is MedlinePlus · NLM

Rectal mesalamine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), proctitis (swelling in the rectum), and proctosigmoiditis (swelling in the rectum and sigmoid colon [last section of the colon]). Rectal mesalamine is in a class of medications called anti-inflammatory agents. It works by stopping the body from producing a certain substance that may cause inflammation.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats ulcerative colitis and, in rectal forms, inflammation in the lower bowel such as proctitis. Some products are for flares, some for keeping remission, and some for both. Y...
  • It depends on your product. Tablets and most capsules are swallowed whole. Rectal forms are usually used at bedtime. Drink plenty of fluids, and follow your label for food and timi...
  • Headache, gas, belly pain and diarrhea are the common ones. Call your doctor if you get severe cramping with bloody diarrhea, fever or rash, since that could be a reaction to the d...
  • Yes. Your kidney function should be checked before starting and periodically after. If you take azathioprine or 6-mercaptopurine, or are 65 or older, blood counts should be monitor...
📖 Read our full Mesalamine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $1.04 $435.37 / 420 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00037-0022-07 You're viewing this Main listing 7 BOTTLE, WITH APPLICATOR in 1 CARTON / 60 mL in 1 BOTTLE, WITH APPLICATOR 2016-03-24 Jul 31, 2026 Discontinued by firm
00037-0022-28 0037-0022-28 28 BOTTLE, WITH APPLICATOR in 1 CARTON / 60 mL in 1 BOTTLE, WITH APPLICATOR 2016-05-24 Jul 31, 2026 Discontinued by firm

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 7 bottle, with applicator in 1 carton / 60 ml in 1 bottle, with applicator.
What NDC number is used to bill for this package of sfRowasa Sulfite-Free Formulation mesalamine 4 g/60mL Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mesalamine 4 g/60mL 21922-0045-47 Encube 7 bottles $0.098 AB Availability likely —
Mesalamine 4 g/60mL 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 —
Mesalamine 45802-0923-41 Padagis 1 kit $134.904 AB Availability likely —
Mesalamine 45802-0929-49 Padagis 1 kit $134.904 AB Availability likely —
sfRowasa Sulfite-Free Formulation 4 g/60mLthis 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 —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1987
First FDA approval
Dec 1987
📍
2026
Currently FDA-listed
39 years listed
🛡️
2027
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2027. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 24, 1987 AB TE-rated RLD RS ⏳ ~0.8 yr to latest listed protection

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.

Patents & exclusivity — FDA Orange Book
US 7645801 — drug substance
1987 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015 2017 2019 2021 2023 2025 2027
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 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.

Listed patents (1)
PatentTypeUse codeExpires
US 7645801 ↗ Drug substance — Jul 24, 2027
Common questions
Is there a generic version of SFROWASA 4 GM/60 ML ENEMA?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for SFROWASA 4 GM/60 ML ENEMA. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerViatris Specialty LLC
Application holderMYLAN SPECIALTY LP
FDA applicationNDA019618 (NDA)
Labeler code00037
First marketedMar 2016
Product typeHuman Prescription Drug
Portfolio120 products on file

More NDCs from Viatris Specialty LLC labeler code 00037

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

1 INDICATIONS AND USAGE sfROWASA is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. sfROWASA is an aminosalicylate indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Evaluate renal function before initiating therapy with sfROWASA [see Warnings and Precautions (5.1) ] . Recommended Dosage The recommended dosage is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours for 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. Administration Instructions • Shake the bottle to ensure the suspension is homogeneous. • Remove the protective sheath from the applicator tip. • Assume the correct body position: o Lie on the left side with the lower leg extended and the upper right leg flexed forward for balance. o Alternatively, sit in the knee to chest position. • Gently insert the applicator tip in the rectum pointing toward the umbilicus. • Steadily squeeze the bottle to discharge the medication. • Remain in the position for at least 30 minutes.

Administer at bedtime with the objective of retaining it all night. • Drink an adequate amount of fluids during treatment [see Warnings and Precautions (5.7) ] . • Evaluate renal function prior to initiation of sfROWASA and periodically while on therapy. ( 2 , 5.1 ) • The recommended dosage is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours for 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. ( 2 ) • Drink an adequate amount of fluids.

