Kit for the Preparation of Technetium Tc 99m Mebrofenin 45 mg/10mL Injection, Powder, Lyophilized, For Solution — NDC 45567-0455-2 (Billing 45567-0455-02)
This is a package of Kit for the Preparation of Technetium Tc 99m Mebrofenin 45 mg/10mL Injection, Powder, Lyophilized, For Solution from Sun Pharmaceutical Industries, Inc., marketed since Jan 2008 and currently FDA-listed.
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): 066237
- GCN: 28468
- GPI-14 (Medi-Span): 94354680456420
- HICL (First Databank): 024573
- AHFS class code: 36:34.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · 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 1, 2026
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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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 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 |
|---|---|---|---|---|
| 45567-0455-01 45567-0455-1 Main listing | 5 VIAL, MULTI-DOSE in 1 KIT / 10 mL in 1 VIAL, MULTI-DOSE | 2008-01-29 | — | Active |
| 45567-0455-02 You're viewing this | 30 VIAL, MULTI-DOSE in 1 KIT / 10 mL in 1 VIAL, MULTI-DOSE | 2008-01-29 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Kit for the Preparation of Technetium Tc 99m Mebrofenin 45 mg/10mL Injection, Powder, Lyophilized, For Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Kit for the Preparation of Technetium Tc 99m Mebrofenin 45 mg/10mLthis 45567-0455-02 | Sun | 30 vials | — | AP | 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
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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.
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5.2 mg / 10 mL
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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0.58 mg / 10 mL
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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0.54 mg / 10 mL
UNII 3FTR44B32Q
Stannous fluoride is a tin-based chemical compound used in oral medications and toothpastes. In medicines, it acts as an active therapeutic agent for tooth sensitivity and cavity prevention, and may serve as a buffer or stabilizer in the formulation.
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
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 Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is: Nonjaundiced patient: 74 - 185 MBq (2-5 mCi) Patient with serum bilirubin level greater than 1.5 mg/dL: 111-370 MBq (3-10 mCi) The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. The patient should be in a fasting state, 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food.
An interval of at least 24 hours should be allowed before repeat examination. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. RADIATION DOSIMETRY The estimated absorbed radiation doses 1,2 to organs and tissues of an average subject (70 kg) from an intravenous injection of 370 MBq (10 millicuries) of Technetium Tc 99m Mebrofenin are shown in Table 4.
TABLE 4 Estimated Absorbed Radiation Doses† Normal Subjects* Severely Jaundiced Patients** Tissue mGy/ 370 MBq rads/ 10 mCi mGy/ 370 MBq rads/ 10 mCi Total Body 2.0 0.2 1.7
0.17Liver 4.7 0.47 8.1
0.81Gallbladder Wall 13.7 1.37 12.5
1.25Small Intestine 29.9 2.99 16.0
1.60Upper Large Intestine Wall 47.4 4.74 24.8
2.48Lower Large Intestine Wall 36.4 3.64 19.7
1.97Kidney 2.2 0.22 1.9
0.19Urinary Bladder Wall 2.9 0.29 24.2
2.42Ovaries 10.1 1.01 6.4
0.64Testes 0.5 0.05 1.1
0.11Red Marrow 3.4 0.34 2.5 0.25 †Method of Calculation: (1) Loberg, M.D., Buddemeyer, E.V.: Application of pharmacokinetic modeling to the radiation dosimetry of hepatobiliary agents. In Third International Radiopharmaceutical Dosimetry Symposium, FDA No. 81-8166, U.S.
Department of Health and Human Services, Public Health Service, FDA, Bureau of Radiological Health, Rockville, MD, (1981) pp. 318-332. (2) Values for S: "S", Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No.
11 (1975). * Bilirubin <1.5 mg/dL Calculations assume that 98% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity. ** Bilirubin >10 mg/dL (mean 21.8 mg/dL) Calculations assume that 66% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity.
