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SUTAB sodium sulfate, magnesium sulfate, and potassium chloride 17.75 g; 2.7 g; 2.25 g Tablet — NDC 24338-0201-01 package photo

SUTAB sodium sulfate, magnesium sulfate, and potassium chloride 17.75 g; 2.7 g; 2.25 g Tablet

by Azurity Pharmaceuticals, Inc. · 2 BOTTLE, PLASTIC in 1 KIT (24338-201-01) / 12 TABLET in 1 BOTTLE, PLASTIC
NDC 24338-0201-01
🏷️ FDA NDC (as labeled) 24338-201-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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

🆔 Identity & classification

FDA NDC (as labeled) 24338-201-01
Product NDC 24338-201
11-digit billing NDC 24338020101
NCPDP billing unit EA — each (per item)
UNII 0YPR65R21J, ML30MJ2U7I, 660YQ98I10
UPC 0324338202012
Application # NDA213135
SPL Set ID c020e973-dccf-4862-999e-17db6209a48a
Established class (EPC) Calculi Dissolution Agent; Inhibition Sma
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-01
Route ORAL
Dosage form TABLET
Substance SODIUM SULFATE; MAGNESIUM SULFATE ANHYDROUS; POTASSIUM CHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 24338-201-01 — 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 → 24338-0201-01. 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.

🏭 Manufacturer & labeler

LabelerAzurity Pharmaceuticals, Inc.
Application holderAZURITY PHARMACEUTICALS INC
FDA applicationNDA213135 (NDA)
Labeler code24338
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio57 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.

🩺 Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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 FC72KVT52F
    A clear, viscous liquid derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in formulations like syrups, gels, and topical products.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • UNII 23ZQ42JZZH
    A synthetic polymer made by chemically linking polyvinyl alcohol to polyethylene glycol. It acts as a binder and film-former to hold tablet ingredients together and create smooth coatings on capsules or tablets.
  • UNII 9XTM81VK2B
    Sodium caprylate is a salt derived from caprylic acid, a naturally occurring fatty acid. In medicines, it acts as a preservative and antimicrobial agent to help prevent contamination and extend shelf life.

4 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.

💲 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 $6.740 $161.75 / 24 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Aug 2026 $6.740 $6.740
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sutab 17.75 g/1; 2.7 g/1; 2.25 g 52268-0201-01 Braintree 12 tablets $6.739 AB Availability likely —
Sutab 17.75 g/1; 2.7 g/1; 2.25 gthis 24338-0201-01 Azurity 12 tablets $6.739 AB Availability likely —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2020
First FDA approval
Nov 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 10, 2020 AB TE-rated RLD RS ⏳ ~10.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11382864 — method of use (U-3164)
US 11033498 — method of use (U-3164)
US 11638697 — drug product
US 10143656 — drug product
2020 2022 2024 2026 2028 2030 2032 2034 2036
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 11382864 ↗ Method of use U-3164 Aug 4, 2037
US 11033498 ↗ Method of use U-3164 Aug 4, 2037
US 11638697 ↗ Drug product — Aug 4, 2037
US 10143656 ↗ Drug product — Aug 4, 2037
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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

Medicare Part D (outpatient prescription) spending for Sutab — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Sutab. 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
$6.79M
Claims incl. refills
41.2K
Beneficiaries
40.6K
Spend / beneficiary
$167.27
Spend / claim
$164.72
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
24338-0201-01 You're viewing this 2 BOTTLE, PLASTIC in 1 KIT (24338-201-01) / 12 TABLET in 1 BOTTLE, PLASTIC 2026-04-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 24338-201-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 24338-0201-01, written without dashes as 24338020101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 24338-0201-01, the first segment (24338) is the labeler code FDA assigned to Azurity Pharmaceuticals, Inc.; the middle segment (0201) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Azurity Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Azurity Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 37 words ▾

1 INDICATIONS AND USAGE SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. SUTAB is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information. ( 2.1 , 2.2 ) Preparation and Administration ( 2.1 ) Administration of two doses (24 tablets) are required for a complete preparation for colonoscopy. SUTAB is supplied as two bottles each containing 12 tablets.

