Home › NDC Lookup › Ingredients › Sorbitol And Mannitol › 00990-7981-08
Sorbitol-Mannitol 2.7 g/100mL; .54 g/100mL Irrigant — NDC 00990-7981-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sorbitol-Mannitol 2.7 g/100mL; .54 g/100mL Irrigant — NDC 0990-7981-08 (Billing 00990-7981-08)

by ICU Medical Inc. · 4 POUCH in 1 CASE / 1 BAG in 1 POUCH / 3000 mL in 1 BAG

This is a package of Sorbitol-Mannitol 2.7 g/100mL; .54 g/100mL Irrigant from ICU Medical Inc., marketed since Oct 2019 and currently FDA-listed. It is this product's only package size.

NDC 00990-7981-08
🏷️ FDA NDC (as labeled) 0990-7981-08 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 Aug 27, 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 0990-7981-08 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0990 labeler · 7981 product · 08 package
Package marketed since
Oct 1, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0990798108 6
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0990-7981-08
Product NDC 0990-7981
11-digit billing NDC 00990798108
NCPDP billing unit ML — per mL (volume)
RxCUI 311446
UNII 506T60A25R, 3OWL53L36A
Application # NDA018316
SPL Set ID 5b44e248-4b7b-4777-954a-921c7b309944
Established class (EPC) Osmotic Diuretic
Mechanism of action Osmotic Activity
Physiologic effect Increased Diuresis
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-01
Route URETHRAL
Dosage form IRRIGANT
Substance SORBITOL; MANNITOL

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

GPI-14 56700084002020
GPI class Sorbitol-Mannitol
GCN Seq No 009829
GCN 91670
HICL code 004287
Ingredient (HICL) Mannitol/Sorbitol Solution
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 40:28.12.00
AHFS class Osmotic Diuretics (40:28)
FDB label name SORBITOL-MANNITOL IRRIG
FDB brand name Sorbitol-Mannitol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009829
  • GCN: 91670
  • GPI-14 (Medi-Span): 56700084002020
  • HICL (First Databank): 004287
  • AHFS class code: 40:28.12.00
  • RxCUI (RxNorm): 311446
Why two NDCs? The FDA registers this code as 0990-7981-08 — 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 → 00990-7981-08. 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 Diuretic class.

Pharmacologic class Osmotic Diuretic
Drug family (ATC) Osmotically acting laxatives, Solutions producing osmotic diuresis, Other irrigating solutions
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

Label name SORBITOL-MANNITOL IRRIG Ingredient Mannitol/Sorbitol Solution

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
00990-7981-08 You're viewing this Main listing 4 POUCH in 1 CASE / 1 BAG in 1 POUCH / 3000 mL in 1 BAG 2019-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sorbitol-Mannitol 2.7 g/100mL; .54 g/100mLthis 00990-7981-08 ICU 4 pouches — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

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

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

Inactive Ingredients / Excipients

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

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

  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerICU Medical Inc.
Application holderOTSUKA ICU MEDICAL LLC
FDA applicationNDA018316 (NDA)
Labeler code00990
First marketedOct 2019
Product typeHuman Prescription Drug
Portfolio48 products on file

More NDCs from ICU Medical Inc. labeler code 00990

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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

INDICATIONS AND USAGE Sorbitol-Mannitol Irrigation is indicated for use as a urologic irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.

⏱️ Dosage and Administration 88 words ▾

DOSAGE AND ADMINISTRATION Sorbitol-Mannitol Irrigation should be administered only by transurethral instillation with appropriate urologic instrumentation. A disposable administration set should be used. The total volume of solution used for irrigation is solely at the discretion of the surgeon.

Height of container(s) above the operating table in excess of 60 cm (approx. 2 ft) has been reported to increase intravascular absorption of the irrigating fluid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever container and solution permit.

(See PRECAUTIONS .)

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. Do not use in patients with anuria.

⚠️ Warnings 137 words ▾

WARNINGS FOR UROLOGIC IRRIGATION ONLY. Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes; thus, sorbitol-mannitol irrigant must be regarded as a systemic drug.

Absorption of large amounts of fluids containing sorbitol-mannitol and the osmotic diuresis it produces may significantly alter cardiopulmonary and renal dynamics. Hyperglycemia from metabolism of sorbitol may occur in patients with diabetes mellitus. Hyperlactatemia from metabolism of sorbitol may potentially produce a significant lactic acidemia in metabolically compromised patients.

The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigation solution since it contains no preservatives. Do not heat over 66°C (150°F).

🤒 Adverse Reactions 118 words ▾

ADVERSE REACTIONS Adverse reactions may result from intravascular absorption of sorbitol and mannitol. The literature reports occasional adverse reactions from intravenous sorbitol-mannitol infusions. Consequences of absorption of urologic irrigating solutions include fluid and electrolyte disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth, thirst and dehydration; cardiovascular disorders such as hypotension, tachycardia, angina-like pains; pulmonary disorders such as pulmonary congestion; and other general reactions such as blurred vision, convulsions, nausea, vomiting, diarrhea, rhinitis, chills, vertigo, backache and urticaria.

Allergic reactions from sorbitol-mannitol have also been reported. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

🆘 Overdosage 30 words ▾

OVERDOSAGE In the event of dehydration, fluid or solute overload, discontinue the irrigation, evaluate the patient and institute corrective measures as indicated. (See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .)

