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Mesalamine 1.2 g Tablet, Delayed Release, 120-count — NDC 00527-3012-48 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mesalamine 1.2 g Tablet, Delayed Release, 120-count — NDC 0527-3012-48 (Billing 00527-3012-48)

by Lannett Company Inc. · 120 TABLET, DELAYED RELEASE in 1 BOTTLE

This is a package of 120 tablets of Mesalamine 1.2 g Tablet, Delayed Release from Lannett Company Inc., marketed since Jun 2023 and currently FDA-listed; retail pharmacies pay about $0.7809 per tablet (NADAC). It is this product's only package size.

NDC 00527-3012-48
🏷️ FDA NDC (as labeled) 0527-3012-48 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 0527-3012-48 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0527 labeler · 3012 product · 48 package
Package marketed since
Jun 3, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
120 EA per package
Barcode (UPC)
0305273012485
Medicaid fills, this package
17,863 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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0527-3012-48
Product NDC 0527-3012
11-digit billing NDC 00527301248
NCPDP billing unit EA — each (per item)
RxCUI 686429
UNII 4Q81I59GXC
UPC 0305273012485
Application # ANDA217337
SPL Set ID 29dbe417-15a9-4c4d-846b-81cabda7ac70
Established class (EPC) Aminosalicylate
Chemical class Aminosalicylic Acids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-03
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance MESALAMINE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 52500030000670
GCN Seq No 062058
GCN 97842
HICL code 001848
Ingredient (HICL) Mesalamine
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6F
Therapeutic class — specific (HIC3) Drug Tx-Chronic Inflam. Colon Dx,5-Aminosalicylat
AHFS code 56:36.00.00
AHFS class Anti-Inflammatory Agents (Gi Drugs)
FDB label name MESALAMINE DR 1.2 GM TABLET
FDB brand name Mesalamine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 062058
  • GCN: 97842
  • GPI-14 (Medi-Span): 52500030000670
  • HICL (First Databank): 001848
  • AHFS class code: 56:36.00.00
  • RxCUI (RxNorm): 686429
Why two NDCs? The FDA registers this code as 0527-3012-48 — 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 → 00527-3012-48. 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 MESALAMINE DR 1.2 GM TABLET Ingredient Mesalamine
📗 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 eaPer package
Retail pharmacies payNADAC · weekly $0.781 $93.71 / 120 tablets
Medicaid paysCMS SDUD · 12 mo $1.33 $159.71 / 120 tablets
Medicare drug plans payPart D · Q2 2026 $1.71 $205.00 / 120 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $2.054 $0.781
▼ Down 60% over the last 13 months.
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
00527-3012-48 You're viewing this Main listing 120 TABLET, DELAYED RELEASE in 1 BOTTLE 2023-06-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mesalamine 1.2 gthis 00527-3012-48 Lannett 120 tablets $0.781 AB Availability likely —
Mesalamine 1.2 g 00591-2245-22 Actavis 120 tablets $0.781 AB Availability likely —
mesalamine 1.2 g 00904-6832-04 Major 1 tablet $0.781 AB Availability likely —
Mesalamine 1.2 g 60687-0397-25 American 1 tablet $0.781 AB Availability likely —
Mesalamine 1.2 g 62135-0714-12 Chartwell 120 tablets $0.781 AB Availability likely —
Mesalamine 1.2 g 63304-0175-13 Sun 120 tablets $0.781 AB Availability likely —
mesalamine 1.2 g 68382-0711-19 Zydus 120 tablets $0.781 AB Availability likely —
Mesalamine 1.2 g 72603-0304-01 NorthStar 120 tablets $0.781 AB Availability likely —
Mesalamine 1.2 g 54092-0100-01 Takeda 120 tablets $0.795 AB Availability likely +2%
Lialda 1.2 g 54092-0476-01 Takeda 120 tablets $8.947 AB Availability likely +1046%
Mesalamine 1.2 g 31722-0043-05 Camber 500 tablets — AB FDA listed —
mesalamine 1.2 g 51407-0900-12 Golden 120 tablets — AB FDA listed —
mesalamine 1.2 g 70771-1071-01 Zydus 120 tablets — AB FDA listed —
Mesalamine 1.2 g 72162-2213-02 Bryant 120 tablets — AB FDA listed —
Mesalamine 1.2 g 72162-2231-02 Bryant 120 tablets — AB FDA listed —
Mesalamine 1.2 g 84612-0175-13 Nuvaila 120 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
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.

🧪 Avoiding an ingredient? See Mesalamine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 36SFW2JZ0W
    Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 74G4R6TH13
    A synthetic polymer made by combining two plastic-like chemicals. It forms a coating on tablets or capsules that dissolves at a specific point in the digestive tract, controlling where and when the medicine releases.
  • UNII 5KY68S2577
    A synthetic plastic polymer made from two chemical compounds combined in a specific ratio. It forms a coating on tablets and capsules to control how and where the medication dissolves in the digestive tract.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

15 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
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

LabelerLannett Company Inc.
Application holderSINOTHERAPEUTICS INC
FDA applicationANDA217337 (ANDA)
Labeler code00527
First marketedJun 2023
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from Lannett Company Inc. labeler code 00527

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 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 86 words ▾

1 INDICATIONS AND USAGE Mesalamine delayed-release tablets are indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. Mesalamine delayed-release tablets are an aminosalicylate indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. ( 1 ) treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg.

(1)

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Administration Instructions Evaluate renal function prior to initiation of mesalamine delayed-release tablets and periodically while on therapy. ( 2 , 5.1 ) Swallow mesalamine delayed-release tablets whole; do not split or crush. ( 2 ) Administer mesalamine delayed-release tablets with food.

( 2 ) Drink an adequate amount of fluids. ( 2 , 5.8 ) Recommended Dosage in Adults For induction of remission : 2.4 g to 4.8 g (two to four 1.2-g tablets) once daily. ( 2 ) For maintenance of remission : 2.4 g (two 1.2-g tablets) once daily.

( 2 ) Recommended Dosage in Pediatric Patients The recommended dosage for treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg who can swallow tablets whole is shown below: (2) Weight of Pediatric Patient Once Daily Mesalamine Delayed-Release Tablets Dosage Week 0 to Week 8 After Week 8 24 kg to 35 kg 2.4 g (two 1.2-g tablets) 1.2 g (one 1.2-g tablet) Greater than 35 kg to 50 kg 3.6 g (three 1.2-g tablets) 2.4 g (two 1.2-g tablets) Greater than 50 kg 4.8 g (four 1.2-g tablets) 2.4 g (two 1.2-g tablets) Administration Instructions Evaluate renal function prior to initiation of mesalamine delayed-release tablets and periodically while on therapy.

Swallow mesalamine delayed-release tablets whole; do not split or crush. Administer mesalamine delayed-release tablets with food [see Clinical Pharmacology (12.3) ] . Drink an adequate amount of fluids [see Warnings and Precautions (5.8) ] .

Adults The recommended dosage for the induction of remission in adult patients with mildly to moderately active ulcerative colitis is 2.4 g to 4.8 g (two to four 1.2-g tablets) taken once daily. The recommended dosage for the maintenance of remission is 2.4 g (two 1.2-g tablets) taken once daily. Pediatric Patients The recommended dosage for treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg who can swallow tablets whole is shown in Table 1: Table 1: Recommended Dosage of Mesalamine Delayed-Release Tablets for the Treatment of Mildly to Moderately Active Ulcerative Colitis in Pediatric Patients Weighing at least 24 kg Weight of Pediatric Patient Once Daily Mesalamine Delayed-Release Tablets Dosage Week 0 to Week 8 After Week 8 24 kg to 35 kg 2.4 g (two 1.2-g tablets) 1.2 g (one 1.2-g tablet) Greater than 35 kg to 50 kg 3.6 g (three 1.2-g tablets) 2.4 g (two 1.2-g tablets) Greater than 50 kg 4.8 g (four 1.2-g tablets) 2.4 g (two 1.2-g tablets)

💊 Dosage Forms and Strengths 34 words ▾

3 DOSAGE FORMS AND STRENGTHS The light red to red ellipsoidal delayed-release tablet containing 1.2 g mesalamine, USP is debossed on one side and imprinted with ‘S1’. Delayed-Release Tablets: 1.2 g ( 3 )

⛔ Contraindications 62 words ▾

4 CONTRAINDICATIONS Mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of mesalamine delayed-release tablets [see Warnings and Precautions (5.3) , Adverse Reactions (6.2) , Description (11) ] . Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release tablets. ( 4 )

⚠️ 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 mesalamine delayed-release tablets in patients with known renal impairment or taking nephrotoxic drugs. Discontinue mesalamine delayed-release tablets if renal function deteriorates while on therapy.

( 5.1 , 7.1 , 8.6 ) Mesalamine-Induced Acute Intolerance Syndrome : Symptoms may be difficult to distinguish from an ulcerative colitis exacerbation. Monitor for worsening symptoms while on treatment. Discontinue treatment if acute intolerance syndrome is suspected.

( 5.2 ) Hypersensitivity Reactions, including myocarditis and pericarditis : Evaluate patients immediately and discontinue mesalamine delayed-release tablets if a hypersensitivity reaction is suspected. ( 5.3 ) Hepatic Failure : Evaluate the risks and benefits of using mesalamine delayed-release tablets in patients with known liver impairment. ( 5.4 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

( 5.5 ) Upper Gastrointestinal Tract Obstruction : Avoid in patients with pyloric stenosis or other organic or functional obstruction. ( 5.6 ) Photosensitivity : Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. ( 5.7 ) 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. ( 5.8 ) Interference With Laboratory Tests : Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection.

