Home › NDC Lookup › Ingredients › Sodium Chloride › 00990-7984-37
Sodium Chloride 900 mg/100mL Injection, Solution — NDC 00990-7984-37 package photo

Sodium Chloride 900 mg/100mL Injection, Solution

by ICU Medical Inc. · 20 POUCH in 1 CASE (0990-7984-37) / 4 BAG in 1 POUCH / 100 mL in 1 BAG
NDC 00990-7984-37
🏷️ FDA NDC (as labeled) 0990-7984-37 billing pads the labeler segment with a zero
This package
Contains100 mL in 1 bag Medicaid pays$0.5260 / unit · 12 mo Per package$4,208.00 / 8000 ml · Medicaid Pack sizes5 compare ↓
Also priced by: Part D plans $0.0121/unit — full pricing hub ↓
Also comes in: 12 pouches 00990-7984-20 20 pouches 00990-7984-36 48 pouches 00990-7984-13 48 pouches 00990-7984-23
Rx only Brand On market Non-controlled
🗂️ Data synced 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

🚨
Active recall for this product.
Class II · Oct 27, 2025 — Lack of Assurance of Sterility: Potential for flexible container leaks. (Otsuka ICU Medical LLC) · FDA recall D-0143-2026
Class II · Nov 9, 2022 — Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility. (ICU Medical Inc) · FDA recall D-0062-2023
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Sodium Chloride (different manufacturers) — 6 · 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 (Huons Co., Ltd.) · FDA recall D-0531-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0433-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0427-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0425-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0429-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0431-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0990-7984-37
Product NDC 0990-7984
11-digit billing NDC 00990798437
NCPDP billing unit ML — per mL (volume)
RxCUI 1807548, 1807549, 1807550, 1807551, 1807552, 1807627, 1807630, 1807631,
UNII 451W47IQ8X
Application # NDA016366
SPL Set ID 5f372b75-d7a4-471e-8ac6-290040fc84b0
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-04-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM CHLORIDE
GPI-14 79750010002021
GPI class Sodium Chloride
GCN Seq No 001210
GCN 02962
HICL code 008255
Ingredient (HICL) 0.9 % Sodium Chloride
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1B
Therapeutic class — specific (HIC3) Sodium/Saline Preparations
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name SODIUM CHLORIDE 0.9% SOLUTION
FDB brand name Sodium Chloride
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0990-7984-37 — 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 → 00990-7984-37. 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 Sodium class.

Drug family (ATC) Sodium, Salt solutions, Electrolyte solutions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerICU Medical Inc.
Application holderOTSUKA ICU MEDICAL LLC
FDA applicationNDA016366 (NDA)
Labeler code00990
First marketedApr 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.

🩺 Clinical

Label name SODIUM CHLORIDE 0.9% SOLUTION Ingredient 0.9 % Sodium Chloride
📗 Our plain-language guide HelloPharmacist
  • Yes, exactly. Saline is just sodium chloride dissolved in water — it's essentially a sterile salt-water solution. Depending on the concentration and form, it can be used as an IV f...
  • I've heard of saline solution — is that the same thing as sodium chloride?
  • In some situations — like after surgery, during serious illness, or when someone can't take anything by mouth — the body needs fluids and electrolytes delivered directly into the b...
  • Why would someone need sodium chloride through an IV? Can't you just drink water?
📖 Read our full Sodium Chloride guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

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

💡 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.

