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mesalamine 800 mg Tablet, Delayed Release, 180-count — NDC 68382-435-28 (Billing 68382-0435-28)

by Zydus Pharmaceuticals USA Inc. · 180 TABLET, DELAYED RELEASE in 1 BOTTLE

This is a package of 180 tablets of mesalamine 800 mg Tablet, Delayed Release from Zydus Pharmaceuticals USA Inc., marketed since Aug 2018 and currently FDA-listed; retail pharmacies pay about $4.02 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 68382-0435-28
🏷️ FDA NDC (as labeled) 68382-435-28 billing pads the product segment with a zero
This package
Contains180-count Cost per ea$4.02 NADAC Per package$723.69 / 180 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $5.01/unit · Part D plans $5.29/unit — full pricing hub ↓
Main listing for product 68382-435 · Also comes in: 10 tablets 68382-435-77
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
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) 68382-435-28
Product NDC 68382-435
11-digit billing NDC 68382043528
NCPDP billing unit EA — each (per item)
RxCUI 833234
UNII 4Q81I59GXC
Application # ANDA203286
SPL Set ID ad8c7930-92e2-4372-a874-da22b9ae333e
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 2018-08-02
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

GCN Seq No 053882
GCN 21663
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 800 MG DR TABLET
FDB brand name Mesalamine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 053882
  • GCN: 21663
  • HICL (First Databank): 001848
  • AHFS class code: 56:36.00.00
  • RxCUI (RxNorm): 833234
Why two NDCs? The FDA registers this code as 68382-435-28 — a 5-3-2 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 product segment → 68382-0435-28. 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 800 MG DR 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 $4.021 $723.69 / 180 tablets
Medicaid paysCMS SDUD · 12 mo $5.01 $902.65 / 180 tablets
Medicare drug plans payPart D · Q2 2026 $5.29 $951.55 / 180 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $6.325 $4.003
▼ Down 34% 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 Per unit Per pack Marketing startMarketing endStatus
68382-0435-28 You're viewing this Main listing 180 TABLET, DELAYED RELEASE in 1 BOTTLE $4.02 / ea $723.68 2018-08-02 — Active
68382-0435-77 68382-435-77 10 BLISTER PACK in 1 CARTON / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK — — 2018-08-02 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 180-count package — 180 tablet, delayed release in 1 bottle.
What NDC number is used to bill for this package of mesalamine 800 mg Tablet, Delayed Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mesalamine 800 mg 00480-7750-80 Teva 180 tablets $4.020 AB Availability likely —
Mesalamine 800 mg 60687-0408-25 American 1 tablet $4.020 AB Availability likely —
Mesalamine 800 mg 65162-0360-18 Amneal 180 tablets $4.020 AB Availability likely —
mesalamine 800 mgthis 68382-0435-28 Zydus 180 tablets $4.020 AB Availability likely —
Mesalamine 800 mg 42291-0489-18 AvKARE 180 tablets — AB FDA listed —
mesalamine 800 mg 70771-1110-04 Zydus 10 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

🏛️
2018
On the market since
Aug 2018
📍
2026
Currently FDA-listed
8 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.

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

  • UNII 0ZBX0N59RZ
    A plasticizer derived from citric acid that is added to tablet coatings and film formulations. It increases flexibility and durability of the coating layer, helping the tablet withstand handling and moisture without cracking.
  • 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 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • 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 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • 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 1CS02G8656
    Methacrylic acid is a synthetic polymer used as a coating material and binder in tablets and capsules. It helps control how and where the medication releases in the digestive system.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your 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.
  • 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.

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

LabelerZydus Pharmaceuticals USA Inc.
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA203286 (ANDA)
Labeler code68382
First marketedAug 2018
Product typeHuman Prescription Drug
Portfolio454 products on file
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 75 words ▾

1 INDICATIONS AND USAGE Mesalamine delayed-release tablets are aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. ( 1 ) Limitation of Use: Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established ( 1 ) Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. Limitations of Use: Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Important Administration Instructions: Do not substitute one mesalamine delayed-release tablet, 800 mg for two mesalamine delayed-release 400 mg oral products. ( 2.1 ) Evaluate renal function prior to initiation of mesalamine delayed-release tablets, 800 mg. ( 2.1 , 5.1 ) Take on an empty stomach, at least 1 hour before and 2 hours after a meal.

