Home › NDC Lookup › Ingredients › Kit For The Preparation Of Technetium Tc... › 65174-0288-30
🫁image loading
(from DailyMed)

DRAXIMAGE DTPA Kit for the preparation of Technetium Tc 99m Pentetate 20 mg Injection, Powder, Lyophilized, For Solution, 30-count — NDC 65174-288-30 (Billing 65174-0288-30)

by Jubilant DraxImage Inc., dba Jubilant Radiopharma · 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT

This is a package of 30 injections of DRAXIMAGE DTPA Kit for the preparation of Technetium Tc 99m Pentetate 20 mg Injection, Powder, Lyophilized, For Solution from Jubilant DraxImage Inc., dba Jubilant Radiopharma, marketed since Dec 1989 and currently FDA-listed. It is this product's only package size.

NDC 65174-0288-30
🏷️ FDA NDC (as labeled) 65174-288-30 billing pads the product 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
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 65174-288-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65174 labeler · 288 product · 30 package
Package marketed since
Dec 29, 1989
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 6517428830 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65174-288-30
Product NDC 65174-288
11-digit billing NDC 65174028830
NCPDP billing unit EA — each (per item)
UNII 7A314HQM0I
Application # NDA018511
SPL Set ID becdab53-f7a7-7280-6930-21f3a61b99e7
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 1989-12-29
Route INTRAVENOUS, RESPIRATORY (INHALATION)
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance PENTETIC ACID
TE code (Orange Book) AP · RLD · RS

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

GCN Seq No 067757
GCN 30377
HICL code 037857
Ingredient (HICL) Kit Prep Tc 99M/Pentetic Acid
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 DRAXIMAGE DTPA PREPARATION KIT
FDB brand name Draximage Dtpa
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 067757
  • GCN: 30377
  • HICL (First Databank): 037857
  • AHFS class code: 36:40.00.00
Why two NDCs? The FDA registers this code as 65174-288-30 — a 5-3-2 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 product segment → 65174-0288-30. 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 DRAXIMAGE DTPA PREPARATION KIT Ingredient Kit Prep Tc 99M/Pentetic Acid

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 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
65174-0288-30 You're viewing this Main listing 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT 1989-12-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Draximage Dtpa 20 mgthis 65174-0288-30 Jubilant 30 injections — 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

🏛️
1989
On the market since
Dec 1989
📍
2026
Currently FDA-listed
37 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 5 mg UNII TL2TJE8QTX
    A white crystalline compound derived from benzoic acid. It serves as a preservative and UV absorber in medications, helping protect the drug from degradation and light damage.
  • 3.73 mg UNII M4I0D6VV5M
    Calcium chloride is a salt compound that acts as a firming agent and source of calcium ions in medications. It's used in formulations to help maintain tablet structure, improve texture, or serve as a buffering agent.
  • 0.25 mg 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.

3 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

LabelerJubilant DraxImage Inc., dba Jubilant Radiopharma
Application holderJUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA
FDA applicationNDA018511 (NDA)
Labeler code65174
First marketedDec 1989
Product typeHuman Prescription Drug
Portfolio9 products on file

More NDCs from Jubilant DraxImage Inc., dba Jubilant Radiopharm... labeler code 65174

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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 151 words ▾

1 INDICATIONS AND USAGE DRAXIMAGE ® DTPA, after radiolabeling with Technetium Tc 99m, is indicated for DRAXIMAGE ® DTPA is a kit for the preparation of Technetium Tc 99m pentetate injection. Technetium Tc 99m pentetate is a radioactive diagnostic agent indicated for: Brain imaging in adults ( 1.1 ). Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients ( 1.2 ).

Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients ( 1.3 ).

1.1Brain Imaging Brain imaging in adults by intravenous administration.

1.2Renal Scintigraphy Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients by intravenous administration.

1.3Lung Ventilation Imaging Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION During preparation and handling, use water proof gloves and effective shielding, to minimize radiation exposure ( 2.1 , 5.3 ). See the Full Prescribing Information for detailed information regarding recommended Dosage and Image Acquisition Instructions ( 2.2 ) and Instructions for Drug Preparation ( 2.4 ). Do not administer more than one dose ( 2.2 ).

