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Plenvu POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE Kit — NDC 65649-0400-01 package photo

Plenvu POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE Kit

by Salix Pharmaceuticals, Inc · 1 KIT in 1 CARTON (65649-400-01) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH
NDC 65649-0400-01
🏷️ FDA NDC (as labeled) 65649-400-01 billing pads the product segment with a zero
This package
Contains1 kit in 1 carton * 46.26 powder, for solution in 1 pouch * 55.65 powder, for solution in 1 pouch * 115.96 powder, for solution in 1 pouch Cost per ea$45.14 NADAC Pack sizes2 compare ↓
Also priced by: Medicaid pays $146.67/unit · Part D plans $48.74/unit — full pricing hub ↓
Also comes in: 1 kit 65649-0400-02
Rx only Brand On market Non-controlled ⚠ On shortage
🗂️ Data synced Aug 20, 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

⚠️
Active FDA shortage. Polyethylene glycol 3350, Sodium Ascorbate, Sodium Sulfate Anhydrous, Ascorbic Acid, Sodium Chloride, and Potassium Chloride Oral Solution is currently reported in shortage by the FDA. Shortage details →

🆔 Identity & classification

FDA NDC (as labeled) 65649-400-01
Product NDC 65649-400
11-digit billing NDC 65649040001
NCPDP billing unit EA — each (per item)
RxCUI 2045233, 2045243, 2045244, 2045245
Application # NDA209381
SPL Set ID 79f930fa-5674-4f30-8ae8-9448d6243797
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-05-04
Marketing end 2027-09-30
Dosage form KIT
GCN Seq No 078699
GCN 43893
HICL code 034026
Ingredient (HICL) Peg3350/Sod Sul/Nacl/Kcl/Asb/C
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6S
Therapeutic class — specific (HIC3) Laxatives And Cathartics
AHFS code 56:12.00.00
AHFS class Cathartics And Laxatives
FDB label name PLENVU POWDER PACKETS
FDB brand name Plenvu
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 65649-400-01 — 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 → 65649-0400-01. 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.

🏭 Manufacturer & labeler

LabelerSalix Pharmaceuticals, Inc
Application holderSALIX PHARMACEUTICALS INC
FDA applicationNDA209381 (NDA)
Labeler code65649
First marketedMay 2018
Product typeHuman Prescription Drug
Portfolio6 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

Label name PLENVU POWDER PACKETS Ingredient Peg3350/Sod Sul/Nacl/Kcl/Asb/C
📖 What it is MedlinePlus · NLM

Polyethylene glycol-electrolyte solution (PEG-ES) is used to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to check for colon cancer and other abnormalities) or barium enema (a test in which the colon is filled with a fluid and then x-rays are taken) so that the doctor will have a clear view of the walls of the colon. PEG-ES is in a class of medications called osmotic laxatives. It works by causing watery diarrhea so that the stool can be emptied from the colon. The medication also contains electrolytes to prevent dehydration and other se...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • No, this is a one-time prescription bowel prep taken only before your colonoscopy. It's not meant for everyday constipation. Its sole job is to flush your colon completely clean so...
  • What exactly is this prep for — is it a laxative I'll take regularly?
  • Most people have their first bowel movement about 1 to 2 hours after starting the preparation. It will be watery and frequent — that's completely expected and is exactly what the p...
  • When will I actually start going to the bathroom after I take it?
📖 Read our full Ascorbic Acid / Polyethylene Glycol 3350 / Potassium Chloride / Sodium Ascorbate / Sodium Chloride / 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.

🧪 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.

💲 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 $45.135 —
Medicaid paysCMS SDUD · 12 mo $146.67 —
Medicare drug plans payPart D · Q2 2026 $48.74 —
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Jan 2022 Oct 2023 Jan 2024 $45.135 $39.379
▲ Up 15% over the last 4 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Plenvuthis 65649-0400-01 Salix 1 kit $45.135 — FDA listed —
MoviPrep 65649-0201-75 Salix 1 kit $120.378 AA FDA listed +167%
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

