EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride 7.5 g/100mL; 540 mg/100mL; 450 mg/100mL; 25.7 mg/100mL; 5.1 mg/100mL Injection, Solution
by Vantive US Healthcare LLC · 5 BAG in 1 CARTON (0941-0719-05) / 2000 mL in 1 BAG (0941-0719-01)
NDC 00941-0719-05
🏷️ FDA NDC (as labeled)
0941-0719-05
billing pads the labeler segment with a zero
Rx only
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 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
FDA NDC (as labeled)
0941-0719-05
Product NDC
0941-0719
11-digit billing NDC
00941071905
UNII
02F3473H9O, 2NX48Z0A9G, M4I0D6VV5M, TU7HW0W0QT, 451W47IQ8X
SPL Set ID
2b327b13-a0e9-4b2c-9875-4470998e2e30
Established class (EPC)
Blood Coagulation Factor; Calculi Dissolution Agent; Cations; Increased Large Intestin
Physiologic effect
Increased Coagulation Factor Activity; Increased Large Intestinal Motility
Chemical class
Calcium; Divalent
DEA schedule
Non-controlled
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Aug 2026)
Marketing start
2024-10-21
Marketing end
2026-08-31
Route
INTRAPERITONEAL
Dosage form
INJECTION, SOLUTION
Substance
ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE
GCN Seq No
061815
GCN
97600
HICL code
034246
Ingredient (HICL)
Peri.dialysis Soln28-Ico 7.5 %
HIC1 code
C
Therapeutic class — broad (HIC1)
Electrolyte Balance/Metabolism/Nutrition
HIC2 code
C1
Therapeutic class — intermediate (HIC2)
Drugs Affecting Electrolyte Balance
HIC3 code
C1Y
Therapeutic class — specific (HIC3)
Dialysis Solutions
AHFS code
40:36.00.00
AHFS class
Irrigating Solutions
FDB label name
EXTRANEAL ICODEXTRIN 2000 ML
FDB brand name
Extraneal Icodextrin Dialysis
Legend status
F — Federal legend — prescription drug or device
Why two NDCs?
The FDA registers this code as 0941-0719-05 — 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 → 00941-0719-05. 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 Organic acids class.
Drug family (ATC)
Organic acids
How it works
Acidifying Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerVantive US Healthcare LLC
Labeler code00941
First marketedOct 2024
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 EXTRANEAL ICODEXTRIN 2000 ML Ingredient Peri.dialysis Soln28-Ico 7.5 %
🧪 What is this product?
Extraneal is an intraperitoneal injection solution containing icodextrin, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride. Icodextrin is a glucose polymer typically used as an osmotic agent in peritoneal dialysis solutions to help remove excess fluid from the body. The other ingredients are electrolytes and buffers that are commonly included in dialysis solutions to maintain proper electrolyte balance and pH. This product is marketed without an approved FDA application.
Patient education
Supplement & herbal interactions
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.
💬 Questions about icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💲 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Extraneal 7.5 g/100mL; 535 mg/100mL; 448 mg/100mL; 25.7 mg/100mL; 5.08 mg/100mL 00941-0679-05 | Vantive | 2500 ml | — | — | FDA listed | — |
| Extraneal 7.5 g/100mL; 540 mg/100mL; 450 mg/100mL; 25.7 mg/100mL; 5.1 mg/100mL 00941-0681-04 | Vantive | 2500 ml | — | — | FDA listed | — |
| Extraneal 7.5 g/100mL; 538 mg/100mL; 448 mg/100mL; 25.7 mg/100mL; 5.08 mg/100mL 00941-0707-06 | Vantive | 2000 ml | — | — | FDA listed | — |
| Extraneal 25.7 mg/100mL; 7.5 g/100mL; 5.1 mg/100mL; 540 mg/100mL; 450 mg/100mL 00941-0717-05 | Vantive | 2000 ml | — | — | Discontinued | — |
| Extraneal 7.5 g/100mL; 540 mg/100mL; 450 mg/100mL; 25.7 mg/100mL; 5.1 mg/100mLthis 00941-0719-05 | Vantive | 2000 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
🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 years 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.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for EXTRANEAL (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 59%
Female · 40%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00941-0719-05 You're viewing this | 5 BAG in 1 CARTON (0941-0719-05) / 2000 mL in 1 BAG (0941-0719-01) | 2024-10-21 | Discontinued by firm |
🧭 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) | — 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 | — 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 For Use In Drug Shortage". 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 FDA registers it as 0941-0719-05, 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: 00941-0719-05, written without dashes as 00941071905. 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 00941-0719-05, the first segment (00941) is the labeler code FDA assigned to Vantive US Healthcare LLC; the middle segment (0719) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Vantive US Healthcare LLC 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.
📄 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.
📄 FDA label ▾
No readable label sections were found for this product.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.