( 5.9 )

5.1Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as mesalamine delayed-release tablets that contain mesalamine or are converted to mesalamine. In animal studies, the kidney was the principal organ of mesalamine toxicity [see Adverse Reactions (6.2) , Nonclinical Toxicology (13.2) ] . Evaluate renal function prior to initiation of mesalamine delayed-release tablets therapy and periodically while on therapy.

Evaluate the risks and benefits of using mesalamine delayed-release tablets in patients with known renal impairment, history of renal disease, or taking concomitant nephrotoxic drugs. Discontinue mesalamine delayed-release tablets 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 an exacerbation of ulcerative colitis. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain, and bloody diarrhea, and sometimes fever, headache, and rash.

Monitor patients closely for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with mesalamine delayed-release tablets.

5.3Hypersensitivity Reactions Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some of these patients may have a similar reaction to mesalamine delayed-release tablets 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 pat… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Renal impairment, including renal failure [see Warnings and Precautions (5.1) ] Mesalamine-induced acute intolerance syndrome [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] Hepatic failure [see Warnings and Precautions (5.4) ] Severe cutaneous adverse reactions [see Warnings and Precautions (5.5) ] Upper gastrointestinal tract obstruction [see Warnings and Precautions (5.6) ] Photosensitivity [see Warnings and Precautions (5.7) ] Nephrolithiasis [see Warnings and Precautions (5.8) ] Most common adverse reactions in: adults (≥2%) are headache, flatulence, liver function test abnormal, abdominal pain, and diarrhea.

( 6.1 ) pediatric patients (≥5%) are abdominal pain, upper respiratory tract infection, vomiting, anemia, headache, and viral infection. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 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. Adults Induction The most common adverse reactions occurring in at least 1% of mesalamine delayed-release tablets - or placebo-treated adult patients with mildly to moderately active ulcerative colitis in two eight-week, randomized, double-blind, placebo-controlled trials (Study 1 and Study 2) [see Clinical Studies (14.1) ] are listed in Table 2.

Table 2: Adverse Reactions Reported in at least 1% of patients in at least one mesalamine delayed-release tablets group and greater than placebo in Two Eight-Week, Placebo-Controlled Trials of Induction Therapy (Study 1 and Study 2) in Adults with Mildly to Moderately Active Ulcerative Colitis Adverse Reaction Mesalamine Delayed-Release Tablets 2.4 g once daily Mesalamine Delayed-Release Tablets 4.8 g once daily Placebo (n=177) (n=179) (n=179) Headache 6% 3% <1% Flatulence 4% 3% 3% Liver Function Test Abnormal <1% 2% 1% Alopecia 0 1% 0 Pruritus <1% 1% 1% Pancreatitis occurred in less than 1% of patients during induction in clinical trials and resulted in discontinuation of therapy with mesalamine delayed-release tablets in patients experiencing this event.

Maintenance of Remission A mesalamine delayed-release tablets dosage of 2.4 g/day, administered as either 1.2 g twice daily or 2.4 g once daily, was evaluated for safety in three maintenance trials in patients with mildly to moderately active ulcerative colitis: a 6-month double-blind, active-controlled study (Study 3) [see Clinical Studies (14.1) ] and two 12- to 14-month open-label studies. The most common adverse reactions with mesalamine delayed-release tablets in these maintenance trials are listed in Table 3. Table 3: Adverse Reactions Reported in at least 1% of patients in Three Trials of Maintenance of Remission in Adults with Ulcerative Colitis Mesalamine Delayed-Release Tablets 2.4 g/day Administered either as 1.2 g twice daily or 2.4 g once daily (n=1,082) Adverse Reaction % Headache 3% Liver function test abnormal 2% Abdominal pain 2% Diarrhea 2% Abdominal distension 1% Abdominal pain upper 1% Dyspepsia 1% Back pain 1% Rash 1% Arthralgia 1% Fatigue 1% Hypertension 1% The following adverse reactions, presented by body system, were reported in less than 1% of mesalamine delayed-release tablets-treated patients with ulcerative colitis in either induction or maintenance trials: Cardiac Disorder : tachycardia Ear and Labyrinth Disorders : ear pain Gastrointestinal Disorders : abdominal distention, colitis, diarrhea, flatulence, nausea, pancreatitis, rectal polyp, vomiting General Disorders and Administrative Site Disorders : asthenia, face edema, fatigue, pyrexia Investigations : decrease… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 194 words ▾

