NEUROLITE Bicisate dihydrochloride Kit
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 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 | 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. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Neurolite 11994-0006-02 | Lantheus | 2 kits | — | — | FDA listed | — |
| Neurolitethis 87333-0006-05 | SHINE | 5 kits | — | — | FDA listed | — |
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.
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 87333-0006-02 | 2 KIT in 1 PACKAGE, COMBINATION (87333-006-02) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (87333-002-01) * 1 mL in 1 VIAL (87333-004-01) | 2026-09-10 | Active |
| 87333-0006-05 You're viewing this | 5 KIT in 1 PACKAGE, COMBINATION (87333-006-05) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (87333-002-01) * 1 mL in 1 VIAL (87333-004-01) | 2026-09-10 | Active |
Pack size FAQ
What quantity is in NDC 87333-0006-05?
What NDC number is used to bill for this package of NEUROLITE Bicisate dihydrochloride Kit?
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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 | — 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS NEUROLITE ® single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. NEUROLITE ® is not indicated for assessment of functional viability of brain tissue. Also, NEUROLITE ® is not indicated for distinguishing between stroke and other brain lesions.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Before administration, a patient should be well hydrated. After administration, the patient should be encouraged to drink fluids liberally and to void frequently. The recommended dose range for intravenous administration for a 70 kg patient is 370-1110 MBq (10-30mCi).
Dose adjustments for age, weight, gender or renal or hepatic impairment have not been studied. The dose for the patient should be measured by a suitable radioactivity calibration system immediately before administration to the patient. Radiochemical purity should be checked before administration to the patient.
NEUROLITE ® , like other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Preparations containing particulate matter or discoloration should not be administered. They should be disposed of in a safe manner, in compliance with all applicable regulations.
Prior to reconstitution, vial A and vial B are stored at 15-25°C. Protect vial A from light. Store at controlled room temperature after preparation.
Aseptic techniques and effective shielding should be employed in withdrawing doses for administration to patients. Waterproof gloves and effective shielding should be worn when handling the product.
⛔ Contraindications ▾
CONTRAINDICATIONS None known.
⚠️ Warnings ▾
WARNINGS None known.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In clinical trials, NEUROLITE ® has been administered to 1063 subjects (255 normals, 808 patients). Of these, 566 (53%) were men and 494 (47%) were women. The mean age was 58 years (range 17 to 92 years).
In the 808 patients, who had experienced neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed toNEUROLITE ® . A total of 60 subjects experienced adverse reactions; the adverse reaction rates were comparable in the <65 year, and the >65 year age groups. The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis.
In clinical trials of 197 patients, there were inconsistent changes in the serum calcium and phosphate levels. The cause of the changes has not been identified and their frequency and magnitude have not been clearly characterized. None of the changes required medical intervention.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with Technetium Tc-99m Bicisate. It is also not known whether Technetium Tc-99m Bicisate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, Technetium Tc-99m Bicisate should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in the pediatric population has not been established.
🧓 Geriatric Use ▾
Geriatric Use Of 808 patients in clinical studies of NEUROLITE®, 421 patients were 65 or older and 190 were 75 or older. Based on the evaluation of the frequency of adverse events and review of vital signs and laboratory data, no overall differences in safety were observed between these subjects and younger subjects. Although reported clinical experience has not identified differences in response between elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.
NEUROLITE ® is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to assess renal function prior to administration.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY General NEUROLITE ® , Kit for the Preparation of Technetium Tc-99m Bicisate for Injection forms a stable, lipophilic complex which can cross the blood brain barrier. Technetium Tc-99m Bicisate crosses intact cell membranes and the intact blood brain barrier by passive diffusion. Five percent of the injected dose remains in the blood at one hour.
The amount of Technetium Tc-99m Bicisate in the brain is stable until about 6 hours. After background clearance, images of the brain can be obtained from 10 minutes to 6 hours after injection. Optimal images occur 30-60 minutes after injection.
Technetium Tc-99m Bicisate is cleared primarily by the kidneys. Pharmacokinetics In a study in 16 normals (13 men and 3 women, mean age of 31 ± 10 years; mean weight of 72 ± 11 kg), the pharmacokinetic profile in blood best fits a three compartment model with half-lives of 43 seconds, 49.5 minutes and 533 minutes. The highest concentration of radioactivity measured in blood was found at 0.5 minutes after intravenous injection and was 13.9% of the injected dose.
