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Kit for the Preparation of Technetium Tc99m Pyrophosphate 12 mg/10mL Injection — NDC 45567-0060-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Kit for the Preparation of Technetium Tc99m Pyrophosphate 12 mg/10mL Injection — NDC 45567-0060-1 (Billing 45567-0060-01)

by Sun Pharmaceutical Industries, Inc. · 5 VIAL, MULTI-DOSE in 1 KIT / 10 mL in 1 VIAL, MULTI-DOSE

This is a package of Kit for the Preparation of Technetium Tc99m Pyrophosphate 12 mg/10mL Injection from Sun Pharmaceutical Industries, Inc., marketed since Jun 1987 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 45567-0060-01
🏷️ FDA NDC (as labeled) 45567-0060-1 billing pads the package segment with a zero
This package
Contains10 mL in 1 vial, multi-dose Pack sizes2 compare ↓
Main listing for product 45567-0060 · Also comes in: 30 vials 45567-0060-2
Rx only Brand On market Non-controlled ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Active FDA shortage. Technetium TC-99M Pyrophosphate Kit Injection is currently reported in shortage by the FDA (Other). Unavailable Shortage details →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45567-0060-1
Product NDC 45567-0060
11-digit billing NDC 45567006001
NCPDP billing unit EA — each (per item)
UNII 5L76I61H2B
Application # NDA019039
SPL Set ID 1f0cbd23-2fb3-43b7-b8af-7de246151149
Established class (EPC) Radioactive Diagnostic Agent
Mechanism of action Radiopharmaceutical Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1987-06-30
Route INTRAVENOUS
Dosage form INJECTION
Substance TECHNETIUM TC-99M PYROPHOSPHATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 94359070406400
GPI class Technetium Tc 99m Pyrophos
GCN Seq No 066246
GCN 28479
HICL code 036423
Ingredient (HICL) Kit For Tc-99M/Sod Pyrophospht
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A6
Therapeutic class — intermediate (HIC2) Cardiovascular Diagnostic Agents
HIC3 code A6W
Therapeutic class — specific (HIC3) Cardiovascular Diagnostics - Radioactive
AHFS code 36:18.00.00
AHFS class Cardiac Function
FDB label name TC99M PYROPHOSPHATE PREP KIT
FDB brand name Tc99M Pyrophosphate Prep
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066246
  • GCN: 28479
  • GPI-14 (Medi-Span): 94359070406400
  • HICL (First Databank): 036423
  • AHFS class code: 36:18.00.00
Why two NDCs? The FDA registers this code as 45567-0060-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 45567-0060-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name TC99M PYROPHOSPHATE PREP KIT Ingredient Kit For Tc-99M/Sod Pyrophospht

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 vials
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
45567-0060-01 You're viewing this Main listing 5 VIAL, MULTI-DOSE in 1 KIT / 10 mL in 1 VIAL, MULTI-DOSE 1987-06-30 — Active
45567-0060-02 45567-0060-2 30 VIAL, MULTI-DOSE in 1 KIT / 10 mL in 1 VIAL, MULTI-DOSE 1987-06-30 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 5 vial, multi-dose in 1 kit / 10 ml in 1 vial, multi-dose.
What NDC number is used to bill for this package of Kit for the Preparation of Technetium Tc99m Pyrophosphate 12 mg/10mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Kit for the Preparation of Technetium Tc99m Pyrophosphate 12 mg/10mLthis 45567-0060-01 Sun 5 vials — AP FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1987
On the market since
Jun 1987
📍
2026
Currently FDA-listed
39 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

  • 2.8 mg / 10 mL UNII 1BQV3749L5
    Stannous chloride is a tin-based chemical compound used as a reducing agent and antioxidant in pharmaceuticals. It helps prevent oxidation of active ingredients and stabilizes certain formulations, particularly in products requiring preservation of potency.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES INC
FDA applicationNDA019039 (NDA)
Labeler code45567
First marketedJun 1987
Product typeHuman Prescription Drug
Portfolio890 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 104 words ▾

INDICATIONS AND USAGE Technetium Tc 99m Pyrophosphate Injection is a bone imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction. Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a blood pool imaging agent which may be used for gated blood pool imaging and for the detection of sites of gastrointestinal bleeding. When reconstituted with sterile non-pyrogenic isotonic saline and administered intravenously 30 minutes prior to the intravenous administration of Sodium Pertechnetate Tc 99m Injection, approximately 76% of the injected radioactivity remains in the blood pool.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Pyrophosphate Injection in the average ADULT patient (70 kg) is: Bone Imaging - 185-555 megabecquerels (5-15 mCi) Cardiac Imaging - 370-555 megabecquerels (10-15 mCi) The suggested dose range of the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection in the average ADULT patient (70 kg) is: Blood Imaging - Administer not less than one-third nor more than the total contents of one vial [555 - 740 megabecquerels (15-20mCi) of Pertechnetate Tc 99m Injection].