🧬 Clinical Pharmacology 150 words ▾

CLINICAL PHARMACOLOGY Sorbitol and mannitol are hexitols and are nonelectrolytes. A solution of these constituents in water is therefore nonconductive and suitable for urologic irrigation during electrosurgical procedures. A 3% (approx.) total concentration of sorbitol-mannitol contains sufficient solute to minimize the risk of intravascular hemolysis which can occur from absorption of plain water through open prostatic veins during transurethral resection (TUR).

Any solution that is absorbed intravascularly during transurethral prostatic or bladder surgery, although variable in amount depending primarily on the extent of surgery, will be excreted by the kidney. When absorbed intravascularly, sorbitol and mannitol act as osmotic diuretics. Intravascular absorption of sorbitol has been shown to produce elevations of serum lactate after TUR above preoperative values owing to sorbitol's favored metabolism to lactate from pyruvate.

Increased lactate levels were not sufficient to produce evidence of metabolic acidosis. Mannitol is only slightly metabolized and rapidly excreted by the kidney.

📦 How Supplied / Storage and Handling 75 words ▾

HOW SUPPLIED Sorbitol-Mannitol Irrigation is supplied in single-dose 3000 mL flexible irrigation container (NDC No. 0409-7981-08 / 0990-7981-08). ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code.

Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Revised: July, 2018 EN-4664 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

📋 Description ~1 min read ▾

DESCRIPTION Sorbitol-Mannitol Irrigation is a sterile, nonpyrogenic, hypotonic, aqueous solution for urologic nonelectrolyte irrigation during transurethral surgical procedures. Each 100 mL contains sorbitol 2.70 g and mannitol 0.54 g in water for injection. The solution is nonelectrolytic and hypotonic (178 mOsmol/liter calc.); pH 5.2 (4.0 to 7.0).

The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose irrigation. When smaller volumes are required the unused portion should be discarded. Sorbitol-Mannitol Irrigation is a nonelectrolyte urologic irrigant.

Sorbitol, NF is chemically designated D-glucitol (C 6 H 14 O 6 ), white powder, granules or flakes very soluble in water. It has the following structural formula: Mannitol, USP is chemically designated D-mannitol (C 6 H 14 O 6 ), white crystalline powder or free-flowing granules, freely soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 0.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin.

It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Sorbitol, NF structrual formula Mannitol, USP structural formula

⚠️ Precautions ~1 min read ▾

PRECAUTIONS Cardiovascular status, especially of the patient with cardiac disease, should be carefully observed before and during transurethral resection of the prostate when using Sorbitol-Mannitol Irrigation, because the quantity of fluid absorbed into the systemic circulation by opened prostatic veins may produce significant expansion of the extracellular fluid and lead to fulminating congestive heart failure. Shift of sodium-free intracellular fluid into the extracellular compartment following systemic absorption of solution may lower serum sodium concentration and aggravate pre-existing hyponatremia.

Excessive loss of water and electrolytes may lead to serious imbalances. With continuous irrigation, loss of water may occur in excess of electrolytes, producing hypernatremia. Sustained diuresis that results from transurethral irrigation with Sorbitol-Mannitol Irrigation may obscure and intensify inadequate hydration or hypovolemia.

Aseptic technique is essential for the use of sterile solutions for irrigation. The administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure.

Do not administer unless solution is clear, seal is intact and container is undamaged. Discard unused portion. Carcinogenesis, Mutagenesis, Impairment of Fertility : Studies with Sorbitol-Mannitol Irrigation have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers : Caution should be exercised when Sorbitol-Mannitol Irrigation is administered to a nursing woman. Pregnancy : Teratogenic Effects. Pregnancy Category C.

Animal reproduction studies have not been conducted with Sorbitol-Mannitol Irrigation. It is also not known whether Sorbitol-Mannitol Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sorbitol-Mannitol Irrigation should be given to a pregnant woman only if clearly needed.

Pediatric Use : The safety and effectiveness of Sorbitol-Mannitol Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

📄 Package Label / Principal Display Panel 169 words ▾

PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label 3000 mL NDC 0990-7981-08 SORBITOL- MANNITOL IRRIGATION EACH 100 mL CONTAINS SORBITOL 2.70 g; MANNITOL 0.54 g. pH 5.2 (4.0 TO 7.0) 178 mOsmol/LITER (CALC.) STERILE, NONPYROGENIC. INDICATIONS: FOR UROLOGIC IRRIGATION. CONTRAINDICATIONS: NOT FOR INJECTION.

USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. WARNINGS: DO NOT HEAT OVER 66°C (150°F) OR STORE ABOVE 40°C (104°F). SINGLE-DOSE CONTAINER.

CONTAINS NO BACTERIOSTAT. DISCARD UNUSED PORTION. USE ASEPTIC TECHNIQUE.

USUAL DOSAGE: SEE INSERT. RX ONLY IM-4383 3 V CONTAINS DEHP ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label

PRINCIPAL DISPLAY PANEL - Overwrap Label 2 HDPE TO OPEN TEAR AT NOTCH DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 PRINCIPAL DISPLAY PANEL - Overwrap Label

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 Sorbitol-Mannitol (this brand).

Top reported reactions

Fluid Imbalance1
Hypokalaemia1
Hyponatraemia1
Procedural Complication1
Pulmonary Oedema1

Reporter sex

1 reports
Female · 100%

Serious outcomes

Hospitalization1
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 ✓ Available
Inactive ingredients (structured) ✓ 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 ICU Medical Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ICU Medical 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.
← 00990-7974-08 · ICU 00990-7982-09 · ICU →
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.