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NephroScan SUCCIMER 1 mg Injection, Powder, Lyophilized, For Solution, 5 vials — NDC 71083-0020-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

NephroScan SUCCIMER 1 mg Injection, Powder, Lyophilized, For Solution, 5 vials — NDC 71083-0020-5 (Billing 71083-0020-05)

by Theragnostics Inc · 5 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

This is a package of 5 vials of NephroScan SUCCIMER 1 mg Injection, Powder, Lyophilized, For Solution from Theragnostics Inc, marketed since Feb 2022 and currently FDA-listed. It is this product's only package size.

NDC 71083-0020-05
🏷️ FDA NDC (as labeled) 71083-0020-5 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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NDC database record

One package, one record: these facts belong to NDC 71083-0020-5 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71083 labeler · 0020 product · 5 package
Package marketed since
Feb 18, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7108300205 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71083-0020-5
Product NDC 71083-0020
11-digit billing NDC 71083002005
UNII DX1U2629QE
Application # NDA214993
SPL Set ID ddd90c4a-5792-49c9-837f-710d1a604742
Established class (EPC) Lead Chelator
Mechanism of action Lead Chelating Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-02-18
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance SUCCIMER

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

GCN Seq No 051314
GCN 18515
HICL code 024542
Ingredient (HICL) Kit For Prep Tc-99M/Succimer
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 36:40.00.00
AHFS class Kidney Function
FDB label name NEPHROSCAN VIAL
FDB brand name Nephroscan
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 051314
  • GCN: 18515
  • HICL (First Databank): 024542
  • AHFS class code: 36:40.00.00
Why two NDCs? The FDA registers this code as 71083-0020-5 — 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 → 71083-0020-05. 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 NEPHROSCAN VIAL Ingredient Kit For Prep Tc-99M/Succimer
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 mLPer 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
71083-0020-05 You're viewing this Main listing 5 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2022-02-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
NephroScan 1 mgthis 71083-0020-05 Theragnostics 5 vials — — 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

🏛️
2022
On the market since
Feb 2022
📍
2026
Currently FDA-listed
4 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.

  • 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.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

4 inactive ingredients 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

LabelerTheragnostics Inc
Application holderTHERAGNOSTICS INC
FDA applicationNDA214993 (NDA)
Labeler code71083
First marketedFeb 2022
Product typeHuman Prescription Drug
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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 71 words ▾

1 INDICATIONS AND USAGE NEPHROSCAN, after radiolabeling with technetium Tc 99m, is indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in adult and pediatric patients including term neonates. NEPHROSCAN, after radiolabeling with technetium Tc 99m, is a radioactive diagnostic agent indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in adults and pediatric patients including term neonates. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Instruct patients to drink a sufficient amount of water before administration and to continue to drink and to void frequently following administration ( 2.2 ) The recommended amount of radioactivity by intravenous injection (bolus) is: For adults: 74 MBq to 222 MBq (2 mCi to 6 mCi) ( 2.3 ) For pediatric patients:

1.85MBq/kg (0.05 mCi/kg) of body weight with a range of 19 MBq to 74 MBq (0.5 mCi to 2 mCi). ( 2.3 ) Begin image acquisition 1 hour to 4 hours after administration ( 2.7 ) Delay imaging up to 6 hours to 24 hours in patients with severely reduced eGFR ( 2.7 ) See Full Prescribing Information for radiation safety, drug preparation, administration, and radiation dosimetry information ( 2.1 , 2.4 , 2.5 , 2.6 , 2.8 )

2.1Radiation Safety – Drug Handling After radiolabeling, handle Technetium Tc 99m Succimer Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.2) ] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Succimer Injection. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

2.2Patient Preparation Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Technetium Tc 99m Succimer Injection and to continue to drink and void frequently following administration to reduce radiation exposure [see Warnings and Precautions (5.2) ].

