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Sterile Water 1 mL/mL Irrigant — NDC 00990-7973-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sterile Water 1 mL/mL Irrigant — NDC 0990-7973-08 (Billing 00990-7973-08)

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

This is a package of Sterile Water 1 mL/mL Irrigant from ICU Medical Inc., marketed since Aug 2019 and currently FDA-listed.

NDC 00990-7973-08
🏷️ FDA NDC (as labeled) 0990-7973-08 billing pads the labeler segment with a zero
This package
Contains3000 mL in 1 bag Medicaid pays$0.0084 / unit · 12 mo Per package$0.03 / 4 bags · Medicaid Pack sizes3 compare ↓
Product page 00990-7973-05 Also comes in: 6 pouches 0990-7973-07 12 pouches 0990-7973-05
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Water (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 2, 2026 — Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. (B BRAUN MEDICAL INC) · FDA recall D-0495-2026
Class II · Dec 22, 2025 — Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution (Baxter Healthcare Corporation) · FDA recall D-0296-2026
Class II · Aug 26, 2025 — Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. (B BRAUN MEDICAL INC) · FDA recall D-0652-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0990-7973-08
Product NDC 0990-7973
11-digit billing NDC 00990797308
NCPDP billing unit ML — per mL (volume)
RxCUI 150985
UNII 059QF0KO0R
Application # NDA018313
SPL Set ID e3484bc6-ed7f-43ef-9d49-c131a8dff2dd
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-08-01
Route IRRIGATION
Dosage form IRRIGANT
Substance WATER
TE code (Orange Book) AT · RLD · RS

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

GPI-14 99750005002000
GPI class Water For Irrigation, Sterile
GCN Seq No 009825
GCN 45340
HICL code 004283
Ingredient (HICL) Water For Irrigation,Sterile
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 STERILE WATER FOR IRRIGATION
FDB brand name Water
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009825
  • GCN: 45340
  • GPI-14 (Medi-Span): 99750005002000
  • HICL (First Databank): 004283
  • AHFS class code: 40:36.00.00
  • RxCUI (RxNorm): 150985
Why two NDCs? The FDA registers this code as 0990-7973-08 — 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 → 00990-7973-08. 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.

Clinical

Label name STERILE WATER FOR IRRIGATION Ingredient Water For Irrigation,Sterile
📗 Our plain-language guide HelloPharmacist
  • It can seem a little odd at first. In these products, sterile water plays the essential role of carrying or dissolving the actual active medication — like insulin — so it can be sa...
  • Why is 'water' listed as the active ingredient on my medicine?
  • No — these are very different products that should never be used interchangeably. Sterile Water for Injection is used only as a diluent for other drugs given by needle, and it must...
  • Is Sterile Water for Injection the same as the eye wash or the irrigation product?
📖 Read our full Water 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 $0.0084 $0.03 / 4 bags
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · A4217 No ASP payment limit on file for A4217 this quarter.
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.

Billing & reimbursement

FDA NDC (as labeled)0990-7973-08
11-digit billing NDC00990-7973-08
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeA4217
DescriptorSTERILE WATER/SALINE, 500 ML
Billing units / pkg0 units
How the units are derivedThis package is 3000 ML; the HCPCS unit is 500 ML, so one package = 0 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00990-7973-05 0990-7973-05 Main listing 12 POUCH in 1 CASE / 1 BAG in 1 POUCH / 1000 mL in 1 BAG 2019-09-01 — Active
00990-7973-07 0990-7973-07 6 POUCH in 1 CASE / 1 BAG in 1 POUCH / 2000 mL in 1 BAG 2019-10-01 — Active
00990-7973-08 You're viewing this 4 POUCH in 1 CASE / 1 BAG in 1 POUCH / 3000 mL in 1 BAG 2019-08-01 — Active