Twelve (12) tablets are equivalent to one dose. Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles the evening prior to the colonoscopy.

Must consume water with each dose and an additional 32 ounces of water after each dose. Do not take other laxatives. Administer oral medications at least 1 hour before starting each dose of SUTAB.

If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of each dose. Recommended Split Dose (2-Day) Dosage Regimen ( 2.2 ) Day 1, Dose 1: On the Evening Prior to Colonoscopy: Open 1 bottle of 12 tablets. Remove and discard the desiccant.

Remove and discard the desiccant from the second bottle and close the bottle. Use the second bottle for the second dose on the morning of the colonoscopy. Fill the provided container with 16 ounces of water (up to the fill line).

Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet is ingested, fill the provided container a second time with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Approximately 30 minutes after finishing the second container of water, fill the provided container with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes.

Day 2, Dose 2: Morning of the Colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1): Continue to consume only clear liquids until after the colonoscopy. Repeat Step 2 to Step 4 from Day 1, Dose 1. If patients experience preparation-related symptoms (e.g., nausea, bloating, cramping), pause or slow the rate of drinking the additional water until symptoms diminish.

Complete all SUTAB tablets and water at least two hours prior to colonoscopy.

2.1Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with SUTAB [see Warnings and Precautions ( 5.1 )] Administration of two doses of SUTAB (24 tablets) are required for a complete preparation for colonoscopy. SUTAB is supplied as two bottles each containing 12 tablets. Twelve (12) tablets are equivalent to one dose.

Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles of SUTAB the evening prior to the colonoscopy [see Dosage and Administration ( 2.2 )]. Must consume water with each dose of SUTAB and an additional 32 ounces of water must be consumed after each dose [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 ) ].

Consume a low residue breakfast on the day before colonoscopy, followed by clear liquids up to 2 hours prior to colonoscopy. Do not drink milk or eat or drink anything colored red or purple. Do not drink alcohol.

Do not take other laxatives while taking SUTAB. Administer oral medications at least 1 hour before starting each dose of SUTAB. If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of each dose of SUTAB.

Stop consumption of all fluids at least 2 hours prior to the colonoscopy.

2.2Recommended Split-Dose (2-Day) Dosage Regimen The recommended Split-Dose (2-day) dosage regimen for adults consists of two doses of SUTAB: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy. Instruct patien…

💊 Dosage Forms and Strengths 53 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride. The tablets are white to off-white, film coated, oblong, and biconvex with flat sides, debossed with S24 on one side. Tablets: 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride.

⛔ Contraindications 94 words ▾

4 CONTRAINDICATIONS SUTAB is contraindicated in the following conditions: Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6 )] Bowel perforation [see Warnings and Precautions ( 5.6 )] Toxic colitis or toxic megacolon Gastric retention Hypersensitivity to any ingredient in SUTAB [see Warnings and Precautions ( 5.7 ) and Description ( 11 )] Gastrointestinal obstruction or ileus ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Hypersensitivity to any ingredient in SUTAB ( 4 , 5.7 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities : Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use. ( 5.1 , 7.1 ) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. (5.2) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold.

( 5.3 , 7.1 ) Patients with renal impairment or taking concomitant medications that affect renal function : Use caution, ensure adequate hydration and consider laboratory testing. ( 5.4 , 7.1 ) Colonic mucosal ulcerations : Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. ( 5.5 ) Suspected GI obstruction or perforation : Rule out the diagnosis before administration.

( 4 , 5.6 ) Hypersensitivity reactions, including anaphylaxis : Inform patients to seek immediate medical care if symptoms occur. ( 5.7 ) Risk of Gastrointestinal Complications with Ingestion of Desiccant : Postmarketing reports of ingestion of the desiccant along with SUTAB tablets has been reported and may be associated with risk of gastrointestinal complications and/or choking. ( 2.2 , 5.8 )

5.1Serious Fluid and Electrolyte Abnormalities Advise all patients to hydrate adequately before, during, and after the use of SUTAB. If a patient develops significant vomiting or signs of dehydration after taking SUTAB, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment.