Bone and Cardiac Imaging Technetium Tc 99m Pyrophosphate Injection is injected intravenously over a 10 to 20 second period. For optimal results, bone imaging should be done 1 to 6 hours following administration. Cardiac imaging should be done 30 to 90 minutes following administration.

The acute myocardial infarct can be visualized from 24 hours to 6 days following onset of symptoms, with maximum localization at 48 to 72 hours. Cardiac imaging should be done with a gamma scintillation camera. It is recommended that images be made of the anterior, left anterior oblique and left lateral projections.

Blood Pool Imaging Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection may be reconstituted with sterile, non-pyrogenic isotonic saline containing no preservatives. Administer not less than one-third nor more than the total contents of one vial 30 minutes prior to the intravenous administration of 555 to 740 megabecquerels (15-20 mCi) Sodium Pertechnetate Tc 99m Injection. The non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection should be injected by direct venipuncture.

Heparinized catheter systems should be avoided. Cardiac imaging should be done 10 to 30 minutes following the administration of Sodium Pertechnetate Tc 99m Injection utilizing a scintillation camera interfaced to an electrocardiographic gating device. 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 Bone and Cardiac Imaging 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 555 megabecquerels (15 mCi) of Technetium Tc 99m Pyrophosphate Injection are shown in Table 4.

TABLE 4: Estimated Absorbed Radiation Doses Bone and Cardiac Imaging* Technetium Tc 99m Pyrophosphate Injection Target Organ mGy/555 MBq rads/15 mCi Total Body 1.8

0.18Kidneys 3.6

0.36Red Marrow 3.5

0.35Bone Surfaces 21.1

2.11Bladder Wall 13.3

1.33Testes 1.4

0.14Ovaries 2.1

0.21Effective Dose Equivalent 3.3 mSv 0.33 rem *Based on the model in MIRD Dose Estimate Report No. 13 (J Nucl Med 30:1117-1122, 1989). Estimate calculated using phantoms of Cristy & Eckerman (Report ORNL/TM-8381/V1 & V7).

Bone and marrow model of Eckerman (Aspects of dosimetry of radionuclides within the skeleton with particular emphasis on the active marrow. In Fourth International Radiopharmaceutical Dosimetry Symposium; A.T. Schlafke-Stelson and E.E.

Watson eds. CONF-851113, Oak Ridge Associated Universities, Oak Ridge, TN 37831, 1986. pp 514-534.) used. The effective dose equivalent is a quantity which may be suitable for comparing risks of different procedures in nuclear medicine, radiology, and other applications involving ionizing radiation, but should not be construed to give information about risks to individual patients and should not be applied to situations involving radiation therapy.

Blood Pool Imaging The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous injection… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings ~1 min read ▾

WARNINGS As an adjunct in the diagnosis of confirmed myocardial infarction (ECG and serum enzymes positive), the incidence of false negative images has been found to be 6 percent. False negative images can also occur if made prior to 24 hours in the evolutionary phase of the infarct or after 6 days in the resolution phase. In a limited study involving 22 patients in whom the ECG was positive and serum enzymes questionable or negative, but in whom the final diagnosis of acute myocardial infarction was made, the incidence of false negative images was 23 percent.

The incidence of false positive images has been found to be 7 to 9 percent. False positive images have also been reported following coronary by-pass graft surgery, in unstable angina pectoris, old myocardial infarcts and in cardiac contusions. Preliminary reports indicate impairment of brain scans using Sodium Pertechnetate Tc99m 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. Alternately, a brain imaging agent such as Technetium Tc 99m Pentetate Injection may be employed.

The biodistribution of technetium Tc 99m pyrophosphate 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 11 words ▾

ADVERSE REACTIONS Some hypersensitivity reactions have been associated with pyrophosphate use.