🏛️
2018
First FDA approval
May 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2033
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 Sep 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 4, 2018 RLD RS ⏳ ~7 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 9326969 — method of use (U-2310)
US 9592252 — method of use (U-2310)
US 11529368 — method of use (U-2310)
US 10792306 — method of use (U-2310)
US 10918723 — method of use (U-2310)
US 12083179 — method of use (U-2310)
US 10780112 — drug product
US 10016504 — drug product
US 10646512 — drug product
US 9707297 — drug product
US 8999313 — drug product
2018 2020 2022 2024 2026 2028 2030 2032
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 (11)
PatentTypeUse codeExpires
US 9326969 ↗ Method of use U-2310 Sep 10, 2033
US 9592252 ↗ Method of use U-2310 Aug 11, 2032
US 11529368 ↗ Method of use U-2310 Mar 9, 2032
US 10792306 ↗ Method of use U-2310 Mar 9, 2032
US 10918723 ↗ Method of use U-2310 Sep 10, 2033
US 12083179 ↗ Method of use U-2310 Sep 10, 2033
US 10780112 ↗ Drug product — Mar 9, 2032
US 10016504 ↗ Drug product — Sep 10, 2033
US 10646512 ↗ Drug product — Mar 25, 2032
US 9707297 ↗ Drug product — Sep 10, 2033
US 8999313 ↗ Drug product — Sep 10, 2033
Common questions
Is there a generic version of PLENVU POWDER PACKETS?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for PLENVU POWDER PACKETS. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2033 — 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 65649-0400-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5.5K
Units reimbursed last 4 qtrs
5.5K
Gross reimbursed last 4 qtrs
$800.1K
Avg / prescription
$145.90
Avg / unit
$146.68
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$146.68
gross reimbursed
vs
NADAC / ea
$45.1350
acquisition cost
=
Spread
+$101.54
+225% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
70% FFS 30% MCO
Fee-for-service · 3,865 Rx Managed care · 1,619 Rx
State Medicaid map
Alaska: 65 units · 8.9 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 20 units · 0.3 per 100k residents WI Michigan: no data reported MI New York: 2,245 units · 11.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 89 units · 2.8 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 84 units · 0.7 per 100k residents IL Indiana: no data reported IN Ohio: 41 units · 0.3 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 130 units · 1.9 per 100k residents MA California: 611 units · 1.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 236 units · 3.8 per 100k residents MO Kentucky: 72 units · 1.6 per 100k residents KY West Virginia: no data reported WV Virginia: 12 units · 0.1 per 100k residents VA Maryland: 28 units · 0.5 per 100k residents MD Connecticut: 374 units · 10.3 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 34 units · 0.5 per 100k residents TN North Carolina: 553 units · 5.1 per 100k residents NC South Carolina: no data reported SC Delaware: 49 units · 4.8 per 100k residents DE Oklahoma: no data reported OK Louisiana: 62 units · 1.4 per 100k residents LA Mississippi: 87 units · 3.0 per 100k residents MS Alabama: 232 units · 4.5 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 411 units · 1.3 per 100k residents TX Florida: 20 units · 0.1 per 100k residents FL
Units reimbursed · per 100k residents
0.111.5
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 11.5 /100k
2 Connecticut 10.3 /100k
3 Alaska 8.9 /100k
4 North Carolina 5.1 /100k
5 Delaware 4.8 /100k
6 Alabama 4.5 /100k
7 Missouri 3.8 /100k
8 Mississippi 3.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 kit this page65649-0400-01 5,484 Rx · $800,112
1 kit65649-0400-02 No Medicaid data
Drug total (last 4 qtrs): 5,484 Rx · 5,455 units · $800,112 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Plenvu — 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 Plenvu. 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
$1.35M
Claims incl. refills
9.1K
Beneficiaries
9K
Spend / beneficiary
$150.97
Spend / claim
$149.09
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 Per unit Per pack Marketing startStatus
65649-0400-01 You're viewing this 1 KIT in 1 CARTON (65649-400-01) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH $45.14 / ea — 2018-05-04 Active
65649-0400-02 1 KIT in 1 CARTON (65649-400-02) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH — — 2018-05-04 Active

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

Pack size FAQ

What quantity is in NDC 65649-0400-01?
NDC 65649-0400-01 is listed by the FDA — 1 kit in 1 carton * 46.26 powder, for solution in 1 pouch * 55.65 powder, for solution in 1 pouch * 115.96 powder, for solution in 1 pouch.
What NDC number is used to bill for this package of Plenvu POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE Kit?
Bill NDC 65649-0400-01 — the 11-digit billing format is 65649040001. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