2.3Recommended Dosage Adults The recommended amount of radioactivity of Technetium Tc 99m Succimer Injection for renal parenchymal imaging in adults is 74 MBq to 222 MBq (2 mCi to 6 mCi) by intravenous injection (bolus). Pediatric Patients The recommended amount of radioactivity of Technetium Tc 99m Succimer Injection for renal parenchymal imaging in pediatric patients is

1.85MBq/kg (0.05 mCi/kg) of body weight with a range of 19 MBq to 74 MBq (0.5 mCi to 2 mCi) by intravenous injection (bolus). Weight based pediatric dosing is shown in Table 1. Table 1 Recommended Radioactivity of Technetium Tc 99m Succimer Injection for Pediatric Patients by Body Weight Body Weight (kg) Recommended Radioactivity MBq (mCi) Body Weight (kg) Recommended Radioactivity MBq (mCi) less than 11 kg 19 MBq (0.5 mCi) 25 to 26 49 MBq (1.3 mCi) 11 to 12 21 MBq (0.6 mCi) 27 to 28 52 MBq (1.4 mCi) 13 to 14 26 MBq (0.7 mCi) 29 to 30 56 MBq (1.5 mCi) 15 to 16 30 MBq (0.8 mCi) 31 to 32 59 MBq (1.6 mCi) 17 to 18 33 MBq (0.9 mCi) 33 to 34 63 MBq (1.7 mCi) 19 to 20 37 MBq (1 mCi) 35 to 36 67 MBq (1.8 mCi) 21 to 22 41 MBq (1.1 mCi) 37 to 38 70 MBq (1.9 mCi) 23 to 24 44 MBq (1.2 mCi) 39 or greater 74 MBq (2 mCi)

2.4Drug Preparation Prepare Technetium Tc 99m Succimer Injection according to the following procedure using asceptic technique: Wear waterproof gloves. Place the kit vial in lead shielding and disinfect the stopper (allow disinfectant to dry). Use a sterile syringe to transfer 5 mL sodium pertechnetate Tc 99m injection obtained from a technetium Tc 99m generator with a maximum activity of 1,480 MBq (40 mCi) to the vial.

The volume of sodium pertechnetate Tc 99m injection may be adjusted to 5 mL prior to adding to the kit vial using 0.9% sodium chloride injection, USP. Use the same syringe to withdraw the appropriate gas volume from the vial for pressure compensation. Lightly shake the vial to completely dissolve the powder.

Ensure the stopper is well moistened. Incubate the vial for 10 minutes at controlled room temperature 20°C to 25°C (68°F to 77°F). Measure the product activity in a dose calibrator; complete the radiolabeled product vial label and affix to the vial shield.

Check radiochemical purity according to the method in

2.5Radi… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 110 words ▾

3 DOSAGE FORMS AND STRENGTHS For Injection: NEPHROSCAN contains 1 mg succimer as a white-yellowish to off-white lyophilized powder in a single-dose vial. Upon radiolabeling with technetium Tc 99m, it provides up to 1,480 MBq (40 mCi) Technetium Tc 99m Succimer Injection as a clear, colorless solution in approximately 5 mL volume at calibration date and time. For Injection: NEPHROSCAN contains 1 mg succimer as a white-yellowish to off-white lyophilized powder in a single dose vial.

Upon radiolabeling with technetium Tc 99m, it provides a clear, colorless solution containing up to 1,480 MBq (40 mCi) technetium Tc 99m succimer in approximately 5 mL volume at calibration time. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Have appropriate instruments and medications necessary for immediate treatment of allergic reactions and monitor patients for hypersensitivity reactions during and after administration ( 5.1 ) Radiation risks: Ensure safe handling to minimize radiation exposure to patients and health care workers ( 5.2 ) Risk in Patients with Advanced Renal Failure: Image interpretation may be affected as the kidneys may not absorb technetium Tc 99m succimer. ( 5.3 )

5.1Hypersensitivity Reactions Hypersensitivity reactions, including urticaria, rash, pruritus, and erythema have been reported with the use of technetium Tc 99m succimer injection in adults and pediatric patients. The time of onset of the reactions varied within 2 hours to several hours after the injection. Have appropriate instruments and medications necessary for immediate treatment of hypersensitivity reactions and monitor patients for reactions during and after administration [see Adverse Reactions (6) ] .