2.1Radiation Safety – Drug Handling Tc 99m labeled DRAXIMAGE ® DTPA injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure to the patient and healthcare worker. During preparation and handling, use water proof gloves and effective shielding, including syringe shields [see Warnings and Precautions ( 5.3 )] .

2.2Recommended Dosage and Image Acquisition Instructions The recommended dose ranges for intravenous or inhalation administration of DRAXIMAGE® DTPA, after reconstitution, are presented in Table 1 through Table 3. Do not administer more than one dose. Table 1 Tc 99m Labeled DRAXIMAGE ® DTPA Injection – Intravenous Administration, Adults Indication Route of Administration Dose Image Acquisition Brain Imaging Intravenous Injection 370 MBq to 740 MBq (10 mCi to 20 mCi) Immediate dynamic imaging.

Obtain at least one blood-pool image in same position as flow. Delayed images can be obtained 1 hour later. Renal Visualization and Perfusion Assessment Intravenous Injection 370 MBq to 740 MBq (10 mCi to 20 mCi) Immediate dynamic imaging.

Static imaging 1 to 30 minutes after injection. Renal Visualization with Estimation of Glomerular Filtration Rate Intravenous Injection 111 MBq to 185 MBq (3 mCi to 5 mCi) Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection.

Estimation of Glomerular Filtration Rate (with no renal imaging) Intravenous Injection

7.4 MBq to

18.5MBq (0.2 mCi to 0.5 mCi) Blood sampling only is performed. Table 2 Tc 99m Labeled DRAXIMAGE ® DTPA Injection – Intravenous Administration, Pediatric Patients Indication Route of Administration Dose Image Acquisition Renal Visualization and Perfusion Assessment Intravenous Injection

3.7 MBq/kg to

7.4MBq/kg (0.1 mCi/kg to 0.2 mCi/kg) Minimum 37 MBq (1 mCi) Maximum 185 MBq (5 mCi) Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection. Estimation of Glomerular Filtration Rate (with no renal imaging) Intravenous Injection

7.4 MBq to

18.5MBq (0.2 mCi to 0.5 mCi) Blood sampling only is performed. Table 3 Tc 99m Labeled DRAXIMAGE ® DTPA – Aerosol Inhalation Administration * For lung imaging performed after perfusion imaging, target count rate should be approximately three times that of perfusion count rate. Indication Route of Administration Dose Image Acquisition Lung Ventilation Adults Aerosol Inhalation 925 MBq to 1850 MBq (25 mCi to 50 mCi) in the nebulizer to achieve a lung dose of approximately

18.5MBq to 37 MBq (0.5 mCi to 1.0 mCi) For lung imaging performed prior to perfusion imaging, the target administered dose to the lungs is achieved after 3 to 5 minutes of inhalation or at an imaging count rate of 50,000 to 100,000 per minute * . Lung Ventilation Pediatric Patients Aerosol Inhalation 925 MBq (25 mCi) in the nebulizer to achieve a lung dose of approximately

18.5MBq (0.5 mCi) For lung imaging performed prior to perfusion imaging, the target administered dose to the lungs is achieved at an imaging count rate of approximately 10,000 to 50,000 per minute * .

2.3Administration Instructions Use aseptic technique for all drug preparation and handling. Visually inspect the Tc 99m labeled DRAXIMAGE ® DTPA injection after reconstitution for particulate matter prior to administration. Do not use or administer if there is evidence of foreign matter or the solution is not clear.

Measure the patient dose by a radioactivity calibration system immediately prior to administration. Intravenous Use Instruct the patient to increase fluid intake and to void frequently for the next 4 to 6 hours after Tc 99m labe… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 134 words ▾

3 DOSAGE FORMS AND STRENGTHS Kit for the preparation of Technetium Tc 99m pentetate injection: multiple-dose 10 mL glass vial contains a non-radioactive (white) lyophilized powder with 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg maximum tin expressed as stannous chloride dihydrate. The lyophilized product is sealed under an atmosphere of nitrogen. Following reconstitution with the Technetium Tc 99m eluate, the radioactive solution produced is a clear solution not exceeding 9250 MBq/mL (250 mCi/mL) of Tc 99m.