💲 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 $0.5260 $4,208.00 / 8000 ml
Medicare drug plans payPart D · Q2 2026 $0.0121 $96.80 / 8000 ml
Medicare Part B allowsASP · J7040 $1.350 / J7040 unit —
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)0990-7984-37
11-digit billing NDC00990-7984-37
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7040
DescriptorINFUSION, NORMAL SALINE SOLUTION, STERILE (500 ML=1 UNIT)
Billing units / pkg0 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Chloride 900 mg/100mL 00409-7101-02 Hospira, 24 pouches $0.021 AP Availability likely —
Sodium Chloride 900 mg/100mL 51662-1522-01 HF 500 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0186-04 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0162-01 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mLthis 00990-7984-37 ICU 20 pouches — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0196-04 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-9159-30 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0166-01 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-9662-35 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0553-11 Baxter 50 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 46163-0300-10 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 49230-0300-10 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00990-7983-02 ICU 24 pouches — AP FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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
Apr 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00990-7984-37, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
13K
Units reimbursed last 4 qtrs
2.7M
Gross reimbursed last 4 qtrs
$1.4M
Avg / prescription
$107.49
Avg / unit
$0.5260
Latest quarter Q4 2025
1.9KRx
Fee-for-service vs managed care ⓘ
23% FFS 77% MCO
Fee-for-service · 2,944 Rx Managed care · 10,061 Rx
State Medicaid map
Alaska: no data reported AK Maine: 38,500 units · 2,760 per 100k residents ME Washington: no data reported WA Idaho: 136,500 units · 6,950 per 100k residents ID Montana: 17,756 units · 1,569 per 100k residents MT North Dakota: 165 units · 21.1 per 100k residents ND Minnesota: 184,154 units · 3,210 per 100k residents MN Wisconsin: no data reported WI Michigan: 17,600 units · 175 per 100k residents MI New York: 241,500 units · 1,234 per 100k residents NY Vermont: 85 units · 13.1 per 100k residents VT New Hampshire: 24,520 units · 1,749 per 100k residents NH Oregon: 3,224 units · 76.2 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 209,250 units · 6,525 per 100k residents IA Illinois: no data reported IL Indiana: 175,000 units · 2,550 per 100k residents IN Ohio: 65,485 units · 556 per 100k residents OH Pennsylvania: 26,226 units · 202 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 149 units · 2.1 per 100k residents MA California: 285,646 units · 733 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 194,700 units · 3,142 per 100k residents MO Kentucky: 675,519 units · 14,925 per 100k residents KY West Virginia: no data reported WV Virginia: 1,950 units · 22.4 per 100k residents VA Maryland: 1,900 units · 30.7 per 100k residents MD Connecticut: 6,003 units · 166 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 63 units · 3.0 per 100k residents NM Kansas: 75,001 units · 2,551 per 100k residents KS Arkansas: no data reported AR Tennessee: 64,550 units · 906 per 100k residents TN North Carolina: 20,900 units · 193 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 89,850 units · 2,217 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 307 units · 6.0 per 100k residents AL Georgia: no data reported GA D.C.: 7,800 units · 1,149 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: 93,250 units · 412 per 100k residents FL
Units reimbursed · per 100k residents
2.114,925
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 Kentucky 14,925 /100k
2 Idaho 6,950 /100k
3 Iowa 6,525 /100k
4 Minnesota 3,210 /100k
5 Missouri 3,142 /100k
6 Maine 2,760 /100k
7 Kansas 2,551 /100k
8 Indiana 2,550 /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.
48 pouches00990-7984-23 14,189 Rx · $572,849
20 pouches this page00990-7984-37 13,005 Rx · $1,397,887
48 pouches00990-7984-13 8,098 Rx · $281,872
20 pouches00990-7984-36 5,382 Rx · $1,019,721
12 pouches00990-7984-20 816 Rx · $52,223
Drug total (last 4 qtrs): 41,490 Rx · 9,312,945 units · $3,324,553 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Sodium Chloride — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Chloride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.42M
Claims incl. refills
105K
Beneficiaries
50.3K
Spend / beneficiary
$48.15
Spend / claim
$23.08
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00990-7984-13 48 POUCH in 1 CASE (0990-7984-13) / 1 BAG in 1 POUCH / 50 mL in 1 BAG 2019-05-01 Active
00990-7984-20 12 POUCH in 1 CASE (0990-7984-20) / 4 BAG in 1 POUCH / 25 mL in 1 BAG 2019-11-01 Active
00990-7984-23 48 POUCH in 1 CASE (0990-7984-23) / 1 BAG in 1 POUCH / 100 mL in 1 BAG 2019-04-01 Active
00990-7984-36 20 POUCH in 1 CASE (0990-7984-36) / 4 BAG in 1 POUCH / 50 mL in 1 BAG 2019-05-01 Active
00990-7984-37 You're viewing this 20 POUCH in 1 CASE (0990-7984-37) / 4 BAG in 1 POUCH / 100 mL in 1 BAG 2019-05-01 Active

This pack accounts for about 31% of this product's recent Medicaid fills; the largest share goes to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00990-7984-37?
NDC 00990-7984-37 is listed by the FDA — 20 pouch in 1 case / 4 bag in 1 pouch / 100 ml in 1 bag.
What NDC number is used to bill for this package of Sodium Chloride 900 mg/100mL Injection, Solution?
Bill NDC 00990-7984-37 — the 11-digit billing format is 00990798437. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ 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 FDA registers it as 0990-7984-37, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00990-7984-37, written without dashes as 00990798437. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00990-7984-37, the first segment (00990) is the labeler code FDA assigned to ICU Medical Inc.; the middle segment (7984) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (37) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: 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 4 other package presentations of this same product, including 12 pouches (00990-7984-20), 20 pouches (00990-7984-36), 48 pouches (00990-7984-13). 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 J7040 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.

