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ISOTONIC SODIUM CHLORIDE .9 g/100mL Injection, 500 mL — NDC 85184-0001-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ISOTONIC SODIUM CHLORIDE .9 g/100mL Injection, 500 mL — NDC 85184-0001-3 (Billing 85184-0001-03)

by HAVER FARMA ILAC ANONIM SIRKETI · 500 mL in 1 BAG

This is a package of 500 mL of ISOTONIC SODIUM CHLORIDE .9 g/100mL Injection from HAVER FARMA ILAC ANONIM SIRKETI, no longer marketed (first marketed Jan 2025), no longer in the FDA NDC Directory.

NDC 85184-0001-03
🏷️ FDA NDC (as labeled) 85184-0001-3 billing pads the package segment with a zero
This package
Contains500 mL Pack sizes4 compare ↓
Also priced by: Part D plans $0.0121/unit — full pricing hub ↓
Product page 85184-0001-01 Also comes in: 100 ml 85184-0001-1 250 ml 85184-0001-2 1000 ml 85184-0001-4
Rx only Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85184-0001-3
Product NDC 85184-0001
11-digit billing NDC 85184000103
RxCUI 1807632, 1807633, 1807634, 1807639
UNII 451W47IQ8X
SPL Set ID 2be5b3e2-c4a4-00ea-e063-6394a90a6163
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2025-01-01
Route INTRAMUSCULAR, INTRAVENOUS, IRRIGATION, SUBCUTANEOUS
Dosage form INJECTION
Substance SODIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1807632
Why two NDCs? The FDA registers this code as 85184-0001-3 — a 5-4-1 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 package segment → 85184-0001-03. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. IV forms replace fluid and salt, while injection diluents dissolve other drugs. Other forms are used for rinsing, nasal congestion and nasal care, or to...
  • Follow the directions on your product. Many are used as often as needed by adults and children 4 and over. Do not share the bottle, because that can spread infection.
  • Some people get fever, irritation or infection at the IV site, or too much fluid in the body. Tell your nurse right away if the IV site hurts or looks red.
  • What side effects should I expect with IV sodium chloride?
📖 Read our full Sodium Chloride guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0121 $0.01 / 1 bag
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85184-0001-01 85184-0001-1 Main listing 100 mL in 1 BAG 2025-01-01 — Inactivated by FDA
85184-0001-02 85184-0001-2 250 mL in 1 BAG 2025-01-01 — Inactivated by FDA
85184-0001-03 You're viewing this 500 mL in 1 BAG 2025-01-01 — Inactivated by FDA
85184-0001-04 85184-0001-4 1000 mL in 1 BAG 2025-01-01 — Inactivated by FDA

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 500 mL — 500 ml in 1 bag.
How does this package differ from NDC 85184-0001-01?
Both are ISOTONIC SODIUM CHLORIDE .9 g/100mL Injection — the drug itself is identical. This page's package is the 500 mL one, while NDC 85184-0001-01 is the 100 ml package.
What NDC number is used to bill for this package of ISOTONIC SODIUM CHLORIDE .9 g/100mL Injection?
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
Isotonic Sodium Chloride .9 g/100mLthis 85184-0001-03 HAVER 500 ml — — Discontinued —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

Inactive Ingredients / Excipients

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

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

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

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerHAVER FARMA ILAC ANONIM SIRKETI
Labeler code85184
First marketedJan 2025
Product typeHuman Prescription Drug
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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 136 words ▾

biofleks 100 mL 0.9 % ISOTONIC SODIUM CHLORIDE SOLUTION STERILE Per 100 mL Sodium Chloride Water for Injection Electrolyte Concentrations (mEq/L) ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet.

Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored.

Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only.

Distributor: Vin Trading LLC Phone: (201) 676-3232 / E-Mail: [email protected] Address: 203 Lemoine Ave #118, Fort Lee, NJ 07024 OSEL llaç San. ve Tic. A.Ş. Beykoz / İstanbul / TURKEY 100mL Bag 250mL Bag 500 mL Bag 1000mL Bag 100 mL 250 mL 500 mL 1000 mL

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

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application No longer marketed (per FDA listing data)

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 100 ml (85184-0001-01), 250 ml (85184-0001-02), 1000 ml (85184-0001-04). 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?
HAVER FARMA ILAC ANONIM SIRKETI is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 85182-0240-04 · NINGBO 85185-0001-30 · Solis →
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.