Kit for the Preparation of Technetium Tc 99M Medronate 20 mg/10mL Injection, Powder, Lyophilized, For Solution — NDC 45567-0040-2 (Billing 45567-0040-02)
This is a package of Kit for the Preparation of Technetium Tc 99M Medronate 20 mg/10mL Injection, Powder, Lyophilized, For Solution from Sun Pharmaceutical Industries, Inc., marketed since Aug 1979 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): 066236
- GCN: 28467
- GPI-14 (Medi-Span): 94358580506400
- HICL (First Databank): 024559
- AHFS class code: 36:68.00.00
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
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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 |
|---|---|---|---|---|
| 45567-0040-01 45567-0040-1 Main listing | 5 VIAL, MULTI-DOSE in 1 KIT / 10 mL in 1 VIAL, MULTI-DOSE | 1979-08-29 | — | Active |
| 45567-0040-02 You're viewing this | 30 VIAL, MULTI-DOSE in 1 KIT / 10 mL in 1 VIAL, MULTI-DOSE | 1979-08-29 | — | 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 Medronate 20 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 Medronate 20 mg/10mLthis 45567-0040-02 | Sun | 30 vials | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 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 Sep 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.
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-
1 mg / 10 mL
UNII PQ6CK8PD0R
Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
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0.38 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.
2 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 Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.
⏱️ Dosage and Administration ▾
DOSAGES AND ADMINISTRATION: Shielding should be utilized when preparing Technetium Tc 99m Medronate Injection. After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Medronate Injection in the average ADULT patient (70 kg.) is: 370-740 megabecquerels: (10-20 millicuries) given intravenously. Imaging is optimal at 1 to 4 hours post Injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Radiation Dosimetry The effective half-life was assumed to be the physical half-life for all calculated values.
The estimated radiation absorbed doses to an average ADULT patient (70 kg) from an intravenous injection of a maximum of 740 megabecquerels (20 millicuries) of Technetium Tc 99m Medronate Injection are shown in Table 4. TABLE 4 Estimated Absorbed Radiation Dose 2 Technetium Tc 99m Medronate Organ (MGy/740 MBq) (Rads / 20 mCi) Total Body 1.3
0.13Bone Total 7.0
0.70Red Marrow 5.6
0.56Kidneys 8.0
0.80Liver 0.6
0.06Bladder Wall 2 hour void 26 2.60 4.8 hour void 62
6.20Ovaries 2 hour void 2.4 0.24 4.8 hour void 3.4
0.34Testes 2 hour void 1.6 0.16 4.8 hour void 2.2 0.22 2 Method of calculation: "S" Absorbed Dose Per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No 11 (1975)
⛔ Contraindications ▾
CONTRAINDICATIONS: None known.
⚠️ Warnings ▾
WARNINGS: This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or may be predisposed to hypocalcemia (i.e., alkalosis). Preliminary reports indicate impairment of brain scans using Sodium Pertechnetate Tc 99m Injection which have been preceded by a bone scan using an agent containing stannous ions.
The impairment may result in false-positive or false-negative brain scans. It is recommended, where feasible, that brain scans precede bone imaging procedures. Alternatively, a brain imaging agent such as Technetium Tc 99m Pentetate Injection may be employed.
The biodistribution of technetium Tc 99m medronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. High levels of these cations may be caused by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.).
Most cases were observed after iron infusion. (See PRECAUTIONS, Drug Interactions .)
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Several adverse reactions due to Technetium Tc 99m Medronate Injection have been reported. These were usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea, and vomiting. There have also been rare cases of dizziness and asthenia associated with the use of Technetium Tc 99m Medronate.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric subjects have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: During the initial 24 hours following intravenous injection of Technetium Tc 99m Medronate, about 50% of each dose is retained in the skeleton, and about 50% is excreted in the urine. Upon intravenous injection, Technetium Tc 99m Medronate exhibits a specific affinity for areas of altered osteogenesis. In humans, blood levels fall to 4 to 10% of the injected dose by two hours post-injection and to 3 to 5% by three hours.
Uptake of Technetium Tc 99m Medronate Injection in bone appears to be related to osteogenic activity and to skeletal blood perfusion. The deposition in the skeleton is bilaterally symmetrical, with increased accumulation in the axial structure as compared to the appendicular skeleton. There is increased activity in the distal aspect on long bones as compared to the diaphyses.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Kit for the Preparation of Technetium Tc 99m Medronate Injection is supplied in kits of five (5) or thirty (30) sterile, non-pyrogenic vials. Each 10 mL multidose vial contains 20 mg medronic acid, 1 mg ascorbic acid, 0.13 mg minimum stannous fluoride (SnF 2 ) and 0.38 mg maximum total tin, as stannous fluoride, SnF 2 in lyophilized form. The pH is adjusted with sodium hydroxide and/or hydrochloric acid prior to lyophilization.
