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Sterile Water 1 mL/mL Irrigant — NDC 00264-2101-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sterile Water 1 mL/mL Irrigant — NDC 0264-2101-10 (Billing 00264-2101-10)

by B. Braun Medical Inc. · 16 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER

This is a package of Sterile Water 1 mL/mL Irrigant from B. Braun Medical Inc., marketed since Sep 1970 and currently FDA-listed.

NDC 00264-2101-10
🏷️ FDA NDC (as labeled) 0264-2101-10 billing pads the labeler segment with a zero
This package
Contains500 mL in 1 container Medicaid pays$0.0120 / unit · 12 mo Per package$0.19 / 16 containers · Medicaid Pack sizes4 compare ↓
Product page 00264-2101-00 Also comes in: 1000 ml 0264-2101-00 2000 ml 0264-2101-50 4000 ml 0264-2101-70
Rx only Brand On market Non-controlled ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

⚠️
Active FDA shortage. Sterile Water Irrigant is currently reported in shortage by the FDA. Available Shortage details →
⚠️
Other active recalls for Water (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 2, 2026 — Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. (B BRAUN MEDICAL INC) · FDA recall D-0495-2026
Class II · Dec 22, 2025 — Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution (Baxter Healthcare Corporation) · FDA recall D-0296-2026
Class II · Aug 26, 2025 — Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. (B BRAUN MEDICAL INC) · FDA recall D-0652-2025
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) 0264-2101-10
Product NDC 0264-2101
11-digit billing NDC 00264210110
NCPDP billing unit ML — per mL (volume)
Application # NDA016734
SPL Set ID f4284eb6-e553-46d4-90d8-efc80a90a480
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1970-09-10
Route IRRIGATION
Dosage form IRRIGANT
Substance WATER
TE code (Orange Book) AT · RLD · RS

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

GCN Seq No 009825
GCN 45340
HICL code 004283
Ingredient (HICL) Water For Irrigation,Sterile
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 STERILE WATER FOR IRRIGATION
FDB brand name Water
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009825
  • GCN: 45340
  • HICL (First Databank): 004283
  • AHFS class code: 40:36.00.00
Why two NDCs? The FDA registers this code as 0264-2101-10 — 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 → 00264-2101-10. 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.

Clinical

Label name STERILE WATER FOR IRRIGATION Ingredient Water For Irrigation,Sterile
📗 Our plain-language guide HelloPharmacist
  • It can seem a little odd at first. In these products, sterile water plays the essential role of carrying or dissolving the actual active medication — like insulin — so it can be sa...
  • Why is 'water' listed as the active ingredient on my medicine?
  • No — these are very different products that should never be used interchangeably. Sterile Water for Injection is used only as a diluent for other drugs given by needle, and it must...
  • Is Sterile Water for Injection the same as the eye wash or the irrigation product?
📖 Read our full Water 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.0120 $0.19 / 16 containers
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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)0264-2101-10
11-digit billing NDC00264-2101-10
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 500 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
00264-2101-00 0264-2101-00 Main listing 16 CONTAINER in 1 CASE / 1000 mL in 1 CONTAINER 1970-09-10 — Active
00264-2101-10 You're viewing this 16 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER 1970-09-10 — Active
00264-2101-50 0264-2101-50 8 CONTAINER in 1 CASE / 2000 mL in 1 CONTAINER 1970-09-10 — Discontinued by firm
00264-2101-70 0264-2101-70 4 CONTAINER in 1 CASE / 4000 mL in 1 CONTAINER 1970-09-10 — Discontinued by firm

