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SODIUM CHLORIDE 900 mg/100mL Irrigant — NDC 00338-0048-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SODIUM CHLORIDE 900 mg/100mL Irrigant — NDC 0338-0048-04 (Billing 00338-0048-04)

by Baxter Healthcare Corporation · 12 BOTTLE, PLASTIC in 1 CARTON / 1000 mL in 1 BOTTLE, PLASTIC

This is a package of SODIUM CHLORIDE 900 mg/100mL Irrigant from Baxter Healthcare Corporation, marketed since Dec 1974 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 00338-0048-04
🏷️ FDA NDC (as labeled) 0338-0048-04 billing pads the labeler segment with a zero
This package
Contains1000 mL in 1 bottle, plastic Medicaid pays$0.0320 / unit · 12 mo Per package$0.38 / 12 bottles · Medicaid Pack sizes3 compare ↓
Also priced by: Part D plans $0.0100/unit — full pricing hub ↓
Main listing for product 0338-0048 · Also comes in: 18 bottles 0338-0048-03 24 bottles 0338-0048-02
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) 0338-0048-04
Product NDC 0338-0048
11-digit billing NDC 00338004804
NCPDP billing unit ML — per mL (volume)
RxCUI 486515
UNII 451W47IQ8X
Application # NDA017427
SPL Set ID b3b4b176-41f0-4ca8-90d4-3fba5707564a
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 1974-12-31
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 0338-0048-04 — 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 → 00338-0048-04. 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 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 $0.0320 $0.38 / 12 bottles
Medicare drug plans payPart D · Q2 2026 $0.0100 $0.12 / 12 bottles
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)0338-0048-04
11-digit billing NDC00338-0048-04
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 1000 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
00338-0048-02 0338-0048-02 24 BOTTLE, PLASTIC in 1 CARTON / 250 mL in 1 BOTTLE, PLASTIC 1974-12-31 — Active
00338-0048-03 0338-0048-03 18 BOTTLE, PLASTIC in 1 CARTON / 500 mL in 1 BOTTLE, PLASTIC 1974-12-31 — Active
00338-0048-04 You're viewing this Main listing 12 BOTTLE, PLASTIC in 1 CARTON / 1000 mL in 1 BOTTLE, PLASTIC 1974-12-31 — Active

In Medicaid, this is the most-dispensed pack of this product — about 75% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 12 bottle, plastic in 1 carton / 1000 ml in 1 bottle, plastic.
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/100mL 00338-0047-44 Baxter 1000 ml — AT FDA listed —
Sodium Chloride 900 mg/100mLthis 00338-0048-04 Baxter 12 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

🏛️
1974
On the market since
Dec 1974
📍
2026
Currently FDA-listed
52 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.

💡 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

LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA017427 (NDA)
Labeler code00338
First marketedDec 1974
Product typeHuman Prescription Drug
Portfolio283 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.
🎯 Indications and Usage ⏱️ Dosage and Administration 📦 How Supplied / Storage and Handling 📋 Description 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

INDICATIONS AND USAGE Isotonic solution for irrigation only. Not for injection.

⏱️ Dosage and Administration 45 words ▾

DOSAGE AND ADMINISTRATION As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

📦 How Supplied / Storage and Handling 10 words ▾

HOW SUPPLIED Recommended storage: Room temperature (25°C). Avoid excessive heat.

📋 Description 34 words ▾

DESCRIPTION 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). Osmolarity 308 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

📄 Package Label / Principal Display Panel 142 words ▾

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING Container Label Container Label 2F7124 NDC 0338-0048-04 1000 mL Baxter Logo 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). Osmolarity 308 mOsmol/L (calc.).

Sterile, nonpyrogenic. Pour Bottle. Isotonic solution for irrigation only.

Dosage and Administration: As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming.

Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

Recommended storage: Room temperature (25°C). Avoid excessive heat. PL 325 plastic Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA LOT EXP 07-09-00-0243 Bar Code Position Only* 303380048045 FPO (91)0709000243 0.9% Sodium Chloride Irrigation, USP Representative Container Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
19.5K
Units reimbursed last 4 qtrs
53.4M
Gross reimbursed last 4 qtrs
$1.71M
Avg / prescription
$87.85
Avg / unit
$0.0320
Latest quarter Q4 2025
4.3KRx
Fee-for-service vs managed care ⓘ
32% FFS 68% MCO
Fee-for-service · 6,304 Rx Managed care · 13,165 Rx
State Medicaid map
Alaska: 467,008 units · 63,712 per 100k residents AK Maine: 429,000 units · 30,753 per 100k residents ME Washington: 718,670 units · 9,200 per 100k residents WA Idaho: no data reported ID Montana: 107,517 units · 9,498 per 100k residents MT North Dakota: no data reported ND Minnesota: 2,298,488 units · 40,064 per 100k residents MN Wisconsin: 2,042,959 units · 34,568 per 100k residents WI Michigan: 734,449 units · 7,317 per 100k residents MI New York: 4,076,576 units · 20,830 per 100k residents NY Vermont: no data reported VT New Hampshire: 127,013 units · 9,059 per 100k residents NH Oregon: 170,000 units · 4,016 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 1,458,252 units · 158,678 per 100k residents SD Iowa: 2,876,006 units · 89,679 per 100k residents IA Illinois: 939,881 units · 7,490 per 100k residents IL Indiana: 2,939,441 units · 42,837 per 100k residents IN Ohio: 5,697,616 units · 48,346 per 100k residents OH Pennsylvania: 1,006,610 units · 7,766 per 100k residents PA New Jersey: 247,962 units · 2,669 per 100k residents NJ Massachusetts: 1,335,000 units · 19,069 per 100k residents MA California: 3,830,787 units · 9,831 per 100k residents CA Utah: 138,988 units · 4,068 per 100k residents UT Colorado: 1,887,361 units · 32,109 per 100k residents CO Nebraska: no data reported NE Missouri: 2,742,260 units · 44,259 per 100k residents MO Kentucky: 1,775,265 units · 39,224 per 100k residents KY West Virginia: 179,000 units · 10,113 per 100k residents WV Virginia: 576,790 units · 6,618 per 100k residents VA Maryland: 163,820 units · 2,651 per 100k residents MD Connecticut: 430,826 units · 11,911 per 100k residents CT Rhode Island: no data reported RI Arizona: 283,850 units · 3,820 per 100k residents AZ New Mexico: 1,205,632 units · 57,031 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 841,219 units · 11,805 per 100k residents TN North Carolina: 3,120,202 units · 28,797 per 100k residents NC South Carolina: 127,000 units · 2,364 per 100k residents SC Delaware: 2,749 units · 267 per 100k residents DE Oklahoma: 1,812,920 units · 44,730 per 100k residents OK Louisiana: 102,000 units · 2,230 per 100k residents LA Mississippi: no data reported MS Alabama: 4,650 units · 91.0 per 100k residents AL Georgia: 146,047 units · 1,324 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 5,055,259 units · 16,573 per 100k residents TX Florida: 1,133,500 units · 5,013 per 100k residents FL
Units reimbursed · per 100k residents
91.0158,678
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 South Dakota 158,678 /100k
2 Iowa 89,679 /100k
3 Alaska 63,712 /100k
4 New Mexico 57,031 /100k
5 Ohio 48,346 /100k
6 Oklahoma 44,730 /100k
7 Missouri 44,259 /100k
8 Indiana 42,837 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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.
12 bottles this page00338-0048-04 19,469 Rx · $1,710,446
18 bottles00338-0048-03 4,588 Rx · $162,366
24 bottles00338-0048-02 1,863 Rx · $85,658
Drug total (last 4 qtrs): 25,920 Rx · 74,915,518 units · $1,958,469 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 ✓ 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 ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 Corporation. 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 2 other package presentations of this same product, including 18 bottles (00338-0048-03), 24 bottles (00338-0048-02). 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 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.
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.
← 00338-0047-44 · Baxter 00338-0049-01 · 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.