This pack accounts for about 10.0% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 4 pouch in 1 case / 1 bag in 1 pouch / 3000 ml in 1 bag.
What NDC number is used to bill for this package of Sterile Water 1 mL/mL Irrigant?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sterile Water 1 mL/mL 00264-2101-00 B. 1000 ml — AT FDA listed —
Sterile Water 100 mL/100mL 00264-7386-50 B. 2000 ml — AT FDA listed —
Sterile Water 100 mL/100mL 00338-0003-44 Baxter 1000 ml — AT FDA listed —
Sterile Water 100 mL/100mL 00338-0004-02 Baxter 24 bottles — AT FDA listed —
Sterile Water 1 mL/mLthis 00990-7973-08 ICU 4 pouches — AT FDA listed —
Sterile Water 1 mL/mL 17271-0802-07 Becton 1000 ml — AT FDA listed —
Sterile Water 1 mL/mL 65219-0495-10 Fresenius 1000 ml — AT FDA listed —
Sterile Water 1 mL/mL 65219-0497-20 Fresenius 2000 ml — AT FDA listed —
Sterile Water 1 mL/mL 65219-0499-30 Fresenius 3000 ml — AT 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
Aug 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.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerICU Medical Inc.
Application holderOTSUKA ICU MEDICAL LLC
FDA applicationNDA018313 (NDA)
Labeler code00990
First marketedAug 2019
Product typeHuman Prescription Drug
Portfolio48 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.

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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

INDICATIONS AND USAGE Sterile Water for Irrigation, USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of sterile, nonpyrogenic, solute-free water.

⏱️ Dosage and Administration 85 words ▾

DOSAGE AND ADMINISTRATION The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a diluent or vehicle for drugs, the manufacturer's recommendations should be followed. Drug Interactions Additives may be incompatible.

Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits.

(See PRECAUTIONS .)

⛔ Contraindications 8 words ▾

CONTRAINDICATIONS NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.

⚠️ Warnings 143 words ▾

WARNINGS FOR IRRIGATION ONLY. This preparation is solute-free and its entry into the circulation will cause hemolysis. 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, Sterile Water for Irrigation, USP must be regarded as a systemic drug. Absorption of large amounts of Sterile Water for Irrigation, USP with or without additives can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered solutions.

The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. Do not heat container over 66°C (150°F).

🤒 Adverse Reactions 94 words ▾

ADVERSE REACTIONS Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are completely avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distention or disruption of tissues.

Accidental contamination from careless technique may transmit infection. 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.

🤰 Pregnancy 61 words ▾

Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for Irrigation, USP. It is also not known whether Sterile Water for Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Irrigation, USP should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 12 words ▾

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

🆘 Overdosage 33 words ▾

OVERDOSAGE In the event of overhydration or solute overload (if solutes have been added to the irrigation), re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .)

🧬 Clinical Pharmacology 134 words ▾

CLINICAL PHARMACOLOGY Sterile Water for Irrigation, USP exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight.

Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

📦 How Supplied / Storage and Handling 157 words ▾

HOW SUPPLIED NDC No. Product Container Size (mL) Container Type 0409-6139-22 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0990-6139-22 Sterile Water for Irrigation USP 250 Semi-Rigid Irrigation 0409-6139-03 0990-6139-03 Sterile Water for Irrigation USP 500 Semi-Rigid Irrigation 0409-7139-09 0990-7139-09 Sterile Water for Irrigation USP 1000 Semi-Rigid Irrigation 0409-7139-36 0990-7139-36 Sterile Water for Irrigation USP 1500 Semi-Rigid Irrigation 0409-7973-05 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0990-7973-05 Sterile Water for Irrigation USP 1000 Flexible Irrigation 0409-7973-07 0990-7973-07 Sterile Water for Irrigation USP 2000 Flexible Irrigation 0409-7973-08 0990-7973-08 Sterile Water for Irrigation USP 3000 Flexible Irrigation 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 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: July, 2018 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA EN-4662

📋 Description ~1 min read ▾

DESCRIPTION Sterile Water for Irrigation, USP is a sterile, distilled, nonpyrogenic water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. pH 5.5 (5.0 to 7.0). Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded.

Sterile Water for Irrigation, USP may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Water for Irrigation, USP is chemically designated H 2 O. 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. 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.

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.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS Do not use for irrigation that may result in absorption into the blood. Caution should be observed when solute-free water is used for continuous irrigation or allowed to "dwell" inside body cavities because of possible absorption into the blood stream and the production of intravascular hemolysis and circulatory overload. Aseptic technique is essential with the use of sterile preparations for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues.