Correct fluid and electrolyte abnormalities before treatment with SUTAB. Use SUTAB with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment [see Drug Interactions ( 7.1 )] .

5.2Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing SUTAB for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

5.3Seizures There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing SUTAB for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions ( 7.1 )] .

5.4Use in Patients with Risk of Renal Injury Use SUTAB with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see Drug Interactions ( 7.1 )] . These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration with SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electroly…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Risk of Gastrointestinal Complications with Ingestion of Desiccant [see Warnings and Precautions ( 5.8 )] Most common gastrointestinal adverse reactions are nausea, abdominal distension, vomiting and upper abdominal pain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. The safety of SUTAB was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials in 941 adult patients undergoing colonoscopy. The active comparators were polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution in Study 1 and sodium picosulfate, magnesium oxide, and anhydrous citric acid for oral solution in Study 2 [see Clinical Studies ( 14 )] .

Adverse Gastrointestinal Reactions Reported by Symptom Questionnaire In Studies 1 and 2, patients were queried for selected gastrointestinal adverse reactions of stomach cramping (upper abdominal pain), stomach bloating (abdominal distention), nausea and vomiting using a standard questionnaire following completion of study drug and prior to colonoscopy on the day of colonoscopy. Patients reporting selected gastrointestinal symptom(s) rated the intensity as mild, moderate or severe. A total of 52% (287/552) of patients in Study 1 and 52% (202/389) in Study 2 reported at least one selected gastrointestinal adverse reaction when queried using the standard questionnaire.

Tables 1 and 2 show results for each gastrointestinal adverse reaction reported by patients using the standard questionnaire, including severity. Table 1: Gastrointestinal Symptoms by Severity a From Symptom Questionnaire in Adult Patients Following Colon Cleansing and Prior to Colonoscopy – Study 1 b Symptom SUTAB Polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate Total Number of Patients per Treatment Arm (N) 281 271 Patients with at Least One Gastrointestinal Adverse Reaction from Symptom Questionnaire 163 124 % Nausea c 48 26 Mild 71 77 Moderate 27 23 Severe 2 0 % Abdominal Distension c,d 29 22 Mild 68 71 Moderate 30 29 Severe 1 0 % Vomiting c 23 5 Mild 48 46 Moderate 52 54 Severe 0 0 % Upper Abdominal Pain c 16 18 Mild 65 71 Moderate 35 29 Severe 0 0 a Mild : barely noticeable, does not influence functioning causing no limitations of usual activities; Moderate: makes participant uncomfortable, influences functioning causing some limitations of usual activities; Severe: severe discomfort, treatment needed, severe and undesirable, causing inability to carry out usual activities b Study 1 was not designed to support comparative claims for SUTAB for the adverse reactions reported in this table. c Percentage represents n/N for patients who experienced each gastrointestinal adverse reaction on the symptom questionnaire based on the total number of patients per treatment arm. d Total not equal to 100% due to rounding.

Table 2: Gastrointestinal Symptom…

🔄 Drug Interactions 189 words ▾

7 DRUG INTERACTIONS Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1 )

7.1Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing SUTAB to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )] .

7.2Potential for Reduced Drug Absorption SUTAB can reduce the absorption of other co-administered drugs [see Dosage and Administration ( 2.1 )] : Administer oral medications at least one hour before starting each dose of SUTAB. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of each dose of SUTAB to avoid chelation with magnesium.

7.3Stimulant Laxatives Concurrent use of stimulant laxatives and SUTAB may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking SUTAB [see Warnings and Precautions ( 5.5 )] .