7 DRUG INTERACTIONS Nephrotoxic Agents including 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 (5.1) ] .

7.2Azathioprine and 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 mesalamine delayed-release tablets 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 mesalamine delayed-release tablets may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.9) ] . 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, there were no adverse developmental outcomes with administration of oral mesalamine during organogenesis to pregnant rats and rabbits at doses 1.8 and 2.9 times, respectively, the maximum recommended human dose (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated populations 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 miscarriages 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 2,500 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 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 increased risk of 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, maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products. Animal Data Reproduction studies with mesalamine during organogenesis have been performed in rats at doses up to 1,000 mg/kg/day (1.8 times the maximum recommended human dose based on a body surface area comparison) and rabbits at doses up to 800 mg/kg/day (2.9 times the maximum recommended human dose based on a body surface area comparison) and have revealed no evidence of harm to the fetus due to mesalamine.

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 in breastfed infants exposed to mesalamine (see Clinical Considerations ) . There is no information on the effects of the drug on milk production.

The lack of clinical data during lactation precludes a clear determination of the risk of mesalamine delayed-release tablets to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mesalamine delayed-release tablets and any potential adverse effects on the breastfed child from mesalamine delayed-release tablets 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 me… [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, there were no adverse developmental outcomes with administration of oral mesalamine during organogenesis to pregnant rats and rabbits at doses 1.8 and 2.9 times, respectively, the maximum recommended human dose (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated populations 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 miscarriages 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 2,500 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 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 increased risk of 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, maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products. Animal Data Reproduction studies with mesalamine during organogenesis have been performed in rats at doses up to 1,000 mg/kg/day (1.8 times the maximum recommended human dose based on a body surface area comparison) and rabbits at doses up to 800 mg/kg/day (2.9 times the maximum recommended human dose based on a body surface area comparison) and have revealed no evidence of harm to the fetus due to mesalamine.

🧒 Pediatric Use 114 words ▾

8.4Pediatric Use The safety and effectiveness of mesalamine delayed-release tablets have been established for the treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. Use of mesalamine delayed-release tablets in this population is supported by evidence from adequate and well-controlled trials in adults, a multicenter, randomized, double-blind, parallel group trial in 105 pediatric patients 5 to 17 years of age, and additional pharmacokinetic analyses. The safety profile in pediatric patients was similar to that observed in adults [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.2)].

The safety and effectiveness of mesalamine delayed-release tablets have not been established in patients weighing less than 24 kg.

🧓 Geriatric Use 159 words ▾

8.5Geriatric Use Clinical trials of mesalamine delayed-release tablets 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 who were 65 years or older who were taking mesalamine-containing products such as mesalamine delayed-release tablets compared to younger patients.

Monitor complete blood cell counts and platelet counts in elderly patients during treatment with mesalamine delayed-release tablets. Systemic exposures are increased in elderly subjects [see Clinical Pharmacology (12.3) ]. In general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing mesalamine delayed-release tablets.

Consider starting at the low end of the dosing range for induction in elderly patients [see Dosage and Administration (2) , Use in Specific Populations (8.6) ] .

🆘 Overdosage 120 words ▾

10 OVERDOSAGE Mesalamine delayed-release tablets are an aminosalicylate, and symptoms of salicylate toxicity may include nausea, vomiting, abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe intoxication with salicylates may lead to electrolyte and blood pH imbalance, and potentially end organ (e.g., renal and liver) damage. There is no specific known 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. Mesalamine delayed-release tablets are a pH-dependent, delayed-release product and this factor should be considered when treating a suspected overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of mesalamine is not fully understood, but it appears to have a topical anti-inflammatory effect on the colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase and lipoxygenase pathways, 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.

12.3Pharmacokinetics Absorption The total absorption of mesalamine from mesalamine delayed-release tablets 2.4 g or 4.8 g given once daily for 14 days to healthy subjects was found to be approximately 21% to 22% of the administered dose. Gamma-scintigraphy studies have shown that a single dose of mesalamine delayed-release tablets 1.2 g (one tablet) passed intact through the upper gastrointestinal tract of fasted healthy subjects. Scintigraphic images showed a trail of radio-labeled tracer in the colon, suggesting that mesalamine had distributed through this region of the gastrointestinal tract.

In a single-dose study, mesalamine delayed-release tablets 1.2 g, 2.4 g, and 4.8 g were administered in the fasted state to healthy subjects. Plasma concentrations of mesalamine were detectable after 2 hours and reached a maximum by 9-12 hours on average for the doses studied. The pharmacokinetic parameters are highly variable among subjects (Table 4).

