Isosulfan Blue 10 mg/mL Injection, Solution
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 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.
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UNII 4J9FJ0HL51
Potassium phosphate, monobasic is a salt compound used in medicines as a pH buffer and electrolyte source. It helps stabilize the acidity level of liquid and powdered formulations.
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UNII 22ADO53M6F
A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
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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.
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 | $98.30 | $2,949.01 / 30 ml |
| 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 |
|---|---|---|---|---|---|---|
| Isosulfan Blue 10 mg/mL 71288-0805-06 | Meitheal | 6 vials | — | AP | FDA listed | — |
| Isosulfan Blue 10 mg/mLthis 67457-0220-05 | Mylan | 6 vials | — | — | FDA listed | — |
| Isosulfan Blue 10 mg/mL 70069-0221-06 | Somerset | 6 vials | — | AP | FDA listed | — |
| Isosulfan Blue 10 mg/mL 72078-0070-03 | Mylan | 1 syringe | — | — | FDA listed | — |
| Isosulfan blue 10 mg/mL 72205-0195-01 | Novadoz | 1 vial | — | AP | FDA listed | — |
| Isosulfan Blue 10 mg/mL 72078-0069-01 | Mylan | 1 syringe | — | — | FDA listed | — |
| Isosulfan Blue 10 mg/mL 73043-0093-06 | Devatis, | 6 vials | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
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Top reported reactions
Age at onset
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 67457-0220-05 You're viewing this | 6 VIAL, GLASS in 1 CARTON (67457-220-05) / 5 mL in 1 VIAL, GLASS (67457-220-00) | 2013-03-14 | Active |
🧭 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 | — Not published for this NDC No photo available yet for this listing. |
| 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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| 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 |
Questions about this listing
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Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Isosulfan blue injection 1% upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities ( 1.1 ).
1.1Lymphatic Vessel Delineation Isosulfan blue injection 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Isosulfan blue injection 1% is to be administered subcutaneously, one-half (1/2) mL into three (3) interdigital spaces of each extremity per study. A maximum dose of 3 mL (30 mg) isosulfan blue is, therefore, injected ( 2.1 ).
2.1Subcutaneous administration Isosulfan blue injection 1% is to be administered subcutaneously, one-half (1/2) mL into three (3) interdigital spaces of each extremity per study. A maximum dose of 3 mL (30 mg) isosulfan blue is, therefore, injected. Discard unused portion.
2.2Instructions for Preparation and Administration of the 1 mL or 3 mL Pre-filled Syringe To be prepared and administered by a healthcare provider only. For subcutaneous injection only. Do not inject by any other route.
As a precaution, always wear gloves. Inspect isosulfan blue injection for particulate matter and discoloration prior to administration. Figure A shows an annotated drawing of the 3 mL syringe.
Appearance may differ for the 1 mL syringe. Figure A 1) Grip the syringe at the luer lock collar and remove the tip cap from the prefilled syringe by twisting the cap anticlockwise and pulling upwards ( See Figure B ) Figure B 2) Hold the luer lock collar and attach the needle to the syringe with a firm clockwise twisting motion ( See Figure C ). Figure C 3) Remove the needle sheath with a straight pull.
Do not twist the sheath as the needle may become loosened from the syringe ( See Figure D ) Figure D 4) Hold the syringe with the attached needle in an upright position. Prime the syringe by tapping the syringe barrel and moving the plunger stopper carefully forward to the first graduation mark (this may expel air and excess solution) ( See Figure E ) Figure E 5) Administer one-half (1/2) mL subcutaneously, into three (3) interdigital spaces of each extremity per study. 6) Dispose of the used supplies in an approved sharps container in accordance with local hospital procedures.
Figure A Figure B Figure C Figure D Figure E
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 1% clear dark blue, sterile, non-pyrogenic aqueous solution (isosulfan blue) for subcutaneous administration available as: • 5 mL single-dose vial • 1 mL single-dose pre-filled syringe • 3 mL single-dose pre-filled syringe 1% clear dark blue, sterile, non-pyrogenic aqueous solution (isosulfan blue) for subcutaneous administration available as: ( 3 ) • 5 mL single-dose vial • 1 mL single-dose pre-filled syringe • 3 mL single-dose pre-filled syringe
⛔ Contraindications ▾
4 CONTRAINDICATIONS Isosulfan blue injection 1% is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds. Hypersensitivity to triphenylmethane or related compounds ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Life threatening anaphylactic reactions have occurred after isosulfan blue injection 1% administration. Monitor patients closely for at least 60 minutes after administration of isosulfan blue injection 1% ( 5.1 ). • The admixture of isosulfan blue injection 1% with local anesthetics results in an immediate precipitation of 4% to 9% drug complex. Use a separate syringe for anesthetics ( 5.2 ). • Isosulfan blue injection 1% interferes with measurements in peripheral blood pulse oximetry.
