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SUFLAVE polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution Kit, 1 kit — NDC 24338-0550-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SUFLAVE polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution Kit, 1 kit — NDC 24338-550-01 (Billing 24338-0550-01)

by Azurity Pharmaceuticals, Inc. · 1 KIT in 1 KIT

This is a package of 1 kit of SUFLAVE polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution Kit from Azurity Pharmaceuticals, Inc., marketed since Apr 2026 and currently FDA-listed; retail pharmacies pay about $61.65 per kit (NADAC). It is this product's only package size.

NDC 24338-0550-01
🏷️ FDA NDC (as labeled) 24338-550-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 24338-550-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24338 labeler · 550 product · 01 package
Package marketed since
Apr 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 2433855001 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24338-550-01
Product NDC 24338-550
11-digit billing NDC 24338055001
NCPDP billing unit EA — each (per item)
RxCUI 2641142, 2641143, 2641144
Application # NDA215344
SPL Set ID d5710a04-2b0a-402c-a8b0-025766f1a437
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-01
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 2641142
Why two NDCs? The FDA registers this code as 24338-550-01 — 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 → 24338-0550-01. 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.

RxNorm drug class

This medicine belongs to the Osmotic Laxative class.

Pharmacologic class Osmotic Laxative
How it works Osmotic Activity
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

📗 Our plain-language guide HelloPharmacist
  • It cleans out your colon so your doctor can get a clear view during a colonoscopy. It is for adults. It is a bowel prep, not a treatment for any illness.
  • You take two doses, one the evening before and one the morning of your colonoscopy. Mix each with water in the bottle, drink it in portions every 15 minutes, then drink extra water...
  • Nausea, bloating, vomiting, belly pain and headache are the most common. If you feel sick or crampy, slow down or pause until it eases. Call your doctor if vomiting is significant...
  • Seek care for swelling, hives, trouble breathing, or throat or chest tightness, which may mean an allergic reaction. Also get help for a seizure, fainting or an irregular heartbeat...
📖 Read our full Magnesium Sulfate / Polyethylene Glycol 3350 / Potassium Chloride / Sodium Chloride For Oral Solution / Sodium Sulfate guide →

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.

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 $61.646 $61.65 / 1 kit
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 · Q2 2026 $62.01 $62.01 / 1 kit
NADAC price history (per ea) — tap or hover for the price & month
Aug 2026 $61.646 $61.646
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
24338-0550-01 You're viewing this Main listing 1 KIT in 1 KIT 2026-04-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Suflave 52268-0550-01 Braintree 1 kit $61.646 — Availability likely —
Suflavethis 24338-0550-01 Azurity 1 kit $61.646 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
First FDA approval
Jun 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2044
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2044. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 15, 2023 RLD RS ⏳ ~17.8 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 12433914 — method of use (U-4143)
US 12239659 — method of use (U-4143)
US 12290529 — drug product
US 12594298 — drug product
Exclusivity NP
2023 2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
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 12433914 ↗ Method of use U-4143 Jun 14, 2044
US 12239659 ↗ Method of use U-4143 Jun 14, 2044
US 12290529 ↗ Drug product — Aug 2, 2044
US 12594298 ↗ Drug product — Jun 14, 2044
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductJun 15, 2026
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Aug 2044 — an estimate, not a guaranteed launch date.
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.

What it looks like

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

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerAzurity Pharmaceuticals, Inc.
Application holderAZURITY PHARMACEUTICALS INC
FDA applicationNDA215344 (NDA)
Labeler code24338
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio57 products on file

More NDCs from Azurity Pharmaceuticals, Inc. labeler code 24338

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🔬 Clinical Studies 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

1 INDICATIONS AND USAGE SUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. SUFLAVE 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 Preparation and Administration ( 2.1 ) Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet. Each bottle must be reconstituted with water before ingestion.

An additional 16 ounces of water must be consumed after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. Recommended Dosage and Administration ( 2.2 ) The recommended Split-Dose (two-day) regimen consists of two doses of SUFLAVE: o Day 1, Dose 1: Evening before Colonoscopy: 1 bottle with flavor enhancing packet o 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): 1 bottle with flavor enhancing packet For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information.

( 2.1 , 2.2 )

2.1Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with SUFLAVE [see Warnings and Precautions ( 5.1 )] Two doses of SUFLAVE are required for a complete preparation for colonoscopy. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet. Reconstitute each bottle with water before ingestion.

Do not reconstitute SUFLAVE with liquids other than water and/or add starch-based thickeners to the mixing bottle [see Warnings and Precautions ( 5.7 )] . Must consume an additional 16 ounces of water after each dose of SUFLAVE. Consume a low residue breakfast on the day before colonoscopy.