Kit for the preparation of Technetium Tc 99m pentetate injection: 10 mL multiple dose vials containing up to 9250 MBq / mL (250 mCi / mL) at time of preparation (reconstitution) ( 3 ).

⛔ Contraindications 35 words ▾

4 CONTRAINDICATIONS Hypersensitivity to the active ingredient or to any component of the product [see Warnings and Precautions ( 5.1 )]. Hypersensitivity to the active ingredient or any component of this product ( 4 ).

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, have been reported during post-approval diagnostic use of Technetium Tc 99m pentetate injection. Monitor all patients for hypersensitivity reactions ( 5.1 ). Image interpretation risks in lung ventilation studies: If proximal airway deposition is observed, consider additional diagnostic options ( 5.2 ).

Radiation exposure risk: Technetium Tc 99m pentetate contributes to a patient’s overall long-term radiation exposure ( 2.1 , 2.3 , 5.3 ). Bronchospasm in lung ventilation studies: Inhalation of Technetium Tc 99m pentetate solution may result in acute bronchoconstriction, especially in patients with heightened bronchoreactivity ( 5.4 ).

5.1Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported during post-approval diagnostic use of Technetium Tc 99m pentetate injection. Monitor all patients for hypersensitivity reactions and have access to cardiopulmonary resuscitation equipment and personnel.

5.2Image Interpretation Risks in Lung Ventilation Studies In patients with obstructive pulmonary disease there may be deposition of particles in the proximal airways influencing image quality and interfering with diagnostic interpretation, therefore to ensure diagnostic quality, careful use of the nebulizer to assure optimal particle delivery is essential. If interfering particle deposition occurs, consider additional diagnostic options.

5.3Radiation Exposure Risk Technetium Tc 99m contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.

Use the lowest dose of Technetium Tc 99m pentetate necessary for imaging. Encourage patients to drink fluids and void as frequently as possible after intravenous administration [see Dosage and Administration ( 2.1 , 2.3 )] . Radiation risks associated with the use of Technetium Tc 99m pentetate are greater in pediatric patients than in adults due to greater radiosensitivity and longer life expectancy.

5.4Bronchospasm in Lung Ventilation Studies As with other inhaled medications, inhalation of Technetium Tc 99m pentetate solution may result in acute bronchoconstriction, especially in patients with heightened bronchoreactivity, such as patients with asthma or other lung or allergic disorders. Monitor all patients for bronchoconstriction.

🤒 Adverse Reactions 142 words ▾

6 ADVERSE REACTIONS The following adverse reactions have been identified post-approval. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their exact frequency or establish a causal relationship to Technetium Tc 99m pentetate exposure. Adverse reactions are presented in decreasing order of reported frequency: Immune system disorders: allergic reaction, anaphylactic reaction, angioedema.

Skin and subcutaneous tissue disorders: rash, itching, hives, erythema. Respiratory, thoracic and mediastinal disorders: throat irritation, wheezing. Vascular disorders: hypotension, hypertension.

Nervous system disorders: headache, fainting, dizziness. General disorders and administration site conditions: chills. Gastrointestinal disorders: nausea, vomiting.

Cardiac disorders: cyanosis, tachycardia. Most common adverse reactions reported with Technetium Tc 99m pentetate injection include allergic reactions, rash, itching ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Limited available data with Technetium Tc 99m pentetate use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. Technetium Tc 99m pentetate is transferred across the placenta (see Data ) . No animal reproductive studies have been conducted with Technetium Tc 99m pentetate.

All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Technetium Tc 99m pentetate administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc 99m pentetate 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 are 2% to 4% and 15% to 20%, respectively. Data Human Data Limited published literature describes Technetium Tc 99m pentetate crossing the placental barrier. No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.

