![DEFENCATH taurolidine and heparin 5000; 67.5 [USP'U]/5mL; mg/5mL Solution — NDC 72990-0105-10 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6&name=defencath-5.jpg)
DEFENCATH taurolidine and heparin 5000; 67.5 [USP'U]/5mL; mg/5mL Solution
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Defencath is a special solution placed inside your dialysis catheter after each hemodialysis session to help prevent serious infections in the bloodstream. When you're on long-term...
- What exactly is Defencath and why has my doctor prescribed it?
- Neither, actually. Defencath is instilled directly into the channels of your dialysis catheter by your healthcare team at the end of each dialysis session. It stays inside the cath...
- How is Defencath given — do I take a pill or get an injection?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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130.5 mg / 5 mL
UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
3 inactive ingredients 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.Inactive ingredient FAQ
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💲 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Defencath 5000; 67.5 [USP'U]/5mL; mg/5mLthis 72990-0105-10 | CorMedix | 10 vials | — | — | Discontinued | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 7696182 ↗ | Drug substance | U-3774 | May 16, 2026 |
| US 7696182 ↗ | Drug substance | U-3774 | May 16, 2026 |
| US 11738120 ↗ | Drug substance | — | Apr 15, 2042 |
| US 11738120 ↗ | Drug substance | — | Apr 15, 2042 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | Nov 15, 2028 |
| NCE | New Chemical Entity (5-year) | Nov 15, 2028 |
| GAIN | Qualified Infectious Disease Product (+5-year) | Nov 15, 2033 |
| GAIN | Qualified Infectious Disease Product (+5-year) | Nov 15, 2033 |
Is there a generic version of DEFENCATH 67.5MG-5,000UNIT/5ML?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
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🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72990-0105-10 You're viewing this | 10 VIAL, SINGLE-DOSE in 1 CARTON (72990-105-10) / 5 mL in 1 VIAL, SINGLE-DOSE (72990-105-05) | 2023-11-15 | Discontinued by firm |
🧭 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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Is the NDC printed on the package the same as the 11-digit billing NDC?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE LIMITED POPULATION: DEFENCATH ® is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients [see Clinical Studies (14) ]. Limitations of Use The safety and effectiveness of DEFENCATH have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC.
LIMITED POPULATION: DEFENCATH is a combination of taurolidine, a thiadiazinane antimicrobial, and heparin, an anti-coagulant, indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients. ( 1 ) Limitations of Use The safety and effectiveness of DEFENCATH have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION DEFENCATH is for instillation into CVCs only [see Indications and Usage (1) ]. DEFENCATH is not intended for systemic administration. Do not use DEFENCATH as a catheter lock flush product.
Withdraw a sufficient volume of DEFENCATH catheter lock solution (CLS) from the vial using a sterile needle and syringe to fill the catheter lumens. Use 3 mL or 5 mL single-dose vial (depending on the volume of the catheter lumens) to instill DEFENCATH into each catheter lumen at the conclusion of each HD session for patients with kidney failure requiring chronic HD. Prior to initiation of the next HD session, DEFENCATH should be aspirated from the catheter and discarded.
If DEFENCATH cannot be aspirated, continue with standard of care CVC preparation and flush with normal saline. If a catheter malfunction is suspected, appropriate standard of care measures should be instituted. Each DEFENCATH single-dose vial is designed for use with a single patient as a single instillation in the CVC.
Discard any unused portion of DEFENCATH remaining in the vial. DEFENCATH is for instillation into CVCs only. ( 2 ) DEFENCATH is not intended for systemic administration.
( 2 ) Do not use DEFENCATH as a catheter lock flush product. ( 2 ) Withdraw a sufficient volume of DEFENCATH catheter lock solution (CLS) from the vial using a sterile needle and syringe to fill the catheter lumens. ( 2 ) Use 3 mL or 5 mL single dose vial (depending on the volume of the catheter lumens) to instill DEFENCATH into each catheter lumen at the conclusion of each HD session.