After breakfast, only consume clear liquids up to 2 hours prior to colonoscopy. Do not eat solid food or drink milk or eat or drink anything colored red or purple. Do not drink alcohol.

Do not take other laxatives while taking SUFLAVE [see Drug Interactions ( 7.3 )]. Do not take oral medications within 1 hour of starting each dose of SUFLAVE [see Drug Interactions ( 7.2 )]. 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 SUFLAVE [see Drug Interactions ( 7.2 )] .

Stop consumption of all fluids at least 2 hours prior to the colonoscopy. If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish.

2.2Split-Dose (2-Day) Recommended Dosage The recommended Split-Dose (two-day) regimen consists of two doses of SUFLAVE: Day 1, Dose 1: Evening before Colonoscopy : 1 bottle with flavor enhancing packet 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) : 1 bottle with flavor enhancing packet

2.3Preparation and Administration Instructions The Day Prior to Colonoscopy: A low residue breakfast may be consumed. Examples of low residue foods are white bread, biscuits, muffins (no wheat), cornflakes, eggs, cream of wheat, grits, yogurt, cottage cheese, coffee, tea, juice without pulp, fruit (no skin or seeds). After breakfast, only consume clear liquids until after the colonoscopy.

Examples of clear liquids are water, fruit juice (without pulp), lemonade, plain coffee, tea (no cream or non-dairy creamer), chicken broth, gelatin dessert (no fruit or topping). No red or purple liquids, no milk or alcoholic beverages. Day 1, Dose 1 - Early in the Evening Prior to Colonoscopy: Open 1 flavor enhancing packet and pour the contents into 1 bottle.

Fill the provided bottle with lukewarm water up to the fill line. After capping the bottle, gently shake the bottle until all powder has dissolved. For best taste, refrigerate the solution for an hour before drinking.

Do not freeze. Use within 24 hours. Drink 8 ounces of solution every 15 minutes until the bottle is empty.

Drink an additional 16 ounces of water during the… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 114 words ▾

3 DOSAGE FORMS AND STRENGTHS SUFLAVE is supplied as a white powder for reconstitution and is available in a carton that contains two bottles and two flavor enhancing packets. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride. The bottle contains lemon-lime flavoring.

When diluted as directed, the solution is slightly hazy to hazy. For Oral Solution: Two bottles and two flavor enhancing packets. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride.

The bottle also contains lemon-lime flavoring. ( 3 )

⛔ Contraindications 87 words ▾

4 CONTRAINDICATIONS SUFLAVE 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 SUFLAVE [see Warnings and Precautions ( 5.8 )] 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 SUFLAVE ( 4 )

⚠️ 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 ) Colonic mucosal ulcerations : Consider potential for ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. ( 5.5 ) 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 ) Suspected GI obstruction or perforation : Rule out the diagnosis before administration.

( 4 , 5.6 ) Patients at risk for aspiration : Observe during administration ( 5.7 ) Hypersensitivity reactions, including anaphylaxis : Inform patients to seek immediate medical care if symptoms occur ( 5.8 )

5.1Serious Fluid and Electrolyte Abnormalities Advise all patients to hydrate adequately before, during, and after the use of SUFLAVE. If a patient develops significant vomiting or signs of dehydration after taking SUFLAVE, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Bowel preparation products can cause fluid and electrolyte disturbances, which can lead to serious adverse reactions including cardiac arrhythmias, seizures, and renal impairment [see Adverse Reactions ( 6.2 )] .

Correct fluid and electrolyte abnormalities before treatment with SUFLAVE. Use SUFLAVE with caution in patients with conditions, or who are using medications [such as diuretics, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)], that increase the risk for fluid and electrolyte disturbances or may increase the risk 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. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbances. Use caution when prescribing SUFLAVE for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT interval, 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 SUFLAVE 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 SUFLAVE 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 adequat… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions 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 )] Aspiration [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (>2%) are: nausea, abdominal distension, vomiting, abdominal pain and headache.

( 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 trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The safety of SUFLAVE was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials in 929 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 sulfate, potassium sulfate, and magnesium sulfate oral solution in Study 2 [see Clinical Studies (14)].

Table 1 shows the most common adverse reactions reported in at least 2% of patients in either treatment group in Study 1. Table 1: Common Adverse Reactions a by Treatment Group in Adult Patients Undergoing Colonoscopy in Study 1 b SUFLAVE (%) N=233 Polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution (%) N= 243 Nausea 13 9 Abdominal distension 6 3 Vomiting 6 3 Abdominal pain c 3 4 Headache 3 2 a Reported in at least 2% of patients in either treatment group. b Study 1 was not designed to support comparative claims for SUFLAVE for the adverse reactions reported in this table. c Abdominal pain is composed of several similar terms.