🧭 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) ✓ Available
“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 65649-400-01, 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: 65649-0400-01, written without dashes as 65649040001. 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 65649-0400-01, the first segment (65649) is the labeler code FDA assigned to Salix Pharmaceuticals, Inc; the middle segment (0400) 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 it is currently marketed — but Salix Pharmaceuticals, Inc has reported a marketing end date of 2027-09-30, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 kit (65649-0400-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Salix 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 39 words ▾

1 INDICATIONS AND USAGE PLENVU ® is indicated for cleansing of the colon in preparation for colonoscopy in adults. PLENVU is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Preparation and Administration: • Two doses of PLENVU are required for a complete preparation for colonoscopy, using a “Two-Day” or “One-Day” dosage regimen. ( 2.1 ) • Reconstitute PLENVU in water prior to ingestion. ( 2.1 ) • Consume additional clear liquids after each dose of PLENVU in both dosing regimens.

( 2.1 , 5.1 ) • Administer oral medications at least 1 hour before starting each dose of PLENVU. ( 2.1 , 7.2 ) Recommended Dosage Regimens: • Two-Day Split Dosage : Dose 1 the evening before the colonoscopy (approximately 4 pm to 8 pm) and Dose 2 the next morning (approximately12 hours after the start of Dose 1). ( 2.1 , 2.2 ) • One-Day Morning Dosage : Dose 1 the morning of the colonoscopy (approximately 3 am to 7 am) and Dose 2 a minimum of 2 hours after the start of Dose 1.

( 2.1 , 2.3 ) • For complete information on dosing, preparation and administration, see full prescribing information. ( 2.1 , 2.2 , 2.3 )

2.1Important Preparation and Administration Instructions • Correct fluid and electrolyte abnormalities before treatment with PLENVU [see Warnings and Precautions ( 5.1 )] . • Two doses of PLENVU are required for a complete preparation for colonoscopy. The time interval between the two doses depends on the regimen prescribed and the planned timing of the colonoscopy procedure [see Dosage and Administration ( 2.2 , 2.3 )] . • The recommended “Two-Day Split Dosage” method consists of two separate doses: the first dose is taken the evening before the colonoscopy and the second dose is taken the next day, the morning of the day of the colonoscopy [see Dosage and Administration ( 2.2 )]. • The recommended “One-Day Morning Dosage” method consists of two separate doses: both doses are taken in the morning of the day of the colonoscopy, with a minimum of 2 hours between the start of the first dose and the start of the second dose [see Dosage and Administration ( 2.3 )]. • Reconstitute each pouch of PLENVU in the mixing container with water prior to ingestion.

It may take 2 to 3 minutes for complete dissolution. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions ( 5.7 )]. • Consume additional clear liquids (including water) in both dosing regimens [see Dosage and Administration ( 2.2 , 2.3 ), Warnings and Precautions ( 5.1 )] . • Consume only clear liquids (no solid food) from the start of PLENVU treatment until after the colonoscopy. • Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material. • Do not take other laxatives while taking PLENVU. • Administer oral medications at least 1 hour before starting each dose of PLENVU [see Drug Interactions ( 7.2 )]. • Ensure completion of Dose 2, including all additional liquids, at least 2 hours before the colonoscopy.

2.2Recommended Two-Day Split Dosage Regimen The recommended Two-Day Split Dosage regimen commences in the evening of the day before the colonoscopy. Instruct adult patients that on the day before the clinical procedure, they can consume a light breakfast followed by a light lunch, which must be completed at least 3 hours prior to the start of the first PLENVU dose. Instruct patients to take two separate doses in conjunction with clear liquids as follows: Dose 1 – In the evening before the colonoscopy, between approximately 4 pm and 8 pm: 1.

Empty the contents of Dose 1 into the mixing container that comes with PLENVU. 2. Add water to the fill line on the mixing container (at least 16 fluid ounces).

Do not add other ingredients to the PLENVU solution. 3. Thoroughly mix with a spoon or shake with lid on securely until completely dissolved (which may take 2 to 3 minutes).

4. Drink over the next 30 minutes. Be sure to drink all of the solution.

5. Refill the mixing container to the fill line (at least 16 fluid ounces) with clear liquids and drink over the next 30 minutes. 6.

