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Sterile Water 1 mL/mL Injection, Solution — NDC 0990-7118-07 (Billing 00990-7118-07)

by ICU Medical Inc. · 6 BAG in 1 CASE / 2000 mL in 1 BAG

This is a package of Sterile Water 1 mL/mL Injection, Solution from ICU Medical Inc., marketed since Jun 2019 and currently FDA-listed. It is this product's only package size.

NDC 00990-7118-07
🏷️ FDA NDC (as labeled) 0990-7118-07 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 Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0990-7118-07 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0990 labeler · 7118 product · 07 package
Package marketed since
Jun 1, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0990711807 9
Medicaid fills, this package
372 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
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) 0990-7118-07
Product NDC 0990-7118
11-digit billing NDC 00990711807
NCPDP billing unit ML — per mL (volume)
UNII 059QF0KO0R
Application # NDA019869
SPL Set ID 1c0bbcb7-5ed6-4ee7-b297-080d3359474e
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance WATER
TE code (Orange Book) AP · RLD · RS

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

GPI-14 98401010002000
GPI class Sterile Water for Injection
GCN Seq No 001166
GCN 02729
HICL code 000517
Ingredient (HICL) Water For Injection,Sterile
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C0
Therapeutic class — intermediate (HIC2) Affect Fluid/Acid-Base Balance/Metabolic Systems
HIC3 code C0B
Therapeutic class — specific (HIC3) Water
AHFS code 96:00.00.00
AHFS class Pharmaceutical Aids
FDB label name STERILE WATER FOR INJECTION
FDB brand name Water
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001166
  • GCN: 02729
  • GPI-14 (Medi-Span): 98401010002000
  • HICL (First Databank): 000517
  • AHFS class code: 96:00.00.00
Why two NDCs? The FDA registers this code as 0990-7118-07 — 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 → 00990-7118-07. 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 INJECTION Ingredient Water For Injection,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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.3800 $4,560.00 / 12000 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · A4216 No ASP payment limit on file for A4216 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)0990-7118-07
11-digit billing NDC00990-7118-07
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeA4216
DescriptorSTERILE WATER, SALINE AND/OR DEXTROSE, DILUENT/FLUSH, 10 ML
Billing units / pkg0.1 units
How the units are derivedThis package is 2000 ML; the HCPCS unit is 10 ML, so one package = 0.1 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
00990-7118-07 You're viewing this Main listing 6 BAG in 1 CASE / 2000 mL in 1 BAG 2019-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sterile Water 1 mL/mL 00517-3020-25 American 25 vials $0.066 — FDA listed —
Sterile Water 1 mL/mL 00517-3010-25 American 25 vials $0.315 — Availability likely —
Sterile Water 1 mL/mL 00264-7385-50 B. 2000 ml — AP FDA listed —
Sterile Diluent for Treprostinil 1 mL/mL 43598-0126-11 Dr.Reddy's 1 vial — AP FDA listed —
Sterile Diluent for Remodulin 1 mL/mL 66302-0150-50 United 1 vial — — FDA listed —
Sterile Water 1 mL/mLthis 00990-7118-07 ICU 2000 ml — AP FDA listed —
Sterile Water 1 mL/mL 84549-0850-10 ProPharma 500 ml — AP FDA listed —
Sterile Water 1 mL/mL 00264-7850-00 B. 1000 ml — AP 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
Jun 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.

🧪 Avoiding an ingredient? See Water inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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 applicationNDA019869 (NDA)
Labeler code00990
First marketedJun 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 15 words ▾

Pharmacy Bulk Package — Not for Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES.

🎯 Indications and Usage 28 words ▾

INDICATIONS AND USAGE Sterile Water for Injection, USP in the Pharmacy Bulk Package is indicated for use with automated compounding devices for preparing intravenous admixtures in the pharmacy.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Sterile Water for Injection, USP in the 2000 mL flexible Pharmacy Bulk Package is designed for use with automated compounding devices for preparing intravenous admixtures. Dosages will be in accordance with the recommendation of the prescribing physician. Sterile Water for Injection, USP is not intended for direct infusion.

Admixtures should be made by or under the direction of a pharmacist using strict aseptic technique under a laminar flow hood. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration.

Drug Interactions The Pharmacy Bulk Package is intended only for use in the preparation of sterile, intravenous admixtures using automated compounding devices. Additives may be incompatible with the fluid withdrawn from this container. Consult with pharmacist, if available.

When compounding admixtures, 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.

Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

Recommended Directions for Use of the Pharmacy Bulk Package Use Aseptic Technique 1. During use, container must be stored, and all manipulations performed, in an appropriate laminar flow hood. 2.