Technetium Tc-99m Bicisate and its major metabolites are not protein-bound. Metabolism Technetium Tc-99m Bicisate is metabolized by endogenous enzymes to the mono- and di-acids of Technetium Tc-99m Bicisate that can be detected in blood and urine. No studies have been performed to compare the concentration of Technetium Tc-99m Bicisate or its metabolites in normal, ischemic and infarcted cells.
Technetium Tc-99m Bicisate is excreted primarily through the kidneys. Within two hours, 50% of the injected dose is excreted and by 24 hours, 74% is found in urine. It is not known whether the parent drug molecule or its metabolites are dialyzable.
Fecal excretion accounts for 12.5% of the injected dose after 48 hours. Pharmacodynamics Localization of the parent compound in the brain in part depends upon both perfusion of the region and uptake of Technetium Tc-99m Bicisate by the cell. Once in the brain cells, the parent compound is metabolized to polar, less diffusible compounds.
Studies in 21 normal volunteers show cellular uptake of 4.8-6.5% of the injected dose at five minutes after injection. The degree of cell function or viability needed for uptake is not known. The degree of cell function or viability needed for metabolism of the parent compound to the less diffusible compounds has not been determined.
The likelihood that the metabolic pathway is damaged by ischemia is not known. Whether or not and to what extent uptake correlates with viability or function is not known. The pharmacodynamics of NEUROLITE ® have not been evaluated for differences associated with age, gender, weight and liver or renal impairment.
It is not known whether dosage adjustments for these factors are needed. Clinical Trials Two clinical trials were performed in a total of 359 subjects (273 with stroke, 86 normal). Of these 56% were men and 44% were women.
The mean age was 60.2 years (range 23 to 92 years). Subjects were 87.2% Caucasian, 8.4% Black, 2.2% Hispanic, 1.7% Oriental and 0.6% other. Eligible patients had a confirmed stroke.
Patients with other brain lesions were not evaluated. Subjects received NEUROLITE ® (mean dose range 10-30mCi) and underwent SPECT imaging and either CT or MRI scans within 0-30 days of the onset of signs and symptoms of stroke. CT or MRI and the administration of NEUROLITE ® occurred at different and variable times after the onset of a stroke.
The effect of the timing on the accuracy of the images cannot be evaluated. The NEUROLITE ® scan results were blindly compared to unblinded CT/MRI results, the short standardized neurologic examination (SSNE) and the final diagnosis (e.g., the overall combined clinical impression with CT/MRI and SSNE). In these studies, at least one of three blinded readers made a diagnosis of stroke in 190 (85%) of the NEUROLITE ® SPECT studies and in 238 (88%) CT/MRI studies.
The NEUROLITE ® and CT/MRI imaging results versus the SSNE and f…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED NEUROLITE ® Kit for the Preparation of Technetium Tc-99m Bicisate for Injection, is supplied in kits of two (2) vials of A and two (2) vials of B (NDC # 87333-006-02); and five (5) vials of A and five (5) vials of B (NDC # 87333-006-05). Included in each kit are one (1) package insert and twelve (12) radiation labels. Prior to reconstitution, vial A and vial B are stored at 15-25°C.
Protect vial A from light. Store at controlled room temperature after preparation. Use within 6 hours of preparation.
This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552 or under equivalent regulations of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.
📋 Description ▾
DESCRIPTION This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic. Vial A – Bicisate dihydrochloride (ECD•2HCl) 0.9 mg Edetate disodium, dihydrate 0.36 mg Mannitol 24 mg Stannous chloride, dihydrate, theoretical (SnCl 2 •2H 2 O) 72 µg Stannous chloride, dihydrate, minimum (SnCl 2 •2H 2 O) 12 µg Total Tin, (stannous and stannic), dihydrate (as SnCl 2 •2H 2 O) 83 µg The contents of vial A are lyophilized and stored under nitrogen.
The pH of the solution before lyophilization is 2.7 ± 0.25. This vial is stored at 15-25°C. Protect from light.
Vial B – Sodium phosphate dibasic heptahydrate 4.1 mg Sodium phosphate monobasic monohydrate 0.46 mg Water for Injection qs 1 mL The contents of vial B are stored under air. The pH of the solution is 7.6 ± 0.4. This vial is stored at 15-25°C.
This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc-99m Injection. The precise structure of the Technetium complex is [ N , N '-ethylenedi- L -cysteinato(3-)]oxo[ 99m Tc] technetium (V), diethyl ester.