⛔ Contraindications ▾
CONTRAINDICATIONS Hypersensitivity to this compound.
⚠️ Warnings ▾
WARNINGS The theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Urticaria and rash have been rarely reported with the use of Technetium Tc 99m Mebrofenin since market introduction. Rare cases of chills and nausea have been reported with related compounds. Infrequently, death has been reported in association with the use of this class of agents.
🤰 Pregnancy ▾
Pregnancy Animal reproduction studies have not been conducted with Technetium Tc 99m Mebrofenin. It is also not known whether Technetium Tc 99m Mebrofenin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m Mebrofenin should be given to a pregnant woman only if the expected benefits to be gained clearly outweigh the potential hazards.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in children below the age of 18 have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mebrofenin is an iminodiacetic acid (HIDA) derivative with no known pharmacologic action at the recommended doses. Following intravenous administration in normal subjects, Technetium Tc 99m Mebrofenin was rapidly cleared from the circulation. The mean percent injected dose remaining in the blood at 10 minutes was 17%.
The injected activity was cleared through the hepatobiliary system with visualization of the liver by 5 minutes and maximum liver uptake occurring at 11 minutes post-injection. Hepatic duct and gallbladder visualization occurred by 10 to 15 minutes and intestinal activity was visualized by 30 to 60 minutes in subjects with normal hepatobiliary function. The mean percent injected dose excreted in the urine during the first 3 hours was 1% (0.4 to 2.0%).
Elevated serum bilirubin levels increase renal excretion of Tc 99m HIDA agents. In two studies in which Tc 99m Mebrofenin was administered to patients having mean elevated serum bilirubin levels of 9.8 mg/dL (1.7 to 46.3 mg/dL), the mean percent injected dose excreted in the urine during the first 3 hours was 3% (0.2 to 11.5%). The mean percent injected dose excreted in the urine during 3-24 hours was 14.9% (0.4 to 34.8%).
In jaundiced patients, the percent injected dose remaining in the blood at 10 minutes may be twice as high or more than the level in normals. Hepatobiliary transit may be delayed and visualization times increased. As a consequence, the quality of the images obtained frequently diminishes.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Kit for the Preparation of Technetium Tc 99m Mebrofenin is supplied in kits of 5 or 30 reaction vials. Each vial contains a sterile, nonpyrogenic lyophilized mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate SnF 2 •2H 2 O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF 2 •2H 2 O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH has been adjusted with hydrochloric acid or sodium hydroxide prior to lyophilization.
The lyophilized vial contents are sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. Sun Pharmaceutical Industries, Inc.
29 Dunham Rd. 781-275-7120 Kit Contents 5 or 30 sterile multidose reaction vials. 12 or 72 radiation labels for Technetium Tc 99m Mebrofenin (for 5 or 30 vial kits, respectively).
1 package insert. Preparation Preparation of Technetium Tc 99m Mebrofenin is done by the following aseptic procedure: 1. Waterproof gloves should be worn during the preparation procedure.
2. Place reaction vial in an appropriate lead shield. 3.
Swab the rubber closure of the reaction vial with a germicide. 4. Inject 1 to 5 mL sterile additive free sodium pertechnetate Tc 99m injection containing up to 3700 MBq (100 mCi) Tc 99m into the reaction vial.
Be sure to maintain a nitrogen atmosphere in the vial by not introducing air during reconstitution. NOTE: If sodium pertechnetate Tc 99m injection must be diluted for use with Kit for the Preparation of Technetium Tc 99m Mebrofenin, only preservative free Sodium Chloride Injection USP should be used. 5.
Secure the lead shield cover. Swirl the vial gently to mix contents and let stand for 15 minutes. 6.
Record the date and time of preparation on radiation label. 7. Affix radiation label to shield.
8. Examine vial contents. If the solution is not clear and free of particulate matter and discoloration on visual inspection, it should not be used.