( 2 . 5.7 )

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS Rectal Suspension: 4 g/60 mL suspension bottle; off-white to tan colored suspension Rectal Suspension: 4 g/60 mL suspension bottle ( 3 )

⛔ Contraindications 49 words ▾

4 CONTRAINDICATIONS sfROWASA is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates or any other component of this medication [see Warnings and Precautions (5.3) ] . Known or suspected hypersensitivity to salicylates, aminosalicylates or any other of the ingredients in sfROWASA. ( 4 , 5.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Renal Impairment : Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits of sfROWASA in patients with known renal impairment or taking nephrotoxic drug. Discontinue sfROWASA if renal function deteriorates while on therapy.

( 7.1 ) • Mesalamine-Induced Acute Intolerance Syndrome : Discontinue treatment if acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, sometimes fever, headache and rash) is suspected. ( 5.2 ) • Hepatic Failure : Evaluate the risks and benefits of using sfROWASA in patients with known liver impairment. ( 5.3 ) • Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other sings of hypersensitivity and consider further evaluation.

( 5.4 ) • Photosensitivity : Avoid sun exposure if pre-existing skin conditions. ( 5.5 ) • Nephrolithiasis : Cases of nephrolithiasis have been reported with the use of mesalamine. Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT).

Ensure adequate hydration during treatment. ( 5.6 ) • Interference with Laboratory Tests : Mesalamine may lead to elevated urinary normetanephrine test results. ( 5.7 )

5.1Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure have been reported in patients given sfROWASA or other products that contain mesalamine or are converted to mesalamine. In animal studies, the kidney was the principal organ of mesalamine toxicity [see Nonclinical Toxicology (13.2) ] . Evaluate the risks and benefits of using sfROWASA in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs.

Evaluate renal function in all patients prior to initiation and periodically while on sfROWASA therapy. Discontinue sfROWASA if renal function deteriorates while on therapy [see Drug Interactions (7.1) , Use in Specific Populations (8.6)] .

5.2Mesalamine-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 sfROWASA.

5.3Hepatic Failure There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered other products containing mesalamine. Evaluate the risks and benefits of using sfROWASA in patients with known liver impairment.

5.4Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of mesalamine [see Adverse Reactions (6) ] . Discontinue sfROWASA at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

5.5Photosensitivity Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.

5.6Nephrolithiasis Cases of nephrolithiasis have been reported with the use of mesalamine, including stones with 100% mesalamine content. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure ad… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Renal impairment [see Warnings and Precautions (5.1) ] • Mesalamine-induced acute intolerance syndrome [see Warnings and Precautions (5.2) ] • Hepatic failure [see Warnings and Precautions (5.3) ] • Severe cutaneous adverse reactions [see Warnings and Precautions (5.4) ] • Photosensitivity [see Warnings and Precautions (5.5) ] • Nephrolithiasis [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥1%) are: gas/flatulence, flu, fever, leg/joint pain, hemorrhoids, rectal pain and hair loss.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc at 1-866-210-5949 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 1: Adverse Reactions reported in 1% or more of sfROWASA-treated patients and greater than placebo in Clinical Trials of sfROWASA in Adult Patients with Ulcerative Colitis, Proctosigmoiditis or Proctitis Adverse Reaction sfROWASA (N=815) % Placebo (N=128) % Gas/Flatulence 6 4 Flu 5 1 Fever 3 0 Leg/Joint pain 2 1 Hemorrhoids 1 1 Rectal pain 1 0 Hair loss 1 0

6.2Postmarketing 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. Gastrointestinal Disorders: pancreatitis Hematologic Disorders: agranulocytosis, aplastic anemia, eosinophilia, leukopenia, neutropenia, pancytopenia, thrombocytopenia Hepatic Disorders: elevated liver enzymes, hepatic failure [see Warnings and Precautions (5.3) ] Nervous System: intracranial hypertension Renal and Urinary Disorders: acute renal failure, chronic renal failure, interstitial nephritis, nephrogenic diabetes insipidus, nephrolithiasis, nephrotoxicity [see Warnings and Precautions (5.1) , (5.6) ] • Urine discoloration occurring ex-vivo caused by contact of mesalamine including inactive metabolite, with surfaces or water treated with hypochlorite-containing bleach Reproductive System and Breast Disorders: reversible oligospermia Respiratory, Thoracic, and Mediastinal Disorders: fibrosing alveolitis, pleurisy/pleuritis Skin and Subcutaneous Tissue Disorders: AGEP, DRESS, SJS/TEN [see Warnings and Precautions (5.4) ]