Consume additional clear liquids during…

💊 Dosage Forms and Strengths 219 words ▾

3 DOSAGE FORMS AND STRENGTHS PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is supplied as a white to yellow powder for reconstitution. First dose: one pouch labeled Dose 1; Second dose: two pouches labeled Dose 2 Pouch A and Dose 2 Pouch B. • Dose 1 contains 100 grams of polyethylene glycol (PEG) 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride. • Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride. • Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid.

For Oral Solution: First dose: one pouch labeled Dose 1; Second dose: two pouches labeled Dose 2 Pouch A and Dose 2 Pouch B. • Dose 1 contains 100 grams of polyethylene glycol (PEG) 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride. ( 3 ) • Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride. ( 3 ) • Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid.

( 3 )

⛔ Contraindications 98 words ▾

4 CONTRAINDICATIONS PLENVU is contraindicated in the following conditions: • Gastrointestinal (GI) obstruction [see Warnings and Precautions ( 5.6 )] • Bowel perforation [see Warnings and Precautions ( 5.6 )] • Gastric retention • Ileus • Toxic megacolon • Hypersensitivity to any ingredient in PLENVU [see Warnings and Precautions ( 5.10 )] • Gastrointestinal (GI) obstruction ( 4 , 5.6 ) • Bowel perforation ( 4 , 5.6 ) • Gastric retention ( 4 ) • Ileus ( 4 ) • Toxic megacolon ( 4 ) • Hypersensitivity to any ingredient in PLENVU ( 4 , 5.10 )

⚠️ 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 use. ( 5.1 , 5.2 , 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 seizure, 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 testing. ( 5.4 , 7.1 , 8.6 ) • 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 diagnosis before administration.

( 4 , 5.6 ) • Patients at risk for aspiration : Observe during administration. ( 5.7 ) • Glucose-6-phosphate dehydrogenase deficiency (G6PD): Use with caution. ( 5.8 ) • Risks in patients with phenylketonuria : Contains phenylalanine.

( 5.9 ) • Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. ( 5.10 )

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

Correct fluid and electrolyte abnormalities before treatment with PLENVU. PLENVU should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities [such as diuretics, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)] [see Drug Interactions ( 7.1 )] . Consider performing pre-dose and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in patients receiving these concomitant medications.

5.2Cardiac Arrhythmias There have been rare reports of serious arrhythmias (including atrial fibrillation) 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 PLENVU 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, cardiomyopathy or electrolyte imbalance).

Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

5.3Seizures There have been rare 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 PLENVU 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 Renal Impairment Use PLENVU with caution in patients with renal impairment or patients taking concomitant medications that affect renal function (such as diuretics, ACE inhibito…

🤒 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 Renal Impairment [see Warnings and Precautions ( 5.4 )] • Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative 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 )] • Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency [see Warnings and Precautions ( 5.8 )] • Risks in Patients with Phenylketonuria [see Warnings and Precautions ( 5.9 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (>2%) are nausea, vomiting, dehydration and abdominal pain/discomfort.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PLENVU Two-Day Split Dosage and One-Day Morning Dosage regimens was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials (Two-Day Split Dosage in the NOCT and MORA trials and One-Day Morning Dosage in the MORA trial) in 1351 adult patients undergoing colonoscopy.

The mean age of the study population was 56 years (range 18 to 86 years), 92% of patients were Caucasian and 51% were female. In the NOCT trial, 61% of patients had mild renal impairment. In the MORA trial, 67% had mild renal impairment and 5% had moderate renal impairment.

Patients with severe renal impairment were not enrolled in the clinical trials of PLENVU [see Clinical Studies ( 14 )]. The most common adverse reactions (>2%) in the PLENVU treatment groups in both trials were: nausea, vomiting, dehydration and abdominal pain/discomfort. Table 1 and Table 2 display adverse reactions reported in at least 1% of patients in one or more treatment group(s) in the NOCT and MORA trials, respectively.