9. Measure the radioactivity by a suitable calibration system and record on the shield label prior to patient administration. 10.
Withdraw material with a sterile lead shielded syringe for use within 18 hours of preparation. Storage Store the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.
Rx only NDC-45567-0455-1 (5 Vial Kit) NDC-45567-0455-2 (30 Vial Kit) This reagent kit for the preparation of a radiopharmaceutical is approved for use by persons licensed pursuant to section 120.547, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State. Manufactured By: Sun Pharmaceutical Industries, Inc.
Billerica, MA 01821 1-800-221-7554 (For International call 781-275-7120) Mar 2020
📋 Description ▾
DESCRIPTION Each multidose reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF 2 •2H 2 O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF 2 •2H 2 O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture.
The pH of the reconstituted product is 4.2 to 5.7. The structure of mebrofenin (2,2'-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below: Molecular Weight = 387.23 When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection. PHYSICAL CHARACTERISTICS Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.
1 The principal photon that is useful for detection and imaging studies is listed in Table 1. TABLE 1 Principal Radiation Emission Data Radiation Mean % per Disintegration Mean Energy (keV) Gamma-2 89.07 140.5 1 Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-11026, (1981) p. 108.
External Radiation The specific gamma ray constant for Tc 99m is
0.78R/hour-millicurie at 1 cm. The first half value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2.
To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. TABLE 2 Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.5 0.08 10 -1 0.16 10 -2 0.25 10 -3 0.33 10 -4 To correct for physical decay of technetium Tc 99m, the fractions that remain at selected intervals after the time of calibration are shown in Table 3. TABLE 3 Physical Decay Chart: Tc 99m half-life 6.02 hours Hours Fraction Remaining Hours Fraction Remaining 0* 1.000 7 0.447 1 0.891 8 0.398 2 0.794 9 0.355 3 0.708 10 0.316 4 0.631 11 0.282 5 0.562 12 0.251 6 0.501 18 0.126 *Calibration time spl-mebrofenin-structure
⚠️ Precautions ▾
PRECAUTIONS General Contents of the reaction vial are intended only for use in the preparation of Technetium Tc 99m Mebrofenin and are not to be administered directly to the patient. Delayed or non-visualization of the gallbladder may occur in the immediate post-prandial period or after prolonged fasting or parenteral feeding. Functional biliary obstruction may accompany chronic cholecystitis or pancreatitis.
In addition, patients with hepatocellular disease may show nonvisualization or delayed visualization of the gallbladder. Delayed intestinal transit may also be noted in such patients. Juvenile hepatitis may be associated with gallbladder nonvisualization and the failure to visualize activity in the intestine.
Administration of meperidine or morphine may delay intestinal transit of the imaging agent and may result in nonvisualization. Septic patients may show absent or delayed hepatobiliary clearance. Thus, a positive finding does not of itself permit a differential diagnosis of any of the above conditions and should be evaluated in the light of the total clinical picture and results of other diagnostic modalities.
The components of the kit are supplied sterile and non-pyrogenic. Aseptic procedures normally employed in making additions and withdrawals from sterile, non-pyrogenic containers should be used during the addition of the pertechnetate solution and the withdrawal of doses for patient administration. The Technetium Tc 99m labeling reactions involved in preparing the agent depend on maintaining the stannous ion in the reduced state.
Any oxidant present in the sodium pertechnetate Tc 99m supply may, thus, adversely affect the quality of the radiopharmaceutical. Hence, sodium pertechnetate Tc 99m containing oxidants should not be employed. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.
As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers. Tc 99m Mebrofenin should be formulated no more than 18 hours prior to clinical use. Carcinogenesis, Mutagenesis, Impairment of Fertility No long term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Mebrofenin may affect fertility in males or females.
Pregnancy Animal reproduction studies have not been conducted with Technetium Tc 99m Mebrofenin. It is also not known whether Technetium Tc 99m Mebrofenin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m Mebrofenin should be given to a pregnant woman only if the expected benefits to be gained clearly outweigh the potential hazards.