🧒 Pediatric Use 12 words ▾

Pediatric use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 148 words ▾

Geriatric use Clinical studies of the Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug 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 monitor renal function.

🧬 Clinical Pharmacology 175 words ▾

CLINICAL PHARMACOLOGY When injected intravenously, Technetium Tc 99m Pyrophosphate Injection has a specific affinity for areas of osteogenesis. It is also concentrated in the injured myocardium, primarily in areas of irreversibly damaged myocardial cells. One to two hours after intravenous injection of Technetium Tc 99m Pyrophosphate Injection, an estimated 40 to 50 percent of the injected dose has been taken up by the skeleton, and approximately 0.01 to 0.02 percent per gram of acutely infarcted myocardium.

Within a period of one hour, 10 to 11 percent remains in the vascular system, declining to approximately 2 to 3 percent twenty-four hours post injection. The average urinary excretion was observed to be about 40 percent of the administered dose after 24 hours. The non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection also has an affinity for red blood cells.

When administered 30 minutes prior to the intravenous administration of Sodium Pertechnetate Tc 99m Injection, approximately 76 percent of the injected activity remains in the blood pool providing excellent images of the cardiac chambers.

📦 How Supplied / Storage and Handling ~3 min read ▾

HOW SUPPLIED The Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is supplied in packages of 5 or 30 sterile, non-pyrogenic, white capped 10mL vials. Each multidose vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted with hydrochloric acid to 5.3-5.7 prior to lyophilization. No bacteriostatic preservative is present.

Sealed under nitrogen. Included in each 5-vial package are one package insert and 10 radiation labels. Included in each 30-vial package are one package insert and 60 radiation labels.

Store the kit as packaged at 20-25°C (68-77°F) [See USP]. Store the reconstituted vials at 20-25°C (68-77°) [See USP]. Directions for use Bone and Cardiac Imaging Technetium Tc 99m Pyrophosphate Injection is prepared from Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection by the following aseptic procedure: Waterproof gloves should be worn during the preparation procedure.

Remove the white flip-off cap from the vial and swab the top of the vial closure with alcohol to sterilize the surface. Complete the radiation label and affix to the vial. Place the vial in an appropriate radiation shield suitably labeled and identified.

With a sterile shielded syringe, aseptically obtain 1-10 milliliters of a suitable, oxidant free, sterile and non-pyrogenic Sodium Pertechnetate Tc 99m Injection containing no more than 3.7 gigabecquerels (100 mCi). Aseptically add the Sodium Pertechnetate Tc 99m Injection to the vial. Swirl the contents of the vial for one minute and let stand for at least 10 minutes.

Record date and time of preparation. It is recommended that the radiochemical purity of the prepared radiopharmaceutical be checked prior to patient administration. Examine vial contents for particulates and discoloration prior to injection.

Withdrawals for administration must be made aseptically using a sterile shielded syringe and needle. Since the vials contain nitrogen to prevent oxidation of the complex, the vials should not be vented. If repeated withdrawals are made from a vial, the replacement of contents with air should be minimized.

Aseptically withdraw material with a sterile lead shielded syringe for use within six (6) hours of preparation. For optimal results, this time should be minimized. The vial contains no bacteriostatic preservative.

Store the reconstituted vial at 20-25°C (68-77°F) [See USP]. Discard the vial six (6) hours after reconstitution. The patient dose should be measured by suitable radioactivity calibration system immediately prior to administration.

Blood Pool Imaging The non-radioactive Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is prepared by adhering to the following aseptic procedure: Remove the white flip-off cap from the vial and swab the top of the vial closure with alcohol to sterilize the surface. Reconstitute the reaction vial with 3 milliliters of sterile, non-pyrogenic, isotonic saline containing no preservatives. Swirl the contents of the vial for one minute and let stand for at least 10 minutes.

Record date and time of preparation. Examine vial contents for particulates and discoloration prior to injection. Withdrawals for administration must be made aseptically using a sterile syringe and needle.

Since the vials contain nitrogen to prevent oxidation of the complex, the vials should not be vented. If repeated withdrawals are made from a vial, the replacement of contents with air should be minimized. Aseptically withdraw the reconstituted non-radioactive Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection with a sterile syringe for use within six (6) hours of preparation.

For optimal results, this time should be minimized. The vial contains no bacteriostatic preservative. Store the reconstituted vial at 20-25°C (68-77°F) [See USP].