🔄 Drug Interactions 195 words ▾

7 DRUG INTERACTIONS • Nephrotoxic Agents including Non-Steroidal Anti-inflammatory Drugs (NSAIDs) : Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. ( 7.1 ) • Azathioprine or 6-Mercaptopurine : Increased risk of blood dyscrasias; monitor complete blood cell counts and platelet counts. ( 7.2 )

7.1Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see Warnings and Precautions (5.2) ] .

7.2Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6‑mercaptopurine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of sfROWASA and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.

7.3Interference with Urinary Normetanephrine Measurements Use of sfROWASA may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.7) ] . Consider an alternative, selective assay for normetanephrine.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatric Patients : Increased risk of blood dyscrasias; monitor complete blood cell counts and platelet counts. ( 8.5 )

8.1Pregnancy Risk Summary Published data from meta-analyses, cohort studies and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . There are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see Clinical Considerations ) . In animal reproduction studies, rats and rabbits administered mesalamine during organogenesis at oral doses up to 5 and 8 times the maximum recommended human dose, respectively, did not reveal any evidence of harm to the embryo or the fetus (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Data Human Data Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of sfROWASA, during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes.

There is no clear evidence that mesalamine exposure in early pregnancy is associated with an increase risk in major congenital malformations, including cardiac malformations. Published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products. Animal Data Reproduction studies have been performed with mesalamine in rats and rabbits during organogenesis at oral doses up to 5 and 8 times respectively, the maximum recommended human dose, and have revealed no evidence of harm to the embryo or the fetus.

8.2Lactation Risk Summary Data from published literature report the presence of mesalamine and its metabolite, N‑acetyl‑5‑aminosalicylic acid in human milk in small amounts with relative infant doses (RID) of 0.1% or less for mesalamine (see Data ) . There are case reports of diarrhea observed in breastfed infants exposed to mesalamine (see Clinical Considerations ) . There is no information on the effects of mesalamine on milk production.

The lack of clinical data during lactation precludes a clear determination of the risk of sfROWASA to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sfROWASA and any potential adverse effects on the breastfed child from sfROWASA or from the underlying maternal condition. Clinical Considerations Advise the caregiver to monitor the breastfed infant for diarrhea. Data In published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 4.8 g daily.

The average concentration of mesalamine in milk ranged from non‑detectable to 0.5 mg/L. The average concentration of N‑acetyl‑5-aminosalicylic acid in milk ranged from 0.2 to 9.3 mg/L. Based on these concentrations, estimated infant… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Published data from meta-analyses, cohort studies and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . There are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see Clinical Considerations ) . In animal reproduction studies, rats and rabbits administered mesalamine during organogenesis at oral doses up to 5 and 8 times the maximum recommended human dose, respectively, did not reveal any evidence of harm to the embryo or the fetus (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Data Human Data Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of sfROWASA, during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes.

There is no clear evidence that mesalamine exposure in early pregnancy is associated with an increase risk in major congenital malformations, including cardiac malformations. Published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products. Animal Data Reproduction studies have been performed with mesalamine in rats and rabbits during organogenesis at oral doses up to 5 and 8 times respectively, the maximum recommended human dose, and have revealed no evidence of harm to the embryo or the fetus.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 133 words ▾

8.5Geriatric Use Clinical trials of sfROWASA 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 sfROWASA who were 65 years or older compared to younger adult 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 patients 65 years and over during treatment with sfROWASA. In general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concurrent disease or other drug therapy in patients 65 years and over when prescribing sfROWASA.

🆘 Overdosage 98 words ▾

10 OVERDOSAGE sfROWASA 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; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent further absorption.

Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of 5-ASA (mesalamine) is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways (i.e., prostanoids), and through the lipoxygenase pathways (i.e., leukotrienes and hydroxyeicosatetraenoic acids) is increased in patients with ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of mesalamine have not been fully characterized.

12.3Pharmacokinetics Absorption Mesalamine administered rectally as sfROWASA 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. Under clinical conditions patients demonstrated plasma levels 10 to 12 hours post mesalamine administration of 2 mcg/mL, about two-thirds of which was the N-acetyl metabolite.

In addition, steady state plasma levels demonstrated a lack of accumulation of either parent drug or N-acetyl metabolite during repeated daily rectal administrations. Distribution Other than the kidney, the organ distribution and other bioavailability characteristics of absorbed mesalamine in man are not known. 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.

Elimination Metabolism It is known that the compound undergoes acetylation but whether this process takes place at colonic or systemic sites has not been elucidated. Excretion Whatever the metabolic site, most of the absorbed mesalamine is excreted in the urine as the N-acetyl-5-ASA metabolite. At steady state, approximately 10 to 30% of the daily 4-gram dose can be recovered in cumulative 24-hour urine collections.

While the elimination half-life of mesalamine is short (0.5 to 1.5 hours), the acetylated metabolite exhibits a half-life of 5 to 10 hours.

🧬 Mechanism of Action 75 words ▾

12.1Mechanism of Action The mechanism of action of 5-ASA (mesalamine) is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways (i.e., prostanoids), and through the lipoxygenase pathways (i.e., leukotrienes and hydroxyeicosatetraenoic acids) is increased in patients with ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

📦 How Supplied / Storage and Handling 153 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING sfROWASA ® (mesalamine) rectal suspension is an off-white to tan colored suspension. Each disposable suspension bottle contains 4 grams of mesalamine in 60 mL aqueous suspension. Suspension bottles are supplied in boxed, foil-wrapped trays as follows: NDC 0037-0022-60 ..................

Sample – 1 Bottle NDC 0037-0022-07 .................. Carton of 7 Bottles NDC 0037-0022-14 .................. Carton of 14 Bottles NDC 0037-0022-28 ..................

Carton of 28 Bottles sfROWASA ® (mesalamine) rectal suspension is for rectal use only. Storage Store at controlled room temperature 20°C to 25°C (68°F to 77°F); Excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Once the foil wrapped unit of seven bottles is opened, all suspensions should be used promptly as directed by your physician.

Contents of suspensions removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, suspensions with dark brown contents should be discarded.

📋 Description 128 words ▾

11 DESCRIPTION The active ingredient in sfROWASA ® (mesalamine) Rectal Suspension, 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: sfROWASA is supplied as a suspension for rectal administration. Each rectal suspension unit contains 4 grams of mesalamine. The inactive ingredients are carbomer 934P, edetate disodium, potassium acetate, purified water, sodium benzoate 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. mesalamine structural formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Instructions for Use ). Renal Impairment Inform patients that sfROWASA may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, and periodic monitoring of renal function will be performed while they are on therapy. Advise patients to complete all blood tests ordered by their healthcare provider [see Warnings and Precautions (5.1) ] .

Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity Reactions Instruct patients to stop taking sfROWASA and report to their healthcare provider if they experience new or worsening symptoms of acute intolerance syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, and rash) or other symptoms suggestive of mesalamine-induced hypersensitivity [see Warnings and Precautions (5.2 , 5.3) ] . Hepatic Failure Advise patients with known liver disease to contact their healthcare provider if they experience signs or symptoms of worsening liver function [see Warnings and Precautions (5.4) ] .

Severe Cutaneous Adverse Reactions Inform patients of the signs and symptoms of severe cutaneous adverse reactions. Instruct patients to stop taking sfROWASA and report to their healthcare provider at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity [see Warnings and Precautions (5.5) ] . Photosensitivity Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors [see Warnings and Precautions (5.7) ] .

Nephrolithiasis Instruct patients to drink an adequate amount of fluids during treatment in order to minimize the risk of kidney stone formation and to contact their healthcare provider if they experience signs or symptoms of a kidney stone (e.g., severe side or back pain, blood in the urine) [see Warnings and Precautions (5.7) ] . Blood Disorders Inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy.

Advise patients to complete all blood tests ordered by their healthcare provider [see Drug Interactions (7.2) , Use in Specific Populations (8.5) ] . Administration Advise patients that sfROWASA will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Administer the product in a suitable location.