Table 2 shows the most common adverse reactions reported in at least 2% of patients in either treatment group in Study 2. Table 2: Common Adverse Reactions a by Treatment Group in Adult Patients Undergoing Colonoscopy in Study 2 b SUFLAVE (%) N=227 Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution (%) N=226 Nausea 7 6 Vomiting 4 7 Headache 2 2 Abdominal pain c 3 1 Abdominal distension 1 1 a Reported in at least 2% of patients in any treatment group. b Study 2 was not designed to support comparative claims for SUFLAVE for the adverse reactions reported in this table. c Abdominal pain is composed of several similar items.

Laboratory Changes Electrolyte Abnormalities In patients with normal baseline values, the most common electrolyte abnormality following study drug, on the day of colonoscopy, was increased magnesium (Study 1: 11% in SUFLAVE-treated patients and 2% in patients treated with active comparator; Study 2: 12% in SUFLAVE-treated patients and 11% in patients treated with active comparator). These changes were transient and resolved without intervention. Renal Function Parameters In patients with normal baseline values, at 48 to 72 hours after bowel preparation, an increase in serum creatinine of > 0.3 mg/dL and/or a decrease in eGFR of > 25% were reported in 2% of SUFLAVE-treated patients and 0 patients treated with active comparator in Study 1 and 1% of SUFLAVE-treated patients and 3% of patients treated with active comparator in Study 2.

These changes were transient and resolved.

6.2Postmarketing Experience The following adverse reactions… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 186 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 SUFLAVE to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of seizure, arrhythmias, and prolonged QT interval 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 SUFLAVE 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 SUFLAVE. 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 SUFLAVE to avoid chelation with magnesium.

7.3Stimulant Laxatives Concurrent use of stimulant laxatives and SUFLAVE may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking SUFLAVE [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 the use of SUFLAVE during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride (SUFLAVE). 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 SUFLAVE in human or animal milk, the effects 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 SUFLAVE and any potential adverse effects on the breastfed child from SUFLAVE or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of SUFLAVE in pediatric patients have not been established.

8.5Geriatric Use Of the 460 patients who received SUFLAVE in clinical trials, 125 (27%) were 65 years of age or older. No differences in effectiveness of SUFLAVE were observed between geriatric patients and younger adult patients. Among geriatric patients, decreases in blood pressure on the day of colonoscopy were reported more frequently with SUFLAVE than with the active comparator in Study 1 (6% in SUFLAVE-treated patients and 1% in patients treated with active comparator) in Study 2 (3% in SUFLAVE-treated patients and 0% treated with active comparator) [see Clinical Studies ( 14 )] .

Geriatric 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 )] . Advise geriatric patients to hydrate adequately before, during, and after the use of SUFLAVE.

8.6Renal Impairment Use SUFLAVE 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 the use of SUFLAVE, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warning and Precautions ( 5.4 )] .

🆘 Overdosage 51 words ▾

10 OVERDOSAGE Overdosage of more than the recommended dose of SUFLAVE 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 195 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The primary mode of action is the osmotic effects of polyethylene glycol 3350, 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 After administration of the first dose of SUFLAVE in 18 healthy subjects, the mean ± SD maximum plasma concentration (C max ) for polyethylene glycol 3350 of 3.4 ± 1.4 mcg/mL was reached at 4 hours, and the mean ± SD serum C max for sulfate of 27.0 ± 11.4 mcg/mL was reached at 6 hours. Following a second dose of SUFLAVE (approximately 12 hours later), the mean ± SD plasma C max for polyethylene glycol 3350 of 2.9 ± 0.97 mcg/mL was reached at 4 hours, and the mean ± SD serum C max for sulfate of 29.2 ± 11.0 mcg/mL was reached at 3 hours.

Sulfate concentrations were below the limit of quantitation (19.2 mcg/mL) for all subjects by follow-up Day 3. Polyethylene glycol 3350 concentrations were below the limit of quantitation (LOQ 0.01 mcg/mL) for 16 of 18 subjects by follow-up Day 7.

📦 How Supplied / Storage and Handling 118 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is supplied as a white powder for reconstitution and is lemon-lime flavored. Each carton of SUFLAVE (NDC 24338-550-01) contains: Two bottles, each bottle (NDC 24338-551-01), closed with child resistant closure, contains a white powder of 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride for reconstitution.