( 2 ) DEFENCATH should be aspirated from the catheter and discarded prior to the initiation of the next HD session. ( 2 ) Discard any unused portion of DEFENCATH remaining in the vial. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS DEFENCATH CLS is available as a sterile, preservative-free, clear, aqueous-based solution in the following strengths: 3 mL of catheter lock solution in a single-dose vial containing taurolidine 40.5 mg/3 mL (13.5 mg/mL), and heparin 3,000 USP Units/3 mL (1,000 USP Units/mL) 5 mL of catheter lock solution in a single-dose vial containing taurolidine 67.5 mg/5 mL (13.5 mg/mL), and heparin 5,000 USP Units/5 mL (1,000 USP Units/mL) DEFENCATH is a sterile catheter lock solution available in single-dose vials in the following strengths: 3 mL containing taurolidine 40.5 mg/3 mL (13.5 mg/mL), and heparin 3,000 USP Units/3 mL (1,000 USP Units/mL) ( 3 ) 5 mL containing taurolidine 67.5 mg/5 mL (13.5 mg/mL), and heparin 5,000 USP Units/5 mL (1,000 USP Units/mL) ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS DEFENCATH is contraindicated in patients with: Known heparin-induced thrombocytopenia (HIT) [see Warnings and Precautions (5.1) ] . Known hypersensitivity to taurolidine, heparin or the citrate excipient (components of DEFENCATH) or pork products [see Warnings and Precautions (5.2) ]. Known heparin-induced thrombocytopenia.
( 4 ) Known hypersensitivity to taurolidine, heparin or the citrate excipient (components of DEFENCATH), or pork products. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Heparin-Induced Thrombocytopenia (HIT) : HIT was reported in Trial 1 at an incidence rate of 0.3% in patients using heparin, a component of DEFENCATH as a CLS. If HIT occurs, discontinue DEFENCATH and institute appropriate supportive measures. ( 5.1 ) Drug Hypersensitivity Reactions : Drug hypersensitivity reactions were reported in Trial 1 at an incidence rate of 0.5% in patients using heparin, a component of DEFENCATH, as a CLS.
If a hypersensitivity reaction occurs, discontinue DEFENCATH and institute appropriate supportive measures. ( 5.2 )
5.1Heparin-Induced Thrombocytopenia Heparin-induced thrombocytopenia (HIT) was reported at an incidence rate of 0.3% in Trial 1 in patients using heparin, a component of DEFENCATH, as a CLS. If HIT occurs, discontinue DEFENCATH and institute appropriate supportive measures [see Contraindications (4) ] .
5.2Drug Hypersensitivity Drug hypersensitivity reactions were reported at an incidence rate of 0.5% in Trial 1 in patients using heparin, a component of DEFENCATH, as a CLS. If a hypersensitivity reaction occurs, discontinue DEFENCATH and institute appropriate supportive measures [see Contraindications (4) ] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Heparin-Induced Thrombocytopenia [see Warnings and Precautions (5.1) ] Drug Hypersensitivity [see Warnings and Precautions (5.2) ] The most frequently reported adverse reactions occurring in greater than or equal to 2% of patients in Trial 1 using DEFENCATH as a CLS were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CorMedix Inc at 1-844-424-6345 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overview of the Safety Evaluation of DEFENCATH The safety of DEFENCATH was evaluated in a single, active-controlled, double-blind, randomized Phase 3 trial, LOCK-IT-100 (referred to as Trial 1), in adult patients with kidney failure receiving chronic HD through a CVC.
In Trial 1, the safety population was comprised of 797 patients with 398 patients using DEFENCATH as a CLS and 399 using heparin as a CLS. Patients used DEFENCATH as a CLS for a mean duration of 173 days, and a range of 4 to 863 days. The mean age of the patients in Trial 1 was 61 years, 58% of patients identified as male (42% patients identified as female), 63% of patients identified as white and 30% identified as black or African-American.
Patients with diabetes at baseline accounted for 70% of patients and the mean body mass index (BMI) of patients in the study was 30. The majority of patients (68%) had been receiving HD for 12 months or less. The location of the CVC was the jugular vein in 92% of patients.
Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In Trial 1, serious adverse reactions occurred in 40% (159/398) of patients receiving DEFENCATH as a CLS and 42% (167/399) of patients receiving heparin as a CLS. Adverse reactions leading to death occurred in 5% (18/398) of patients in the DEFENCATH arm and 5% (21/399) of patients in the heparin arm. Adverse reactions leading to discontinuation of study drug occurred in 17% (69/398) of patients in the DEFENCATH arm and 18% (72/399) of patients in the heparin arm.
Common Adverse Reactions In Trial 1, adverse reactions were reported in 79% (314/398) of patients using DEFENCATH as a CLS and 79% (315/399) of patients using heparin. Table 1 lists selected adverse reactions occurring in ≥2% of patients using DEFENCATH or heparin in Trial 1. Table 1: Selected Adverse Reactions Occurring in Greater Than or Equal to 2% of Patients Receiving DEFENCATH in Trial 1 Adverse Reactions DEFENCATH (N=398) N (%) Heparin (N=399) N (%) Product Issues Hemodialysis catheter malfunction Grouped term includes device malfunction 68 (17) 47 (12) Blood and lymphatic system disorders Hemorrhage/bleeding Grouped term includes: hematoma/hemorrhage, intracranial hemorrhage, arteriovenous graft or fistula site hemorrhage, catheter site hematoma/hemorrhage, cerebral/cerebellar hemorrhage, eye/conjunctival hemorrhage, gastrointestinal hemorrhage, hematuria, hemobilia, hemoptysis, renal hematoma, vaginal/uterine hemorrhage 27 (7) 34 (9) Thrombocytopenia 7 (2) 4 (1) Gastrointestinal disorders Nausea Grouped term includes nausea and procedural nausea 28 (7) 44 (11) Vomiting Grouped term includes vomiting and procedural vomiting 24 (6) 32 (8) Nervous system disorders Dizziness 22 (6) 16 (4) Musculoskeletal and Connective Tissue Disorders Musculoskeletal chest pain Grouped term Includes non-cardiac chest pain, musculoskeletal chest pain, chest discomfort 11 (3) 7 (2) Table 2 lists the proportion of patients in Trial 1 that developed loss of catheter patency defined as requiring use of…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary DEFENCATH is not intended for systemic administration. It is intended for use as a CLS in patients with kidney failure requiring chronic HD; therefore, maternal use is not expected to result in fetal exposure to the drug [see Dosage and Administration (2) ] . No animal reproduction study was conducted with DEFENCATH.
8.2Lactation Risk Summary DEFENCATH is not intended for systemic administration. It is intended for use as a CLS in patients with kidney failure requiring chronic HD; therefore, breastfeeding is not expected to result in exposure of the infant to DEFENCATH [see Dosage and Administration (2) ] .
8.4Pediatric Use The safety and effectiveness of DEFENCATH have not been established in pediatric patients. There are no available data on DEFENCATH use in pediatric patients.
8.5Geriatric Use There were 327 patients 65 years of age and older in Trial 1 [see Clinical Studies (14) ] . Of the total number of patients using DEFENCATH in this study, 162 (41%) were 65 years of age and older, while 64 (16%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary DEFENCATH is not intended for systemic administration. It is intended for use as a CLS in patients with kidney failure requiring chronic HD; therefore, maternal use is not expected to result in fetal exposure to the drug [see Dosage and Administration (2) ] . No animal reproduction study was conducted with DEFENCATH.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of DEFENCATH have not been established in pediatric patients. There are no available data on DEFENCATH use in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use There were 327 patients 65 years of age and older in Trial 1 [see Clinical Studies (14) ] . Of the total number of patients using DEFENCATH in this study, 162 (41%) were 65 years of age and older, while 64 (16%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Heparin Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and larger amounts inhibit thrombin (Factor IIa). Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor.
Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots. Taurolidine Taurolidine is an antimicrobial drug [see Microbiology (12.4) ] .
12.2Pharmacodynamics The pharmacodynamics of DEFENCATH are unknown.
12.3Pharmacokinetics No pharmacokinetic studies were conducted because DEFENCATH is intended to be instilled into the catheter lumens at the conclusion of each HD session for patients with kidney failure requiring chronic HD. DEFENCATH is not intended for systemic administration [see Dosage and Administration (2) ] .