Remove cover from outlet port at bottom of container. 3. Insert piercing pin of transfer set and suspend unit in a laminar flow hood.

Insertion of a piercing pin into the outlet port should be performed only once in a Pharmacy Bulk Package solution. Once the outlet site has been entered, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from transfer set pin or implement insertion is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture.

4. Sequentially dispense aliquots of Sterile Water for Injection, USP into I.V. containers using appropriate transfer set. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling.

⛔ Contraindications 12 words ▾

CONTRAINDICATIONS NOT FOR DIRECT INFUSION. DO NOT USE FOR NON-AUTOMATED ADMIXTURE PREPARATIONS.

⚠️ Warnings 187 words ▾

WARNINGS FOR DILUTION ONLY. Do not heat over 66°C (150°F). This preparation is solute-free and its entry into the circulation undiluted will cause hemolysis .

Absorption of large amounts of Sterile Water for Injection, USP with 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.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

🤒 Adverse Reactions 34 words ▾

ADVERSE REACTIONS Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.

🧬 Clinical Pharmacology 79 words ▾

CLINICAL PHARMACOLOGY 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 94 words ▾

HOW SUPPLIED Sterile Water for Injection, USP is supplied in 2000 mL flexible Pharmacy Bulk Packages. NDC No. Product Container Size (mL) 0409-7118-07 Sterile Water for Injection, USP 2000 0990-7118-07 Sterile Water for Injection, USP 2000 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code.

Both 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. Patent 4,368,765 Revised: July, 2018 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA EN-4665

📋 Description 163 words ▾

DESCRIPTION Sterile Water for Injection, USP is a sterile, nonpyrogenic water for injection intended only for dilution purposes. The pH is 5.4 (5.0 to 7.0). The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program.

Sterile Water for Injection, USP contains no bacteriostat, antimicrobial agent or added buffer. Sterile Water for Injection, USP may be classified as a sterile diluent and pharmaceutical vehicle. Sterile Water for Injection, 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. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained.

However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

⚠️ Precautions 36 words ▾

PRECAUTIONS Do not use unless water is clear, seal is intact and container is undamaged. Aseptic technique is essential with the use of sterile preparations for compounding admixtures. Discard container within 4 hours of entering closure.

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 2000 mL Bag Label 2000 mL NDC 0990-7118-07 STERILE WATER FOR INJECTION, USP PHARMACY BULK PACKAGE — Not For Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES. STERILE, NONPYROGENIC. pH 5.4 (5.0 TO 7.0).

INDICATIONS: FOR PREPARATION OF INTRAVENOUS ADMIXTURES USING AUTOMATED COMPOUNDING DEVICES. CONTRAINDICATIONS: NOT FOR DIRECT INFUSION. DO NOT USE FOR NON-AUTOMATED ADMIXTURE PREPARATIONS.

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

DO NOT HEAT OVER 66°C (150°F). CONTAINS NO BACTERIOSTAT. DISCARD UNUSED PORTION.

USE ASEPTIC TECHNIQUE. DOSAGE AND ADMINISTRATION: AS DIRECTED BY PHYSICIAN. SEE INSERT FOR COMPLETE INFORMATION.

DATE ENTERED:___________________________ TIME OF ENTRY:___________________________ CAUTION: USE ONLY IN LAMINAR FLOW HOOD. ONCE THE OUTLET SITE HAS BEEN ENTERED, THE WITHDRAWAL OF CONTAINER CONTENTS SHOULD BE PROMPTLY COMPLETED IN ONE CONTINUOUS OPERATION. DISCARD CONTAINER NOT LATER THAN 4 HOURS AFTER INITIAL CLOSURE PUNCTURE.

SEE INSERT. CONTAINS NO MORE THAN 25 mcg/L OF ALUMINUM. Rx ONLY 3 V CONTAINS DEHP IM-4366 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 2000 mL Bag Label

PRINCIPAL DISPLAY PANEL - 2000 mL Bag Overwrap TO OPEN TEAR AT NOTCH 2 HDPE 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 - 2000 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
372
Units reimbursed last 4 qtrs
279K
Gross reimbursed last 4 qtrs
$106K
Avg / prescription
$284.99
Avg / unit
$0.3800
Latest quarter Q1 2026
67Rx
Fee-for-service vs managed care ⓘ
64% FFS 36% MCO
Fee-for-service · 237 Rx Managed care · 135 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 17,883 units · 229 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: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 257,421 units · 661 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: no data reported 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: 3,649 units · 12.0 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
12.0661
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 California 661 /100k
2 Washington 229 /100k
3 Texas 12.0 /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.

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 ✓ 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.
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 A4216 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.
← 00990-7116-09 · ICU 00990-7120-07 · 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.