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Mesalamine 400 mg Capsule, Delayed Release, 180-count — NDC 0093-5907-86 (Billing 00093-5907-86)

by Teva Pharmaceuticals USA, Inc. · 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE

This is a package of 180 capsules of Mesalamine 400 mg Capsule, Delayed Release from Teva Pharmaceuticals USA, Inc., marketed since May 2019 and currently FDA-listed; retail pharmacies pay about $2.70 per capsule (NADAC). It is this product's only package size.

NDC 00093-5907-86
🏷️ FDA NDC (as labeled) 0093-5907-86 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 0093-5907-86 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0093 labeler · 5907 product · 86 package
Package marketed since
May 9, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
180 EA per package
Barcode (UPC-A, from the NDC)
3 0093590786 4
Medicaid fills, this package
7,553 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) 0093-5907-86
Product NDC 0093-5907
11-digit billing NDC 00093590786
NCPDP billing unit EA — each (per item)
RxCUI 1368954
UNII 4Q81I59GXC
Application # ANDA207873
SPL Set ID 6fd0a906-e1b5-4238-a79b-a195510ddc84
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 2019-05-09
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance MESALAMINE

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

GPI-14 52500030006530
GPI class Mesalamine
GCN Seq No 076143
GCN 41428
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 400 MG CAPSULE
FDB brand name Mesalamine Dr
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 076143
  • GCN: 41428
  • GPI-14 (Medi-Span): 52500030006530
  • HICL (First Databank): 001848
  • AHFS class code: 56:36.00.00
  • RxCUI (RxNorm): 1368954
Why two NDCs? The FDA registers this code as 0093-5907-86 — 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 → 00093-5907-86. 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 400 MG CAPSULE Ingredient Mesalamine
📖 What it is MedlinePlus · NLM

Mesalamine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) and also to maintain improvement of ulcerative colitis symptoms. 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 eaPer package
Retail pharmacies payNADAC · weekly $2.699 $485.82 / 180 capsules
Medicaid paysCMS SDUD · 12 mo $2.24 $402.68 / 180 capsules
Medicare drug plans payPart D · Q2 2026 $2.27 $408.10 / 180 capsules
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $2.699 $1.834
▲ Up 25% over the last 24 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
00093-5907-86 You're viewing this Main listing 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE 2019-05-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mesalamine 400 mgthis 00093-5907-86 Teva 180 capsules $2.699 — Availability likely —
Mesalamine 400 mg 60687-0556-32 American 1 capsule $2.699 — Availability likely —
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

🏛️
2019
On the market since
May 2019
📍
2026
Currently FDA-listed
7 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.

What it looks like

Color white
ShapeCapsule
ImprintTEVA;5907
Size22 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 4W5IH7FLNY
    A clear, oily liquid derived from sebacic acid and butanol. It works as a plasticizer and solvent in pharmaceutical coatings and films, helping them stay flexible and smooth.
  • 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 XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 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 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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.

16 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

LabelerTeva Pharmaceuticals USA, Inc.
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA207873 (ANDA)
Labeler code00093
First marketedMay 2019
Product typeHuman Prescription Drug
Portfolio504 products on file

More NDCs from Teva Pharmaceuticals USA, Inc. labeler code 00093

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 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 96 words ▾

1 INDICATIONS AND USAGE Mesalamine delayed-release capsules are an aminosalicylate indicated for: Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. ( 1.1 ) Maintenance of remission of ulcerative colitis in adults. ( 1.2 )

1.1Treatment of Mildly to Moderately Active Ulcerative Colitis Mesalamine delayed-release capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

1.2Maintenance of Remission of Ulcerative Colitis Mesalamine delayed-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Important Administration Instructions : Do not substitute two mesalamine delayed-release 400 mg capsules with one mesalamine delayed-release 800 mg tablet. ( 2.1 ) Evaluate renal function prior to initiation of mesalamine delayed-release capsules. ( 2.1 , 5.1 ) Take with or without food.

( 2.1 ) Swallow the capsules whole; do not cut, break, crush or chew. ( 2.1 ) For patients who are unable to swallow the capsules, the capsules can be opened and the inner tablets swallowed. ( 2.1 ) Drink an adequate amount of fluids.

( 2.1 , 5.7 ) Treatment of Mildly to Moderately Active Ulcerative Colitis: Adults: 800 mg (two 400 mg capsules) three times daily for 6 weeks. Pediatric Patients 5 years or older: See weight-based dosing table in the full prescribing information; twice daily dosing for 6 weeks. ( 2.2 ) Maintenance of Remission of Ulcerative Colitis: Adults: 1.6 grams (four 400 mg capsules) daily, in two to four divided doses.