Nursing Mothers Technetium Tc 99m is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings. Pediatric Use Safety and effectiveness in children below the age of 18 have not been established.
🍼 Nursing Mothers ▾
Nursing Mothers Technetium Tc 99m is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility No long term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Mebrofenin may affect fertility in males or females.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CONTAINER (10 mL) NDC 045567-0455-1 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial For Intravenous Use after Reconstitution Rx Only Dosage: See Package Insert Store at 20-25°C (68-77°F) [See USP] before and after reconstitution. Use within 18 hours after reconstitution. Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000013 Rev
0.2 Mar 2020 Vial Label
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CARTON NDC 045567-0455-1 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial For Intravenous Use after Reconstitution Rx Only Nonradioactive Diagnostic Multidose Vial contents are sealed under Nitrogen at time of manufacture. The pH of the reconstituted product is 4.2 -
5.7Dosage: See Package Insert Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 For Customer Service call: 1-800-221-7554 Kit for the Preparation of Technetium Tc99m Mebrofenin for: Hepatobiliary Imaging Rx Only Each sterile, lyophilized vial contains: 45mg Mebrofenin; 0.54mg minimum stannous fluoride dihydrate; 1.03mg total tin maximum (as stannous fluoride dihydrate); and not more than 5.2mg methylparaben and 0.58mg propylparaben as preservatives. pH of reconstituted product is 4.2 -
5.7Store at 20-25°C (68-77°F) [See USP] before and after reconstitution Use within 18 hours after reconstitution Contents: 1 package insert, 12 radiation labels and 5 reaction vials Preparation: See Package Insert for complete information, use and directions Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000015 Rev
0.3 Mar 2020 5 Vial Carton Label
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CONTAINER (10 mL) NDC 045567-0455-2 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial For Intravenous User after Reconstitution Rx Only Dosage: See Package Insert Store at 20-25°C (68-77°F) [See USP] before and after reconstitution. Use within 18 hours after reconstitution. Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000013 Rev
0.2 Mar 2020 30-Vial Label
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CARTON NDC 045567-0455-2 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial for Hepatobiliary Imaging For Intravenous Use after Reconstitution Rx Only Nonradioactive Diagnostic Multidose Vial contents are sealed under Nitrogen at time of manufacture. The pH of the reconstituted product is 4.2 -
5.7Dosage: See Package Insert Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica MA, 01821 For Customer Service call: 1-800-221-7554 Contents: 1 Package Insert, 72 radiation labels and 30 reaction vials Each sterile, lyophilized vial contains: 45mg Mebrofenin; 0.54mg minimum stannous fluoride dihydrate; 1.03mg total tin maximum (as stannous fluoride dihydrate); and not more than 5.2mg methylparaben and 0.58mg propylparaben as preservatives. pH of reconstituted product is 4.2 -
5.7Store at 20-25°C (68-77°F) [See USP] before and after reconstitution Use within 18 hours after reconstitution Preparation: See Package Insert for complete information, use and directions Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica MA, 01821 PL-000016 Rev
0.3 Mar 2020 30 Vial Carton Label
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – SHIELD LABEL CAUTION: RADIOACTIVE MATERIAL See Package Insert for full prescribing information Rx Only Technetium Tc99m Mebrofenin Injection Contents Mebrofenin 45 mg Stannous fluoride dihydrate 0.54 mg minimum and 1.03 mg total tin maximum Methylparaben 5.2 mg, maximum Propylparaben 0.58, maximum _________________________________________________ MBq (mCi) Tc99m/mL _________________________________________________ Volume mL _________________________________________________ Date / Time Prepared Expiration Time _________________________________________________ Lot No.
PL-000014 Rev
0.2Mar 2… [Excerpted — this section continues on DailyMed.]
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