Mesalamine systemic exposure in terms of area under the plasma concentration-time curve (AUC) was slightly more than dose proportional between 1.2 g and 4.8 g mesalamine delayed-release tablets. Maximum plasma concentrations (C max ) of mesalamine increased approximately dose proportionately between 1.2 g and 2.4 g and sub-proportionately between 2.4 g and 4.8 g of mesalamine delayed-release tablets, with the dose normalized value at 4.8 g representing, on average, 74% of that at 2.4 g based on geometric means. Table 4: Mean (SD) Pharmacokinetic Parameters for Mesalamine Following Single-Dose Administration of Mesalamine Delayed-Release Tablets Under Fasting Conditions Parameter Arithmetic mean of parameter values are presented except for Tmax and Tlag. of Mesalamine Mesalamine Delayed-Release Tablets 1.2 g (N=47) Mesalamine Delayed-Release Tablets 2.4 g (N=48) Mesalamine Delayed-Release Tablets 4.8 g (N=48) AUC 0-t (ng∙h/mL) 9,039 N=43 (5,054) 20,538 (12,980) 41,434 (26,640) AUC 0- (ng∙h/mL) 9,578 N=27 (5,214) 21,084 (13,185) 44,775 N=36 (30,302) C max (ng/mL) 857 (638) 1,595 (1,484) 2,154 (1,140) T max Median (min, max) (h)

9.0N=46 (4.0-32.1) 12.0 (4.0-34.1) 12.0 (4.0-34.0) T lag¶ (h) 2.0# (0-8.0) 2.0 (1.0-4.0) 2.0 (1.0-4.0) T 1/2 (h) (Terminal Phase) 8.56(6.38)

7.05N=33 5.54) 7.25 § (8.32) Food Effects Administration of a single dose of mesalamine delayed-release tablets 4.8 g with a high-fat meal resulted in further delay in absorption, and plasma concentrations of mesalamine were detectable 4 hours following dosing. However, a high-fat meal increased systemic exposure of mesalamine (mean C max : increased 91%; mean AUC: increased 16%) compared to results in the fasted state. Mesalamine delayed-release tablets were administered with food in the controlled clinical trials [see Dosage and Administration (2) ] .

In a single- and multiple-dose pharmacokinetic study of mesalamine delayed-release tablets, 2.4 g or 4.8 g was administered once daily with standard meals to 28 healthy subjects per dose group. Plasma concentrations of mesalamine were detectable after 4 hours and were maximal by 8 hours after the single dose. Steady state was achieved generally by 2 days after dosing.

Mean AUC at steady state was only modestly greater (1.1- to 1.4-fold) than predictable from single dose pharmacokinetics. Distribution Mesalamine is approximately 43% bound to plasma proteins at the concentration of 2.5 mcg/mL. Elimination Metabolism The only major metabolite of mesalamine (5-aminosalicylic acid) is… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 66 words ▾

12.1Mechanism of Action The mechanism of action of mesalamine is not fully understood, but it appears to have a topical anti-inflammatory effect on the colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase and lipoxygenase pathways, 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 65 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Mesalamine delayed-release tablets, USP are available as light red to red, oval, bi-convex, film-coated, with ‘S1’ debossed on one side and plain on the reverse side. NDC 0527-3012-48 HDPE Bottle with a child-resistant closure of 120 delayed-release tablets. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.

📋 Description 150 words ▾

11 DESCRIPTION Each mesalamine delayed-release tablet, USP for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine, USP also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula:C 7 H 7 NO 3 Molecular weight:153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine, USP then begins to be released from the tablet core.

The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of mesalamine delayed-release tablets, USP are colloidal silicon dioxide, magnesium stearate, carboxymethylcellulose sodium, sodium starch glycolate, hypromellose, microcrystalline cellulose, methacrylic acid-methyl methacrylate copolymer 1:1, methacrylic acid-methyl methacrylate copolymer 1:2, triethyl citrate, talc, polyvinyl alcohol, titanium dioxide, macrogol/PEG, iron oxide red and iron oxide yellow.

FDA approved dissolution test specifications differ from USP. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Renal Impairment Inform patients that mesalamine delayed-release tablets 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 mesalamine delayed-release tablets 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 mesalamine delayed-release tablets 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) ] .

Upper Gastrointestinal Tract Obstruction Advise patients to contact their healthcare provider if they experience signs and symptoms of upper gastrointestinal tract obstruction [see Warnings and Precautions (5.6) ] . 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 (5.8) ] .

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 Instruct patients: Swallow mesalamine delayed-release tablets whole; do not split or crush.

Take mesalamine delayed-release tablets with food [see Clinical Pharmacology (12.3) ] . Urine may become discolored reddish-brown while taking mesalamine delayed-release tablets 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). Drink an adequate amount of fluids [see Warnings and Precautions (5.8) ] .