Instruct patients: • Shake the bottle to ensure the suspension is homogeneous. • Remove the protective sheath from the applicator tip. • Lie on the left side with the lower leg extended and the upper right leg flexed forward for balance. Alternatively, alternative is the knee-chest position. • Gently insert the applicator tip in the rectum pointing toward the umbilicus. • Steadily squeeze the bottle to discharge the medication. • Administer at bedtime with the objective of retaining it all night. • Drink an adequate amount of fluids during treatment [see Warnings and Precautions (5.7) ] . • Advise patients that urine may become discolored reddish-brown while taking sfROWASA when it comes in contact with surfaces or water treated with hypochlorite-containing bleach.

If discolored urine is observed, advise patients to observe their urine flow. Report to the healthcare provider only if urine is discolored on leaving the body, before contact with any surface or water (e.g., in the toilet). IN-003260-08 Distributed by: Meda Pharmaceuticals Canonsburg, PA 15317 U.S.A. © 2024 Viatris Inc. sfROWASA is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company.

For Medical Inquiries, Call Toll Free: 1-866-210-5949

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption Mesalamine administered rectally as sfROWASA 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. Under clinical conditions patients demonstrated plasma levels 10 to 12 hours post mesalamine administration of 2 mcg/mL, about two-thirds of which was the N-acetyl metabolite.

In addition, steady state plasma levels demonstrated a lack of accumulation of either parent drug or N-acetyl metabolite during repeated daily rectal administrations. Distribution Other than the kidney, the organ distribution and other bioavailability characteristics of absorbed mesalamine in man are not known. 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.

Elimination Metabolism It is known that the compound undergoes acetylation but whether this process takes place at colonic or systemic sites has not been elucidated. Excretion Whatever the metabolic site, most of the absorbed mesalamine is excreted in the urine as the N-acetyl-5-ASA metabolite. At steady state, approximately 10 to 30% of the daily 4-gram dose can be recovered in cumulative 24-hour urine collections.

While the elimination half-life of mesalamine is short (0.5 to 1.5 hours), the acetylated metabolite exhibits a half-life of 5 to 10 hours.

🧬 Pharmacodynamics 23 words ▾

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of mesalamine have not been fully characterized.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES In a 6-week placebo-controlled trial, international, multicenter trial of 153 patients with active distal ulcerative colitis, proctosigmoiditis or proctitis, sfROWASA ® (mesalamine) rectal suspension reduced the overall disease activity index (DAI) and individual components as follows: EFFECT OF TREATMENT ON SEVERITY OF DISEASE DATA FROM U.S.-CANADA TRIAL COMBINED RESULTS OF EIGHT CENTERS Each parameter has a 4-point scale with a numerical rating: 0 = normal, 1 = mild, 2 = moderate, 3 = severe. The four parameters are added together to produce a maximum overall DAI of 12.

Activity Indices, mean N Baseline Day 22 End Point Change Baseline to End Point * Percent change for overall DAI only (calculated by taking the average of the change for each individual patient). Overall DAI sfROWASA ® Placebo 76 77 7.42 7.40 4.05 † Significant sfROWASA®/placebo difference. p < 0.01 6.03 3.37 ‡ Significant sfROWASA®/placebo difference. p < 0.001 5.83 -55.07% -21.58% Stool Frequency sfROWASA ® Placebo 1.58 1.92 1.11 § Significant sfROWASA®/placebo difference. p < 0.05 1.47 1.01 1.50 -0.57 -0.41 Rectal Bleeding sfROWASA ® Placebo 1.82 1.73 0.59 1.21 0.51 1.11 -1.30 -0.61 Mucosal Inflammation sfROWASA ® Placebo 2.17 2.18 1.22 1.74 0.96 1.61 -1.21 -0.56 Physician’s Assessment of Disease Severity sfROWASA ® Placebo 1.86 1.87 1.13 1.62 0.88 1.55 -0.97 -0.30 Differences between sfROWASA ® (mesalamine) Rectal Suspension and placebo were also statistically different in subgroups of patients on concurrent sulfasalazine and in those having an upper disease boundary between 5 and 20 or 20 and 40 cm.