When used as a "pour" irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the semi-rigid wide mouth container. The flexible container is designed for use with nonvented irrigation sets. When used for irrigation via appropriate irrigation equipment, 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. For repeated irrigations of urethral catheters, a separate container should be used for each patient. Do not administer unless water is clear, seal is intact and container is undamaged.

Discard unused portion. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Sterile Water for Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Nursing Mothers: Caution should be exercised when Sterile Water for Irrigation, USP is administered to a nursing woman.

Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for Irrigation, USP.

It is also not known whether Sterile Water for Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Irrigation, USP should be given to a pregnant woman only if clearly needed. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

🍼 Nursing Mothers 18 words ▾

Nursing Mothers: Caution should be exercised when Sterile Water for Irrigation, USP is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 26 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Sterile Water for Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label 500 mL NDC 0990-6139-03 Sterile Water for Irrigation, USP Sterile, distilled, nonpyrogenic, pH 5.5 (5.0 to 7.0). Warning: Not isotonic. Hemolytic.

Indications: For irrigation only. Contraindications: Not for injection. Use only if clear and seal intact.

Warnings: Do not heat bottle over 66°C (150°F). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert.

Single- dose container. Contains no bacteriostat. Discard unused portion.

Usual dosage: See insert. Rx only AQUALITE™ SYSTEM Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA RL-7290 LOT EXP PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 1500 mL Bottle Label 1500 mL NDC 0990-7139-36 Sterile Water for Irrigation, USP Sterile, distilled, nonpyrogenic, pH 5.5 (5.0 – 7.0) Warnings: Not isotonic. Hemolytic. Indications: For irrigation only.

Contraindications: Not for injection. Use only if clear and seal intact. Warning: Do not heat bottle over 66°C (150°F).

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. Single-dose container.

Contains no bacteriostat. Discard unused portion. Usual dosage: See insert.

Rx only icu medical AQUALITE™ SYSTEM Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA RL-7294 LOT EXP PRINCIPAL DISPLAY PANEL - 1500 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label 3000 mL NDC 0990-7973-08 Sterile Water for IRRIGATION, USP STERILE, DISTILLED, NONPYROGENIC. INDICATIONS: FOR IRRIGATION. CONTRAINDICATIONS: NOT FOR INJECTION.

USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. WARNINGS: NOT ISOTONIC. HEMOLYTIC.

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.

DOSAGE AND ADMINISTRATION: AS DIRECTED BY PHYSICIAN. pH 5.5 (5.0 TO 7.0) RX ONLY 3 V CONTAINS DEHP IM-4379 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label

PRINCIPAL DISPLAY PANEL - 3000 mL Bag Overwrap 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 - 3000 mL Bag Overwrap

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

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 this package alone, 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 – Q1 2026 · 5 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
152
Units reimbursed last 4 qtrs
533.9K
Gross reimbursed last 4 qtrs
$4.5K
Avg / prescription
$29.37
Avg / unit
$0.0084
Latest quarter Q1 2026
50Rx
Fee-for-service vs managed care ⓘ
23% FFS 77% MCO
Fee-for-service · 35 Rx Managed care · 117 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 7,889 units · 101 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 14,058 units · 119 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 63 units · 0.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 1,703 units · 19.5 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported 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: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 510,145 units · 2,256 per 100k residents FL
Units reimbursed · per 100k residents
0.22,256
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 Florida 2,256 /100k
2 Ohio 119 /100k
3 Washington 101 /100k
4 Virginia 19.5 /100k
5 California 0.2 /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.
12 pouches00990-7973-05 1,373 Rx · $41,941
4 pouches this page00990-7973-08 152 Rx · $4,465
6 pouches00990-7973-07 No Medicaid data
Drug total (last 4 qtrs): 1,525 Rx · 1,483,305 units · $46,406 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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) — 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 ✓ Available
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

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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 6 pouches (00990-7973-07), 12 pouches (00990-7973-05). 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?
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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code A4217 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 00990-7972-05 · ICU 00990-7974-08 · 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.