( 2.1 ) Swallow whole; do not cut, break or chew the tablets. ( 2.1 ) Drink an adequate amount of fluids. ( 2.1 , 5.7 ) Treatment of Moderately Active Ulcerative Colitis: Recommended dosage is 1600 mg (two 800 mg tablets) three times daily for 6 weeks.

( 2.2 )

2.1Important Administration Instructions Do not substitute one mesalamine delayed-release tablet 800 mg for two mesalamine delayed-release 400 mg oral products [see Clinical Pharmacology ( 12.3 )]. Evaluate renal function prior to initiation of mesalamine delayed-release tablets. Take mesalamine delayed-release tablets on an empty stomach, at least 1 hour before and 2 hours after a meal [see Clinical Pharmacology ( 12.3 )] .

Swallow mesalamine delayed-release tablets whole. Do not cut, break 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 tablets from moisture.

2.2Dosage Information For the treatment of moderately active ulcerative colitis, the recommended dosage of mesalamine delayed-release tablets in adults is 1600 mg (two 800 mg tablets) three times daily (total daily dosage of 4.8 grams) for a duration of 6 weeks.

💊 Dosage Forms and Strengths 36 words ▾

3 DOSAGE FORMS AND STRENGTHS Delayed-release tablets: 800 mg ( 3 ) Mesalamine delayed-release tablets are available as reddish-brown colored, capsule-shaped, biconvex, enteric coated tablets imprinted with "435" on one side and plain on other side.

⛔ Contraindications 69 words ▾

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

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Renal Impairment : Assess renal function at the beginning to treatment and periodically during treatment. Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function. Discontinue mesalamine if renal function deteriorates.

( 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; discontinue if acute intolerance syndrome suspected. ( 5.2 ) Hypersensitivity Reactions , including Myocarditis and Pericarditis: Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected. ( 5.3 ) Hepatic Failure : Evaluate the risks and benefits 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 preexisting skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. ( 5.6 ) Nephrolithiasis: Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT).

Ensure adequate hydration during treatment. ( 5.7 ) 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 ) Intracranial Hypertension: If an unusual headache or visual disturbance occurs during treatment, immediately discontinue treatment and refer patient for further evaluation.

( 5.10 )

5.1Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients taking products such as mesalamine delayed-release tablets that contain or are converted to mesalamine [see Adverse Reactions ( 6.2 )] . 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 and periodically while on therapy.

Evaluate the risks and benefits of using mesalamine delayed-release tablets in patients with known renal impairment or history of renal disease or taking concomitant nephrotoxic drugs. Discontinue mesalamine 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. Exacerbation of the symptoms of colitis has been reported in 2.3% of mesalamine-treated patients in controlled clinical trials. This acute reaction, characterized by cramping, abdominal pain, bloody diarrhea, and occasionally by fever, headache, malaise, pruritus, rash, and conjunctivitis, has been reported after the initiation of mesalamine delayed-release tablets as well as other mesalamine products.

Symptoms usually abate when mesalamine delayed-release tablets are discontinued. Monitor patients 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 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 patients i… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (≥ 2%) are headache, nausea, nasopharyngitis, abdominal pain, and worsening of ulcerative colitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious or clinically significant adverse described elsewhere in labeling 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 )] Intracranial Hypertension [see Warnings and Precautions ( 5.10 )]

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. Mesalamine has been evaluated in 896 patients with ulcerative colitis in controlled studies. Three six-week, active-controlled studies were conducted comparing mesalamine 4.8 grams per day with mesalamine-delayed release tablets 2.4 grams per day in patients with mildly to moderately active ulcerative colitis.

In these studies, 727 patients were dosed with the mesalamine delayed-release tablet, 800 mg and 732 patients were dosed with mesalamine delayed-release tablets, 400 mg. The most common reactions reported in the mesalamine group were headache (4.7%), nausea (2.8%), nasopharyngitis (2.5%), abdominal pain (2.3%), diarrhea (1.7%), and dyspepsia (1.7%); Table 1 enumerates adverse reactions that occurred in the three studies. The most common reactions in patients with moderately active ulcerative colitis (602 patients dosed with mesalamine delayed-release tablet, 800 mg and 618 patients dosed with the mesalamine delayed-release tablet, 400 mg) were the same as all treated patients.