The bottle contains lemon-lime flavor. Two flavor enhancing packets (NDC 24338-552-01). Storage Store SUFLAVE at room temperature between 20ºC to 25°C (68ºF to 77°F), excursions permitted from 15ºC to 30°C (59ºF to 86°F).

See USP controlled room temperature.

📋 Description 210 words ▾

11 DESCRIPTION SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative and is provided in two bottles and two flavor enhancing packets for oral solution. The active ingredients contained in SUFLAVE are provided in Table 3. Table 3: Active Ingredients in SUFLAVE Chemical Name Chemical Formula Average Molecular Weight (g/mol) Chemical Structure Polyethylene Glycol 3350, USP 3350 Sodium Sulfate, USP Na 2 SO 4 142.04 Magnesium Sulfate, USP MgSO 4 120.37 Potassium Chloride, USP KCl

74.55 Sodium Chloride, USP NaCl

58.44Na + Cl - Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride, plus the following excipients: advantame, lemon-lime flavor, and neotame. Each flavor enhancing packet contains anhydrous citric acid, colloidal silicon dioxide, malic acid, and sucralose. Each dose of reconstituted oral solution is one liter of slightly hazy to hazy liquid that contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride and the following excipients: advantame, anhydrous citric acid, colloidal silicon dioxide, lemon-lime flavor, malic acid, neotame, and sucralose. peg3350 peg3350 sod sulfate mg sulfate 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 SUFLAVE are required for a complete preparation for colonoscopy. Must reconstitute each bottle with water before ingestion.

Must consume an additional 16 ounces of water after each dose of SUFLAVE. To hydrate adequately with clear liquids before, during, and after the use of SUFLAVE to prevent dehydration [see Warnings and Precautions (5.1)] . Examples of clear liquids can be found in the Instructions for Use .

If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish. Do not take other laxatives while taking SUFLAVE. Do not drink milk or eat or drink anything colored red or purple.

Do not drink alcohol. Do not take oral medications within one hour of starting each dose of SUFLAVE [see Drug Interactions ( 7.2 )] . 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 SUFLAVE [see Drug Interactions ( 7.2 )] .

Complete all SUFLAVE 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 SUFLAVE or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Seek immediate medical care if signs and symptoms of a hypersensitivity reaction occur [see Warnings and Precautions ( 5.8 )] .

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

💬 Medication Guide ~3 min read ▾

Medication Guide SUFLAVE ® (Soo-FLAVE) (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) Read and understand this Medication Guide and the Instructions for Use at least 2 days before your colonoscopy and again before you start taking SUFLAVE. What is the most important information I should know about SUFLAVE? SUFLAVE and other bowel preparations can cause serious side effects, including: Serious loss of body fluid (dehydration) and changes in blood 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 SUFLAVE is higher if you: have heart problems. have kidney problems. take water pills (diuretics), high blood pressure medicine, 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 SUFLAVE: vomiting • urinating less often than normal dizziness • headache See “What are the possible side effects of SUFLAVE?” for more information about side effects. What is SUFLAVE? SUFLAVE is a prescription medicine used by adults to clean the colon before a colonoscopy.

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

Do not take SUFLAVE 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). an allergy to any ingredient in SUFLAVE. See the end of this Medication Guide for a complete list of the ingredients in SUFLAVE.

Before taking SUFLAVE, tell your healthcare provider about all of your medical conditions, including if you: have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes). have heart problems. have stomach or bowel problems including ulcerative colitis. have problems with swallowing, gastric reflux, or if you inhale food or fluid into your lungs when eating or drinking (aspirate). 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 SUFLAVE 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 SUFLAVE passes into your breast milk.

You and your healthcare provider should decide if you will take SUFLAVE while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SUFLAVE 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 SUFLAVE. Especially tell your healthcare provider if you take: medicines to treat a blood salt (electrolyte) imbalance. 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 SUFLAVE. starch-based thickeners.

For patients who have trouble swallowing, do not mix SUFLAVE with starch-based thickeners. The following medicines should be taken at least 2 hours before starting each dose of SUFLAVE and not less than 6 ho… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The colon cleansing efficacy of SUFLAVE was evaluated in two randomized, single-blind, active-controlled, multicenter trials (Study 1 and Study 2). These trials included adult patients undergoing colonoscopy for colorectal cancer screening and surveillance, or diagnostic colonoscopy, including patients with abdominal pain, diarrhea, constipation and non-severe inflammatory bowel disease. In Study 1 (NCT04446299), 471 adult patients were included in the efficacy analysis.