Discard the vial six (6) hours after reconstitution. Between one-third a… [Excerpted — this section continues on DailyMed.]

📋 Description ~2 min read ▾

DESCRIPTION Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Pyrophosphate Injection for diagnostic use by intravenous injection. Each 10 mL vial contains 12.0 mg of sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted to 5.3-5.7 with hydrochloric acid prior to lyophilization.

No bacteriostatic preservative is present. Sealed under nitrogen. The chemical names are: (1) Diphosphoric acid, Ditin (2 + ) salt; (2) Ditin (2 + ) pyrophosphate (4 - ).

The structural formula is: When a solution of sterile, non-pyrogenic, oxidant-free isotonic Sodium Pertechnetate Tc 99m Injection U.S.P. is added to the vial, Technetium Tc 99m Pyrophosphate Injection is formed for intravenous injection. When a solution of sterile, non-pyrogenic, isotonic saline is added to the vial, it forms a blood pool imaging agent when Sodium Pertechnetate Tc 99m Injection is injected intravenously 30 minutes after the intravenous administration of the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection.

The precise structure of Technetium Tc 99m Pyrophosphate 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 Percent Per Disintegration Mean Energy (keV) Gamma-2 89.07 140.5 ¹Kocher DC: Radioactive decay data tables.

DOE/TIC-11026: 108, 1981 External Radiation The specific gamma ray constant for Tc 99m is

0.78R/hr-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.

For example, 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 6.02 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 * Calibration time

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General The lyophilized contents of the Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection reaction vial are to be administered to the patient only as an intravenous solution (see Procedures for Reconstitution). Any Sodium Pertechnetate Tc 99m solution which contains an oxidizing agent is not suitable for use with Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection. When reconstituted with Sodium Pertechnetate Tc 99m, Technetium Tc 99m Pyrophosphate Injection must be used within 6 hours.

Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection may also be reconstituted with sterile, non-pyrogenic isotonic saline containing no preservatives and injected intravenously prior to the administration of Sodium Pertechnetate Tc 99m Injection. Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection contains no preservatives. 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 Pyrophosphate 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 Sodium Pertechnetate Tc 99m Injection and the withdrawal of doses for patient administration. Shielding should be utilized when preparing Technetium Tc 99m Pyrophosphate Injection.

Technetium Tc 99m Pyrophosphate 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 patients and clinical personnel consistent with proper patient management. The solution should not be used if cloudy, discolored, or found to contain particulate matter. 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.

No special handling is required for the non-radioactive drug product. Bone Imaging Both prior to and following Technetium Tc 99m Pyrophosphate Injection administration, if not contraindicated for the patient’s cardiac condition, patients should be encouraged to drink fluids. Patients should void as often as possible after the Technetium Tc 99m Pyrophosphate Injection to minimize background interference and unnecessary radiation exposure from accumulation in the bladder.

Cardiac Imaging Patient’s cardiac condition should be stable before beginning the cardiac imaging procedure. Interference from chest wall lesions such as breast tumors and healing rib fractures can be minimized by employing the three recommended projections. (See DOSAGE AND ADMINISTRATION ).

False-positive and false-negative myocardial scans may occur; therefore, the diagnosis of acute myocardial infarction depends on the overall assessment of laboratory and clinical findings. Blood Pool Imaging The non-radioactive reconstituted agent should be injected by direct venipuncture. Heparinized catheter systems should be avoided, as interference with red blood cell tagging will result.

Cardiac pool imaging should be initiated 15 to 30 minutes after the administration of Sodium Pertechnetate Tc 99m Injection. The imaging of gastrointestinal bleeding is dependent on such factors as the region of imaging, rate and volume of the bleed, efficacy of the labeling of the red blood cells and timeliness of imaging. Due to these factors, images should be taken sequentially over a period of time until a positive image is obtained or clinical conditions warrant the discontinuance of the procedure.

The period of time for collecting the images may range up to 36 hours. Technetium Tc 99m Pyrophosphate Injection and the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyr… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 23 words ▾

Nursing mothers Technetium Tc 99m Pyrophosphate Injection is excreted in human milk during lactation, therefore, formula feeding should be substituted for breast feeding.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 35 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Pyrophosphate Injection affects fertility in males or females. Mutagenesis studies have not been conducted.