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption The total absorption of mesalamine from mesalamine delayed-release tablets 2.4 g or 4.8 g given once daily for 14 days to healthy subjects was found to be approximately 21% to 22% of the administered dose. Gamma-scintigraphy studies have shown that a single dose of mesalamine delayed-release tablets 1.2 g (one tablet) passed intact through the upper gastrointestinal tract of fasted healthy subjects. Scintigraphic images showed a trail of radio-labeled tracer in the colon, suggesting that mesalamine had distributed through this region of the gastrointestinal tract.

In a single-dose study, mesalamine delayed-release tablets 1.2 g, 2.4 g, and 4.8 g were administered in the fasted state to healthy subjects. Plasma concentrations of mesalamine were detectable after 2 hours and reached a maximum by 9-12 hours on average for the doses studied. The pharmacokinetic parameters are highly variable among subjects (Table 4).

Mesalamine systemic exposure in terms of area under the plasma concentration-time curve (AUC) was slightly more than dose proportional between 1.2 g and 4.8 g mesalamine delayed-release tablets. Maximum plasma concentrations (C max ) of mesalamine increased approximately dose proportionately between 1.2 g and 2.4 g and sub-proportionately between 2.4 g and 4.8 g of mesalamine delayed-release tablets, with the dose normalized value at 4.8 g representing, on average, 74% of that at 2.4 g based on geometric means. Table 4: Mean (SD) Pharmacokinetic Parameters for Mesalamine Following Single-Dose Administration of Mesalamine Delayed-Release Tablets Under Fasting Conditions Parameter Arithmetic mean of parameter values are presented except for Tmax and Tlag. of Mesalamine Mesalamine Delayed-Release Tablets 1.2 g (N=47) Mesalamine Delayed-Release Tablets 2.4 g (N=48) Mesalamine Delayed-Release Tablets 4.8 g (N=48) AUC 0-t (ng∙h/mL) 9,039 N=43 (5,054) 20,538 (12,980) 41,434 (26,640) AUC 0- (ng∙h/mL) 9,578 N=27 (5,214) 21,084 (13,185) 44,775 N=36 (30,302) C max (ng/mL) 857 (638) 1,595 (1,484) 2,154 (1,140) T max Median (min, max) (h)

9.0N=46 (4.0-32.1) 12.0 (4.0-34.1) 12.0 (4.0-34.0) T lag¶ (h) 2.0# (0-8.0) 2.0 (1.0-4.0) 2.0 (1.0-4.0) T 1/2 (h) (Terminal Phase) 8.56(6.38)

7.05N=33 5.54) 7.25 § (8.32) Food Effects Administration of a single dose of mesalamine delayed-release tablets 4.8 g with a high-fat meal resulted in further delay in absorption, and plasma concentrations of mesalamine were detectable 4 hours following dosing. However, a high-fat meal increased systemic exposure of mesalamine (mean C max : increased 91%; mean AUC: increased 16%) compared to results in the fasted state. Mesalamine delayed-release tablets were administered with food in the controlled clinical trials [see Dosage and Administration (2) ] .

In a single- and multiple-dose pharmacokinetic study of mesalamine delayed-release tablets, 2.4 g or 4.8 g was administered once daily with standard meals to 28 healthy subjects per dose group. Plasma concentrations of mesalamine were detectable after 4 hours and were maximal by 8 hours after the single dose. Steady state was achieved generally by 2 days after dosing.

Mean AUC at steady state was only modestly greater (1.1- to 1.4-fold) than predictable from single dose pharmacokinetics. Distribution Mesalamine is approximately 43% bound to plasma proteins at the concentration of 2.5 mcg/mL. Elimination Metabolism The only major metabolite of mesalamine (5-aminosalicylic acid) is N-acetyl-5-aminosalicylic acid.

Its formation is brought about by N-acetyltransferase (NAT) activity in the liver and intestinal mucosa cells, principally by NAT-1. Excretion Excretion of mesalamine is mainly via the renal route following metabolism to N-acetyl-5-aminosalicylic acid (acetylation); however, there is also limited excretion of the parent drug in urine. Of the approximately 21% to 22% of the dose absorbed, less than 8% of the dose was excreted unchanged in the urine after 24 hours, compa… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Adults with Mildly to Moderately Active Ulcerative Colitis Induction of Remission Two similarly designed, randomized, double-blind, placebo-controlled trials (Study 1, NCT00503243 and Study 2, NCT00548574 ) were conducted in 517 adult patients with mildly to moderately active ulcerative colitis. The study population was primarily Caucasian (80%), had a mean age of 42 years (6% age 65 years or older), and was approximately 50% male. Both studies used mesalamine delayed-release tablets dosages of 2.4 g and 4.8 g administered once daily for 8 weeks, except in Study 1 the 2.4 g dosage was administered as two divided doses (i.e., 1.2 g twice daily).

