Acetic Acid .25 g/100mL Irrigant — NDC 0264-2304-00 (Billing 00264-2304-00)
This is a package of Acetic Acid .25 g/100mL Irrigant from B. Braun Medical Inc., marketed since Aug 1979 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 0264-2304-00 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0264 labeler · 2304 product · 00 package
- Package marketed since
- Aug 6, 1979
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0264230400 4
- Medicaid fills, this package
- 1,116 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 009834
- GCN: 45390
- GPI-14 (Medi-Span): 56700040002005
- HICL (First Databank): 003597
- AHFS class code: 40:36.00.00
- RxCUI (RxNorm): 307707
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Organic acids class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.0118 | $0.19 / 16 containers |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00264-2304-00 You're viewing this | 16 CONTAINER in 1 CASE / 1000 mL in 1 CONTAINER | 1979-08-06 | — | Active |
| 00264-2304-10 0264-2304-10 Main listing | 16 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER | 1979-08-06 | — | Active |
This pack accounts for about 31% 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?
What NDC number is used to bill for this package of Acetic Acid .25 g/100mL Irrigant?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Acetic Acid .25 g/100mLthis 00264-2304-00 | B. | 1000 ml | — | AT | FDA listed | — |
| Acetic Acid 250 mg/100mL 00338-0656-04 | Baxter | 1000 ml | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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?
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from B. Braun Medical Inc. labeler code 00264
- Balanced Salt Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate 6.4 mg/mL; .75 mg/mL; .48 mg/mL; .3 mg/mL; 3.9 mg/mL; 1.7 mg/mL Solution NDC 0264-1945-10
- Sterile Water 1 mL/mL Irrigant NDC 0264-2101-00
- Sodium Chloride .9 g/100mL Irrigant NDC 0264-2201-00
- Ringers Sodium Chloride, Potassium Chloride, and Calcium Chloride .86 g/100mL; .03 g/100mL; .033 g/100mL Irrigant NDC 0264-2202-00
- Lactated Ringers Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride .6 g/100mL; .31 g/100mL; .03 g/100mL; .02 g/100mL Irrigant NDC 0264-2203-00
- Physiolyte Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride .53 g/100mL; .5 g/100mL; .37 g/100mL; .037 g/100mL; .03 g/100mL Irrigant NDC 0264-2205-00
- Cefazolin Sodium 1 g/50mL Solution NDC 0264-3103-11
- Cefazolin Sodium 2 g/50mL Solution NDC 0264-3105-11
- Cefazolin Sodium 3 g/50mL Solution NDC 0264-3107-11
- Cefuroxime and Dextrose 750 mg/50mL Injection, Solution NDC 0264-3112-11
- Cefuroxime and Dextrose 1.5 g/50mL Injection, Solution NDC 0264-3114-11
- Cefoxitin and Dextrose CEFOXITIN SODIUM 1 g/50mL Injection, Solution NDC 0264-3123-11
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 0.25% Acetic Acid Irrigation USP is indicated as a constant or intermittent bladder rinse to help prevent the growth and proliferation of susceptible urinary pathogens (especially ammonia-forming bacteria) in the management of patients who require prolonged placement of an indwelling urethral catheter. It also may be used for periodic irrigation of an indwelling catheter to help maintain patency by reducing the formation of calcium encrustations.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION As required for urologic irrigation. 0.25% Acetic Acid Irrigation USP may be administered by gravity drip via an administration set connected to an indwelling urethral catheter designed for continuous or intermittent two-way flow. For continuous or intermittent irrigation, the rate of administration will correspond roughly to the rate of urine flow and should be adjusted to maintain a urinary effluent pH of 4.5 to 5.0.
Nitrazine or other pH paper may be used to monitor pH, preferably at least four times daily. Drip rate should be adjusted as necessary to maintain desired pH; increasing flow rate reduces pH value and vice versa. With continuous or intermittent irrigation, each patient will require a volume of approximately 500 to 1500 mL per 24 hours.
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques.
Mix thoroughly. Do not store. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
⛔ Contraindications ▾
CONTRAINDICATIONS 0.25% Acetic Acid Irrigation USP is not for injection. This solution is contraindicated for irrigation during transurethral surgical procedures.
⚠️ Warnings ▾
WARNINGS FOR UROLOGIC IRRIGATION ONLY. NOT FOR INJECTION. Use of this solution in patients with mucosal lesions of the urinary bladder may be harmful due to irritation of the lesion.
Absorption via open lesions of the bladder mucosa may result in systemic acidosis. Do not warm above 150°F (66°C). After opening container, the contents should be used promptly in order to minimize the possibility of bacterial growth or pyrogen formation.
Discard unused portion of irrigating solution since it contains no preservative.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Systemic acidosis, pain, and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% acetic acid solution. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination, if deemed necessary.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with 0.25% Acetic Acid Irrigation USP. It is also not known whether 0.25% Acetic Acid Irrigation USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.25% Acetic Acid Irrigation USP should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of 0.25% Acetic Acid Irrigation USP have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Although systemic absorption of the product is unlikely, greater sensitivity of some older individuals cannot be ruled out.