The vial does not contain a preservative. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 5.4 to 6.8.
Kit Contents Included in each five (5) vial kit is one (1) package insert and ten (10) radiation labels. Included in each thirty (30) vial kit is one (1) package insert and sixty (60) radiation labels. Storage Store the product as supplied at 20-25°C (68-77°F) [See USP].
After reconstitution store at 20-25°C (68-77°F) [See USP] (see DOSAGE AND ADMINISTRATION).
📦 Storage and Handling ▾
Storage Store the product as supplied at 20-25°C (68-77°F) [See USP]. After reconstitution store at 20-25°C (68-77°F) [See USP] (see DOSAGE AND ADMINISTRATION).
📋 Description ▾
Description Kit for the Preparation of Technetium Tc 99m Medronate is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by Intravenous injection. Each 10mL multidose vial contains: Medronic acid: 20 mg Ascorbic acid: 1 mg Stannous fluoride, SnF 2 : 0.13 mg (minimum) Total tin (maximum, as stannous fluoride, SnF 2 ): 0.38 mg The pH is adjusted to 6.5 (6.3 to 6.7) with sodium hydroxide and/or hydrochloric acid prior to lyophilization.
No bacteriostatic preservative is present in the vial. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The structural formula is: When a solution of sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc 99m Injection is added to the vial, the diagnostic agent, Technetium Tc 99m Medronate is formed for administration by intravenous injection.
The pH of the reconstituted product is 5.4 to 6.8. The precise structure of Technetium Tc 99m Medronate Injection is not known at this time. Structural Formula 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, DC: Radioactive Decay Data Tables, DOE/TIC-11026, 108, 1981 . EXTERNAL RADIATION: The specific gamma ray constant for Tc 99m is
0.78R/millicurie-hr 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 the 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 this radionuclide, 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
6.02Hours 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 * Calibration Time
⚠️ Precautions ▾
PRECAUTIONS: General Contents of the vial are intended only for use in the preparation of Technetium Tc 99m Medronate Injection and are NOT to be administered directly to the patient. Technetium Tc 99m Medronate Injection as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patient and clinical personnel consistent with proper patient management. To minimize radiation dose to the bladder, the patients should be encouraged to drink fluids and to void immediately before the examination and as often thereafter as possible for the next 4 to 6 hours.
Technetium Tc 99m Medronate Injection should be formulated within six (6) hours prior to clinical use. Optimal imaging results are obtained 1 to 4 hours after administration. The finding of an abnormal concentration of radioactivity implies the existence of underlying pathology, but further study is required to distinguish benign from malignant lesions.
The image quality may be adversely affected by obesity, old age, or impaired renal function. The components of the kit are sterile and non-pyrogenic. It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation.
Technetium Tc 99m labeling reactions involved depend on maintaining the stannous ion in the reduced state. Hence, Sodium Pertechnetate Tc 99m Injection containing oxidants should not be used. The preparation contains no bacteriostatic preservative.
Technetium Tc 99m Medronate Injection should be stored at 20-25ºC (68-77ºF) and discarded 6 hours after reconstitution. The solution should not be used if the contents are cloudy. Vials are sealed under nitrogen: air or oxygen is harmful to the contents of the vials and the vials should not be vented.
The components of the Kit for the Preparation of Technetium Tc 99m Medronate for Injection are supplied sterile and non-pyrogenic. Aseptic procedures normally employed in making additions and withdrawals for sterile, non-pyrogenic containers should be used during addition of the pertechnetate solution and the withdrawal of doses for patient administration. Shielding should be utilized when preparing Technetium Tc 99m Medronate Injection.
No special handling is required for the non-radioactive drug product. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Drug Interactions The biodistribution of technetium Tc 99m medronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum).
This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. In patients with high levels of these cations caused by concomitant medications, particularly patients receiving iron infusions, consider performing an imaging study with technetium Tc 99m medronate injection once the cation levels have normalized (e.g., after 3 to 5 half-lives of the cation). (See WARNINGS .) Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Medronate Injection affects fertility in males or females.
