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Sodium Chloride 900 mg/100mL Irrigant — NDC 0338-0047-46 (Billing 00338-0047-46)

by Baxter Healthcare Company · 6 BAG in 1 CARTON / 2000 mL in 1 BAG

This is a package of Sodium Chloride 900 mg/100mL Irrigant from Baxter Healthcare Company, marketed since May 1980 and currently FDA-listed.

NDC 00338-0047-46
🏷️ FDA NDC (as labeled) 0338-0047-46 billing pads the labeler segment with a zero
This package
Contains2000 mL in 1 bag Pack sizes5 compare ↓
Also priced by: Part D plans $0.0100/unit — full pricing hub ↓
Product page 00338-0047-47 Also comes in: 1000 ml 0338-0047-44 3000 ml 0338-0047-47 3000 ml 0338-0047-27 5000 ml 0338-0047-29
Rx only Brand On market Non-controlled ⇄ 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

⚠️
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 I · Aug 17, 2026 — Presence of particulate matter: Particulates identified as fiberglass (Baxter Healthcare Corporation) · FDA recall D-0849-2026
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-0427-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0424-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0432-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0426-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-0047-46
Product NDC 0338-0047
11-digit billing NDC 00338004746
NCPDP billing unit ML — per mL (volume)
RxCUI 486515
UNII 451W47IQ8X
Application # NDA017867
SPL Set ID 886f889b-f3cf-4197-b307-6cfa88c89436
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 1980-05-30
Route IRRIGATION
Dosage form IRRIGANT
Substance SODIUM CHLORIDE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 56700060002010
GPI class Sodium Chloride
GCN Seq No 009827
GCN 45360
HICL code 004285
Ingredient (HICL) Sodium Chloride Irrig Solution
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W8
Therapeutic class — intermediate (HIC2) Antiseptics
HIC3 code W8F
Therapeutic class — specific (HIC3) Irrigants
AHFS code 40:36.00.00
AHFS class Irrigating Solutions
FDB label name SODIUM CHLORIDE 0.9% IRRIG.
FDB brand name Sodium Chloride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009827
  • GCN: 45360
  • GPI-14 (Medi-Span): 56700060002010
  • HICL (First Databank): 004285
  • AHFS class code: 40:36.00.00
  • RxCUI (RxNorm): 486515
Why two NDCs? The FDA registers this code as 0338-0047-46 — 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 → 00338-0047-46. 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

Label name SODIUM CHLORIDE 0.9% IRRIG. Ingredient Sodium Chloride Irrig Solution
📗 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 →
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 $0.0100 $0.06 / 6 bags
Medicare Part B allowsASP · A4217 No ASP payment limit on file for A4217 this quarter.
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)0338-0047-46
11-digit billing NDC00338-0047-46
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeA4217
DescriptorSTERILE WATER/SALINE, 500 ML
Billing units / pkg0 units
How the units are derivedThis package is 2000 ML; the HCPCS unit is 500 ML, so one package = 0 billing 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00338-0047-44 0338-0047-44 14 BAG in 1 CARTON / 1000 mL in 1 BAG 1980-05-30 — Active
00338-0047-46 You're viewing this 6 BAG in 1 CARTON / 2000 mL in 1 BAG 1980-05-30 — Active
00338-0047-47 0338-0047-47 Main listing 4 BAG in 1 CARTON / 3000 mL in 1 BAG 1980-05-30 — Active
00338-0047-27 0338-0047-27 4 BAG in 1 CARTON / 3000 mL in 1 BAG 1980-05-30 — Active
00338-0047-29 0338-0047-29 2 BAG in 1 CARTON / 5000 mL in 1 BAG 1980-05-30 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 6 bag in 1 carton / 2000 ml in 1 bag.
What NDC number is used to bill for this package of Sodium Chloride 900 mg/100mL Irrigant?
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
Sodium Chloride .9 g/100mL 00264-2201-00 B. 1000 ml — AT FDA listed —
Sodium Chloride for Irrigation .9 g/100mL 00264-7388-50 B. 2000 ml — AT FDA listed —
Sodium Chloride 900 mg/100mLthis 00338-0047-46 Baxter 2000 ml — AT FDA listed —
Sodium Chloride 900 mg/100mL 00338-0048-02 Baxter 24 bottles — AT FDA listed —
Sodium Chloride 900 mg/100mL 00338-0050-47 Baxter 3000 ml — AT FDA listed —
Sodium Chloride 9 g/1000mL 00338-0051-44 Baxter 1000 ml — — FDA listed —
Sodium Chloride 900 mg/100mL 00338-0110-04 Baxter 3000 ml — — FDA listed —
Sodium Chloride 900 mg/100mL 00338-9834-04 Baxter 3000 ml — — FDA listed —
Sodium Chloride 900 mg/100mL 00990-7972-05 ICU 1000 ml — AT FDA listed —
Sodium chloride .9 g/100mL 17271-0800-07 Becton 1000 ml — AT FDA listed —
Sodium chloride .9 g/100mL 65219-0502-10 Fresenius 1000 ml — AT FDA listed —
Sodium chloride .9 g/100mL 65219-0504-20 Fresenius 2000 ml — AT FDA listed —
Sodium chloride .9 g/100mL 65219-0506-30 Fresenius 3000 ml — AT FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
1980
On the market since
May 1980
📍
2026
Currently FDA-listed
46 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerBaxter Healthcare Company
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA017867 (NDA)
Labeler code00338
First marketedMay 1980
Product typeHuman Prescription Drug
Portfolio121 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.

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 150 words ▾

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING 3000 mL 2B77127 NDC 0338-0047-47 NOT FOR INJECTION 0.9% SODIUM CHLORIDE Irrigation USP Each 100 mL contains 900 mg Sodium Chloride USP No antimicrobial agent has been added pH 5.5 (4.5 to 7.0) mEq/L Sodium 154 Chloride 154 Osmolarity 308 mOsmol/L (calc) Sterile Nonpyrogenic Single dose container Do not use unless solution is clear Discard unused portion Cautions Squeeze and inspect inner bag which maintains product sterility Discard if leaks are found Rx Only Store unit in moisture barrier overwrap at room temperature (25°C) until ready to use Avoid excessive heat See insert 0.9% Sodium Chloride NaCl Irrigation USP UROMATIC container PL 146 plastic BAXTER UROMATIC and PL 146 are trademarks of Baxter International Inc For product information 1-800-933-0303 Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Mexico 2700 2400 2100 1800 1500 1200 900 600 300 Representative Container Label 0338-0047-44

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

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.
3 ml00338-0047-47 1,097 Rx · $136,819
1 ml00338-0047-44 437 Rx · $30,672
3 ml00338-0047-27 222 Rx · $57,306
5 ml00338-0047-29 12 Rx · $339
2 ml this page00338-0047-46 No Medicaid data
Drug total (last 4 qtrs): 1,768 Rx · 1,816,439 units · $225,135 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.

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 — Not published for this NDC No photo available yet for this listing.
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 ✓ Available
HCPCS J-code billing crosswalk ✓ Available
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

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 Company. 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 1000 ml (00338-0047-44), 3000 ml (00338-0047-47), 3000 ml (00338-0047-27). 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?
Baxter Healthcare Company 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 A4217 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.
← 00338-0043-03 · Baxter 00338-0048-02 · 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.