8.2Lactation Risk Summary There are limited data available in scientific literature on the presence of Technetium Tc 99m pentetate in human milk. There are no data available on the effects of Technetium Tc 99m pentetate on the breastfed infant or the effects on milk production. Based on the United States Nuclear Regulatory Commission guidelines for breast feeding interruption after exposure to radiopharmaceuticals, breastfeeding interruption is not recommended for Technetium 99m pentetate at levels less than 1000 MBq (30 mCi).

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Technetium Tc 99m pentetate, any potential adverse effects on the breastfed child from Technetium Tc 99m pentetate or from the underlying maternal condition.

8.4Pediatric Use Technetium Tc 99m pentetate is indicated for lung ventilation and evaluation of pulmonary embolism when paired with perfusion imaging and for renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in pediatric patients ages birth to less than 17 years of age. Pediatric use is supported by evidence from controlled studies in adults and dosing and safety are based on clinical experience. The radiation risk of Technetium Tc 99m pentetate is greater in pediatric patients than adults [See Warnings and Precautions, ( 5.3 )].

8.5Geriatric Use No formal studies of Technetium Tc 99m pentetate in the elderly were performed 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.

🤰 Pregnancy 200 words ▾

8.1Pregnancy Risk Summary Limited available data with Technetium Tc 99m pentetate use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. Technetium Tc 99m pentetate is transferred across the placenta (see Data ) . No animal reproductive studies have been conducted with Technetium Tc 99m pentetate.

All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Technetium Tc 99m pentetate administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc 99m pentetate 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 are 2% to 4% and 15% to 20%, respectively. Data Human Data Limited published literature describes Technetium Tc 99m pentetate crossing the placental barrier. No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.

🧒 Pediatric Use 90 words ▾

8.4Pediatric Use Technetium Tc 99m pentetate is indicated for lung ventilation and evaluation of pulmonary embolism when paired with perfusion imaging and for renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in pediatric patients ages birth to less than 17 years of age. Pediatric use is supported by evidence from controlled studies in adults and dosing and safety are based on clinical experience. The radiation risk of Technetium Tc 99m pentetate is greater in pediatric patients than adults [See Warnings and Precautions, ( 5.3 )].

🧓 Geriatric Use 81 words ▾

8.5Geriatric Use No formal studies of Technetium Tc 99m pentetate in the elderly were performed 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.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Intravenous Administration Following intravenous administration for brain and renal imaging, Technetium Tc 99m pentetate is distributed in the vascular compartment. It is cleared by the kidneys, which results in the ability to image the kidney. Aerosolized Inhalation Administration Following inhalation of the aerosol, Technetium Tc 99m pentetate deposits on the epithelium of ventilated alveoli.

12.2Pharmacodynamics Brain Imaging Technetium Tc 99m pentetate with intravenous administration tends to accumulate in intra-cranial lesions with excessive neovascularity or an altered blood brain barrier. Technetium Tc 99m pentetate accumulation in the brain is prevented by an intact blood brain barrier. It does not accumulate in the choroid plexus.

Renal Scintigraphy The first few minutes after intravenous administration, Technetium Tc 99m pentetate is present in the vascular compartment within the renal system. Lung Ventilation Imaging In patients with normal lungs, the deposition of Technetium Tc 99m pentetate is homogeneous throughout the lungs. In patients with airway disease, the deposition patterns become inhomogeneous with irregular deposition of Technetium Tc 99m pentetate in the airways and alveolar regions of the lung.

12.3Pharmacokinetics After an intravenous administration, the pharmacokinetics of Technetium Tc 99m pentetate were studied by monitoring radioactivity in serial venous blood samples for 7 hours post-administration. The mean plasma clearance rate was 6.8 (L/h) and the mean plasma elimination half-life (t½) was 2.1 hours. The mean volume of distribution at steady state conditions calculated with clearance and mean residence time was 17 L.