Significant differences between sfROWASA ® (mesalamine) Rectal Suspension and placebo were not achieved in those subgroups of patients on concurrent prednisone or with an upper disease boundary between 40 and 50 cm.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 2-year carcinogenicity study in Wistar rats fed up to 320 mg/kg/day (approximately 0.78 times the maximum recommended human dose, based on a body surface area comparison). of mesalamine admixed with diet, mesalamine did not cause an increase in the incidence of neoplastic lesions over controls. Mutagenesis Mesalamine is not mutagenic to Salmonella typhimurium tester strains TA98, TA100, TA1535, TA1537, TA1538. There were no reverse mutations in an assay using E. coli strain WP2UVRA.

There were no evidence of genotoxicity in an in vivo mouse micronucleus assay at 600 mg/kg and in an in vivo sister chromatid exchange assay at doses up to 610 mg/kg. Impairment of Fertility Mesalamine had no effects on fertility in rats at doses up to 320 mg/kg/day (approximately 0.78 times the maximum recommended human dose, based on a body surface area comparison).

13.2Animal Toxicology and/or Pharmacology 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 145 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 2-year carcinogenicity study in Wistar rats fed up to 320 mg/kg/day (approximately 0.78 times the maximum recommended human dose, based on a body surface area comparison). of mesalamine admixed with diet, mesalamine did not cause an increase in the incidence of neoplastic lesions over controls. Mutagenesis Mesalamine is not mutagenic to Salmonella typhimurium tester strains TA98, TA100, TA1535, TA1537, TA1538. There were no reverse mutations in an assay using E. coli strain WP2UVRA.

There were no evidence of genotoxicity in an in vivo mouse micronucleus assay at 600 mg/kg and in an in vivo sister chromatid exchange assay at doses up to 610 mg/kg. Impairment of Fertility Mesalamine had no effects on fertility in rats at doses up to 320 mg/kg/day (approximately 0.78 times the maximum recommended human dose, based on a body surface area comparison).

📄 Patient Package Insert ~3 min read ▾

INSTRUCTIONS FOR USE sfROWASA ® [s f ro wa sa] (mesalamine) rectal suspension sulfite-free formulation This Instructions for Use contains information on how to use sfROWASA ® (mesalamine) rectal suspension. Read these Instructions for Use that come with your sfROWASA (mesalamine) rectal suspension before you start using it and each time you get a refill. There may be new information.

This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. How should I Store sfROWASA? • Store sfROWASA at room temperature between 68°F to 77°F (20°C to 25°C). • sfROWASA is an off-white to tan colored suspension. The medicine removed from the foil pouch may darken with time.

Slight darkening will not affect how well sfROWASA works. • Throw away sfROWASA (mesalamine) rectal suspensions with dark brown medicine. • Keep sfROWASA and all medicines out of the reach of children. Important Information You Need to Know Before Using sfROWASA • sfROWASA is for rectal use only. • Do not share sfROWASA with other people, it may harm them. • If a caregiver is giving sfROWASA make sure they read and understand these Instructions for Use. • Use sfROWASA exactly as your healthcare provider tells you to use it. • It is recommended to use 1 sfROWASA bottle each day. • After the foil wrapped unit of 7 bottles is opened, use each bottle of sfROWASA (mesalamine) rectal suspension right away. • Empty bowels right before the medicine is given. • Give at bedtime. • sfROWASA will stain some surfaces including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel.

Take care in choosing the right place for giving the sfROWASA (mesalamine) rectal suspension. Preparing to use sfROWASA Step 1. Remove the bottles. • Remove all the bottles from the protective foil pouch by grasping at the seam and tearing downward or by using scissors at the top of the foil pouch (See Figure A). • Be careful not to squeeze or puncture bottles.

Figure A Step 2. Prepare to give the medicine. • Shake the first bottle well to make sure that the medicine is mixed well. • Remove the protective sheath from the applicator tip. Hold the bottle at the neck so as not to cause any of the medicine to be released (See Figure B) .

Figure B Step 3. Get in position. • Lay on your left side with your left leg extended and your right leg flexed forward for balance (See Figure C) . Figure C or • Get in the knee-chest position as shown here (See Figure D) .