Patients ranged in age from 20 to 84 years (median age 58 years) and 54% were female. The racial distribution was 70% White, 27% African-American, 2% Asian, and 1% American Indian or Alaska Native. The population was 8% Hispanic or Latino.

Patients were randomized to one of the following two colon preparation regimens: SUFLAVE or polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution. Both preparations were administered according to a split-dose regimen [see Dosage and Administration ( 2.2 )] . Patients receiving SUFLAVE were limited to a low residue breakfast followed by clear liquids on the day prior to the colonoscopy; patients receiving the comparator bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids and/or yogurt for dinner on the day prior to the colonoscopy.

In Study 2 (NCT04446312), 450 adult patients were included in the efficacy analysis. Patients ranged in age from 18 to 80 years (median age 57 years) and 58% were female. The racial distribution was 85% White, 10% African-American, 3% Asian, and < 1% American Indian or Alaska Native.

The population was 21% Hispanic or Latino. Patients were randomized to one of the following two colon preparation regimens: SUFLAVE or sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Both preparations were administered according to a split-dose regimen [see Dosage and Administration ( 2.2 )] .

Patients receiving SUFLAVE were limited to a low residue breakfast followed by clear liquids on the day prior to the colonoscopy; patients receiving the comparator bowel prep were allowed a light breakfast followed by clear liquids on the day prior to the colonoscopy. The primary efficacy endpoint in each trial was the proportion of patients with successful colon cleansing, as assessed by the blinded colonoscopist utilizing the four-point scale described in Table 4. Success was defined as an overall cleansing assessment of 3 (Good) or 4 (Excellent).

Table 4: Description of Colonoscopy Scoring Score Grade Description 1 Poor Large amount of fecal residue, additional bowel preparation required. 2 Fair Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa. 3 Good Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa.

4 Excellent No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa. Results for the primary endpoint in Studies 1 and 2 are shown in Table 5. In both trials, SUFLAVE was non-inferior to the active comparator.

Table 5: Proportion of Adult Patients with Overall Cleansing Success a in Two Controlled Trials with a Split-Dose Regimen SUFLAVE % (n/N) Active Comparator % (n/N) SUFLAVE-Active Comparator Difference b (%) 95% Confidence Interval b Study 1 93% (215/232) 89% c (212/239) 3.4% (-1.7%, 8.5%) e Study 2 94% (212/226) 94% d (211/224) 0.2% (-4.0%, 4.3%) e a success was defined as an overall cleaning assessment of 3 (Good) or 4 (Excellent) by the blinded endoscopist, with scores assigned on withdrawal of colonoscope. b common risk differences and confidence intervals were based on the Mantel-Haenszel method adjusting for study site c active comparator in Study 1 was polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic a… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 193 words ▾

Principal Display Panel - Carton Label NDC 24338-550-01 Dispense the enclosed Medication Guide to each patient. SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) 178.7 g/7.3 g/1.12 g/0.9 g/0.5 g 2 Doses of SUFLAVE are required for a complete preparation. This carton contains: 2 Flavor Enhancing Packets 2 Bottles 1 Patient booklet, which includes: 1.

Instructions for Use 2. Full Prescribing Information 3. Medication Guide © 2026 Azurity Pharmaceuticals, Inc.

All rights reserved. 01/2026 Rx only carton

Principal Display Panel - Bottle Label NDC 24338-551-01 SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) 178.7 g/7.3 g/1.12 g/0.9 g/0.5 g Dispense the enclosed Medication Guide to each patient. 2 Doses of SUFLAVE are required for a complete preparation. Rx only Net Weight 188.73 g bottle-label

Principal Display Panel - Flavor Enhancing Packet NDC 24338-552-01 SUFLAVE For use with 1 SUFLAVE Bottle This packet contains: citric acid, anhydrous, USP, 0.820 g; colloidal silicon dioxide, NF, 0.009 g; malic acid, FCC, 0.718 g; sucralose, FCC, 0.300 g. Dispense the enclosed Medication Guide to each patient. Net Weight 1.847 g flavor-pack

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

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

Medicare Part D (outpatient prescription) spending for Suflave — 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 Suflave. 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
$2M
Claims incl. refills
16K
Beneficiaries
15.8K
Spend / beneficiary
$127.06
Spend / claim
$125.52
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SUFLAVE (this brand).

Top reported reactions

Nausea29
Vomiting22
Abdominal Distension12
Headache10
Pruritus8
Dehydration7
Dizziness7

Reporter sex

102 reports

Serious outcomes

Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 15 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
← 24338-0530-25 · Azurity 24338-0850-03 · Azurity →
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.