Arterial blood gas analysis may be needed ( 5.3 ).
5.1Hypersensitivity Reactions Life threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after isosulfan blue injection 1% administration. Reactions are more likely to occur in patients with a history of bronchial asthma, allergies, drug reactions or previous reactions to tri-phenylmethane dyes. Monitor patients closely for at least 60 minutes after administration of isosulfan blue injection 1%.
Trained personnel should be available to administer emergency care including resuscitation.
5.2Precipitation of Isosulfan Blue Injection 1% by Lidocaine The admixture of isosulfan blue injection 1% (with local anesthetics (i.e. lidocaine)) in the same syringe results in an immediate precipitation of 4% to 9% drug complex. Use a separate syringe to administer a local anesthetic.
5.3Interference with Oxygen Saturation and Methemoglobin Measurements Isosulfan blue injection 1% interferes with measurements of oxygen saturation in peripheral blood by pulse oximetry and can cause falsely low readings. The interference effect is maximal at 30 minutes and minimal generally by 4 hours after administration. Arterial blood gas analysis may be needed to verify decreased arterial partial pressure of oxygen.
Isosulfan blue injection 1% may also cause falsely elevated readings of methemoglobin by arterial blood gas analyzer. Therefore, cooximetry may be needed to verify methemoglobin level.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Hypersensitivity Reactions: Hypersensitivity reactions occur in approximately 2% of patients and include life threatening anaphylactic reactions with respiratory distress, shock, angioedema, urticaria, pruritus. A death has been reported following IV administration of a similar compound ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Postmarketing Experience Hypersensitivity Reactions: Case series report an overall incidence of hypersensitivity reactions in approximately 2% of patients. Life threatening anaphylactic reactions have occurred. Manifestations include respiratory distress, shock, angioedema, urticaria, pruritus.
A death has been reported following administration of a similar compound employed to estimate the depth of a severe burn. Reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, drug reactions or previous reactions to triphenylmethane dyes [see Warnings and Precautions (5) ] . Laboratory Tests: Isosulfan blue injection 1% interferes with measurements of oxygen saturation by pulse oximetry and of methemoglobin by gas analyzer [see Warnings and Precautions (5) ] .
Skin: transient or long-term (tattooing) blue coloration.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug interactions have been identified with isosulfan blue injection 1%. No drug interactions have been identified for isosulfan blue injection 1% ( 7 ).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Caution should be exercised when isosulfan blue injection 1% is administered to nursing mothers ( 8.3 ). • Safety and effectiveness of isosulfan blue injection 1% in children has not been established ( 8.4 ).
8.3Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isosulfan blue injection 1% is administered to a nursing mother.
8.4Pediatric Use Safety and effectiveness of isosulfan blue injection 1% in children have not been established.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of isosulfan blue injection 1% in children have not been established.
🆘 Overdosage ▾
10 OVERDOSAGE Do not exceed indicated recommended dosage as overdosage levels have not been identified for isosulfan blue injection 1%.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.2Pharmacodynamics Following subcutaneous administration, isosulfan blue injection 1% binds to serum proteins and is picked up by the lymphatic vessels. Thus, the lymphatic vessels are delineated by the blue dye.
12.3Pharmacokinetics Up to 10% of the subcutaneously administered dose of isosulfan blue injection 1% is excreted unchanged in the urine in 24 hours in humans.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Isosulfan Blue Injection 1% is supplied as a 5 mL single-dose vial, 1 mL and 3 mL pre-filled syringe containing 1% clear dark blue, aqueous solution in a phosphate buffer prepared by appropriate manufacturing to be sterile and pyrogen-free. NDC 67457-220-05 50 mg/5 mL (10 mg/mL) carton containing 6 x 5 mL single-dose vials NDC 72078-069-01 10 mg/mL carton containing 1 x 1 mL pre-filled syringe NDC 72078-070-03 30 mg/3 mL (10 mg/mL) carton containing 1 x 3 mL pre-filled syringe Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat.
Discard unused portion.
📋 Description ▾
11 DESCRIPTION The chemical name of isosulfan blue injection 1% is N-[4- [[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is: ISOSULFAN BLUE Isosulfan blue injection 1% is a clear dark blue, sterile, non-pyrogenic aqueous solution for subcutaneous administration. Phosphate buffer in sterile, pyrogen free water is added in sufficient quantity to yield a final pH of 6.8 to 7.4.
Each mL of solution contains 10 mg isosulfan blue, 6.6 mg sodium monohydrogen phosphate and 2.7 mg potassium dihydrogen phosphate. Each mL of isosulfan blue injection contains 2 mg of sodium and less than 5 mg of phosphorus. The solution contains no preservative.
Isosulfan blue injection 1% is a contrast agent for the delineation of lymphatic vessels. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Inform patients that urine color may be blue for 24 hours following administration of isosulfan blue injection 1%. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland Revised: 12/2025 MI:ISOSIJ:R7