Since diarrhea was considered as a part of the efficacy assessment, it was not defined as an adverse reaction in these trials. Table 1: Common Adverse Reactions* in Patients Undergoing Colonoscopy in the NOCT Trial by Treatment Group Preferred Term PLENVU Two-Day Split Dosage Regimen (N = 275) % Trisulfate Trisulfate: Two 6-ounce bottles of oral solution each containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams Two-Day Split Dosage Regimen (N = 271) % Nausea 7 2 Vomiting 6 3 Dehydration Includes signs and symptoms of dehydration, including dizziness, dry mouth, orthostatic hypotension, pre-syncope, syncope, and thirst 4 2 Abdominal Pain/Discomfort Includes abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, and abdominal tenderness 2 2 Decline in Glomerular Filtration Rate (GFR) Decreased or abnormal GFR 2 2 Electrolyte Abnormalities Includes increased anion gap, decreased blood bicarbonate, hypomagnesemia, hyperosmolarity, hypokalemia, hyperkalemia, hypercalcemia, hypernatremia, hyperosmolar state, hyperuricemia, hypocalcemia, and hypophosphatemia 2 1 Fatigue 2 1 Headache 2 1 Abdominal Distension 1 1 Gastritis 1 1 Hiatus Hernia 1 0 Nasopharyngitis 1 1 * Reported in at least 1% of patients in either treatment group N = Total number of patients in the treatment group Table 2: Common Adverse Reactions* in Patients Undergoing Colonoscopy in the MORA Trial by Treatment Group Preferred Term PLENVU One-Day Morning Dosage Regimen (N…

🔄 Drug Interactions 168 words ▾

7 DRUG INTERACTIONS Drugs that increase risks due to fluid and electrolyte changes. ( 7.1 )

7.1Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities Use caution when prescribing PLENVU for patients with conditions and/or who are using medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias, or QT prolongation in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )]. Consider additional patient evaluations as appropriate.

7.2Potential for Reduced Drug Absorption PLENVU can reduce the absorption of other coadministered oral drugs . Administer oral medications at least 1 hour before starting each dose of PLENVU [see Dosage and Administration ( 2.1 )].

7.3Stimulant Laxatives Concurrent use of stimulant laxatives and PLENVU may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking PLENVU [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 with PLENVU in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with PLENVU. 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 data available to assess the presence of PLENVU in human milk, the effects on the breastfed child or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of PLENVU to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PLENVU and any potential adverse effects on the breastfed child from PLENVU or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of PLENVU in pediatric patients has not been established.

8.5Geriatric Use Of the approximately 1,000 patients in clinical trials receiving PLENVU, 217 (21%) patients were over 65 years of age. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients. However, 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 PLENVU with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions ( 7.1 )] . 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 PLENVU, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions ( 5.4 )] .

🤰 Pregnancy 90 words ▾

8.1Pregnancy Risk Summary There are no available data with PLENVU in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with PLENVU. 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.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of PLENVU in pediatric patients has not been established.

🧓 Geriatric Use 90 words ▾

8.5Geriatric Use Of the approximately 1,000 patients in clinical trials receiving PLENVU, 217 (21%) patients were over 65 years of age. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients. However, 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 )] .

🆘 Overdosage 47 words ▾

10 OVERDOSAGE Overdosage of more than the recommended dose of PLENVU 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 )] . 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 the components of PLENVU (PEG 3350 plus sodium sulfate components in Dose 1, and sodium ascorbate and ascorbic acid plus PEG 3350 components in Dose 2) which induce the laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

12.2Pharmacodynamics The osmotic effect of the unabsorbed PEG, ascorbate and sulfate ions, when ingested, produces a copious watery diarrhea. The first bowel movement may happen about 1 to 2 hours after the start of PLENVU intake.

12.3Pharmacokinetics The plasma pharmacokinetic parameters for PEG 3350, ascorbate and sulfate are shown in Table 4. Table 4: Plasma Pharmacokinetic Data Following Two-Day Split Dosage Regimen of 140 grams PEG 3350, 33.9 grams Sodium Ascorbate, 9 grams Sodium Sulfate, 20.1 grams Ascorbic Acid, 4.8 grams Sodium Chloride and 2.3 grams Potassium Chloride in Healthy Subjects Four-day study with controlled diet including fasting from 2 pm on Day 1 to 2 pm on Day 2. (N=21) Product studied contains the same amount of PEG 3350 and sodium sulfate, although the amount of sodium ascorbate and ascorbic acid are slightly different, compared to PLENVU.