( 2.3 )

2.1Important Administration Instructions Do not substitute two mesalamine delayed-release 400 mg capsules with one mesalamine delayed-release 800 mg tablet. Evaluate renal function prior to initiation of mesalamine delayed-release capsules. Take mesalamine delayed-release capsules with or without food.

Swallow the capsules whole; do not cut, break, crush or chew the capsules. For patients who are unable to swallow the capsules whole, carefully open the capsule(s) and swallow the contents (four 100 mg tablets). Open the number of capsules required to make up a complete dose [see Dosage and Administration ( 2.2 , 2.3 )] .

There are 4 tablets per capsule. Ensure all tablets per capsule are swallowed and no tablets are retained in the mouth. Swallow the tablets whole; do not cut, break, crush or chew the tablets.

Drink an adequate amount of fluids [see Warnings and Precautions ( 5.7 )] . Intact, partially intact, and/or tablet shells have been reported in the stool; Instruct patients to contact their healthcare provider if this occurs repeatedly. Protect mesalamine delayed-release capsules from moisture.

Close the container tightly and leave any desiccant pouches present in the bottle along with the capsules.

2.2Dosage for Treatment of Mildly to Moderately Active Ulcerative Colitis Adults For adults, the recommended dosage of mesalamine delayed-release capsules is 800 mg (two 400 mg capsules) three times daily (total daily dosage of 2.4 grams) for a duration of 6 weeks [see Clinical Studies ( 14.1 )] . Pediatrics For pediatric patients 5 years of age and older, the recommended total daily dosage of mesalamine delayed-release capsules is weight-based (up to maximum of 2.4 grams per day) divided into two daily doses for a duration of 6 weeks (see Table 1).

Table 1. Pediatric Dosage by Weight Weight Group (kg) Daily Dosage (mg/kg/day) Maximum Daily Dosage (grams per day) Morning Dosage Afternoon Dosage 17 to 32 36 to 71 1.2 two 400 mg capsules one 400 mg capsules 33 to 53 37 to 61 2 three 400 mg capsules two 400 mg capsules 54 to 90 27 to 44 2.4 three 400 mg capsules three 400 mg capsules

2.3Dosage for Maintenance of Remission of Ulcerative Colitis The recommended dosage of mesalamine delayed-release capsules in adults is 1.6 grams (four 400 mg capsules) daily in two to four divided doses.

💊 Dosage Forms and Strengths 49 words ▾

3 DOSAGE FORMS AND STRENGTHS Mesalamine delayed-release capsules are clear capsules imprinted with “TEVA” and “5907” on both the cap and the body in black ink. Each capsule contains four reddish-brown, film-coated round 100 mg mesalamine tablets. Delayed-release capsules (containing four 100 mg tablets): 400 mg ( 3 )

⛔ Contraindications 68 words ▾

4 CONTRAINDICATIONS Mesalamine delayed-release capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release capsules [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 capsules. ( 4 , 5.3 )

⚠️ Warnings and Cautions ~2 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 using mesalamine delayed-release capsules in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function. Discontinue mesalamine delayed-release capsules if renal function deteriorates.

( 5.1 , 7.1 , 8.6 , 13.2 ) 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 capsules, if a hypersensitivity reaction is suspected. ( 5.3 ) Hepatic Failure: Evaluate the risks and benefits of using mesalamine delayed-release capsules 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 ) Photosensitivity: Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. ( 5.6 ) Nephrolithiasis: Mesalamine-containing stones undetectable by standard radiography or computed tomography (CT).

Ensure adequate fluid intake during treatment. ( 5.7 ) Iron Content of Mesalamine Delayed-Release Capsules: Consider the iron content of mesalamine delayed-release capsules in patients taking iron supplementation and those at risk of iron overload. ( 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 renal failure, has been reported in patients taking products such as mesalamine delayed-release capsules 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 capsules and periodically while on therapy.

Discontinue mesalamine delayed-release capsules if renal function deteriorates while on therapy. Evaluate the risks and benefits of using mesalamine delayed-release capsules in patients with known renal impairment or history of renal disease or taking concomitant nephrotoxic drugs [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 controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, malaise, pruritus, conjunctivitis 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 capsules.

5.3Hypersensitivity Reactions Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to mesalamine or to other compounds that contain or are converted to mesalamine. As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities.

