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Plasma-Lyte 148 (pH 7.4) Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution — NDC 00338-9593-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Plasma-Lyte 148 (pH 7.4) Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution — NDC 0338-9593-10 (Billing 00338-9593-10)

by Baxter Healthcare Corporation · 10 BAG in 1 CARTON / 1000 mL in 1 BAG

This is a package of Plasma-Lyte 148 (pH 7.4) Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution from Baxter Healthcare Corporation, marketed since Nov 2024 and currently FDA-listed. It is this product's only package size.

NDC 00338-9593-10
🏷️ FDA NDC (as labeled) 0338-9593-10 billing pads the labeler segment with a zero
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 0338-9593-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 9593 product · 10 package
Package marketed since
Nov 8, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0338959310 2
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-9593-10
Product NDC 0338-9593
11-digit billing NDC 00338959310
NCPDP billing unit ML — per mL (volume)
RxCUI 801109, 801357
UNII 451W47IQ8X, R6Q3791S76, 4550K0SC9B, 660YQ98I10, 02F3473H9O
SPL Set ID fe935c8d-f42d-42e4-8665-0dc66829f231
Established class (EPC) Calculi Dissolution Agent; Inhibition Large Intestine Fluid/E
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
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 2024-11-08
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE

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

GCN Seq No 001451
GCN 04200
HICL code 000622
Ingredient (HICL) Electrolyte-148 (Ph 7.4)
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1W
Therapeutic class — specific (HIC3) Electrolyte Maintenance
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name PLASMA-LYTE 148 PH 7.4 SOLN
FDB brand name Plasma-Lyte 148 Ph 7.4
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001451
  • GCN: 04200
  • HICL (First Databank): 000622
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 801109
Why two NDCs? The FDA registers this code as 0338-9593-10 — 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 → 00338-9593-10. 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 Electrolyte solutions class.

Drug family (ATC) 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

Label name PLASMA-LYTE 148 PH 7.4 SOLN Ingredient Electrolyte-148 (Ph 7.4)
📗 Our plain-language guide HelloPharmacist
  • The IV versions replace water and electrolytes and help balance acid levels. Normosol-R is also used for fluid loss in surgery, trauma, burns or shock. Physiolyte is different: it...
  • The IV products are given by healthcare staff through a vein with sterile equipment. Your team decides the amount and speed based on your age, weight and condition. Normosol-R may...
  • You might get irritation, infection or a clot near the IV site, or a fever. Too much fluid can also occur. Tell your nurse about any pain or swelling at the site.
  • Tell your care team right away about chest pain, trouble breathing, a racing heartbeat, flushing, confusion, seizures, severe weakness or swelling. These could be allergic reaction...
📖 Read our full Magnesium Chloride / Potassium Chloride / Sodium Acetate / Sodium Chloride / Sodium Gluconate 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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00338-9593-10 You're viewing this Main listing 10 BAG in 1 CARTON / 1000 mL in 1 BAG 2024-11-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Plasma-Lyte A 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL 00338-0221-03 Baxter 500 ml — — FDA listed —
Plasma-Lyte 148 (pH 7.4) 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mLthis 00338-9593-10 Baxter 1000 ml — — FDA listed —
Multiple Electrolytes pH 5.5 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL 65219-0387-05 Fresenius 500 ml — — FDA listed —
Multiple Electrolytes pH 7.4 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL 65219-0389-05 Fresenius 500 ml — AP FDA listed —
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
Nov 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.

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

  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

2 inactive ingredients 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

LabelerBaxter Healthcare Corporation
Labeler code00338
First marketedNov 2024
Product typeHuman Prescription Drug
Portfolio285 products on file

More NDCs from Baxter Healthcare Corporation labeler code 00338

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 170 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Baxter Viaflo GCCE0324 1000 mL 100 200 300 400 500 600 700 800 900 Plasma-Lyte 148 (pH 7.4) Solution for Infusion pH 6.5 –

8.0Isotonic Osmolarity 295 m0sm/l (approx) Formula per 1000ml Sodium Chloride 5.26 g Potassium Chloride 0.37 g Magnesium Chloride hexahydrate 0.30 g Sodium Acetate trihydrate 3.68 g Sodium Gluconate 5.02 g Water for Injections Sodium Hydroxide mmol per 100 mL (approx) Sodium 140 Chloride 98 Potassium 5 Acetate 27 Magnesium

1.5Gluconate 23 IV administration Read package leaflet before use Keep out of the sight and reach of children Do not remove from overwrap until ready for use Do not use unless solution is clear without visible particles and container undamaged Do not reconnect partially used bags Store below 30 o C POM 07 0 UN-35-03-560 1 Marketing Authorization Holder: Baxter Healthcare Ltd. Caxton Way Thetford Norfolk IP 24 3SE United Kingdom Manufacturer: Bieffe Medital S.A. Ctra de Biescas-Senegüé 22666 Sabiñánigo (Huesca) Spain LOT EXP PlasmaLyte 1000ml Representative Container Label.jpg

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

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 Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride — the ingredient across all brands.

Top reported reactions

Atrial Fibrillation9
Bradycardia8
Caesarean Section1

Reporter sex

17 reports
Female · 100%
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.

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) ✓ 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: this package is listed as actively marketed, with no marketing end date reported by Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Corporation 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.
← 00338-9581-02 · Baxter 00338-9632-24 · Baxter →
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.