PK Parameter PEG 3350 Mean (SD) Ascorbate Baseline-corrected Mean (SD) Sulfate Mean (SD) C max [mcg/mL] 2.7 (1.17) 70.8 (22.37) 17.6 (4.80) T max [h] 3.0 (0.61) 16.8 (0.75) 8.1 (5.51) AUC(0-t last ) [mcg●h/mL] 17.3 (7.19) 433.1 (157.29) 206.2 (74.32) V d [l] 48,481 (29,811) 1,026 (675) 231 (205) t 1/2 [h] 4.1 (2.34) 7.2 (6.16) 10.5 (15.19) SD = standard deviation; C max = maximum concentration; T max = time to maximum concentration from start of dosing; AUC(0-t last ) = area under the curve from t 0 to t last ; V d = volume of distribution; t 1/2 = half-life.

A pharmacokinetic study measured up to 85% to 99% of a 140 grams oral PEG 3350 dose in excreted feces. A pharmacokinetic study measured up to 69% of a 50 grams oral ascorbate dose in excreted feces and up to 5% of the 50 grams oral ascorbate dose is recovered in the urine (with up to 0.07% as the ascorbate metabolite, oxalic acid). Sulfate is endogenous and also present in the diet.

A pharmacokinetic study measured up to 69% to 73% of a 9 grams oral sodium sulfate dose in excreted feces, with approximately 43% recovered in the urine. Following a One-Day Morning Dosage regimen of PLENVU, C max values of glycolic acid (after baseline correction) ranged from 76 to 1,770 ng/mL with a median T max of 9 hours and AUC 0-last in the range of 3,770 to 17,700 ng●h/mL. The concentrations of ethylene glycol and diethylene glycol in any individual subject were lower than 2.5 mcg/mL (lower limit of quantitation (LLOQ): 2.5 mcg/mL) and oxalic acid was not measurable (LLOQ: 10 mcg/mL).

🧬 Mechanism of Action 61 words ▾

12.1Mechanism of Action The primary mode of action is osmotic action of the components of PLENVU (PEG 3350 plus sodium sulfate components in Dose 1, and sodium ascorbate and ascorbic acid plus PEG 3350 components in Dose 2) which induce the laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

📦 How Supplied / Storage and Handling 189 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is supplied as a white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride: NDC 65649-400-01. Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride: NDC 65649-400-01.

Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid: NDC 65649-400-01. PLENVU, single-use inner carton: The inner carton contains three pouches labeled Dose 1, Dose 2 Pouch A and Dose 2 Pouch B: NDC 65649-400-01. PLENVU, single-use outer carton: Each outer carton contains the inner carton, prescribing information and patient information and a disposable mixing container with lid for reconstitution of PLENVU: NDC 65649-400-01.

Storage Store pack at room temperature, between 68°F to 77°F (20°C to 25°C) with excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. The pack may be stored in a refrigerator.

📋 Description ~2 min read ▾

11 DESCRIPTION The active ingredients contained in PLENVU are provided in Table 3. Table 3: Details of Active Ingredients contained in PLENVU Chemical Name Chemical Formula Average Molecular Weight (g/mol) Chemical Structure Polyethylene Glycol (PEG) 3350 H-(OCH 2 -CH 2 ) n -OH 3350 Table 3: Details of Active Ingredients contained in PLENVU Sodium Ascorbate C 6 H 7 NaO 6 198.1 Table 3: Details of Active Ingredients contained in PLENVU Sodium Sulfate Na 2 SO 4 142.0 Table 3: Details of Active Ingredients contained in PLENVU Ascorbic Acid C 6 H 8 O 6 176.1 Table 3: Details of Active Ingredients contained in PLENVU Sodium Chloride NaCl

58.4 Na + Cl - Potassium Chloride KCl

74.6K + Cl + PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative consisting of three pouches (one for Dose 1, one for Dose 2 Pouch A and one for Dose 2 Pouch B) containing white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride, and the following excipients: sucralose, encapsulated citric acid and mango flavoring.

When Dose 1 is dissolved in water to a volume of 16 fluid ounces, PLENVU Dose 1 (PEG 3350, sodium sulfate, sodium chloride and potassium chloride) is an oral solution having a mango flavor. Each Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride, and the following excipients: aspartame and fruit punch flavoring. Each Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid.