Evaluate patients immediatel… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most serious adverse reactions seen in mesalamine clinical trials or with other products that contain or are metabolized to mesalamine are: Renal Impairment [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 )] Photosensitivity [see Warnings and Precautions ( 5.6 )] Nephrolithiasis [see Warnings and Precautions ( 5.7 )] The most common adverse reactions (≥5%) are: Adults: eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, and rash.

( 6.1 ) Pediatrics: nasopharyngitis, headache, abdominal pain, dizziness, sinusitis, rash, cough and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 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. The safety of mesalamine has been established based on adequate and well-controlled studies of mesalamine delayed-release tablets. In total, mesalamine delayed-release 400 mg tablets have been evaluated in 2690 patients with ulcerative colitis in controlled and open-label trials.

Below is a description of the adverse reactions of mesalamine delayed-release tablets in these adequate and well-controlled studies. Clinical studies supporting mesalamine delayed-release tablets use for the treatment of mildly to moderately active ulcerative colitis included two 6-week, placebo-controlled, randomized, double-blind studies in adults with mildly to moderately active ulcerative colitis (Studies 1 and 2), and one 6-week, randomized, double-blind, study of 2 dosage levels in children with mildly to moderately active ulcerative colitis (Study 3).

Clinical studies supporting the use of mesalamine delayed-release tablets in the maintenance of remission of ulcerative colitis included a 6-month, randomized, double-blind, placebo-controlled, multi-center study (Study 4) and four active-controlled maintenance trials comparing mesalamine delayed-release with sulfasalazine. Mesalamine delayed-release tablets have been evaluated in 427 adults and 107 children with ulcerative colitis in these controlled studies. Treatment of Mildly to Moderately Active Ulcerative Colitis Adults In a 6-week placebo-controlled clinical study (Study 1) involving 105 patients, 53 of whom were randomized to mesalamine delayed-release tablets 2.4 grams per day [see Clinical Studies ( 14.1 )], 4% of the mesalamine delayed release tablets-treated patients in 2.4 grams per day group discontinued therapy because of adverse reactions as compared to 0% of the placebo-treated patients.

The average age of patients was 41 years and 49% of patients were male. Adverse reactions leading to withdrawal from mesalamine delayed-release tablets included (each in one patient): diarrhea and colitis flare; dizziness, nausea, joint pain, and headache. The most common adverse reactions in patients treated with mesalamine delayed release tablets 2.4 grams per day in Study 1 are listed in Table 2 below.

Table 2. Most Common Adverse Reactions Reported in Study 1 for the Treatment of Mild to Moderate Ulcerative Colitis in Adults* Adverse Reaction % of Patients with Adverse Reactions Mesalamine Delayed-Release 2.4 grams per day Placebo (n = 53) (n = 52) Eructation 26 19 Abdominal pain 21 12 Constipation 11 0 Dizziness 9 8 Rhinitis 8 6 Back pain 6 4 Rash 6 4 Dyspepsia 4 0 Flu syndrome 4 2 * At Least 2% of Patients in the Mesalamine Delayed-Release Tablets Group and at a Rate Greater than Placebo Pediatric Patients 5 to 17 Years Old A randomiz… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 193 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 disorders; 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 or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or 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 capsules 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 capsules 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 There are no adequate and well controlled studies of mesalamine use in pregnant women. Limited published human data on mesalamine show no increase in the overall rate of congenital malformations. Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease.

Furthermore, all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. No evidence of fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose. Mesalamine should be used during pregnancy only if clearly needed.

Human Data Mesalamine crosses the placenta. In prospective and retrospective studies of over 600 women exposed to mesalamine during pregnancy, the observed rate of congenital malformations was not increased above the background rate in the general population. Some data show an increased rate of preterm birth, stillbirth, and low birth weight, but it is unclear whether this was due to underlying maternal disease, drug exposure, or both, as active inflammatory bowel disease is also associated with adverse pregnancy outcomes.

Animal data Reproduction studies with mesalamine were performed during organogenesis in rats and rabbits at oral doses up to 480 mg/kg/day. There was no evidence of impaired fertility or harm to the fetus. These mesalamine doses were about 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose, based on body surface area.

8.2Lactation Mesalamine and its N-acetyl metabolite are present in human milk. In published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 3 g daily. The concentration of mesalamine in milk ranged from non-detectable to 0.11 mg/L.