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on SUTAB use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (SUTAB). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

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

8.2Lactation Risk Summary There are no available data on the presence of SUTAB in human or animal milk, the effects of on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SUTAB and any potential adverse effects on the breastfed child from SUTAB or from the underlying maternal condition.

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

8.5Geriatric Use Of the 471 patients who received SUTAB in pivotal clinical trials, 150 (32%) were 65 years of age or older, and 25 (5%) were 75 years of age or older. No differences in safety or effectiveness of SUTAB were observed between geriatric patients and younger patients. Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 )] .

8.6Renal Impairment Use SUTAB with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions ( 5.4 )] .

🆘 Overdosage 51 words ▾

10 OVERDOSAGE Overdosage of more than the recommended dose of SUTAB may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Monitor for fluid and electrolyte disturbances and treat symptomatically.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The primary mode of action is osmotic action of sodium sulfate and magnesium sulfate, which induce a laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

12.3Pharmacokinetics Absorption After the oral administration of SUTAB to patients in clinical studies, the median serum sulfate concentration increased by about 2.5-fold at 5 to 8 hours post Dose 2 (0.61 mmol/L) compared to baseline (0.25 mmol/L) and returned to baseline by 24 to 48 hours after colonoscopy. Elimination Fecal excretion is the primary route of sulfate elimination. Use in Specific Populations Patients with Renal Impairment The disposition of sulfate after ingestion of a sulfate-based product containing sodium sulfate, potassium sulfate, and magnesium sulfate similar to SUTAB was studied in patients (N=6) with moderate renal impairment (creatinine clearance of 30 to 49 mL/min).

In patients with moderate renal impairment, mean AUC was 54% higher and mean C max was 44% higher than healthy subjects. The mean sulfate concentrations in healthy subjects and in patients with moderate renal impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was approximately 16% lower in patients with moderate renal impairment than in healthy subjects.

These differences are not considered clinically meaningful. Patients with Hepatic Impairment The disposition of sulfate after ingestion of a sulfate-based product containing sodium sulfate, potassium sulfate, and magnesium sulfate similar to SUTAB was also studied in patients (N=6) with mild-moderate hepatic impairment (Child-Pugh grades A and B). Systemic exposure of serum sulfate (AUC and C max ) was similar between healthy subjects and patients with hepatic impairment.

The mean sulfate concentrations in healthy subjects and in patients with mild to moderate hepatic impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was similar between patients with hepatic impairment and healthy subjects.

📦 How Supplied / Storage and Handling 120 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Each tablet of SUTAB contains 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride. The tablets are white to off-white, film coated, oblong, and biconvex with flat sides, debossed with S24 on one side. Each carton of SUTAB (NDC 24338-201-01) contains: Two bottles, each bottle (NDC 24338-202-01) contains 12 tablets.

One container with a 16-ounce fill line. Note to Pharmacist : Inform the patient to remove and discard the desiccant from both bottles of SUTAB the evening prior to the colonoscopy [see Dosage and Administration ( 2.2 )] Storage Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F).

See USP controlled room temperature.

📋 Description 125 words ▾

11 DESCRIPTION SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets is an orally administered osmotic laxative and is provided as two bottles, each containing 12 tablets. Each tablet contains: 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride. Inactive ingredients include: polyethylene glycol 8000, sodium caprylate, and ethylene glycol and vinyl alcohol graft copolymer.

Sodium Sulfate, USP The molecular formula is Na 2 SO 4 . The average molecular weight is 142.04. The structural formula is: Magnesium Sulfate, USP The molecular formula is MgSO 4 .

The average molecular weight is 120.37. The structural formula is: Potassium Chloride, USP The molecular formula is KCl. The average molecular weight is 74.55.

The structural formula is: sod sulf Mg sulf pot chlo

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instruct patients: Administration of two doses of SUTAB (24 tablets) are required for a complete preparation for colonoscopy. SUTAB is supplied as two bottles each containing 12 tablets.

Twelve (12) tablets are equivalent to one dose. Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles of SUTAB the evening prior to the colonoscopy [see Dosage and Administration ( 2.2 )].