5.2Radiation Risks Technetium Tc 99m succimer injection contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers.

Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.1 , 2.2) ] .

5.3Risk in Patients with Advanced Renal Failure The use of technetium Tc 99m succimer injection in patients with severely reduced estimated glomerular filtration (eGFR) may have an effect on image interpretation as the kidneys may not absorb the technetium Tc 99m succimer and thus the Tc 99m succimer may distribute to organs or parts of the body other than the kidneys. It has been reported that satisfactory images may be obtained in some of these patients by delaying imaging between 6 hours to 24 hours [see Dosage and Administration (2.7) ] .

🤒 Adverse Reactions 125 words ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] The following adverse reactions associated with the use of NEPHROSCAN were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders : Hypersensitivity including urticaria, rash, pruritus, and erythema General Disorders : syncope, fever, and nausea. The following adverse reactions have been reported: urticaria, rash, pruritus, erythema, syncope, fever, and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Theragnostics, Inc., at 1-888-286-3848 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 24 hours after Technetium Tc 99m Succimer Injection administration. ( 8.2 )

8.1Pregnancy Risk Summary Available data with technetium Tc 99m succimer use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies with technetium Tc 99m succimer have not been conducted. Although all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose, the radiation exposure to the fetus from technetium Tc 99m succimer is expected to be low (less than 0.50 mGy) (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.

Data Human Data No adverse fetal effects of radiation risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10mGy fetal doses.

8.2Lactation Risk Summary Technetium Tc 99m succimer is present in breast milk. There are no data on the effects of technetium Tc 99m succimer on the breastfed infant or the effects on milk production. NEPHROSCAN is used for imaging in infants with renal disease; exposure to technetium Tc 99m succimer via breast milk is expected to be lower.

Based on clinical guidelines, exposure of technetium Tc 99m succimer to a breastfed infant may be minimized by advising a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for a minimum of at least 24 hours after administration of Technetium Tc 99m Succimer Injection. The developmental and health benefits of breastfeeding should be considered along with a mother's clinical need for NEPHROSCAN, any potential adverse effects on the breastfed child from technetium Tc 99m succimer or from the underlying maternal condition.

8.4Pediatric Use NEPHROSCAN, after radiolabeling with technetium Tc 99m, is indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in pediatric patients, including term neonates. Use of NEPHROSCAN in this age group for this indication is supported by evidence from effectiveness established in adult studies and data from published pediatric studies supporting the safety and effectiveness of weight-based dosing of Technetium Tc 99m Succimer Injection in renal parenchymal imaging in pediatric patients including term neonates [see Dosage and Administration (2.3) ] .

The recommended amount of radioactivity in pediatric patients,

1.85MBq/kg (0.05 mCi/kg) with a range of 19 MBq to 74 MBq (0.5 mCi to 2 mCi), is based on published studies that used technetium Tc 99m succimer for the evaluation of acute pyelonephritis, renal scarring, and split renal function in pediatric patients [see Dosage and Administration (2.2) ] . Hypersensitivity reactions, including urticaria, rash, pruritus, and erythema have been reported with the use of technetium Tc 99m succimer in pediatric patients [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] .

8.5Geriatric Use Clinical studies of technetium Tc 99m succimer did not include sufficient numbers of subjects 65 years of age and over to determine whether they respond differently from younger patients. 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 administering the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 175 words ▾

8.1Pregnancy Risk Summary Available data with technetium Tc 99m succimer use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies with technetium Tc 99m succimer have not been conducted. Although all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose, the radiation exposure to the fetus from technetium Tc 99m succimer is expected to be low (less than 0.50 mGy) (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.

Data Human Data No adverse fetal effects of radiation risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10mGy fetal doses.

🧒 Pediatric Use 180 words ▾

8.4Pediatric Use NEPHROSCAN, after radiolabeling with technetium Tc 99m, is indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in pediatric patients, including term neonates. Use of NEPHROSCAN in this age group for this indication is supported by evidence from effectiveness established in adult studies and data from published pediatric studies supporting the safety and effectiveness of weight-based dosing of Technetium Tc 99m Succimer Injection in renal parenchymal imaging in pediatric patients including term neonates [see Dosage and Administration (2.3) ] .

The recommended amount of radioactivity in pediatric patients,

1.85MBq/kg (0.05 mCi/kg) with a range of 19 MBq to 74 MBq (0.5 mCi to 2 mCi), is based on published studies that used technetium Tc 99m succimer for the evaluation of acute pyelonephritis, renal scarring, and split renal function in pediatric patients [see Dosage and Administration (2.2) ] . Hypersensitivity reactions, including urticaria, rash, pruritus, and erythema have been reported with the use of technetium Tc 99m succimer in pediatric patients [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] .

🧓 Geriatric Use 143 words ▾

8.5Geriatric Use Clinical studies of technetium Tc 99m succimer did not include sufficient numbers of subjects 65 years of age and over to determine whether they respond differently from younger patients. 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 administering 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 decreased 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.

🆘 Overdosage 61 words ▾

10 OVERDOSAGE In the event of an overdose of technetium Tc 99m succimer, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding. A diuretic might also be considered. If possible, an estimate of the radiation effective dose given to the patient should be made.

🧬 Clinical Pharmacology 145 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Technetium Tc 99m succimer binds to the cortical region of kidneys and in conjunction with gamma scintigraphy or single photon emission computed tomography (SPECT) is used to image the renal cortices.

12.2Pharmacodynamics Technetium Tc 99m succimer only stays bound to viable cortical tissue for >24 hours following administration. The relationship between technetium Tc 99m succimer plasma concentrations and successful imaging is not known.

12.3Pharmacokinetics Distribution Technetium Tc 99m succimer is distributed in the plasma, bound to plasma proteins following intravenous administration. In humans, 53% to 70% of the intravenously administered technetium Tc 99m is protein bound. There is negligible activity in the red blood cells.

At 6 hours about 20% of the dose is concentrated in each kidney. Elimination Approximately 16% of the technetium Tc 99m succimer activity is excreted in the urine within 2 hours.

🧬 Mechanism of Action 35 words ▾

12.1Mechanism of Action Technetium Tc 99m succimer binds to the cortical region of kidneys and in conjunction with gamma scintigraphy or single photon emission computed tomography (SPECT) is used to image the renal cortices.

📦 How Supplied / Storage and Handling 132 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied NEPHROSCAN (kit for the preparation of technetium Tc 99m succimer injection), containing 1 mg succimer, is supplied as a white-yellowish to off-white lyophilized powder packaged in a sterile, single-dose vial as a carton of 5 vials (NDC 71083-0020-5). Storage and Handling Before radiolabeling, store NEPHROSCAN in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton. Do not freeze.

After radiolabeling, store Technetium Tc 99m Succimer Injection upright, shielded, for up to 4 hours, at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see Dosage and Administration (2.4) ]. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

📦 Storage and Handling 87 words ▾

Storage and Handling Before radiolabeling, store NEPHROSCAN in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton. Do not freeze. After radiolabeling, store Technetium Tc 99m Succimer Injection upright, shielded, for up to 4 hours, at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see Dosage and Administration (2.4) ].

This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

📋 Description ~2 min read ▾

11 DESCRIPTION

11.1Chemical Characteristics NEPHROSCAN is a sterile, single-dose kit for the preparation of Technetium Tc 99m Succimer Injection a radioactive diagnostic agent, for intravenous use. The active ingredient, succimer is meso-2,3-dimercaptosuccinic acid with a molecular weight of 182.22 g/mol. The chemical structure of succimer is shown below.

Subsequent to radiolabeling with sodium pertechnetate Tc 99m, the active moiety technetium Tc 99m succimer is obtained in situ. Each vial contains 1 mg succimer, 0.1 mg ascorbic acid, 0.42 mg stannous (tin) chloride dihydrate, 0.02 mg hydrochloric acid and 0.2 mg sodium hydroxide as a white-yellowish to off-white lyophilized powder. In addition, after radiolabeling with sodium pertechnetate Tc 99m injection, each vial contains up to 1,480 MBq (40 mCi) of technetium Tc 99m succimer in 0.9% sodium chloride injection as a sterile, clear, and colorless solution. pH of the final solution is between 3 and 3.5.

FDA approved pH specifications differ from USP. Chemical Structure

11.2Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. The principal photon that is useful for detection and imaging studies is listed in Table 3. Table 3 Principal Radiation Emission Data for Technetium Tc 99m Radiation/ Emission Mean % / Disintegration Mean Energy (keV) Gamma 2 89.07 140.5 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 4.

Table 4 Physical Decay Chart for Tc 99m, half-life 6.02 hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration time 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

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

0.78R/hr-mCi at 1 cm. The first half value layer is 0.017 cm of Pb. 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 5 displays the radiation attenuation by lead shielding. Table 5 Radiation Attenuation by Lead (Pb) Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 0.02 0.5 0.08 0.1 0.16 0.01 0.25 0.001 0.33 0.0001

💬 Information for Patients 110 words ▾

17 PATIENT COUNSELING INFORMATION Adequate Hydration Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their imaging and urge them to drink and urinate as often as possible during the first hours following the administration of Technetium Tc 99m Succimer Injection, in order to reduce radiation exposure [see Dosage and Administration (2.2) and Warnings and Precautions (5.2) ] . Lactation Advise a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for at least 24 hours after Technetium Tc 99m Succimer Injection administration in order to minimize radiation exposure to a breastfed infant [see Use in Specific Populations (8.2) ] .

🧬 Pharmacokinetics 74 words ▾

12.3Pharmacokinetics Distribution Technetium Tc 99m succimer is distributed in the plasma, bound to plasma proteins following intravenous administration. In humans, 53% to 70% of the intravenously administered technetium Tc 99m is protein bound. There is negligible activity in the red blood cells.

At 6 hours about 20% of the dose is concentrated in each kidney. Elimination Approximately 16% of the technetium Tc 99m succimer activity is excreted in the urine within 2 hours.

🧬 Pharmacodynamics 33 words ▾

12.2Pharmacodynamics Technetium Tc 99m succimer only stays bound to viable cortical tissue for >24 hours following administration. The relationship between technetium Tc 99m succimer plasma concentrations and successful imaging is not known.

🧪 Nonclinical Toxicology 25 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies were performed to evaluate the carcinogenicity potential of technetium Tc 99m succimer.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 22 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies were performed to evaluate the carcinogenicity potential of technetium Tc 99m succimer.

📄 Package Label / Principal Display Panel 56 words ▾

PRINCIPAL DISPLAY PANEL - 1 mg Vial Carton NEPHROSCAN ® Kit for the Preparation of Technetium Tc 99m Succimer Injection 1 mg per vial Succimer For intravenous use only after radiolabeling with Sodium Pertechnetate Tc 99m Injection, USP THERAGNOSTICS NDC:71083-0020-5 Rx Only 5 Single-Dose Vials. Discard Unused Portion PRINCIPAL DISPLAY PANEL - 1 mg Vial Carton

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Chemet (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Chemet. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$48.2K
Claims incl. refills
24
Beneficiaries
12
Spend / beneficiary
$4,013.55
Spend / claim
$2,006.77
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 NephroScan (this brand).

Top reported reactions

Hypertension4
Skin Striae4
Weight Increased4
Cushingoid3
Blood Lead Increased2
Cough2
Drug Ineffective For Unapproved Indication2

Age at onset

Adolescent2
Adult2

Reporter sex

23 reports
Male · 52%
Female · 48%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 8 0
Most recent year is provisional (FAERS lags ~3 months).
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
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 Theragnostics Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Theragnostics 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.
← 71082-0210-01 · Freh 71085-0008-60 · IPG →
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.