This pack accounts for about 13% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 16 container in 1 case / 500 ml in 1 container.
What NDC number is used to bill for this package of Sterile Water 1 mL/mL 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
Sterile Water 1 mL/mLthis 00264-2101-10 B. 500 ml — AT FDA listed —
Sterile Water 100 mL/100mL 00264-7386-50 B. 2000 ml — AT FDA listed —
Sterile Water 100 mL/100mL 00338-0003-44 Baxter 1000 ml — AT FDA listed —
Sterile Water 100 mL/100mL 00338-0004-02 Baxter 24 bottles — AT FDA listed —
Sterile Water 1 mL/mL 00990-7973-05 ICU 12 pouches — AT FDA listed —
Sterile Water 1 mL/mL 17271-0802-07 Becton 1000 ml — AT FDA listed —
Sterile Water 1 mL/mL 65219-0495-10 Fresenius 1000 ml — AT FDA listed —
Sterile Water 1 mL/mL 65219-0497-20 Fresenius 2000 ml — AT FDA listed —
Sterile Water 1 mL/mL 65219-0499-30 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

🏛️
1970
On the market since
Sep 1970
📍
2026
Currently FDA-listed
56 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.

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

LabelerB. Braun Medical Inc.
Application holderB BRAUN MEDICAL INC
FDA applicationNDA016734 (NDA)
Labeler code00264
First marketedSep 1970
Product typeHuman Prescription Drug
Portfolio94 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 41 words ▾

INDICATIONS AND USAGE Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION ).

⏱️ Dosage and Administration 80 words ▾

DOSAGE AND ADMINISTRATION Irrigation Use as directed by physician. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Nutrient Mixtures Sterile Water for Irrigation USP may be used to prepare non-intravenously administered nutrient mixtures.

It contains no electrolytes or other added substances. Refer to preparation instructions of particular mixture to be used. The plastic container may be used for administration of non-intravenous nutrient mixture to the patient as appropriate.

⛔ Contraindications 4 words ▾

CONTRAINDICATIONS Not for injection.

⚠️ Warnings 51 words ▾

WARNINGS Sterile Water for Irrigation USP is hypotonic and will cause hemolysis, and is not recommended for use during surgical procedures. After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservative.

🤒 Adverse Reactions 4 words ▾

ADVERSE REACTIONS None known.

🆘 Overdosage 3 words ▾

OVERDOSAGE None known.

🧬 Clinical Pharmacology 75 words ▾

CLINICAL PHARMACOLOGY Sterile Water for Irrigation USP is utilized for a variety of clinical indications. Because of its low refractive index (1.3325), water provides excellent visibility during endoscopic urological procedures. It is also utilized as a pharmaceutic aid, as well as in the preparation of enteral nutrient products.

Water is hypotonic and will cause hemolysis and will be readily absorbed by the tissues during surgical procedures; therefore, its use under such conditions is not recommended.

📦 How Supplied / Storage and Handling 93 words ▾

HOW SUPPLIED Sterile Water for Irrigation USP is supplied sterile and nonpyrogenic in plastic irrigating containers. The 1000 mL and 500 mL containers are packaged 16 per case. NDC Cat.

No. Size Sterile Water for Irrigation USP (Canada DIN 01963961) 0264-2101-00 R5000-01 1000 mL 0264-2101-10 R5001-01 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).

📋 Description 144 words ▾

DESCRIPTION Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) entirely composed of Sterile Water for Injection USP. It is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. The pH is 5.7 (5.0–7.0) The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs.

The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures.

The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

Not made with natural rubber Latex, PVC or DEHP.

⚠️ Precautions 13 words ▾

PRECAUTIONS Use only if solution is clear and container and seal are intact.

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 1000 mL Container Sterile Water for Irrigation USP Warnings: Hypotonic and Hemolytic REF R5000-01 NDC 0264-2101-00 DIN 01963961 HK 23675 1000 mL PIC™ Container Rx only Lot Exp. No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) Not for Injection. See Package Insert.

Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single-dose container.

Discard unused portion. Warning: Do not warm above 150°F (66°C). Recommended Storage: Room temperature (25°C).

Avoid excessive heat. Protect from freezing. Dosage: See Prescribing Information.