The primary efficacy endpoint in both trials was to compare the percentage of patients in remission after 8 weeks of treatment for the mesalamine delayed-release tablets treatment groups versus placebo. Remission was defined as an Ulcerative Colitis Disease Activity Index (UC-DAI) of ≤1, with scores of zero for rectal bleeding and for stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline. In both studies, the mesalamine delayed-release tablets dosages of 2.4 g and 4.8 g once daily demonstrated superiority over placebo in the primary efficacy endpoint (Table 6).

Both mesalamine delayed-release tablets dosages also provided consistent benefit in secondary efficacy parameters, including clinical improvement, clinical remission, and sigmoidoscopic improvement. Both mesalamine delayed-release tablets dosages had similar efficacy profiles. Table 6: Proportion of Adult Patients with Mildly to Moderately Active Ulcerative Colitis in Remission at Week 8 in Two Double-Blind Placebo-Controlled Induction Trials Dose Study 1 (n=262) n/N (%) Study 2 (n=255) n/N (%) Mesalamine delayed-release tablets 2.4 g/day 30/88 (34) 34/84 (41) Mesalamine delayed-release tablets 4.8 g/day 26/89 (29) 35/85 (41) Placebo 11/85 (13) 19/86 (22) Maintenance of Remission A multicenter, randomized, double-blind, active comparator study (Study 3, NCT00151892 ) was conducted in a total of 826 adult patients in remission from ulcerative colitis.

Patients were randomized in a 1:1 ratio to receive either mesalamine delayed-release tablets 2.4 g administered once daily or another mesalamine delayed-release product administered as 0.8 g twice daily. The study population had a mean age of 45 years (8% age 65 years or older), were 52% male, and were primarily Caucasian (64%). Maintenance of remission was assessed using a modified UC-DAI.

For this trial, maintenance of remission was based on maintaining endoscopic remission defined as a modified UC-DAI endoscopy subscore of ≤1. An endoscopy subscore of 0 represented normal mucosal appearance with intact vascular pattern and no friability or granulation. For this trial the endoscopy score definition of 1 (mild disease) was modified such that it could include erythema, decreased vascular pattern, and minimal granularity; however, it could not include friability.

The proportion of patients who maintained remission at Month 6 in this study using mesalamine delayed-release tablets 2.4 g once daily (84%) was similar to the comparator (82%).

14.2Pediatric Patients with Mildly to Moderately Active Ulcerative Colitis Weighing at Least 24 kg A multicenter, randomized, double-blind, parallel-group study (NCT02093663) was conducted in pediatric patients aged 5 through 17 years with mildly to moderately active ulcerative colitis to determine the safety and effectiveness of mesalamine delayed-release tablets. The study consisted of two treatment phases, an initial 8-week phase and a 26-week phase. The overall population consisted of 105 patients, of whom 27 patients participated in both the 8-week and 26-week phases.

Each phase included two dosage arms and patients were randomized at the beginning of each phase in a 1:1 ratio, stratified by body weight group. Patients received a low or a high weight-based dosage of mesalamine delayed-rele… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 104-week dietary carcinogenicity study in CD-1 mice, mesalamine at doses up to 2,500 mg/kg/day was not tumorigenic. This dose is 2.2 times the maximum recommended human dose (based on a body surface area comparison) of mesalamine delayed-release tablets. Furthermore, in a 104-week dietary carcinogenicity study in Wistar rats, mesalamine up to a dose of 800 mg/kg/day was not tumorigenic.

This dose is 1.4 times the recommended human dose (based on a body surface area comparison) of mesalamine delayed-release tablets. Mutagenesis No evidence of mutagenicity was observed in an in vitro Ames test or an in vivo mouse micronucleus test. Impairment of Fertility No effects on fertility or reproductive performance were observed in male or female rats at oral doses of mesalamine up to 400 mg/kg/day (0.7 times the maximum recommended human dose based on a body surface area comparison).

13.2Animal Toxicology and/or Pharmacology In animal studies with mesalamine, a 13-week oral toxicity study in mice and 13-week and 52-week oral toxicity studies in rats and cynomolgus monkeys have shown the kidney to be the major target organ of mesalamine toxicity. Oral daily doses of 2,400 mg/kg in mice and 1,150 mg/kg in rats produced renal lesions including granular and hyaline casts, tubular degeneration, tubular dilation, renal infarct, papillary necrosis, tubular necrosis, and interstitial nephritis. In cynomolgus monkeys, oral daily doses of 250 mg/kg or higher produced nephrosis, papillary edema, and interstitial fibrosis.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 148 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 104-week dietary carcinogenicity study in CD-1 mice, mesalamine at doses up to 2,500 mg/kg/day was not tumorigenic. This dose is 2.2 times the maximum recommended human dose (based on a body surface area comparison) of mesalamine delayed-release tablets. Furthermore, in a 104-week dietary carcinogenicity study in Wistar rats, mesalamine up to a dose of 800 mg/kg/day was not tumorigenic.