The concentration of the N-acetyl-5-aminosalicylic acid metabolite ranged from 5 mg/L to 18.1 mg/L. Based on these concentrations, estimated infant daily doses for an exclusively breastfed infant are 0 mg/kg/day to 0.017 mg/kg/day of mesalamine and 0.75 mg/kg/day to 2.72 mg/kg/day of N-acetyl-5-aminosalicylic acid. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mesalamine and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Caution should be exercised when mesalamine delayed-release capsules are administered to a nursing woman.

8.4Pediatric Use The safety and effectiveness of mesalamine delayed-release capsules for the treatment of mildly to moderately active ulcerative colitis in pediatric patients 5 to 17 years of age has been established based on adequate and well-controlled studies using mesalamine delayed-release 400 mg tablets. Use of mesalamine delayed-release capsules in these pediatric age groups is supported by evidence from adequate and well controlled studies of mesalamine delayed-release 400 mg tablets in adults and a single 6-week study in 82 pediatric patients 5 to 17 years of age [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.1 )] .

The safety and effectiveness of mesalamine delayed-release capsules for the treatment of mildly to moderately active ulcerative colitis in pediatric patients below the age of 5 years have not been established. The safety and effectiveness of mesalamine delayed-release capsules in the maintenance of remission of ulcerative colitis in pediatric patients have not been established.

8.5Geriatric Use Clinical studies of mesalamine delayed-release tablets did not include sufficient numbers of patients aged 65 y… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well controlled studies of mesalamine use in pregnant women. Limited published human data on mesalamine show no increase in the overall rate of congenital malformations. Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease.

Furthermore, all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. No evidence of fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose. Mesalamine should be used during pregnancy only if clearly needed.

Human Data Mesalamine crosses the placenta. In prospective and retrospective studies of over 600 women exposed to mesalamine during pregnancy, the observed rate of congenital malformations was not increased above the background rate in the general population. Some data show an increased rate of preterm birth, stillbirth, and low birth weight, but it is unclear whether this was due to underlying maternal disease, drug exposure, or both, as active inflammatory bowel disease is also associated with adverse pregnancy outcomes.

Animal data Reproduction studies with mesalamine were performed during organogenesis in rats and rabbits at oral doses up to 480 mg/kg/day. There was no evidence of impaired fertility or harm to the fetus. These mesalamine doses were about 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose, based on body surface area.

🧒 Pediatric Use 159 words ▾

8.4Pediatric Use The safety and effectiveness of mesalamine delayed-release capsules for the treatment of mildly to moderately active ulcerative colitis in pediatric patients 5 to 17 years of age has been established based on adequate and well-controlled studies using mesalamine delayed-release 400 mg tablets. Use of mesalamine delayed-release capsules in these pediatric age groups is supported by evidence from adequate and well controlled studies of mesalamine delayed-release 400 mg tablets in adults and a single 6-week study in 82 pediatric patients 5 to 17 years of age [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.1 )] .

The safety and effectiveness of mesalamine delayed-release capsules for the treatment of mildly to moderately active ulcerative colitis in pediatric patients below the age of 5 years have not been established. The safety and effectiveness of mesalamine delayed-release capsules in the maintenance of remission of ulcerative colitis in pediatric patients have not been established.

🧓 Geriatric Use 127 words ▾

8.5Geriatric Use Clinical studies of mesalamine delayed-release tablets did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Reports from uncontrolled clinical studies and postmarketing experience suggest a higher incidence of blood dyscrasias (agranulocytosis, neutropenia, pancytopenia) in subjects receiving mesalamine delayed-release tablets who are 65 years or older compared to younger patients taking mesalamine-containing products such as mesalamine delayed-release capsules.

Monitor complete blood cell counts and platelet counts in elderly patients during treatment with mesalamine delayed-release capsules. 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 capsules [see Use in Specific Populations ( 8.6 )] .

🆘 Overdosage 121 words ▾

10 OVERDOSAGE Mesalamine delayed-release capsules 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 of further absorption.

Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function. Mesalamine delayed-release capsules is a pH dependent delayed-release product and this factor should be considered when treating a suspected overdose.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of 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, that is, prostanoids, and through the lipoxygenase pathways, that is, 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.

12.3Pharmacokinetics Absorption Approximately 28% of mesalamine in mesalamine delayed-release formulation is absorbed after oral ingestion. Following replicate single dose oral administration of mesalamine delayed-release 400 mg capsules containing four 100 mg tablets in healthy subjects (N = 146) under fasted conditions, the mean C max , AUC 8-48 and AUC tldc values were 150 ± 235 ng/mL, 640 ± 521 ng.h/mL, and 909 ± 777 ng.h/mL, respectively. The median [range] T max for mesalamine following mesalamine delayed-release 400 mg capsules containing four 100 mg tablets was approximately 10 hours [5.5 to 48 hours], reflecting the delayed-release characteristics of the formulation.