12.4Microbiology Mechanism of Action The mechanism of action of taurolidine and its metabolites is non-specific, causing damage to microbial cell walls and inhibiting adherence of microorganisms to biological surfaces. Resistance Time kill studies showed that taurolidine is bactericidal (>3 log 10 CFU reduction) at 1x to 4x minimum inhibitory concentration (MIC). The frequency of resistant mutants was <10 -9 at 2x and 4x MIC for two strains each of Escherichia coli, Staphylococcus aureus, Enterococcus faecalis, Enterococcus faecium and Pseudomonas aeruginosa .
1 Antimicrobial Activity The following in vitro data are available but their clinical significance is unknown. Taurolidine has been shown to be active against most isolates of the following microorganisms: Gram-positive Staphylococcus aureus (including methicillin-sensitive Staphylococcus aureus (MSSA) and methicillin-resistant Staphylococcus aureus (MRSA)) Staphylococcus epidermidis Enterococcus faecalis Gram-negative Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Serratia marcescens Fungi Candida albicans Candida glabrata
🧬 Mechanism of Action ▾
12.1Mechanism of Action Heparin Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and larger amounts inhibit thrombin (Factor IIa). Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor.
Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots. Taurolidine Taurolidine is an antimicrobial drug [see Microbiology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING DEFENCATH cathether lock solution is available in: 3 mL of catheter lock solution in a single-dose vial containing taurolidine 40.5 mg/3 mL (13.5 mg/mL), and heparin 3,000 USP Units/3 mL (1,000 USP Units/mL) (NDC 72990-103-03) 5 mL of catheter lock solution in a single-dose vial containing taurolidine 67.5 mg/5 mL (13.5 mg/mL), and heparin 5,000 USP Units/5 mL (1,000 USP Units/mL) (NDC 72990-105-05) Each vial contains a sterile, preservative-free, clear aqueous-based solution for instillation in central venous catheters.
Each carton contains 10 single-dose vials. DEFENCATH vials must be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.
DEFENCATH vials must be stored in the commercial carton, prior to the instillation in central venous catheters. Manufactured for: CorMedix Inc. 389 Interpace Pkwy, Suite 450 Parsippany, NJ 07054 USA
📋 Description ▾
11 DESCRIPTION DEFENCATH (taurolidine and heparin) CLS contains taurolidine, a thiadiazinane antimicrobial, and heparin sodium, an anti-coagulant. Taurolidine Taurolidine is an antimicrobial agent derived from the naturally occurring amino acid taurine. The chemical name is 4,4'-methylenebis(1,2,4-thiadiazinane)-1,1,1',1'-tetraoxide.
The molecular weight is 284.36, and the molecular formula is C 7 H 16 N 4 O 4 S 2 . The structural formula of taurolidine is: Heparin Sodium Heparin is an anticoagulant consisting of heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans. It is composed of polymers of alternating derivatives of α-D-glucosamido ( N -sulfated, O -sulfated, or N -acetylated) and O -sulfated uronic acid (α-L-iduronic acid or β-D-glucuronic acid).
Heparin is derived from porcine intestinal mucosa. The structure of heparin sodium (representative subunits) is: DEFENCATH is for central venous catheter instillation use. DEFENCATH CLS is available as a sterile, non-pyrogenic, preservative-free, clear, aqueous-based solution of taurolidine and heparin with a pH of 5.5-6.5 in the following strengths: 3 mL of catheter lock solution in a single-dose vial containing taurolidine 40.5 mg/3 mL (13.5 mg/mL), and heparin 3,000 USP Units/3 mL (1,000 USP Units/mL) 5 mL of catheter lock solution in a single-dose vial containing taurolidine 67.5 mg/5 mL (13.5 mg/mL), and heparin 5,000 USP Units/5 mL (1,000 USP Units/mL) The heparin potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram.
The inactive ingredients are 26.1 mg/mL of citric acid, anhydrous (which is added to control pH and maintain the solubility of taurolidine),and may include hydrochloric acid and/or sodium hydroxide for pH adjustment. Figure1 Figure2