Discontinuations due to adverse reactions occurred in 3.9% of patients in the mesalamine delayed-release tablet, 800 mg group and in 4.2% of patients in the mesalamine delayed-release tablet, 400 mg comparator group. The most common cause for discontinuation was gastrointestinal symptoms associated with ulcerative colitis. Serious adverse reactions occurred in 0.8% of patients in the mesalamine delayed-release tablet, 800 mg group and in 1.8% of patients in the mesalamine delayed-release tablet, 400 mg comparator group.

The majority involved the gastrointestinal system. Table 1 Adverse Reactions Occurring in ≥1% of All Treated Patients (Three studies combined) N = number of patients within specified treatment group Percent = percentage of patients in category and treatment group Adverse Reaction Mesalamine delayed-release 2.4 grams per day (400 mg Tablet) (N = 732) Mesalamine delayed-release 4.8 grams per day (800 mg Tablet) (N = 727) Headache 4.9 % 4.7 % Nausea 2.9 % 2.8 % Nasopharyngitis 1.4 % 2.5 % Abdominal pain 2.3 % 2.3 % Diarrhea 1.9 % 1.7 % Dyspepsia 0.8 % 1.7 % Vomiting 1.6 % 1.4 % Flatulence 0.7 % 1.2 % Influenza 1.2 % 1 % Pyrexia 1.2 % 0.7 % Cough 1.4 % 0.3 %

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of mesalamine delayed-release tablet 800 mg or other mesalamine-containing products or products that are metabolized to mesalamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole Facial edema, edema, peripheral edema, asthenia, chills, infection, malaise, pain, neck pain, chest pain, back pain, abdominal enlargement, lupus-… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 196 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 nonsteroidal 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 tablet 800 mg 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 Limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. No fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data 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 harm to the fetus.

These mesalamine doses were about 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose of 4.8 grams per day, based on body surface area.

8.2Lactation Risk Summary Mesalamine and its N-acetyl metabolite are present in human milk in undetectable to small amounts [ see Data ]. There are limited reports of diarrhea in breastfed infants. There is no information on the effects of the drug on milk production.

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 infant from the drug or from the underlying maternal condition. Clinical Considerations Monitor breastfed infants for diarrhea. Data Human Data 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 Nacetyl-5-aminosalicylic acid metabolite ranged from 5 to 18.1 mg/L. Based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.017 mg/kg/day of mesalamine and 0.75 to 2.72 mg/kg/day of N-acetyl-5-aminosalicylic acid.

8.4Pediatric Use Safety and effectiveness of mesalamine in pediatric patients have not been established. See the prescribing information for other approved mesalamine products for the safety and effectiveness of these products in pediatric patients.

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 reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia, and pancytopenia) in patients who were 65 years or older compared to younger patients taking mesalamine containing products such as mesalamine delayed-release tablets, 800 mg.

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

8.6Renal Impairment Mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Evaluate renal function in all patients prior to initiation and periodically while on mesalamine delayed-release tablets therapy. Monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions.

Discontinue mesalamine if renal function deteriorates while on therapy [ see Warnings and Precauti… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 154 words ▾

8.1Pregnancy Risk Summary Limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. No fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data 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 harm to the fetus.

These mesalamine doses were about 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose of 4.8 grams per day, based on body surface area.

🧒 Pediatric Use 35 words ▾

8.4Pediatric Use Safety and effectiveness of mesalamine in pediatric patients have not been established. See the prescribing information for other approved mesalamine products for the safety and effectiveness of these products in pediatric patients.

🧓 Geriatric Use 129 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 reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia, and pancytopenia) in patients who were 65 years or older compared to younger patients taking mesalamine containing products such as mesalamine delayed-release tablets, 800 mg.

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

🆘 Overdosage 117 words ▾

10 OVERDOSAGE Mesalamine 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 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 Plasma concentrations of mesalamine (5-aminosalicylic acid; 5-ASA) and its metabolite, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA) are highly variable following administration of mesalamine delayed-release tablets. Following single dose oral administration of mesalamine delayed-release tablet 800 mg in healthy subjects (N = 139) under fasted conditions, the mean C max , AUC 8-48h and AUC 0-tldc values were 208 ng/mL, 2296 ng.h/mL, and 2533 ng.h/mL, respectively. The median [range] T max for mesalamine following administration of mesalamine delayed-release tablet 800 mg was approximately 24 hours [4 to 72 hours], reflecting the delayed-release characteristics of the formulation.

Based on cumulative urinary recovery of mesalamine and N-Ac-5-ASA from single dose studies in healthy subjects, approximately 20% of the orally administered mesalamine in mesalamine delayed-release tablets is systemically absorbed. Food Effect: A high calorie (800 to 1000 calories), high fat (approximately 50 % of total caloric content) meal increased mesalamine C max by 2.4-fold and mesalamine systemic exposure (AUC 8-48 and AUC 0-tldc ) by 2.8-fold; the median lag-time increased by 8 hours and median t max by 6 hours (from 24 to 30 hours) [see Dosage and Administration ( 2.1 )] .

Comparative exposure between one mesalamine delayed-release tablet 800 mg and two mesalamine delayed-release 400 mg oral products is unknown [see Dosage and Administration ( 2.1 )]. Elimination Metabolism The absorbed mesalamine is acetylated in the gut mucosal wall and by the liver to N-Ac- 5-ASA. Excretion Absorbed mesalamine is excreted mainly by the kidneys as N-acetyl-5-aminosalicylic acid.

Unabsorbed mesalamine is excreted in feces.

🧬 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 81 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Mesalamine Delayed-release Tablets, USP 800 mg are reddish-brown colored, capsule-shaped, biconvex, enteric coated tablets, imprinted with "435" on one side and plain on other side and are supplied as follows: NDC 68382-435-28 in bottles of 180 tablets NDC 68382-435-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Tablets can be dispensed without desiccant for up to 6 weeks.

📋 Description ~1 min read ▾

11 DESCRIPTION Each mesalamine delayed-release tablet for oral administration contains 800 mg of mesalamine USP, an aminosalicylate. Mesalamine, USP is light tan to pink colored, needle-shaped crystals. Color may darken on exposure to air.

It is odorless or may have a slight characteristic odor, slightly soluble in water; very slightly soluble in methanol, in dehydrated alcohol, and in acetone; practically insoluble in n - butyl alcohol, in chloroform, in ether, in ethyl acetate, in n-hexane, in methylene chloride, and in n-propyl alcohol and soluble in dilute hydrochloric acid and in dilute alkali hydroxides. Mesalamine delayed-release tablets 800 mg have single layered coating consisting of an acrylic based resin Eudragit S (methacrylic acid copolymer B, NF), which dissolves at pH 7 or greater, releasing mesalamine for topical anti-inflammatory action in the colon.

Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Each mesalamine delayed-release tablet contains 800 mg of mesalamine. In addition, each tablet contains the following inactive ingredients: acetyltributyl citrate, colloidal silicone dioxide, ferric oxide red, magnesium stearate, methacrylic acid copolymer type B, microcrystalline cellulose, povidone, sodium starch glycolate, talc and titanium dioxide. The tablet is printed with opacode black S-1-17823 which contains following ingredients: ammonium hydroxide, butyl alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol and shellac.

Mesalamine Delayed-release Tablets, USP

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Administration [see Dosage and Administration ( 2.1 )] Inform patients that if they are switching from a previous oral mesalamine therapy to mesalamine delayed-release tablets to discontinue their previous oral mesalamine therapy and follow the dosing instructions for mesalamine delayed-release tablets. One mesalamine delayed-release tablet 800 mg is not substitutable for two mesalamine delayed-release 400 mg oral products. Inform patients to take mesalamine delayed-release tablets on an empty stomach, at least 1 hour before and 2 hours after a meal.