A high fat meal increased systemic exposure of mesalamine (geometric mean C max : ↑ 32%; AUC 8-48 h: ↑ 46%; AUC: ↑ 29%) and delayed the median t max by approximately 4 hours compared to results in the fasted state. The observed differences in mesalamine exposure due to concomitant food intake are not considered to be clinically relevant at the total daily dosage of 2.4 grams per day. Elimination Metabolism The absorbed mesalamine is rapidly acetylated in the gut mucosal wall and by the liver to N-acetyl-5-aminosalicylic acid.

Excretion Absorbed mesalamine is excreted mainly by the kidney as N-acetyl-5-aminosalicylic acid. Unabsorbed mesalamine is excreted in feces. After intravenous administration, the elimination half-life of mesalamine is reported to be approximately 40 minutes.

After oral dosing, the median terminal t 1/2 values for mesalamine are usually about 25 hours, but are variable, ranging from 1.5 to 296 hours. There is a large inter-subject and intra-subject variability in the plasma concentrations of mesalamine and N-acetyl-5-aminosalicylic acid and in their terminal half-lives following administration of mesalamine. Specific Populations Pediatric Patients In a dose-ranging pharmacokinetic study evaluating 30 mg/kg, 60 mg/kg and 90 mg/kg per day doses of mesalamine delayed-release 400 mg tablets administered twice daily for four weeks, the mean C avg values of mesalamine in pediatric ulcerative colitis patients ranged from approximately 400 ng/mL to 2100 ng/mL based on data from all dose levels.

In a study evaluating mesalamine delayed-release tablets in pediatric ulcerative colitis patients (Study 3), mean plasma concentrations of mesalamine (based on sparse sampling) were 820 to 988 ng/mL at the low dose level (that is, 1.2, 2 or 2.4 grams/day based on body weight strata of 17 to less than 33 kg, 33 to less than 54 kg, and 54 to 90 kg, respectively).

🧬 Mechanism of Action 76 words ▾

12.1Mechanism of Action The mechanism of action of 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, that is, prostanoids, and through the lipoxygenase pathways, that is, 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 58 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Mesalamine delayed-release capsules are available as clear capsules imprinted with “TEVA” and “5907” on both the cap and the body in black ink. Each capsule contains four reddish-brown, film-coated round 100 mg mesalamine tablets. NDC 0093-5907-86 Bottle of 180 capsules Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

📋 Description 124 words ▾

11 DESCRIPTION Each Mesalamine delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, USP an aminosalicylate. Mesalamine delayed-release capsules contain acrylic based resin, methacrylic acid copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine, USP (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid.

Its structural formula is: C 7 H 7 NO 3 M.W. 153.14 Inactive Ingredients: Each capsule contains colloidal silicon dioxide, dibutyl sebacate, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, potassium hydroxide, povidone, propylene glycol, shellac, sodium starch glycolate (potato), strong ammonia solution and talc. 1

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Inform patients that if they are switching from a previous oral mesalamine therapy to mesalamine delayed-release capsules to discontinue their previous oral mesalamine therapy and follow the dosing instructions for mesalamine delayed-release capsules. Inform patients that two mesalamine delayed-release 400 mg capsules cannot be substituted for one mesalamine delayed-release 800 mg tablet. Inform patients that mesalamine delayed-release capsules can be taken with or without food.

Instruct patients to swallow the mesalamine delayed-release capsules whole. Do not cut, break, crush or chew the capsules. For patients who are unable to swallow the capsules whole, carefully open the capsules and swallow the contents (four 100 mg tablets).

Open the number of capsules required to make up a complete dose. There are 4 tablets per capsule. Ensure all tablets per capsule are swallowed and no tablets are retained in the mouth.

Swallow the tablets whole; do not cut, break, crush or chew the tablets. Drink an adequate amount of fluids. Inform patients that intact, partially intact, and/or tablet shells have been reported in the stool.

Instruct patients to contact their healthcare provider if this occurs repeatedly. Inform patients that urine may become discolored reddish-brown while taking mesalamine delayed-release capsules 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). Instruct patients to protect mesalamine delayed-release capsules from moisture. Instruct patients to close the container tightly and to leave any desiccant pouches present in the bottle along with the capsules.