🆘 Overdosage ▾
OVERDOSAGE Systemic absorption is unlikely unless there are open lesions of the bladder mucosa that have gone undetected. In such event, discontinue the irrigation, evaluate the patient for possible systemic acidosis, intravascular hemolysis, and circulatory overload and institute appropriate countermeasures as indicated. See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS .
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Irrigation of the urinary bladder with acetic acid solution in a concentration of 0.25% has been shown to exert an antimicrobial action against a variety of microorganisms (especially ammonia-forming bacteria) that frequently gain access to the urinary bladder in patients who require prolonged indwelling urethral catheterization. Its antimicrobial action is dependent on administration via the indwelling catheter at a sufficient rate (continuous or intermittent) to maintain an effluent pH of 5.0 or lower.
Maintenance of low pH of bladder urine also helps reduce formation of calcium encrustations in the indwelling catheter.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED 0.25% Acetic Acid Irrigation USP is supplied sterile and nonpyrogenic in 1000 mL and 500 mL PIC™ (Plastic Irrigation Containers) packaged 16 per case. NDC Cat. No.
Size 0.25% Acetic Acid Irrigation USP 0264-2304-00 R6600-01 1000 mL 0264-2304-10 R6601-01 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
📦 Storage and Handling ▾
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
📋 Description ▾
DESCRIPTION Each 100 mL contains: Glacial Acetic Acid USP 0.25 g Water for Injection USP qs pH: 3.1 (2.8-3.4) Calculated Osmolarity: 42 mOsmol/liter The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Glacial Acetic Acid USP CH 3 COOH 60.05 0.25% Acetic Acid Irrigation USP is a prediluted, sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. It contains no preservatives or added buffers. The solution is hypotonic.
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 ▾
PRECAUTIONS General Use aseptic technique when preparing and administering sterile irrigation solutions. Use only if solution is clear and container and seal are intact. If pain or hematuria should occur during irrigation, it should be discontinued and the patient reevaluated.
When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.
Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 0.25% Acetic Acid Irrigation USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with 0.25% Acetic Acid Irrigation USP. It is also not known whether 0.25% Acetic Acid Irrigation USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
0.25% Acetic Acid Irrigation USP should be given to a pregnant woman only if clearly needed. Nursing Mothers Caution should be exercised when 0.25% Acetic Acid Irrigation USP is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Geriatric Use Clinical studies of 0.25% Acetic Acid Irrigation USP have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Although systemic absorption of the product is unlikely, greater sensitivity of some older individuals cannot be ruled out.
🍼 Nursing Mothers ▾
Nursing Mothers Caution should be exercised when 0.25% Acetic Acid Irrigation USP is administered to a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 0.25% Acetic Acid Irrigation USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
📄 Patient Package Insert ▾
Directions for Use of PIC™ (Plastic Irrigation Container) Not for injection. Aseptic technique is required. Caution – Before use, perform the following checks: (a) Read the label.
Ensure solution is the one ordered and is within the expiration date. (b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.
Use only if solution is clear and container and seal are intact. Single-dose container. Discard unused portion.
Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off. (Figure 1) Connect the administration set through the sterile set port according to set instructions (Figure 2) or remove screw cap and pour.
Do not warm above 150°F (66°C) to assure minimal bottle distortion. Keep bottles upright. Figure 1 Figure 2
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label 0.25% Acetic Acid Irrigation USP REF R6600-01 NDC 0264-2304-00 1000 mL PIC™ Container Rx only Each 100 mL contains: Glacial Acetic Acid USP 0.25 g Water for Injection USP qs pH: 3.1 (2.8–3.4) Calc. Osmolarity: 42 mOsmol/liter, hypotonic Not for Injection or Transurethral Surgery: Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic.
Single-dose container. Warning: Do not warm above 150°F (66°C). Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat.
Protect from freezing. Dosage: See Prescribing Information. Rx only Not made with natural rubber latex, PVC or DEHP.
B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Lot Exp.
Y37-002-526 LD-778-1 0.25% Acetic Acid Irrigation USP Principal Display Panel - 1000 mL Bag Label
PRINCIPAL DISPLAY PANEL - 500 mL Bag Label 0.25% Acetic Acid Irrigation USP REF R6601-01 NDC 0264-2304-10 500 mL PIC™ Container Rx only Each 100 mL contains: Glacial Acetic Acid USP 0.25 g Water for Injection USP qs pH: 3.1 (2.8–3.4) Calc. Osmolarity: 42 mOsmol/liter, hypotonic Not for Injection or Transurethral Surgery: Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic.
Single-dose container. Warning: Do not warm above 150°F (66°C). Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat.
Protect from freezing. Dosage: See Prescribing Information. Rx only Not made with natural rubber latex, PVC or DEHP.
B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Lot Exp.
Y37-002-527 LD-779-1 0.25% Acetic Acid Irrigation USP Principal Display Panel - 500 mL Bag Label
Medicaid utilization & spend
Medicaid utilization by pack size
Medicare Part D spend CMS · PART D · 2026 (Q1)
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
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 | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |