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Kit for the Prepartion of Technetium Tc99m Sulfur Colloid Technetium Tc 99m Kit — NDC 45567-0030-1 (Billing 45567-0030-01)

by Sun Pharmaceutical Industries, Inc. · 1 KIT in 1 PACKAGE * 3 mL in 1 VIAL * 3 mL in 1 VIAL * 10 mL in 1 VIAL

This is a package of Kit for the Prepartion of Technetium Tc99m Sulfur Colloid Technetium Tc 99m Kit from Sun Pharmaceutical Industries, Inc., marketed since Apr 1978 and currently FDA-listed. It is this product's only package size.

NDC 45567-0030-01
🏷️ FDA NDC (as labeled) 45567-0030-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ 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
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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45567-0030-1
Product NDC 45567-0030
11-digit billing NDC 45567003001
NCPDP billing unit EA — each (per item)
Application # NDA017858
SPL Set ID eeaf70fd-46bd-4fec-ba9d-2366fdf07888
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1978-04-19
Dosage form KIT
TE code (Orange Book) AP · RLD · RS

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

GPI-14 94359070506410
GPI class Technet Tc 99m Sulfur Colloid
GCN Seq No 060642
GCN 26844
HICL code 033570
Ingredient (HICL) Kit For Tc 99M/Sod Thiosulfate
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z9
Therapeutic class — intermediate (HIC2) Unclassified Drugs
HIC3 code Z9D
Therapeutic class — specific (HIC3) Diagnostic Preparations,Miscellaneous
AHFS code 36:68.00.00
AHFS class Roentgenography And Other Imaging Agents
FDB label name TC 99M SULFUR COLLOID PREP KIT
FDB brand name Tc 99M Sulfur Colloid Prep
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 060642
  • GCN: 26844
  • GPI-14 (Medi-Span): 94359070506410
  • HICL (First Databank): 033570
  • AHFS class code: 36:68.00.00
Why two NDCs? The FDA registers this code as 45567-0030-1 — 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 → 45567-0030-01. 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 TC 99M SULFUR COLLOID PREP KIT Ingredient Kit For Tc 99M/Sod Thiosulfate

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.
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
45567-0030-01 You're viewing this Main listing 1 KIT in 1 PACKAGE * 3 mL in 1 VIAL * 3 mL in 1 VIAL * 10 mL in 1 VIAL 1978-04-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Kit for the Prepartion of Technetium Tc99m Sulfur Colloidthis 45567-0030-01 Sun 1 kit — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
1978
On the market since
Apr 1978
📍
2026
Currently FDA-listed
48 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 applicationNDA017858 (NDA)
Labeler code45567
First marketedApr 1978
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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 166 words ▾

1 INDICATIONS AND USAGE Technetium Tc 99m Sulfur Colloid Injection is indicated: In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency. In adults and pediatric patients, for imaging: areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.

Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated (1) : In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency in adults. In adults and pediatric patients, for: imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Technetium Tc 99m Sulfur Colloid Injection emits radiation. Use procedures to minimize radiation exposure. Measure patient dose by a suitable radioactivity calibration system immediately before administration.

Minimize Tc99m Sulfur Colloid radiation exposure and measure patient doses immediately before administration. Breast cancer or malignant melanoma setting: by subcutaneous injection, 3.7 to 37 MBq (0.1 to 1 mCi in volumes ranging from 0.1 to 1 mL) ( 2.1 ). Peritoneo-venous (LeVeen) shunt setting in adults: ( 2.1 ) by intraperitoneal injection: 37 to 111 MBq (1 to 3 mCi); by percutaneous transtubal injection: 12 to 37 MBq (0.3 to 1 mCi) in a volume not to exceed 0.5 mL.

Imaging areas of functioning reticuloendothelial cells by intravenous injection ( 2.1 ): In adults: Liver/spleen imaging: 37 to 296 MBq (1 to 8 mCi); Bone marrow imaging: 111 to 444 MBq (3 to 12 mCi); In pediatric patients: Liver/spleen imaging in newborns: 7.4 to

18.5MBq (0.2 to 0.5 mCi); Liver/spleen imaging in children: 0.56 to

2.78MBq (0.015 to 0.075 mCi) per kg of body weight (BW); Bone marrow imaging: 1.11 to

5.55MBq (0.03 to 0.15 mCi) per kg of BW. Gastroesophageal and pulmonary aspiration studies by oral route ( 2.1 ): In adults: Gastroesophageal studies: 5.55 to

11.1MBq (0.15 to 0.30 mCi); Pulmonary aspiration studies: 11.1 to

18.5MBq (0.30 to 0.50 mCi). In pediatric patients: 3.7 to

11.1MBq (0.10 to 0.30 mCi).

2.1Recommended Doses Breast cancer or malignant melanoma setting in adults: 3.7 to 37 MBq (0.1 to 1 mCi) in volumes ranging from 0.1 to 1 mL by subcutaneous injection. Peritoneo-venous (LeVeen) shunt setting in adults: 37 to 111 MBq (1 to 3 mCi) by intraperitoneal injection, or 12 to 37 MBq (0.3 to 1 mCi) in a volume not to exceed 0.5 mL by percutaneous transtubal (efferent limb) injection. Patient repositioning or other measures may be used to help assure uniform mixing of the radiopharmaceutical with peritoneal fluid.

Imaging areas of functioning reticuloendothelial cells: In adults: liver/spleen imaging: 37 to 296 MBq (1 to 8 mCi) by intravenous injection; bone marrow imaging: 111 to 444 MBq (3 to 12 mCi) by intravenous injection. In pediatric patients: liver/spleen imaging in children: 0.56 to

2.78MBq (0.015 to 0.075 mCi) per kg of body weight (BW) by intravenous injection; liver/spleen imaging in newborns: 7.4 to

18.5MBq (0.20 to 0.50 mCi) by intravenous injection; bone marrow imaging: 1.11 to

5.55MBq (0.03 to 0.15 mCi) per kg of BW by intravenous injection. Gastroesophageal and pulmonary aspiration imaging studies: In adults: gastroesophageal studies: 5.55 to

11.1MBq (0.15 to 0.30 mCi) by oral administration; pulmonary aspiration studies: 11.1 to

18.5MBq (0.30 to 0.50 mCi) by oral administration. In pediatric patients: gastroesophageal and pulmonary aspiration studies: 3.7 to

11.1MBq (0.10 to 0.30 mCi) by oral or nasogastric tube administration. For oral administration, combine the radiopharmaceutical with a milk feeding. For nasogastric tube administration, administer the radiopharmaceutical into the stomach then instill a normal volume of dextrose or milk feeding.

2.2Drug Preparation and Administration The contents of the two Solution vials, the Solution A vial containing the appropriate acidic solution and the Solution B vial containing the appropriate buffer solution, are intended only for use in the preparation of the Technetium Tc 99m Sulfur Colloid Injection and are not to be directly administered to the patient. Do not use Sodium Pertechnetate Tc 99m containing oxidants to reconstitute this kit. The contents of the kit are not radioactive.

However, after the Sodium Pertechnetate Tc 99m is added, maintain adequate shielding of the final preparation. Wear waterproof gloves during the preparation procedure. Do not use Sodium Pertechnetate Tc 99m containing more than 10 micrograms per mL of aluminum ion because a flocculent precipitate may occur and such a precipitate may localize in the lu… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 164 words ▾

3 DOSAGE FORMS AND STRENGTHS Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied in a package that contains 5 kits. All components of a kit are sterile and non-pyrogenic. Each 10mL multi-dose Reaction Vial contains, in lyophilized form, 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; each Solution A vial contains 1.8 mL 0.148 N hydrochloric acid solution and each Solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide.

Included in each 5-kit package are one package insert and 10 radiation labels. The Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied as a package that contains 5 kits. Each kit contains three vials: one 10 mL multi-dose Reaction Vial, a Solution A vial and a Solution B vial.

The vials contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection ( 3 ).

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None None

⚠️ Warnings and Cautions 195 words ▾

5 WARNINGS AND PRECAUTIONS Anaphylactic reactions including rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid. Have resuscitation equipment and personnel immediately available ( 5.1 ).

5.1Anaphylactic Reactions Anaphylactic reactions with bronchospasm, hypotension, urticaria and rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid Injection. Have emergency resuscitation equipment and personnel immediately available.

5.2Radiation Risks Radiation-emitting products, including Technetium Tc 99m Sulfur Colloid Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker. [see Dosage and Administration (2.3)] .

5.3Altered Distribution, Accumulation of Tracer in the Lungs Technetium Tc 99m Sulfur Colloid Injection is physically unstable, and the particles will settle with time or with exposure to polyvalent cations. These larger particles are likely to be trapped by the pulmonary capillary bed following intravenous injection and result in non-uniform distribution of radioactivity. Agitate the vial adequately before administration of sulfur colloid to avoid particle aggregation and non-uniform distribution of radioactivity.

Discard unused drug after 6 hours from the time of formulation. [see Dosage and Administration (2.2)]

🤒 Adverse Reactions 102 words ▾

6 ADVERSE REACTIONS The most frequently reported adverse reactions, across all categories of use and routes of administration, include rash, allergic reaction, urticaria, anaphylaxis/anaphylactic shock, and hypotension. Less frequently reported adverse reactions are fatal cardiopulmonary arrest, seizures, dyspnea, bronchospasm, abdominal pain, flushing, nausea, vomiting, itching, fever, chills, perspiration, numbness, and dizziness. Local injection site reactions, including burning, blanching, erythema, sclerosis, swelling, eschar, and scarring, have also been reported.

The most frequently reported adverse reactions include rash, urticaria, anaphylactic shock, and hypotension. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-221-7554 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🔄 Drug Interactions 10 words ▾

7 DRUG INTERACTIONS Specific drug-drug interactions have not been studied.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise a lactating woman to pump and discard breast milk for 24 hours and minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection ( 8.2 ).

8.1Pregnancy Risk Summary Limited available data with Technetium Tc 99m Sulfur Colloid Injection use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; technetium Tc 99m crosses the placenta (see Data) . Animal reproduction studies have not been conducted with Technetium Tc 99m Sulfur Colloid Injection. All radiopharmaceuticals, including Technetium Tc 99m Sulfur Colloid Injection, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose.

If considering Technetium Tc 99m Sulfur Colloid Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Data Human Data Among 14 infants born to pregnant patients exposed to Technetium Tc 99m Sulfur Colloid Injection for lymph node localization, no birth defects were reported following drug exposure.

8.2Lactation Risk Summary Technetium Tc 99m is excreted in human milk during lactation. Exposure of Technetium Tc 99m Sulfur Colloid Injection to a breastfed infant can be minimized by temporary discontinuation of breastfeeding [see Clinical Considerations] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Technetium Tc 99m Sulfur Colloid Injection and any potential adverse effects on the breastfed child from Technetium Tc 99m Sulfur Colloid Injection or from the underlying maternal condition.

Clinical Considerations To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours after administration of Technetium Tc 99m Sulfur Colloid Injection. Following higher dose procedures [greater than 370 MBq (10 mCi)], patients should minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection.

8.4Pediatric Use The safety and efficacy of Technetium Tc 99m Sulfur Colloid kit in pediatric patients has been shown for the following indications: liver, spleen, and bone marrow imaging, and gastroesophageal and pulmonary aspiration studies.

8.5Geriatric Use Clinical studies of Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy 195 words ▾

8.1Pregnancy Risk Summary Limited available data with Technetium Tc 99m Sulfur Colloid Injection use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; technetium Tc 99m crosses the placenta (see Data) . Animal reproduction studies have not been conducted with Technetium Tc 99m Sulfur Colloid Injection. All radiopharmaceuticals, including Technetium Tc 99m Sulfur Colloid Injection, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose.

If considering Technetium Tc 99m Sulfur Colloid Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Data Human Data Among 14 infants born to pregnant patients exposed to Technetium Tc 99m Sulfur Colloid Injection for lymph node localization, no birth defects were reported following drug exposure.

🧒 Pediatric Use 36 words ▾

8.4Pediatric Use The safety and efficacy of Technetium Tc 99m Sulfur Colloid kit in pediatric patients has been shown for the following indications: liver, spleen, and bone marrow imaging, and gastroesophageal and pulmonary aspiration studies.

🧓 Geriatric Use 37 words ▾

8.5Geriatric Use Clinical studies of Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🆘 Overdosage 17 words ▾

10 OVERDOSAGE The clinical consequences of overdosing with Technetium Tc 99m Sulfur Colloid Injection are not known.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Technetium Tc 99m decays by isomeric transition, emitting a photon that can be detected for imaging purposes. [see Description (11.1)] Following subcutaneous injection, Technetium Tc 99m Sulfur Colloid enters the lymphatic capillaries and is transported with lymph to lymph nodes. However, when there is massive nodal metastatic involvement, the normal transport to lymph nodes is lost because few normal cells remain in the node. [ see Dosage and Administration (2.4) ] Following intraperitoneal injection, Technetium Tc 99m Sulfur Colloid mixes with the peritoneal fluid; rate of clearance from the cavity allows assessment of the patency of the shunt.

Clearance varies from insignificant, which may occur with complete shunt blockage, to very rapid clearance with subsequent transfer into the systemic circulation when the shunt is patent. Following intravenous injection, Technetium Tc 99m Sulfur Colloid is taken up by the reticuloendothelial system (RES), allowing RES rich structures to be imaged. With oral administration, Technetium Tc 99m Sulfur Colloid is not absorbed accounting for its function in esophageal transit studies, gastroesophageal reflux scintigraphy, and for the detection of pulmonary aspiration of gastric contents.

12.3Pharmacokinetics Following intravenous administration, Technetium Tc 99m Sulfur Colloid Injection is rapidly cleared from the blood by the reticuloendothelial system with a nominal half-life of approximately 2 1/2 minutes. Uptake of the radioactive colloid by organs of the RES is dependent upon both their relative blood flow rates and the functional capacity of the phagocytic cells. In the average patient 80 to 90% of the injected collodial particles are phagocytized by the Kupffer cells of the liver, 5 to 10% by the spleen and the balance by the bone marrow.

Following oral ingestion, Technetium Tc 99m Sulfur Colloid is distributed primarily through the gastrointestinal tract with elimination primarily through the feces.

🧬 Mechanism of Action 184 words ▾

12.1Mechanism of Action Technetium Tc 99m decays by isomeric transition, emitting a photon that can be detected for imaging purposes. [see Description (11.1)] Following subcutaneous injection, Technetium Tc 99m Sulfur Colloid enters the lymphatic capillaries and is transported with lymph to lymph nodes. However, when there is massive nodal metastatic involvement, the normal transport to lymph nodes is lost because few normal cells remain in the node. [ see Dosage and Administration (2.4) ] Following intraperitoneal injection, Technetium Tc 99m Sulfur Colloid mixes with the peritoneal fluid; rate of clearance from the cavity allows assessment of the patency of the shunt.

Clearance varies from insignificant, which may occur with complete shunt blockage, to very rapid clearance with subsequent transfer into the systemic circulation when the shunt is patent. Following intravenous injection, Technetium Tc 99m Sulfur Colloid is taken up by the reticuloendothelial system (RES), allowing RES rich structures to be imaged. With oral administration, Technetium Tc 99m Sulfur Colloid is not absorbed accounting for its function in esophageal transit studies, gastroesophageal reflux scintigraphy, and for the detection of pulmonary aspiration of gastric contents.

📦 How Supplied / Storage and Handling 152 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied in a package that contains 5 kits. All kit components are sterile and non-pyrogenic. Each 10mL multi-dose Reaction Vial contains, in lyophilized form, 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; each Solution A vial contains 1.8 mL 0.148 N hydrochloric acid solution and each Solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide.

Included in each 5-kit package are one package insert and 10 radiation labels. Store the kit at 20-25°C (68-77°F) as packaged and after reconstitution. This reagent kit for 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 to the U.S.

Nuclear Regulatory Commission or an Agreement State. NDC #45567-0030-1

📋 Description ~2 min read ▾

11 DESCRIPTION Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection contains a multi-dose Reaction Vial, a Solution A vial and a Solution B vial which contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection for diagnostic use by subcutaneous, intraperitoneal, or intravenous injection or by oral administration. Each 10 mL multi-dose Reaction Vial contains, in lyophilized form 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; a Solution A vial contains 1.8 mL of 0.148 N hydrochloric acid solution and a Solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide.

When a solution of sterile and non-pyrogenic Sodium Pertechnetate Tc 99m Injection in isotonic saline is mixed with these components, following the instructions provided with the kit, Technetium Tc 99m Sulfur Colloid Injection is formed. The product is intended for subcutaneous, intraperitoneal, or intravenous injection or for oral administration. The precise structure of Technetium Tc 99m Sulfur Colloid Injection is not known at this time.

11.1Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. 4 The principal photon that is useful for detection and imaging studies is listed in Table 7. Table 7. Principal Radiation Emission Data 4 Radiation Mean Percent Per Disintegration Mean Energy (keV) Gamma-2 89.07 140.5 4 Kocher DC: Radioactive decay data tables. DOE/TIC-11026: 108, 1981

11.2 External Radiation The specific gamma ray constant for Tc 99m is

0.78R/millicurie-hr at 1cm. 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 8.

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 8. 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 9.

Table 9. Physical Decay Chart: Tc 99m, half-life 6.02 hours Hours Fraction Remaining Hours Fraction Remaining 0* 1.000 6 0.501 1 0.891 7 0.447 2 0.794 8 0.398 3 0.708 9 0.355 4 0.631 10 0.316 5 0.562 11 0.282 - - 12 0.251 *Calibration time

💬 Information for Patients 80 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients they may experience a burning sensation at the injection site. Inform lactating woman to pump and discard breast milk for 24 hours after administration of Technetium Tc 99m Sulfur Colloid Injection and minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection ( 8.2 ). Manufactured By: Sun Pharmaceutical Industries, Inc.

29 Dunham Road Billerica, MA 01821 1-800-221-7554 (for International dial: 1-781-275-7120) PL-000001 Rev

2.0 Mar 2020

🧬 Pharmacokinetics 112 words ▾

12.3Pharmacokinetics Following intravenous administration, Technetium Tc 99m Sulfur Colloid Injection is rapidly cleared from the blood by the reticuloendothelial system with a nominal half-life of approximately 2 1/2 minutes. Uptake of the radioactive colloid by organs of the RES is dependent upon both their relative blood flow rates and the functional capacity of the phagocytic cells. In the average patient 80 to 90% of the injected collodial particles are phagocytized by the Kupffer cells of the liver, 5 to 10% by the spleen and the balance by the bone marrow.

Following oral ingestion, Technetium Tc 99m Sulfur Colloid is distributed primarily through the gastrointestinal tract with elimination primarily through the feces.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Tracer Localization to Lymph Nodes in Breast Cancer A systematic review of 43 publications examined procedures that used the injection of Technetium Tc 99m Sulfur Colloid Injection and a blue dye (tracers) to assist surgeons in the localization of lymph nodes among patients with a primary breast cancer lesion. From these publications, 15 studies were identified for inclusion within a meta-analysis, based upon the following criteria: prospective design, minimum number of 50 lymph node localization procedures, and paired outcome data available for both Technetium Tc 99m Sulfur Colloid Injection and blue dye.

Within these studies, the number of procedures ranged from 62 to 6,197; in general one procedure involved a single patient but in some uncommon situations, one patient underwent more than one procedure. The patients received subcutaneous Technetium Tc 99m Sulfur Colloid Injection doses ranging between 0.1 and 2 mCi. The mean age of patients ranged from 52 to 60 years, and almost all were female.

Lymph nodes that contained radioactivity were generally localized based upon increased counts, in comparison to a background threshold (e.g., nodes containing a minimum of radioactive counts 3 times higher than background or containing at least 10 fold higher counts than contiguous nodes). Radioactivity was measured using a handheld gamma counter. Table 10 shows the tracer localization rates where the tracer localization rate (%) is defined as the percentage of procedures which had at least one lymph node containing the specific tracer.

Random effect meta-analytic measures were used for estimating various rates of tracer localization by procedure along with the respective confidence intervals. The random effect meta-analytical methods take into account the sample size of each study as well as within and between study variability. In general, most procedures involved the resection of lymph nodes in which a tracer had localized to at least one node.

However, in some procedures (estimated at approximately 3.4%) neither tracer was localized to a resected lymph node. The reports were insufficient to establish the basis for failed tracer localization. [ see Dosage and Administration (2.4) ] Table 10 . Tracer Localization by Procedure – Breast Cancer* Number of Clinical Studies Number of Procedures BD Present (%) SCI Present (%) Only BD Present (%) Only SCI Present (%) Neither SCI nor BD Present (%) 15 9,213 85.1 94.1 3.8 12.1 3.4 95% Confidence Intervals** 81.4, 88.2 91.4, 96.0 2.8, 5.2 9.9, 15.0 2.1,

5.4BD = blue dye, SCI = Technetium Tc 99m Sulfur Colloid Injection * Percentage of procedures in which at least one lymph node contained the specific tracer; the percents do not add to 100% due to rounding. ** 95% Confidence Intervals are based on meta-analysis and represent the spread in the individual estimates. In some of the publications, different methods of Technetium Tc 99m Sulfur Colloid Injection administration were compared: intradermal (ID), subareolar (SA) and intraparenchymal (IP) methods. Generally, more favorable results were seen using the ID and SA routes, with less favorable results reported when surgeons used the IP method.

14.2Tracer Localization to Lymph Nodes in Malignant Melanoma A systematic review of eight publications examined the use of Technetium Tc 99m Sulfur Colloid and a blue dye (tracers) to assist surgeons in the localization of lymph nodes among patients with malignant melanoma. A meta-analysis was performed using data from the studies that reported the resected lymph node content of Technetium Tc 99m Sulfur Colloid Injection and blue dye. Four of the eight publications met this criterion and were included in the meta-analysis.

Within these four studies, the number of reported patients ranged from 12 to 94. The patients received subcutaneous Technetium Tc 99m Sulfur Colloid Injection doses ranging between 0.25 to 2 mCi. The patients were aged 15 to 89 years and most (53 to 70%) were… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 30 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies to evaluate the carcinogenicity, mutagenesis, or reproductive toxicity potentials of Technetium Tc 99m Sulfur Colloid have not been conducted.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 27 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies to evaluate the carcinogenicity, mutagenesis, or reproductive toxicity potentials of Technetium Tc 99m Sulfur Colloid have not been conducted.

📚 References 80 words ▾

15 REFERENCES Bergqvist L, Strand S-E, Persson B, et al. Dosimetry in Lymphoscintigraphy of Tc 99m Antimony Sulfide Colloid, J Nucl Med., 23: 698-705, 1982. Summary of Current Radiation Dose Estimates to Humans with Various Liver Conditions from 99m Tc-Sulfur Colloid, MIRD Dose Estimate Report No 3, J Nucl Med., 16: 108A - 108B, 1975 Henrichs et al.

Estimation of age-dependent internal dose from radiopharmaceuticals, Phys. Med. Biol., 27: 775-784, 1982.

Kocher DC: Radioactive decay data tables. DOE/TIC-11026: 108, 1981.

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - VIAL CONTAINER (PART 1 - 10mL multi-dose Reaction Vial) NDC 045567-0030-1 STERILE DIAGNOSTIC MULTIDOSE NON-PYROGENIC Multi-Dose Reaction Vial for use in the Preparation of Technetium Tc 99m Sulfur Colloid Injection. Each 10 mL reaction vial contains in lyophilized form 2.0 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin. Usual Dosage: See complete prescribing information.

Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000004 Rev

0.3Mar 2020 CONTAINS NO BACTERIOSTATIC PRESERVATIVE FOR USE ONLY AFTER LABELING WITH OCIDANT-FREE TECHENTIUM Tc 99m. Store the kit at 20-25°C (68-77°F) [See USP] as packaged and after reconstitution with Technetium Tc 99m. Use within 6 hours after reconstitution. Rx ONLY PL-000004

PACKAGE/LABEL - PRINCIPAL DISPLAY PANEL - VIAL CONTAINER (PART 2 - 3mL Solution A Vial) NDC 045567-0030-1 A Solution A vial contains 1.8mL sterile, non pyrogenic 0.148 N hydrochloric acid solution. To be used only with the Sulfur Colloid Multi-dose Reaction Vial. Single Use Vial-Discard Unused Portion NOT FOR DIRECT INTRAVENOUS INJECTION.

R X ONLY . STORE AT 20-25°C (68-77°F) [See USP] Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000002 Rev

0.2 Mar 2020 VIAL CONTAINER (PART 2- 3 mL Solution A Vial)

PACKAGE/LABEL - PRINCIPAL DISPALY PANEL - VIAL CONTAINER (PART 3 - 3mL Solution B Vial) NDC 045567-0030-1 B Solution B vial contains 1.8mL sterile, non pyrogenic aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. To be used only with the Sulfur Colloid Multi-dose Reaction Vial. Single Use Vial-Discard Unused Portion.

NOT FOR DIRECT INTRAVENOUS INJECTION. R X ONLY . STORE AT 20-25°C (68-77°F) [See USP] Manufactured By: Sun Pharmaceutical Industries, Inc.

Billerica MA 01821 PL-000003 Rev

0.2 Mar 2020 VIAL CONTAINER (PART 3-3 mL Solution B Vial)

PACKAGE/LABEL - PRINCIPAL DISPLAY PANEL - RADIATION LABEL CAUTION RADIOACTIVE MATERIAL STERILE, NON-PYROGENIC, DIAGNOSTIC MULTIDOSE TECHNETIUM Tc 99m SULFUR COLLOID Subcutaneous, Intravenous, Oral, and Intraperitoneal Use Total MBq (mCi)_____Volume_____ Assay_____MBq/mL(mCi/mL) as of _____ The 10 mL vial contents are made with 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium, 18.1 mg bovine gelatin, the added 1.5 mL of 0.148 N hydrochloric acid solution and the added 1.5 mL aqueous solution of 36.9 mg sodium biphosphate anhydrous and 11.9 mg sodium hydroxide.

Contains no bacteriostatic preservative. For use only after labeling with oxidant-free Technetium Tc 99m. Store reconstituted vial at 20-25°C (68-77°F) [See USP].

Use within 6 hours after labeling with Technetium Tc 99m. Usual Dosage: See complete prescribing information. (SEE ENCLOSED PACKAGE INSERT) R x only Manufactured by: Sun Pharmaceutical Industries, Inc.

Billerica, MA 01821 PL-000005 Rev

0.2 Mar 2020 RADIATION LABEL

PACKAGE/LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL BOX NDC 045567-0030-1 Kit for the Preparation of Technetium Tc99m Sulfur Colloid Injection CAUTION: Federal (U.S.A.) law prohibits dispensing without prescription 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, 10 radiation labels, 5 multi-dose reaction vials, 5 Solution A vials and 5 Solution B vials.

Each 10 mL multi-dose reaction vial contains 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin. Each Solution A vial contains 1.8 mL 0.148 N hydrochloric acid. Each solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide.

Contains no bacteriostatic preservative. For intravenous use only after labeling with oxidant-free Technetium Tc 99m. Store the kit at 20-25°C (68-77°F) [See USP] as packaged and after reconstitution Use within 6 hours af… [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 ↗

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← 45562-1742-00 · Lundbeck 45567-0040-01 · Sun →
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