Renal Impairment Inform patients that mesalamine delayed-release capsules may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, including NSAIDs, 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 ), Drug Interactions ( 7.1) ] . Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity Reactions Inform patients of the signs and symptoms of hypersensitivity reactions.

Instruct patients to stop taking mesalamine delayed-release capsules and report to their healthcare provider if they experience new or worsening symptoms of Acute Intolerance Syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, malaise, conjunctivitis and rash) or other symptoms suggestive of mesalamine-induced hypersensitivity [see Warnings and Precautions ( 5.2 , 5.3 )] . Hepatic Failure Inform patients with known liver disease of the signs and symptoms of worsening liver function and advise them to report to their healthcare provider if they experience such signs or symptoms [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 capsules 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 ( 5.6 )] .

Nephrolithiasis Instruct patients to maintain an adequate fluid intake 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… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption Approximately 28% of mesalamine in mesalamine delayed-release formulation is absorbed after oral ingestion. Following replicate single dose oral administration of mesalamine delayed-release 400 mg capsules containing four 100 mg tablets in healthy subjects (N = 146) under fasted conditions, the mean C max , AUC 8-48 and AUC tldc values were 150 ± 235 ng/mL, 640 ± 521 ng.h/mL, and 909 ± 777 ng.h/mL, respectively. The median [range] T max for mesalamine following mesalamine delayed-release 400 mg capsules containing four 100 mg tablets was approximately 10 hours [5.5 to 48 hours], reflecting the delayed-release characteristics of the formulation.

A high fat meal increased systemic exposure of mesalamine (geometric mean C max : ↑ 32%; AUC 8-48 h: ↑ 46%; AUC: ↑ 29%) and delayed the median t max by approximately 4 hours compared to results in the fasted state. The observed differences in mesalamine exposure due to concomitant food intake are not considered to be clinically relevant at the total daily dosage of 2.4 grams per day. Elimination Metabolism The absorbed mesalamine is rapidly acetylated in the gut mucosal wall and by the liver to N-acetyl-5-aminosalicylic acid.

Excretion Absorbed mesalamine is excreted mainly by the kidney as N-acetyl-5-aminosalicylic acid. Unabsorbed mesalamine is excreted in feces. After intravenous administration, the elimination half-life of mesalamine is reported to be approximately 40 minutes.

After oral dosing, the median terminal t 1/2 values for mesalamine are usually about 25 hours, but are variable, ranging from 1.5 to 296 hours. There is a large inter-subject and intra-subject variability in the plasma concentrations of mesalamine and N-acetyl-5-aminosalicylic acid and in their terminal half-lives following administration of mesalamine. Specific Populations Pediatric Patients In a dose-ranging pharmacokinetic study evaluating 30 mg/kg, 60 mg/kg and 90 mg/kg per day doses of mesalamine delayed-release 400 mg tablets administered twice daily for four weeks, the mean C avg values of mesalamine in pediatric ulcerative colitis patients ranged from approximately 400 ng/mL to 2100 ng/mL based on data from all dose levels.

In a study evaluating mesalamine delayed-release tablets in pediatric ulcerative colitis patients (Study 3), mean plasma concentrations of mesalamine (based on sparse sampling) were 820 to 988 ng/mL at the low dose level (that is, 1.2, 2 or 2.4 grams/day based on body weight strata of 17 to less than 33 kg, 33 to less than 54 kg, and 54 to 90 kg, respectively).

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The safety and efficacy of mesalamine has been established based on adequate and well-controlled studies of mesalamine delayed-release tablets. Below is a description of the results of the adequate and well-controlled studies of mesalamine delayed-release tablets for the treatment of mildly to moderately active ulcerative colitis in adults and pediatric patients 5 to 17 years of age and the maintenance of remission of ulcerative colitis in adults.

14.1Treatment of Mildly to Moderately Active Ulcerative Colitis Adults Two placebo-controlled studies (Studies 1 and 2) have demonstrated the efficacy of mesalamine delayed-release tablets in patients with mildly to moderately active ulcerative colitis. In one randomized, double-blind, multi-center, placebo-controlled clinical trial of 6 weeks’ duration in 158 patients (Study 1), patients received mesalamine delayed release dosages of 1.6 grams per day (800 mg twice a day; n=53) and 2.4 grams per day (800 mg three times a day; n=53), compared to placebo (n=52).

