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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 — NDC 00941-0681-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

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 — NDC 0941-0681-04 (Billing 00941-0681-04)

by Vantive US Healthcare LLC · 4 BAG in 1 CARTON / 2500 mL in 1 BAG

This is a package of 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 from Vantive US Healthcare LLC, marketed since Oct 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00941-0681-04
🏷️ FDA NDC (as labeled) 0941-0681-04 billing pads the labeler segment with a zero
This package
Contains2500 mL in 1 bag Pack sizes2 compare ↓
Main listing for product 0941-0681 · Also comes in: 2500 ml 0941-0681-08
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 0941-0681-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0941 labeler · 0681 product · 04 package
Barcode (UPC-A, from the NDC)
3 0941068104 6
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0941-0681-04
Product NDC 0941-0681
11-digit billing NDC 00941068104
RxCUI 1100742, 1100746
UNII 2NX48Z0A9G, 451W47IQ8X, TU7HW0W0QT, M4I0D6VV5M, 02F3473H9O
SPL Set ID e18bacfe-af60-49dc-bd30-cb3c29fa16db
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 On market
FDA listing status Listed (active directory)
Marketing start 2024-10-21
Marketing end 2027-01-31
Route INTRAPERITONEAL
Dosage form INJECTION, SOLUTION
Substance ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE

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

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 2500 ML
FDB brand name Extraneal Icodextrin Dialysis
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 061815
  • GCN: 97600
  • HICL (First Databank): 034246
  • AHFS class code: 40:36.00.00
  • RxCUI (RxNorm): 1100742
Why two NDCs? The FDA registers this code as 0941-0681-04 — 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 → 00941-0681-04. 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.

Clinical

Label name EXTRANEAL ICODEXTRIN 2500 ML Ingredient Peri.dialysis Soln28-Ico 7.5 %
🧪 What is this product?

Extraneal is an injectable solution given directly into the abdominal cavity (intraperitoneal route), typically used during peritoneal dialysis treatments. The solution contains icodextrin, a glucose polymer that helps remove excess fluid and waste products from the blood when kidney function is reduced. The other ingredients (sodium chloride, sodium lactate, calcium chloride, and magnesium chloride) are electrolytes and buffer substances that mimic the body's natural fluid balance and are commonly included in dialysis solutions. This product is marketed without an approved FDA application.

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 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.
Try another pack size: 2500 ml
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
00941-0681-04 You're viewing this Main listing 4 BAG in 1 CARTON / 2500 mL in 1 BAG 2024-10-21 — Active
00941-0681-08 0941-0681-08 4 BAG in 1 CARTON / 2500 mL in 1 BAG 2024-10-21 Jan 31, 2027 Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 4 bag in 1 carton / 2500 ml in 1 bag.
What NDC number is used to bill for this package of 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?
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
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/100mLthis 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/100mL 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.

Inactive Ingredients / Excipients

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerVantive US Healthcare LLC
Labeler code00941
First marketedOct 2024
Product typeHuman Prescription Drug
Portfolio48 products on file

More NDCs from Vantive US Healthcare LLC labeler code 00941

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel ~3 min read ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Lot EXP B5268 2000 ml Baxter EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution UK: Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom IE and MT: Baxter Holding B.V., Kobaltweg 49, 3542CE, Utrecht, Netherlands PL 00116/0266 PA 2299/017/001 MA 1277/01101 POM Symbol Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-608 EXTRANEAL FPB5268C 2000 ml x 5 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children UK: Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom IE and MT: Baxter Holding B.V.

Kobaltweg 49, 3542CE, Utrecht, Netherlands 88-46-13-196 Lot: EXP Do not store below 4°C Twin bag with Luer connector MA 1277/01101 PA 2299/017/001 PL 00116/0266 POM Symbol Barcode (01)554 13760423833(17)201200(10)88C88C88B2 EXTRANEAL FPB5268C 2000 ml x 5 Lot: EXP Lot EXP B5268 2000 ml Vantive EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58711/0005 POM Symbol CB-35-05-250 EXTRANEAL FPB5268C 2000 ml x 5 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom 88-46-14-007 Lot: EXP UK Only Do not store below 4°C Twin bag with Luer connector PL 58711/0005 POM Symbol Barcode (01)57332414203103 (17)201200(10)88C88C88B2 EXTRANEAL FPB5268C 2000 ml x 5 Lot: EXP Lot EXP B5270 2500 ml Baxter EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear an… [Excerpted — this section continues on DailyMed.]

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

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.
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 it is currently marketed — but Vantive US Healthcare LLC has reported a marketing end date of 2027-01-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 2500 ml (00941-0681-08). 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?
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.
← 00941-0679-05 · Vantive 00941-0684-04 · Vantive →
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.