Instruct patients to swallow the mesalamine delayed-release tablets whole, taking care not to break, cut, or chew the tablets, because the coating is an important part of the delayed-release formulation. 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. Instruct patients to protect mesalamine delayed-release tablets from moisture. 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, 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 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, 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 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 )] .

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

Advise patients to complete all blood tests ordered by their healthcare provider [see Drug Interactions ( 7.2 ), Use in Specific Populations ( 8.5 )] . Intracranial Hypertension Instruct patients to discontinue mesalamine delayed-release tablets and immediately report to their healthcare provider if unusual headache or visual disturbances occur [see Warnings and Precautions ( 5.10 )] . Urine Discoloration Advise patients that urine may become discolored reddish-brown while taking Mesalamine Delayed-Release Tablets when it comes in contact with surfaces or w… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption Plasma concentrations of mesalamine (5-aminosalicylic acid; 5-ASA) and its metabolite, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA) are highly variable following administration of mesalamine delayed-release tablets. Following single dose oral administration of mesalamine delayed-release tablet 800 mg in healthy subjects (N = 139) under fasted conditions, the mean C max , AUC 8-48h and AUC 0-tldc values were 208 ng/mL, 2296 ng.h/mL, and 2533 ng.h/mL, respectively. The median [range] T max for mesalamine following administration of mesalamine delayed-release tablet 800 mg was approximately 24 hours [4 to 72 hours], reflecting the delayed-release characteristics of the formulation.

Based on cumulative urinary recovery of mesalamine and N-Ac-5-ASA from single dose studies in healthy subjects, approximately 20% of the orally administered mesalamine in mesalamine delayed-release tablets is systemically absorbed. Food Effect: A high calorie (800 to 1000 calories), high fat (approximately 50 % of total caloric content) meal increased mesalamine C max by 2.4-fold and mesalamine systemic exposure (AUC 8-48 and AUC 0-tldc ) by 2.8-fold; the median lag-time increased by 8 hours and median t max by 6 hours (from 24 to 30 hours) [see Dosage and Administration ( 2.1 )] .

Comparative exposure between one mesalamine delayed-release tablet 800 mg and two mesalamine delayed-release 400 mg oral products is unknown [see Dosage and Administration ( 2.1 )]. Elimination Metabolism The absorbed mesalamine is acetylated in the gut mucosal wall and by the liver to N-Ac- 5-ASA. Excretion Absorbed mesalamine is excreted mainly by the kidneys as N-acetyl-5-aminosalicylic acid.

Unabsorbed mesalamine is excreted in feces.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The efficacy of mesalamine delayed-release tablets at 4.8 grams per day was studied in a six-week, randomized, double-blind, active-controlled study in 772 patients with moderately active ulcerative colitis (UC). Moderately active UC was defined as a Physician's Global Assessment (PGA) score of 2; the PGA is a four-point scale (0 to 3) that encompasses the clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy findings. Patients were randomized 1:1 to the mesalamine delayed-release tablets 4.8 grams per day group (two mesalamine delayed-release tablets three times a day) or the mesalamine delayed-release 2.4 grams per day group (two mesalamine delayed-release 400 mg tablets three times a day).

Patients characteristically had a history of previous use of oral 5-ASAs (86%), steroids (41%), and rectal therapies (49%), and demonstrated clinical symptoms of three or more stools over normal per day (87%) and obvious blood in the stool most or all of the time (70%). The study population was primarily Caucasian (97%), had a mean age of 43 years (8% aged 65 years or older), and included slightly more males (56%) than females (44%). The primary endpoint was treatment success defined as improvement from baseline to Week 6 based on the PGA.

Treatment success rates were similar in the two groups: 70% in the mesalamine group and 66% in the mesalamine delayed-release 400 mg tablets group (difference: 5%; 95% CI: [-1.9%, 11.2%]). A second controlled study supported the efficacy of mesalamine at 4.8 grams per day. Treatment success was 72% in patients with moderately active UC treated with mesalamine.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Dietary mesalamine was not carcinogenic in rats at doses as high as 480 mg/kg/day, or in mice at 2000 mg/kg/day. These doses are approximately 0.97 and 2.0 times the 4.8 grams per day mesalamine delayed-release tablets dose (based on body surface area). Mesalamine was not genotoxic in the Ames test, the Chinese hamster ovary cell chromosomal aberration assay, and the mouse micronucleus test.