The scoring system for determination of treatment efficacy included assessment of stool frequency, rectal bleeding, sigmoidoscopic findings, patient’s functional assessment, and physician global assessment. At the dosage of 2.4 grams per day, 21 of 43 (49%) patients using mesalamine delayed release tablets showed an improvement in sigmoidoscopic appearance of the bowel compared to 12 of 44 (27%) patients using placebo (p = 0.048). In addition, significantly more patients in the mesalamine delayed release tablets 2.4 grams per day group showed improvement in rectal bleeding and stool frequency.

The 1.6 grams per day dosage regimen is not recommended because it did not produce consistent evidence of effectiveness [see Dosage and Administration ( 2.2 )] . In a second randomized, double-blind, placebo-controlled clinical trial of 6 weeks’ duration in 87 patients (Study 2), patients received mesalamine delayed release tablets of 1.6 grams per day (400 mg four times a day; n=11) and 4.8 grams per day (1.2 grams four times a day; n=38), compared to placebo four times a day (n=38). Mesalamine delayed release tablets 4.8 grams per day for 6 weeks resulted in sigmoidoscopic improvement in 28 of 38 (74%) patients compared to 10 of 38 (26%) placebo patients (p less than 0.001).

Also, more patients in the mesalamine delayed release tablets 4.8 grams per day group than the placebo group showed improvement in overall symptoms. The 4.8 grams per day dosage regimen is not recommended because greater efficacy was not demonstrated with this dosage compared to the 2.4 grams per day dosage [see Dosage and Administration ( 2.2 )] . Pediatrics The safety and effectiveness of mesalamine delayed release in pediatric patients 5 to 17 years of age for treatment of mildly to moderately active ulcerative colitis are supported by evidence from adequate and well controlled studies of mesalamine delayed release in adults and a single study in pediatric patients.

A randomized, double-blind, 6-week study of two dosage levels of mesalamine delayed release tablets (Study 3) was conducted in 82 pediatric patients 5 to 17 years of age with mildly or moderately active ulcerative colitis defined as a score of 10 to 55 on the Pediatric Ulcerative Colitis Activity Index (PUCAI) (which includes assessment of abdominal pain, rectal bleeding, stool consistency, number of stools per 24 hours, presence of nocturnal bowel movement and activity level, and has a total maximum score of 85; each of the subscales are scored from 0 to 10 except rectal bleeding which is scored from 0 to 30, and number of stools per 24 hours which is scored from 0 to 15) and rectal bleeding and stool frequency Mayo subscale scores of ≥1 (each of these subscales are scored from zero (normal) to three (most severe).

All patients were divided by weight category (17 to less than 33 kg, 33 to less than 54 kg, and 54 to 90 kg) and randomly assigned to receive a low dosage (1.2, 2, an… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Mesalamine was not carcinogenic at dietary doses of up to 480 mg/kg/day in rats and 2000 mg/kg/day in mice, which are about 2.9 and 6.1 times the maximum recommended maintenance dose of mesalamine of 1.6 grams per day or 26.7 mg/kg/day, based on 60 kg body weight, respectively, based on body surface area. Mutagenesis Mesalamine was negative in the Ames assay for mutagenesis, negative for induction of sister chromatid exchanges (SCE) and chromosomal aberrations in Chinese hamster ovary cells in vitro , and negative for induction of micronuclei (MN) in mouse bone marrow polychromatic erythrocytes.

Impairment of Fertility Mesalamine, at oral doses up to 480 mg/kg/day (about 1.9 times the recommended human treatment dose on a body surface area basis), was found to have no effect on fertility or reproductive performance of male and female rats.

13.2Animal Toxicology and/or Pharmacology In animal studies (rats, mice, dogs), the kidney was the principal organ for toxicity. (In the following, comparisons of animal dosing to recommended human dosing are based on body surface area and a 2.4 grams per day dose for a 60 kg person.) Mesalamine causes renal papillary necrosis in rats at single doses of approximately 750 mg/kg to 1000 mg/kg (approximately 3 to 4 times the recommended human dose based on body surface area). Doses of 170 and 360 mg/kg/day (about 0.7 and 1.5 times the recommended human dose based on body surface area) given to rats for six months produced papillary necrosis, papillary edema, tubular degeneration, tubular mineralization, and urothelial hyperplasia.