This dose is 1.4 times the recommended human dose (based on a body surface area comparison) of mesalamine delayed-release tablets. Mutagenesis No evidence of mutagenicity was observed in an in vitro Ames test or an in vivo mouse micronucleus test. Impairment of Fertility No effects on fertility or reproductive performance were observed in male or female rats at oral doses of mesalamine up to 400 mg/kg/day (0.7 times the maximum recommended human dose based on a body surface area comparison).

📄 Package Label / Principal Display Panel 24 words ▾

PRINCIPAL DISPLAY PANEL - 1.2 g Tablet Bottle Label ONCE-DAILY NDC 0527-3012-48 Mesalamine delayed-release tablets 1.2 g per tablet Rx Only 120 Tablets 120s

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
17.9K
Units reimbursed last 4 qtrs
2M
Gross reimbursed last 4 qtrs
$2.71M
Avg / prescription
$151.48
Avg / unit
$1.3309
Latest quarter Q1 2026
3.9KRx
Medicaid pays / ea
$1.3309
gross reimbursed
vs
NADAC / ea
$0.7809
acquisition cost
=
Spread
+$0.5500
+70% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
46% FFS 54% MCO
Fee-for-service · 8,250 Rx Managed care · 9,613 Rx
State Medicaid map
Alaska: 4,124 units · 563 per 100k residents AK Maine: no data reported ME Washington: 98,602 units · 1,262 per 100k residents WA Idaho: 13,396 units · 682 per 100k residents ID Montana: 11,102 units · 981 per 100k residents MT North Dakota: 6,320 units · 807 per 100k residents ND Minnesota: 34,008 units · 593 per 100k residents MN Wisconsin: 53,954 units · 913 per 100k residents WI Michigan: 91,098 units · 908 per 100k residents MI New York: 231,644 units · 1,184 per 100k residents NY Vermont: no data reported VT New Hampshire: 15,866 units · 1,132 per 100k residents NH Oregon: 82,059 units · 1,939 per 100k residents OR Nevada: 7,604 units · 238 per 100k residents NV Wyoming: no data reported WY South Dakota: 8,280 units · 901 per 100k residents SD Iowa: 30,994 units · 966 per 100k residents IA Illinois: 18,302 units · 146 per 100k residents IL Indiana: 33,267 units · 485 per 100k residents IN Ohio: 78,577 units · 667 per 100k residents OH Pennsylvania: 117,686 units · 908 per 100k residents PA New Jersey: 92,756 units · 998 per 100k residents NJ Massachusetts: 26,802 units · 383 per 100k residents MA California: 461,164 units · 1,184 per 100k residents CA Utah: 22,762 units · 666 per 100k residents UT Colorado: 28,794 units · 490 per 100k residents CO Nebraska: 11,436 units · 578 per 100k residents NE Missouri: 70,017 units · 1,130 per 100k residents MO Kentucky: no data reported KY West Virginia: 3,180 units · 180 per 100k residents WV Virginia: 27,539 units · 316 per 100k residents VA Maryland: 21,018 units · 340 per 100k residents MD Connecticut: 32,398 units · 896 per 100k residents CT Rhode Island: no data reported RI Arizona: 42,528 units · 572 per 100k residents AZ New Mexico: 17,627 units · 834 per 100k residents NM Kansas: 1,970 units · 67.0 per 100k residents KS Arkansas: no data reported AR Tennessee: 12,180 units · 171 per 100k residents TN North Carolina: 51,746 units · 478 per 100k residents NC South Carolina: 1,260 units · 23.5 per 100k residents SC Delaware: 4,090 units · 397 per 100k residents DE Oklahoma: 40,154 units · 991 per 100k residents OK Louisiana: 21,000 units · 459 per 100k residents LA Mississippi: no data reported MS Alabama: 12,518 units · 245 per 100k residents AL Georgia: 12,746 units · 116 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 41,792 units · 137 per 100k residents TX Florida: 33,028 units · 146 per 100k residents FL
Units reimbursed · per 100k residents
23.51,939
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 Oregon 1,939 /100k
2 Washington 1,262 /100k
3 New York 1,184 /100k
4 California 1,184 /100k
5 New Hampshire 1,132 /100k
6 Missouri 1,130 /100k
7 New Jersey 998 /100k
8 Oklahoma 991 /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.

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

Medicare Part D (outpatient prescription) spending for Mesalamine — 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. 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.
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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.