Not made with natural rubber latex, PVC or DEHP. Y37-002-594 LD-775-1 B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA 1-800-227-2862 Imported by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Sterile Water for Irrigation USP 1000 mL Container Label R5000-01

PRINCIPAL DISPLAY PANEL - 500 mL Container Sterile Water for Irrigation USP Warnings: Hypotonic and Hemolytic REF R5001-01 NDC 0264-2101-10 DIN 01963961 HK 23675 500 mL PIC™ Container Rx only Lot Exp. No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) Not for Injection. See Package Insert.

Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single-dose container.

Discard unused portion. Warning: Do not warm above 150°F (66°C). Recommended Storage: Room temperature (25°C).

Avoid excessive heat. Protect from freezing. Dosage: See Prescribing Information.

Not made with natural rubber latex, PVC or DEHP. Y37-002-595 LD-776-1 B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA 1-800-227-2862 Imported by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Sterile Water for Irrigation USP 500 mL Container Label R5001-01

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
3.5K
Units reimbursed last 4 qtrs
5.3M
Gross reimbursed last 4 qtrs
$63.3K
Avg / prescription
$17.84
Avg / unit
$0.0120
Latest quarter Q4 2025
593Rx
Fee-for-service vs managed care ⓘ
42% FFS 58% MCO
Fee-for-service · 1,493 Rx Managed care · 2,056 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 243,000 units · 12,373 per 100k residents ID Montana: 5,568 units · 492 per 100k residents MT North Dakota: 725 units · 92.6 per 100k residents ND Minnesota: 111,354 units · 1,941 per 100k residents MN Wisconsin: 244,196 units · 4,132 per 100k residents WI Michigan: 15,224 units · 152 per 100k residents MI New York: 508,514 units · 2,598 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,353,500 units · 31,975 per 100k residents OR Nevada: 1,578 units · 49.4 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 2,054 units · 16.4 per 100k residents IL Indiana: 9,866 units · 144 per 100k residents IN Ohio: 41,928 units · 356 per 100k residents OH Pennsylvania: 49,584 units · 383 per 100k residents PA New Jersey: 38,037 units · 409 per 100k residents NJ Massachusetts: 38,535 units · 550 per 100k residents MA California: 131,276 units · 337 per 100k residents CA Utah: 1,979 units · 57.9 per 100k residents UT Colorado: 23,227 units · 395 per 100k residents CO Nebraska: 5,055 units · 256 per 100k residents NE Missouri: 7,130 units · 115 per 100k residents MO Kentucky: 151 units · 3.3 per 100k residents KY West Virginia: 31,053 units · 1,754 per 100k residents WV Virginia: 1,545 units · 17.7 per 100k residents VA Maryland: 2,550 units · 41.3 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 91,658 units · 846 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 10,040 units · 220 per 100k residents LA Mississippi: 1,674,000 units · 56,939 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 361,595 units · 1,185 per 100k residents TX Florida: 276,680 units · 1,224 per 100k residents FL
Units reimbursed · per 100k residents
3.356,939
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 Mississippi 56,939 /100k
2 Oregon 31,975 /100k
3 Idaho 12,373 /100k
4 Wisconsin 4,132 /100k
5 New York 2,598 /100k
6 Minnesota 1,941 /100k
7 West Virginia 1,754 /100k
8 Florida 1,224 /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.
1 ml00264-2101-00 23,474 Rx · $563,018
5 ml this page00264-2101-10 3,549 Rx · $63,300
2 ml00264-2101-50 No Medicaid data
4 ml00264-2101-70 No Medicaid data
Drug total (last 4 qtrs): 27,023 Rx · 48,339,772 units · $626,318 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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) — 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) ✓ 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 B. Braun Medical Inc.. 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 3 other package presentations of this same product, including 1000 ml (00264-2101-00), 2000 ml (00264-2101-50), 4000 ml (00264-2101-70). 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?
B. Braun Medical Inc. 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.
← 00264-1945-10 · B. 00264-2201-00 · B. →
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.