This relatively low volume of distribution after intravenous administration suggests that Technetium Tc 99m pentetate distributes to the extracellular fluid only. The rate of elimination of Technetium Tc 99m pentetate from the systemic circulation appears to be constant over an approximately 20-fold intravenous dose range. Absorption Following inhalation Technetium Tc 99m pentetate was absorbed (T max < 2 hours after inhalation) and distributed across the lung epithelium (bioavailability approximately 70%) and into the systemic circulation.

Distribution Following intravenous administration, Technetium Tc 99m pentetate is distributed throughout the extracellular fluid space and is cleared from the body by the kidney. The steady-state volume of distribution (Vss) was 17 L following an intravenous administration. Technetium Tc 99m pentetate distribution appears to be limited to the extravascular compartment.

A variable percentage of the Technetium Tc 99m pentetate binds to the serum proteins; this ranges from 3.7% following a single injection to approximately 10% if the material is continuously infused. Although the chelate gives useful information on the glomerular filtration rate, the variable percent which is protein bound leads to a measured renal clearance rate which is lower than that determined by inulin clearance. Elimination Metabolism Technetium Tc 99m pentetate is not metabolized.

Excretion After either intravenous administration or inhalation, excretion is by glomerular filtration. The mean fraction of intravenously administered Technetium Tc 99m pentetate excreted in urine over 24 hours was 102%.

🧬 Mechanism of Action 58 words ▾

12.1Mechanism of Action Intravenous Administration Following intravenous administration for brain and renal imaging, Technetium Tc 99m pentetate is distributed in the vascular compartment. It is cleared by the kidneys, which results in the ability to image the kidney. Aerosolized Inhalation Administration Following inhalation of the aerosol, Technetium Tc 99m pentetate deposits on the epithelium of ventilated alveoli.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied DRAXIMAGE ® DTPA is supplied as multiple dose kits consisting of 10 mL reaction vials containing a white, lyophilized powder with 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg tin expressed as stannous chloride dihydrate. The radionuclide is not part of the kit. Before reconstitution and radiolabeling with sodium pertechnetate Tc 99m injection USP, the contents of the kit are not radioactive.

The kits are supplied in the following formats: Carton containing 30 (thirty) kits NDC 65174.288.30

16.2Storage and Handling Store the unreconstituted reaction vials at 25 °C (77 °F); excursions permitted between 15 °C and 30 °C (59 °F and 86 °F). This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

16.1How Supplied DRAXIMAGE ® DTPA is supplied as multiple dose kits consisting of 10 mL reaction vials containing a white, lyophilized powder with 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg tin expressed as stannous chloride dihydrate. The radionuclide is not part of the kit. Before reconstitution and radiolabeling with sodium pertechnetate Tc 99m injection USP, the contents of the kit are not radioactive.

The kits are supplied in the following formats: Carton containing 30 (thirty) kits NDC 65174.288.30

📦 Storage and Handling 51 words ▾

16.2Storage and Handling Store the unreconstituted reaction vials at 25 °C (77 °F); excursions permitted between 15 °C and 30 °C (59 °F and 86 °F). This radiopharmaceutical 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 DRAXIMAGE ® DTPA is a kit for the preparation of Technetium Tc 99m pentetate injection, a radioactive diagnostic agent, for intravenous or inhalation use. Each multiple-dose 10 mL glass vial contains a sterile, non-pyrogenic, non-radioactive lyophilized powder of 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg maximum tin expressed as stannous chloride dihydrate. The lyophilized product is sealed under an atmosphere of nitrogen.

No bacteriostatic preservative is present. Its chemical name is: Technetate (1-)99mTc,[N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato(5-)]-, sodium. The structure of the technetium labeled form is: The pH is adjusted with HCl and/or NaOH prior to lyophilization so that the pH range of the reconstituted radiopharmaceutical is 6.5 to 7.5. structure

11.2Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6 hours. The principal photon that is useful for detection and imaging studies is listed in Table 7 . Table 7 Principal Radiation Emission Data Radiation Mean % per Disintegration Mean Energy (keV) Gamma-2 88.5 140.5 The air-kerma-rate (exposure-rate) constant for Technetium Tc 99m is 5.23 m 2 ·pGy·(MBq) − 1 ·s − 1 [0.795 cm 2 ·R·(mCi) − 1 ·h − 1 ].