In mice, oral doses of 4000 mg/kg/day mesalamine (approximately 8 times the recommended human dose based on body surface area) for three months produced tubular nephrosis, multifocal/diffuse tubulo-interstitial inflammation, and multifocal/diffuse papillary necrosis. In dogs, single doses of 6000 mg (approximately 8 times the recommended human dose based on body surface area) of delayed-release mesalamine tablets resulted in renal papillary necrosis but were not fatal. Renal changes have occurred in dogs given chronic administration of mesalamine at doses of 80 mg/kg/day (1.1 times the recommended human dose based on body surface area).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 143 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Mesalamine was not carcinogenic at dietary doses of up to 480 mg/kg/day in rats and 2000 mg/kg/day in mice, which are about 2.9 and 6.1 times the maximum recommended maintenance dose of mesalamine of 1.6 grams per day or 26.7 mg/kg/day, based on 60 kg body weight, respectively, based on body surface area. Mutagenesis Mesalamine was negative in the Ames assay for mutagenesis, negative for induction of sister chromatid exchanges (SCE) and chromosomal aberrations in Chinese hamster ovary cells in vitro , and negative for induction of micronuclei (MN) in mouse bone marrow polychromatic erythrocytes.

Impairment of Fertility Mesalamine, at oral doses up to 480 mg/kg/day (about 1.9 times the recommended human treatment dose on a body surface area basis), was found to have no effect on fertility or reproductive performance of male and female rats.

📄 Recent Major Changes 5 words ▾

Warnings and Precautions Renal impairment

📄 Package Label / Principal Display Panel 56 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0093-5907-86 Mesalamine Delayed-Release Capsules 400 mg Swallow the capsule or tablets whole; do not cut, break, crush or chew the capsule or tablets. The capsule may be carefully opened and the contents (tablets) can be swallowed. Not Bioequivalent to Asacol ® HD * Rx only 180 CAPSULES 400 mg Container Label

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
7.6K
Units reimbursed last 4 qtrs
1.3M
Gross reimbursed last 4 qtrs
$3M
Avg / prescription
$397.71
Avg / unit
$2.2371
Latest quarter Q1 2026
1.6KRx
Medicaid pays / ea
$2.2371
gross reimbursed
vs
NADAC / ea
$2.6990
acquisition cost
=
Spread
−$0.4619
-17% 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 ⓘ
35% FFS 65% MCO
Fee-for-service · 2,648 Rx Managed care · 4,905 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 27,053 units · 346 per 100k residents WA Idaho: 1,860 units · 94.7 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 11,460 units · 200 per 100k residents MN Wisconsin: no data reported WI Michigan: 26,628 units · 265 per 100k residents MI New York: 134,594 units · 688 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 9,942 units · 235 per 100k residents OR Nevada: 13,186 units · 413 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 3,540 units · 110 per 100k residents IA Illinois: 19,530 units · 156 per 100k residents IL Indiana: 28,904 units · 421 per 100k residents IN Ohio: 116,494 units · 988 per 100k residents OH Pennsylvania: 175,186 units · 1,352 per 100k residents PA New Jersey: 27,323 units · 294 per 100k residents NJ Massachusetts: 10,757 units · 154 per 100k residents MA California: 323,627 units · 831 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 2,486 units · 54.9 per 100k residents KY West Virginia: no data reported WV Virginia: 41,721 units · 479 per 100k residents VA Maryland: 31,886 units · 516 per 100k residents MD Connecticut: 1,860 units · 51.4 per 100k residents CT Rhode Island: 2,286 units · 209 per 100k residents RI Arizona: 38,726 units · 521 per 100k residents AZ New Mexico: 13,319 units · 630 per 100k residents NM Kansas: 18,459 units · 628 per 100k residents KS Arkansas: no data reported AR Tennessee: 16,482 units · 231 per 100k residents TN North Carolina: 11,268 units · 104 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 2,640 units · 65.1 per 100k residents OK Louisiana: 10,500 units · 230 per 100k residents LA Mississippi: no data reported MS Alabama: 1,740 units · 34.1 per 100k residents AL Georgia: no data reported GA D.C.: 9,642 units · 1,420 per 100k residents DC Hawaii: no data reported HI Texas: 20,954 units · 68.7 per 100k residents TX Florida: 23,010 units · 102 per 100k residents FL
Units reimbursed · per 100k residents
34.11,420
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 D.C. 1,420 /100k
2 Pennsylvania 1,352 /100k
3 Ohio 988 /100k
4 California 831 /100k
5 New York 688 /100k
6 New Mexico 630 /100k
7 Kansas 628 /100k
8 Arizona 521 /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.
← 00093-5572-01 · Teva 00093-5938-98 · Teva →
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.