Must consume water with each dose of SUTAB and an additional 32 ounces of water after each dose. After breakfast, only clear liquids may be consumed until after the colonoscopy. Examples of clear liquids are coffee or tea (no cream or non-dairy creamer), fruit juices (without pulp), gelatin desserts (no fruit or topping), water, chicken broth, clear soda (such as ginger ale).

If preparation-related symptoms occur (e.g., nausea, bloating, cramping), pause or slow the rate of drinking the additional water until symptoms diminish. Do not take other laxatives while they are taking SUTAB. Do not drink milk or eat or drink anything colored red or purple.

Do not drink alcohol. Administer oral medications at least one hour before starting each dose of SUTAB. If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of each dose of SUTAB.

Complete all SUTAB tablets and required water at least two hours prior to colonoscopy. Contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking SUTAB or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Seek immediate medical care should signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions ( 5.7 )] Manufactured for: Azurity Pharmaceuticals, Inc.

Woburn, MA 01801 USA Please see www.azurity.com for patent information. © Azurity Pharmaceuticals, Inc.

💬 Medication Guide ~3 min read ▾

Medication Guide SUTAB ® (Sootab) (sodium sulfate, magnesium sulfate and potassium chloride) tablets, for oral use Read and understand these Medication Guide instructions at least 2 days before your colonoscopy and again before you start taking SUTAB. What is the most important information I should know about SUTAB? SUTAB and other bowel preparations can cause serious side effects, including: Serious loss of body fluid (dehydration) and changes in body salts (electrolytes) in your blood.

These changes can cause: abnormal heartbeats that can cause death. seizures. This can happen even if you have never had a seizure. kidney problems. Your chance of having fluid loss and changes in body salts with SUTAB is higher if you: have heart problems. have kidney problems. take water pills (diuretics) or non-steroidal anti-inflammatory drugs (NSAIDs).

Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking SUTAB: vomiting • urinating less often than normal dizziness • headache See “What are the possible side effects of SUTAB?” for more information about side effects. What is SUTAB? SUTAB is a prescription medicine used by adults to clean the colon before a colonoscopy.

SUTAB cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if SUTAB is safe and effective in children.

Do not take SUTAB if your healthcare provider has told you that you have: a blockage in your bowel (obstruction) or a problem with food moving too slowly through your intestines (ileus). an opening in the wall of your stomach or intestine (bowel perforation). a very dilated intestine (toxic colitis or toxic megacolon). problems with food and fluid emptying from your stomach (gastric retention). allergies to any ingredient in SUTAB. See the end of this Medication Guide for a complete list of ingredients in SUTAB. Before taking SUTAB, tell your healthcare provider about all of your medical conditions, including if you: have heart problems. have stomach or bowel problems including ulcerative colitis. have problems with swallowing or gastric reflux. have a history of seizures. are withdrawing from drinking alcohol or from taking benzodiazepines. have a low blood salt (sodium) level. have kidney problems. are pregnant.

It is not known if SUTAB will harm your unborn baby. Talk to your healthcare provider if you are pregnant. are breastfeeding or plan to breastfeed. It is not known if SUTAB passes into your breast milk.

You and your healthcare provider should decide if you will take SUTAB while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SUTAB may affect how other medicines work.

Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of SUTAB. Especially tell your healthcare provider if you take: medicines for blood pressure or heart problems. medicines for kidney problems. medicines for seizures. water pills (diuretics). non-steroidal anti-inflammatory drugs (NSAIDs). medicines for depression or other mental health problems. laxatives. Do not take other laxatives while taking SUTAB.

The following medicines should be taken at least 2 hours before starting each dose of SUTAB and not less than 6 hours after taking each dose of SUTAB: • tetracycline • iron • chlorpromazine • fluoroquinolone antibiotics • digoxin • penicillamine Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take SUTAB? See the Instructions for Use for dosing instructions. You must read, understand, an…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.