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TIS-U-SOL sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate 800 mg/100mL; 40 mg/100mL; 20 mg/100mL; 8.75 mg/100mL; 6.25 mg/100mL Irrigant — NDC 0338-0190-04 (Billing 00338-0190-04)

by Baxter Healthcare Corporation · 12 BOTTLE, PLASTIC in 1 CARTON / 1000 mL in 1 BOTTLE, PLASTIC

This is a package of TIS-U-SOL sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate 800 mg/100mL; 40 mg/100mL; 20 mg/100mL; 8.75 mg/100mL; 6.25 mg/100mL Irrigant from Baxter Healthcare Corporation, marketed since Feb 1982 and currently FDA-listed. It is this product's only package size.

NDC 00338-0190-04
🏷️ FDA NDC (as labeled) 0338-0190-04 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 0338-0190-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 0190 product · 04 package
Package marketed since
Feb 19, 1982
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0338019004 1
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-0190-04
Product NDC 0338-0190
11-digit billing NDC 00338019004
NCPDP billing unit ML — per mL (volume)
RxCUI 801442, 801445
UNII 451W47IQ8X, 660YQ98I10, SK47B8698T, 70WT22SF4B, 4J9FJ0HL51
Application # NDA018508
SPL Set ID 9da4121f-d62d-4da4-8dfb-0494da16015f
Established class (EPC) Calculi Dissolution Agent; Inhibition Large Intestine Fluid/Electrolyte Absorptio
Physiologic effect Increased Large Intestinal Motility
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1982-02-19
Route IRRIGATION
Dosage form IRRIGANT
Substance SODIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; MONOBASIC POTASSIUM PHOSPHATE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 99750020002000
GPI class Tis-U-Sol
GCN Seq No 022437
GCN 76109
HICL code 014758
Ingredient (HICL) Sod,Pot Chlor/Mag/Sod,Pot Phos
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W8
Therapeutic class — intermediate (HIC2) Antiseptics
HIC3 code W8F
Therapeutic class — specific (HIC3) Irrigants
AHFS code 40:36.00.00
AHFS class Irrigating Solutions
FDB label name TIS-U-SOL PENTALYTE IRRIG SOLN
FDB brand name Tis-U-Sol Pentalyte
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 022437
  • GCN: 76109
  • GPI-14 (Medi-Span): 99750020002000
  • HICL (First Databank): 014758
  • AHFS class code: 40:36.00.00
  • RxCUI (RxNorm): 801442
Why two NDCs? The FDA registers this code as 0338-0190-04 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00338-0190-04. 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.

Clinical

Label name TIS-U-SOL PENTALYTE IRRIG SOLN Ingredient Sod,Pot Chlor/Mag/Sod,Pot Phos
📗 Our plain-language guide HelloPharmacist
  • Tis-u-sol is an isotonic solution for irrigation, meaning rinsing or flushing. It is for irrigation only, and your physician will direct how it is used.
  • No. It is not for injection. Use it only for irrigation as your physician directs.
  • Check that the solution is clear and the seal is intact. If either is off, do not use it. Ask your pharmacist if you are unsure.
  • Yes, the label allows warming in an oven to no more than 50°C for a maximum of 60 days. After 60 days of warming, discard it.
📖 Read our full Magnesium Sulfate / Potassium Chloride / Potassium Phosphate / Sodium Chloride / Sodium Phosphate 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
00338-0190-04 You're viewing this Main listing 12 BOTTLE, PLASTIC in 1 CARTON / 1000 mL in 1 BOTTLE, PLASTIC 1982-02-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tis-U-Sol 800 mg/100mL; 40 mg/100mL; 20 mg/100mL; 8.75 mg/100mL; 6.25 mg/100mLthis 00338-0190-04 Baxter 12 bottles — AT FDA listed —
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

🏛️
1982
On the market since
Feb 1982
📍
2026
Currently FDA-listed
44 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA018508 (NDA)
Labeler code00338
First marketedFeb 1982
Product typeHuman Prescription Drug
Portfolio283 products on file

More NDCs from Baxter Healthcare Corporation labeler code 00338

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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 📦 How Supplied / Storage and Handling 📋 Description 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

INDICATIONS AND USAGE Isotonic solution for irrigation only. Not for injection.

⏱️ Dosage and Administration 45 words ▾

DOSAGE AND ADMINISTRATION As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

📦 How Supplied / Storage and Handling 10 words ▾

HOW SUPPLIED Recommended storage: Room temperature (25°C). Avoid excessive heat.

📋 Description 58 words ▾

DESCRIPTION Tis-U-Sol ® Solution (Pentalyte Irrigation) Each 100 mL contains: 800 mg Sodium Chloride, USP, 40 mg Potassium Chloride, USP, 20 mg Magnesium Sulfate, Heptahydrate, USP, 8.75 mg Dibasic Sodium Phosphate, Heptahydrate, USP, 6.25 mg Monobasic Potassium Phosphate, NF. No antimicrobial agent has been added. pH 6.5 (4.0 to 7.0). Osmolarity 288 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

📄 Package Label / Principal Display Panel 171 words ▾

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING 2F7144 NDC 0338-0190-04 1000 mL DIN 00800007 Baxter Logo Not for Injection Tis-U-Sol ® Solution (Pentalyte Irrigation) Each 100 mL contains: 800 mg Sodium Chloride, USP, 40 mg Potassium Chloride, USP, 20 mg Magnesium Sulfate, Heptahydrate, USP, 8.75 mg Dibasic Sodium Phosphate, Heptahydrate, USP, 6.25 mg Monobasic Potassium Phosphate, NF. No antimicrobial agent has been added. pH 6.5 (4.0 to 7.0). Osmolarity 288 mOsmol/L (calc.).

Sterile, nonpyrogenic. Pour Bottle. Isotonic solution for irrigation only.

Dosage and Administration: As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming.

Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

Recommended storage: Room temperature (25°C). Avoid excessive heat. PL 325 plastic Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA Distributed in Canada by Baxter Corporation Mississauga, ON L5N OC2 07-09-68-118 Bar Code Position Only* 303380190041 LOT EXP Representative Container Label for Tis-U-Sol, NDC 0338-0190-04

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

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 Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate — the ingredient across all brands.

Top reported reactions

Abdominal Distension1
Abnormal Faeces1
Dehydration1
Device Leakage1
Faeces Discoloured1
Food Intolerance1
Vomiting1

Reporter sex

1 reports

Serious outcomes

Disabling1
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
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 — Not published for this NDC No photo available yet for this listing.
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Corporation 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.
← 00338-0188-06 · Baxter 00338-0192-04 · Baxter →
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.