📄 Package Label / Principal Display Panel ~3 min read ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- VIAL CONTAINER STERILE NON-PYROGENIC DIAGNOSTIC MULTIDOSE KIT FOR THE PREPARTION OF TECHNETIUM Tc 99m PYROPHOSPHATE INJECTION Each 10mL reaction vial contains in 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dehydrate; pH is adjusted to 5.3-5.7 with HCI prior to lyophilization. Sealed under nitrogen. Refer to Package Insert for directions for use and the recommended adult doses.

Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000018 Rev

0.2Mar 2020 CONTAINS NO BACTERIOSTATIC PRESERVATIVE. FOR INTRAVENOUS USE ONLY AFTER RECONSTITION WITH LABELING OXIDANT-FREE TECHENTIUM Tc 99m or ISOTONIC SALINE. . Store at 20-25°C (68-77°F) [See USP] after reconstitution and use within 6 hours. Rx Only Vial Label

Package/Label Display Panel-5 VIAL BOX Kit for the Preparation of Technetium Tc99m Pyrophosphate Injection Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 For Customer Service call: 1-800-221-7554 CONTENTS: 1 package insert, 10 radiation labels and 5 reaction vials. Each 10 mL reaction vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dehydrate and 4.9 mg maximum total tin as stannous chloride deihydrate. pH is adjusted to 5.3 – 5.7 with HCI prior to lyophilization.

Sealed under nitrogen. Contains no bacteriostatic preservative. For intravenous use only after reconstitution with oxidant-free Technetium Tc 99m or isotonic saline.

Do not use if solution is cloudy. STORE KIT AS PACKAGED AT 20-25°C (68-77°F) [SEE USP] Store reconstituted vials at 20-25°C (68-77°F) [See USP]. Use within 6 hours after reconstitution.

Refer to Package Insert for recommended adult doses. IMPORTANT: Read enclosed Package Insert for full information on preparation, use and indications. Manufactured By: Sun Pharmaceutical Industries, Inc.

Billerica, MA 01821 For Customer Service call: 1-800-221-7554 PL-000020 Rev

0.3 Mar 2020 5 Vial Carton

Package/Label Display Panel- Radiation Label CAUTION RADIOACTIVE MATERIAL STERILE, NON-PYROGENIC, DIAGNOSTIC, MULTIDOSE TECHNETIUM Tc 99m PYROPHOSPHATE INJECTION FOR INTRAVENOUS USE Total MBq (mCi)_____Volume_____ Assay_____MBq/mL(mCi/mL) as of _____ Each 10mL reaction vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted to 5.3-5.7 with HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative.

For intravenous use only after reconstitution with oxidant-free Technetium Tc 99m. Do not use if solution is cloudy. Store reconstituted vial at 20-25°C (68-77°F) [see USP].

Use within 6 hours after labeling with Technetium Tc 99m. Refer to Package Insert for recommended adult doses. (SEE ENCLOSED PACKAGE INSERT) RX ONLY Manufactured By: Sun Pharmaceutical Industries, Inc.

Billerica, MA 01821 PL-000019 Rev

0.2 Mar 2020 Shield Label

Package/Label Display Panel-30 Vial Box Kit for the preparation of Technetium Tc99m Pyrophosphate Injection STERILE, NON-PYROGENIC, DIAGNOSTIC, MULTIDOSE Rx only. Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 For Customer Service call: 1-800-221-7554 Sterile Diagnostic Multidose Non-Pyrogenic CONTENTS: 1 Package insert, 60 radiation labels and 30 reaction vials.

Each 10 mL vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate. pH is adjusted to 5.3 – 5.7 with HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative.

For intravenous use only after reconstitution with oxidant-free Technetium Tc 99m or isotonic saline. Do not use if solution is cloudy. Store the kit as packaged AT 20-25°C (68-77°F) [See USP] Store reconstituted vials at 20-25°C (68-77°F) [See… [Excerpted — this section continues on DailyMed.]

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Kit for the Preparation of Technetium Tc99m Pyrophosphate (this brand).

Top reported reactions

Abdominal Distension1
Condition Aggravated1
Drug Level Changed1
Dyspnoea1
Flushing1
Headache1
Jaundice1

Reporter sex

4 reports
Male · 75%
Female · 25%

Serious outcomes

Death1
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

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) ✓ 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 vials (45567-0060-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 45567-0040-01 · Sun 45567-0455-01 · Sun →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.