Figure D Step 4. Giving the medicine. • Lubricate the applicator tip. • Gently insert the lubricated applicator tip into the rectum pointing slightly toward the belly button (navel) to prevent damage to the rectal wall. • Grasp the bottle firmly, then tilt slightly so that the nozzle is aimed toward the back. • Squeeze the bottle slowly to release the medicine into the rectum (See Figure E) . • Steady hand pressure will release most of the medicine. Figure E • After giving the medicine, withdraw the applicator tip. • Remain in position for at least 30 minutes to allow the medicine to spread inside the body. • Throw away (discard) the bottle. • Try to keep the medicine inside your body all night, if possible.

Distributed by: Meda Pharmaceuticals Canonsburg, PA 15317 U.S.A. © 2024 Viatris Inc. U.S. Patent No.

7,645,801 sfROWASA is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. IN-003260-08 Rev. 7/2024 For Medical Inquiries, Call Toll Free: 1-866-210-5949 Figure A Figure B Figure C Figure D Figure E

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL – 4 g/60 mL NDC 0037-0022-07 7 X 60 mL Unit-Dose Bottles sfROWASA® (mesalamine) rectal suspension, 4 g/60 Ml Sulfite-Free Formulation 7 pack For Rectal Use Only Rx Only Each disposable unit contains: Mesalamine (5-aminosalicylic acid)........................................................4 grams in suspension containing carbomer 934P, edetate disodium, potassium acetate, purified water, sodium benzoate, and xanthan gum. USUAL DOSE: One unit-dose suspension in the evenings before going to bed.

See package insert for complete prescribing information including usual dose. See enclosed directions for use. Use as directed by your physician.

KEEP THIS AND ANY MEDICATION OUT OF REACH OF CHILDREN. SHAKE WELL BEFORE USING. FOIL WRAP PROTECTS PRODUCT FROM DISCOLORATION.

DO NOT REMOVE PRODUCT FROM FOIL WRAP UNTIL READY TO USE. Once the foil-wrapped unit of seven bottles is opened, any bottles remaining after 14 days should be discarded. Product contents may darken with time.

NOTE: product contents will cause staining of most direct contact surfaces. Store at controlled room temperature 20° to 25°C (68° to 77°F); brief excursions permitted 15° to 30°C (59° to 86°F) [See USP]. Dispensed in original foil-wrapped package.

For medical inquiries, call toll-free 1-866-210-5950. SHAKE WELL BEFORE USING Distributed by: MEDA PHARMACEUTICALS® Canonsburg, PA 15317 U.S.A. © 2024 Viatris Inc SFROWASA is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. U.S.

Patent No. 7,645,801 UC-003207-05 Rev. 8/2024 Container Label 4 g/60 mL

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
110
Units reimbursed last 4 qtrs
157.8K
Gross reimbursed last 4 qtrs
$163.6K
Avg / prescription
$1,487.03
Avg / unit
$1.0366
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 110 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 73,080 units · 983 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 84,720 units · 375 per 100k residents FL
Units reimbursed · per 100k residents
375983
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Arizona 983 /100k
2 Florida 375 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
7 bottles this page00037-0022-07 110 Rx · $163,573
28 bottles00037-0022-28 No Medicaid data
Drug total (last 4 qtrs): 110 Rx · 157,800 units · $163,573 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Mesalamine (matched by generic name) — the program that covers self-administered drugs. 14 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Mesalamine. CMS lists 9 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$39.58M
Claims incl. refills
102.6K
Beneficiaries
69.2K
Spend / beneficiary
$571.72
Spend / claim
$385.73
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Mesalamine — the ingredient across all brands.

Top reported reactions

Colitis Ulcerative6,708
Diarrhoea4,922
Condition Aggravated4,591
Fatigue3,838
Abdominal Pain3,746
Haematochezia3,666
Nausea3,316

Age at onset

Neonate48
Infant27
Child174
Adolescent340
Adult5,174
Elderly1,648

Reporter sex

55,833 reports
Male · 42%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization17,400
Death2,749
Life-threatening1,784
Disabling1,350
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 5,522 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 28 bottles (00037-0022-28). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Viatris Specialty LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00032-3016-12 · AbbVie 00037-0066-03 · Viatris →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.