Mesalamine, at oral doses up to 480 mg/kg/day (about 0.97 times the recommended human treatment dose based on body surface area), 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 4.8 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 (1.5 to 2.0 times the recommended human dose).

Doses of 170 and 360 mg/kg/day (about 0.3 and 0.73 times the recommended human dose) 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 (approximately 4.1 times the recommended human dose) for three months produced tubular nephrosis, multifocal/diffuse tubulo-interstitial inflammation, and multifocal/diffuse papillary necrosis. In dogs, single doses of 6000 mg (approximately 6.25 times the recommended human dose) 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 (0.5 times the recommended human dose).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 106 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Dietary mesalamine was not carcinogenic in rats at doses as high as 480 mg/kg/day, or in mice at 2000 mg/kg/day. These doses are approximately 0.97 and 2.0 times the 4.8 grams per day mesalamine delayed-release tablets dose (based on body surface area). Mesalamine was not genotoxic in the Ames test, the Chinese hamster ovary cell chromosomal aberration assay, and the mouse micronucleus test.

Mesalamine, at oral doses up to 480 mg/kg/day (about 0.97 times the recommended human treatment dose based on body surface area), was found to have no effect on fertility or reproductive performance of male and female rats.

📄 Recent Major Changes 12 words ▾

RECENT MAJOR CHANGES Warnings and Precautions, Intracranial Hypertension ( 5.10 ) 07/2026

📄 Package Label / Principal Display Panel 29 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-435-28 in bottle of 180 tablets Mesalamine Delayed-release Tablets USP, 800 mg R x only 180 tablets ZYDUS Mesalamine Delayed-release Tablets USP, 800 mg

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
3.5K
Units reimbursed last 4 qtrs
457.9K
Gross reimbursed last 4 qtrs
$2.3M
Avg / prescription
$650.50
Avg / unit
$5.0147
Latest quarter Q1 2026
651Rx
Medicaid pays / ea
$5.0147
gross reimbursed
vs
NADAC / ea
$4.0205
acquisition cost
=
Spread
+$0.9942
+25% 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 ⓘ
45% FFS 55% MCO
Fee-for-service · 1,579 Rx Managed care · 1,951 Rx
State Medicaid map
Alaska: 9,064 units · 1,237 per 100k residents AK Maine: no data reported ME Washington: 3,120 units · 39.9 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 1,768 units · 30.8 per 100k residents MN Wisconsin: no data reported WI Michigan: 4,090 units · 40.7 per 100k residents MI New York: 60,931 units · 311 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 1,380 units · 43.2 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 6,052 units · 48.2 per 100k residents IL Indiana: no data reported IN Ohio: 8,670 units · 73.6 per 100k residents OH Pennsylvania: 28,909 units · 223 per 100k residents PA New Jersey: 3,470 units · 37.4 per 100k residents NJ Massachusetts: 25,587 units · 365 per 100k residents MA California: 132,734 units · 341 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: 11,703 units · 259 per 100k residents KY West Virginia: no data reported WV Virginia: 13,135 units · 151 per 100k residents VA Maryland: 27,272 units · 441 per 100k residents MD Connecticut: 7,864 units · 217 per 100k residents CT Rhode Island: no data reported RI Arizona: 6,855 units · 92.2 per 100k residents AZ New Mexico: 1,590 units · 75.2 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,410 units · 30.8 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 16,392 units · 53.7 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
30.81,237
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 Alaska 1,237 /100k
2 Maryland 441 /100k
3 Massachusetts 365 /100k
4 California 341 /100k
5 New York 311 /100k
6 Kentucky 259 /100k
7 Pennsylvania 223 /100k
8 Connecticut 217 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
180 tablets this page68382-0435-28 3,530 Rx · $2,296,276
10 tablets68382-0435-77 No Medicaid data
Drug total (last 4 qtrs): 3,530 Rx · 457,913 units · $2,296,276 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Mesalamine — 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.
← 68382-0412-01 · Zydus 68382-0441-06 · Zydus →
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.