Mutagenesis studies have not been conducted. Pregnancy Animal reproduction and teratogenicity studies have not been conducted on Technetium Tc 99m Medronate Injection. It is also not known whether Technetium Tc 99m Medronate Injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Technetium Tc 99m Medronate Injection should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, on a woman of childbearin… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing mothers Technetium Tc 99m Medronate Injection is excreted in human milk during lactation; therefore, formula feeding should be substituted for breast feeding.
📄 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 Medronate Injection affects fertility in males or females. Mutagenesis studies have not been conducted.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CONTAINER NDC 045567-0040-1 Sun Pharmaceutical Industries, Inc. Kit for the Preparation of Technetium Tc99m Medronate for Injection Rx Only STERILE DIAGNOSTIC MULTIDOSE NON-PYROGENIC Each 10mL multidose reaction vial contains: 20 mg medronic acid; 1 mg ascorbic acid; 0.13mg (minimum) stannous fluoride; 0.38 mg total tin (maximum, as stannous fluoride) in lyophilized form. The pH is adjusted to 6.5 (6.3 - 6.7) with NaOH and/or HCI prior to lyophilization.
Sealed under nitrogen. The recommended adult dose is 370 - 740 megabecquerels (10-20 millicuries). Refer to the package insert for directions for use.
CONTAINS NO BACTERIOSTATIC PRESERVATIVE. FOR INTRAVENOUS USE ONLY AFTER LABELING WITH OXIDANT-FREE TECHNETIUM Tc99m. After labeling with Technetium Tc99m, store at 20-25°C (68-77°F), see USP.
Use within 6 hours after reconstitution. 10 mL Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000008 Rev
0.2 Mar 2020 5 Vial Container Label
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CARTON NDC 045567-0040-1 Sun Pharmaceutical Industries, Inc. Kit for the Preparation of Technetium Tc99m Medronate for Injection Rx Only STERILE DIAGNOSTIC MULTIDOSE NON-PYROGENIC CONTENTS: 1 Package insert, 10 radiation labels and 5 reaction vials. Each 10 mL multidose reaction vial contains: 20 mg medronic acid; 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride; 0.38 mg total tin (maximum, as stannous fluoride) in lyophilized form.
The pH is adjusted to 6.5 (6.3-6.7) with NaOH and/or HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative.
For intravenous use only after labeling with oxidant-free Technetium Tc 99m. Do not use if solution is cloudy. Store as packaged at 20-25°C (68-77°F), see USP IMPORTANT: Read the enclosed package insert for full information on preparation, use and directions.
Store reconstituted vials at 20-25°C (68-77°F), see USP. Use within 6 hours after reconstitution. The recommended adult dose is 370-740 megabecquerels (10-20 millicuries).
Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000010 Rev
0.3 Mar 2020 5 Vial Carton Label
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CONTAINER NDC 045567-0040-2 Sun Pharmaceutical Industries, Inc. Kit for the Preparation of Technetium Tc99m Medronate for Injection Rx Only STERILE DIAGNOSTIC MULTIDOSE NON-PYROGENIC Each 10mL multidose reaction vial contains: 20 mg medronic acid; 1 mg ascorbic acid; 0.13mg (minimum) stannous fluoride; 0.38 mg total tin (maximum, as stannous fluoride) in lyophilized form. The pH is adjusted to 6.5 (6.3 - 6.7) with NaOH and/or HCI prior to lyophilization.
Sealed under nitrogen. The recommended adult dose is 370 - 740 megabecquerels (10-20 millicuries). Refer to the package insert for directions for use.
CONTAINS NO BACTERIOSTATIC PRESERVATIVE. FOR INTRAVENOUS USE ONLY AFTER LABELING WITH OXIDANT-FREE TECHNETIUM Tc99m. After labeling with Technetium Tc99m, store at 20-25°C (68-77°F), see USP.
Use within 6 hours after reconstitution. 10 mL Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000008 Rev
0.2 Mar 2020 30 Vial Container Lable
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CARTON NDC 045567-0040-2 Sun Pharmaceutical Industries, Inc. Kit for the Preparation of Technetium Tc99m Medronate for Injection Rx Only STERILE DIAGNOSTIC MULTIDOSE NON-PYROGENIC CONTENTS: 1 Package insert, 60 radiation labels and 30 reaction vials. Each 10 mL multidose reaction vial contains: 20 mg medronic acid; 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride; 0.38 mg total tin (maximum, as stannous fluoride) in lyophilized form.
The pH is adjusted to 6.5 (6.3-6.7) with NaOH and/or HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative.
For intravenous use only after labeling with oxidant-free Technetium Tc 99m. Do not use if solution is cloudy. Store as p… [Excerpted — this section continues on DailyMed.]
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