📄 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 🔄 Drug Interactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 27 words ▾

INDICATIONS AND USAGE Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.

⏱️ Dosage and Administration 61 words ▾

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. 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 and container permit. (See PRECAUTIONS .)

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 117 words ▾

WARNINGS Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. The intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections.

The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. In patients with diminished renal function, administration of Sodium Chloride Injection, USP may result in sodium retention.

🤒 Adverse Reactions 87 words ▾

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. In addition to the above listed adverse reactions hyponatremia has been reported for 0.45% Sodium Chloride Injection, USP (see Pediatric Use section).

🔄 Drug Interactions ~2 min read ▾

DRUG INTERACTIONS Caution must be exercised in the administration of Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility. Pregnancy: Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP.

It is also not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed. Labor and Delivery Studies have not been conducted to evaluate the effects of Sodium Chloride Injection, USP on labor and delivery.

Caution should be exercised when administering this drug during labor and delivery. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing mother.

Pediatric Use The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. The infusion of hypotonic fluids (0.45% Sodium Chloride Injection, USP) together with the non-osmotic secretion of ADH may result in hyponatremia in patients with acute volume depletion.

Hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency. Geriatric Use Clinical studies of Sodium Chloride Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

🆘 Overdosage 26 words ▾

OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS .)

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY When administered intravenously, these solutions provide a source of water and electrolytes. Solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements. Isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss.

Hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. A hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome. Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl − ) ions.

Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl − ) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na + ) and chloride (Cl − ) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range 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 ~1 min read ▾

HOW SUPPLIED Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying Table. NDC No. Product Container size mL 0409-7730-36 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0.45% Sodium Chloride Inj., USP 50 0990-7730-36 0.45% Sodium Chloride Inj., USP 50 0409-7730-37 0.45% Sodium Chloride Inj., USP 100 0990-7730-37 0.45% Sodium Chloride Inj., USP 100 0409-7985-02 0.45% Sodium Chloride Inj., USP 250 0990-7985-02 0.45% Sodium Chloride Inj., USP 250 0409-7985-03 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0.45% Sodium Chloride Inj., USP 500 0990-7985-03 , 0.45% Sodium Chloride Inj., USP 500 0409-7985-09 , 0.45% Sodium Chloride Inj., USP 1000 0990-7985-09 , 0.45% Sodium Chloride Inj., USP 1000 0409-7984-20 0.9% Sodium Chloride Inj., USP 25 0990-7984-20 0.9% Sodium Chloride Inj., USP 25 0409-7984-36 0.9% Sodium Chloride Inj., USP 50 0990-7984-36 0.9% Sodium Chloride Inj., USP 50 0409-7984-13 0.9% Sodium Chloride Inj., USP 50 0990-7984-13 0.9% Sodium Chloride Inj., USP 50 0409-7984-37 0.9% Sodium Chloride Inj., USP 100 0990-7984-37 0.9% Sodium Chloride Inj., USP 100 0409-7984-23 0.9% Sodium Chloride Inj., USP 100 0990-7984-23 0.9% Sodium Chloride Inj., USP 100 0409-7983-61 0.9% Sodium Chloride Inj., USP 150 0990-7983-61 0.9% Sodium Chloride Inj., USP 150 0409-7983-02 , 0.9% Sodium Chloride Inj., USP 250 0990-7983-02 , 0.9% Sodium Chloride Inj., USP 250 0409-7983-53 0.9% Sodium Chloride Inj., USP 250 0990-7983-53 0.9% Sodium Chloride Inj., USP 250 0409-7983-03 0.9% Sodium Chloride Inj., USP 500 0990-7983-03 , 0.9% Sodium Chloride Inj., USP 500 0409-7983-55 0.9% Sodium Chloride Inj., USP 500 0990-7983-55 0.9% Sodium Chloride Inj., USP 500 0409-7983-09 , 0.9% Sodium Chloride Inj., USP 1000 0990-7983-09 , 0.9% Sodium Chloride Inj., USP 1000 ICU Medical is transitioning NDC codes from "0409" to "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: April, 2020 IFU0000188

📋 Description ~1 min read ▾

DESCRIPTION Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium chloride in water for injection.

Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection.

Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH for both concentrations in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6.

The pH range is 4.5 to 7.0 for all containers. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded.

The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. 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 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00990-7983-02 · ICU 00990-7985-02 · 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.