When Dose 2 Pouch A and Dose 2 Pouch B are dissolved together in water to a volume of 16 fluid ounces, PLENVU Dose 2 (sodium ascorbate, PEG 3350, ascorbic acid, sodium chloride and potassium chloride) is an oral solution having a fruit punch flavor. The entire reconstituted 32 fluid ounces of PLENVU bowel preparation contains 140 grams of PEG 3350, 48.11 grams of sodium ascorbate, 9 grams of sodium sulfate, 7.54 grams of ascorbic acid, 5.2 grams of sodium chloride and 2.2 grams of potassium chloride and the following excipients: aspartame, sucralose, encapsulated citric acid, mango and fruit punch flavorings.

A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 491 mg per treatment. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). table3image1 table3image2 table3image3 table3image4

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instruct patients: • Two doses of PLENVU are required for a complete preparation for colonoscopy either as a Two-Day Split Dosage or One-Day Morning Dosage regimen [see Instructions for Use]. • Follow the directions in the Instructions for Use , for either the Two-Day Split Dosage or the One-Day Morning Dosage regimen, as prescribed. • Reconstitute each pouch of PLENVU in the mixing container with water before ingestion and drink additional clear liquids.

Examples of clear liquids can be found in the Instructions for Use. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)]. • Consume additional clear liquids before, during, and after the use of PLENVU to prevent dehydration [see Warnings and Precautions (5.1)] . • Consume only clear liquids (no solid food) from the start of PLENVU treatment until after the colonoscopy. • Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material. • Do not take other laxatives while taking PLENVU. • PLENVU contains 491 mg of phenylalanine per treatment [see Warnings and Precautions (5.9)] . • Administer oral medications at least 1 hour before starting each dose of PLENVU. • Contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking PLENVU or if they experience altered consciousness or seizures [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)]. • Stop drinking PLENVU temporarily or drink each portion at longer intervals if severe abdominal discomfort or distention develops until these symptoms diminish.

If severe symptoms persist, contact their healthcare provider. Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Norgine Limited 7 Tir-y-berth Industrial Estate New Road, Tir-y-berth Hengoed, CF82 8SJ United Kingdom (GBR) Patented. See https://patents.salix.com for US patent information.

PLENVU is a registered trademark of the Norgine group of companies used under license. © 2023 Salix Pharmaceuticals, Inc. or its affiliates 9643003

💬 Medication Guide ~3 min read ▾

Medication Guide MEDICATION GUIDE PLENVU ® (plen-vu) (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) Read this Medication Guide and Instructions for Use before your colonoscopy and again before you start taking PLENVU. What is the most important information I should know about PLENVU? PLENVU 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 PLENVU 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 serious loss of body fluid (dehydration) while taking PLENVU: • vomiting • dizziness • urinating less often than normal • headache See “What are the possible side effects of PLENVU?” for more information about side effects. What is PLENVU? PLENVU is a prescription medicine used by adults to clean the colon before a colonoscopy.

PLENVU 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 PLENVU is safe and effective in children.

Do not take PLENVU if your healthcare provider has told you that you have: • a blockage in your intestine (bowel obstruction). • an opening in the wall of your stomach or intestine (bowel perforation). • problems with food and fluid emptying from your stomach (gastric retention). • a problem with food moving too slowly through your intestines (ileus). • a very dilated intestine (toxic megacolon). • an allergy to any of the ingredients in PLENVU. See the end of this Medication Guide for a complete list of ingredients in PLENVU.

Before taking PLENVU, 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 seizures or take medicines for seizures. • have kidney problems or take medicines for kidney 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 condition called glucose-6-phosphate dehydrogenase (G6PD) deficiency that destroys red blood cells. • are withdrawing from drinking alcohol. • have phenylketonuria (PKU).

PLENVU contains phenylalanine. • are allergic to any of the ingredients in PLENVU. • are pregnant or plan to become pregnant. It is not known if PLENVU 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 PLENVU passes into your breast milk. You and your healthcare provider should decide if you will take PLENVU while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

PLENVU may affect how other medicines work. If you need to take any other medicines by mouth, take those medicines at least 1 hour before starting each dose of PLENVU. 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 seizures (antiepileptics). • medicines for kidney problems. • water pills (diuretics). • non-steroidal anti-inflammatory drugs (NSAIDs). • laxatives.

Do not take other laxatives while taking PLENVU. • medicin…

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.