A range of values for the relative radiation attenuation by the various thicknesses of lead is shown in Table 8 . For example, the use of a 3 mm thickness of lead 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 0.25 0.5 1 10 -1 2 10 -2 3 10 -3 4 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 of Technetium 99m Tc, Half Life: 6 Hours *Calibration Time Hours Fraction Remaining Hours Fraction Remaining 0 * 1.000 5 0.562 1 0.891 6 0.501 2 0.794 8 0.398 3 0.708 10 0.316 4 0.631 12 0.251

💬 Information for Patients 106 words ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Intravenous Use Advise patients to hydrate after administration of Tc 99m labeled DRAXIMAGE ® DTPA injection and to void frequently to minimize radiation dose [see Dosage and Administration ( 2.3 )] . Inhalation Use To minimize the potential of mouth and esophageal activity of Tc 99m labeled DRAXIMAGE ® DTPA, advise the patient to rinse their mouth with water and spit it out prior to imaging [see Dosage and Administration ( 2.3 )] . Pregnancy Advise pregnant women of the risk of fetal exposure to radiation if they undergo a radionuclide procedure [see Use in Specific Populations ( 8.1 )].

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics After an intravenous administration, the pharmacokinetics of Technetium Tc 99m pentetate were studied by monitoring radioactivity in serial venous blood samples for 7 hours post-administration. The mean plasma clearance rate was 6.8 (L/h) and the mean plasma elimination half-life (t½) was 2.1 hours. The mean volume of distribution at steady state conditions calculated with clearance and mean residence time was 17 L.

This relatively low volume of distribution after intravenous administration suggests that Technetium Tc 99m pentetate distributes to the extracellular fluid only. The rate of elimination of Technetium Tc 99m pentetate from the systemic circulation appears to be constant over an approximately 20-fold intravenous dose range. Absorption Following inhalation Technetium Tc 99m pentetate was absorbed (T max < 2 hours after inhalation) and distributed across the lung epithelium (bioavailability approximately 70%) and into the systemic circulation.

Distribution Following intravenous administration, Technetium Tc 99m pentetate is distributed throughout the extracellular fluid space and is cleared from the body by the kidney. The steady-state volume of distribution (Vss) was 17 L following an intravenous administration. Technetium Tc 99m pentetate distribution appears to be limited to the extravascular compartment.

A variable percentage of the Technetium Tc 99m pentetate binds to the serum proteins; this ranges from 3.7% following a single injection to approximately 10% if the material is continuously infused. Although the chelate gives useful information on the glomerular filtration rate, the variable percent which is protein bound leads to a measured renal clearance rate which is lower than that determined by inulin clearance. Elimination Metabolism Technetium Tc 99m pentetate is not metabolized.

Excretion After either intravenous administration or inhalation, excretion is by glomerular filtration. The mean fraction of intravenously administered Technetium Tc 99m pentetate excreted in urine over 24 hours was 102%.

🧬 Pharmacodynamics 120 words ▾

12.2Pharmacodynamics Brain Imaging Technetium Tc 99m pentetate with intravenous administration tends to accumulate in intra-cranial lesions with excessive neovascularity or an altered blood brain barrier. Technetium Tc 99m pentetate accumulation in the brain is prevented by an intact blood brain barrier. It does not accumulate in the choroid plexus.

Renal Scintigraphy The first few minutes after intravenous administration, Technetium Tc 99m pentetate is present in the vascular compartment within the renal system. Lung Ventilation Imaging In patients with normal lungs, the deposition of Technetium Tc 99m pentetate is homogeneous throughout the lungs. In patients with airway disease, the deposition patterns become inhomogeneous with irregular deposition of Technetium Tc 99m pentetate in the airways and alveolar regions of the lung.

📄 Recent Major Changes 11 words ▾

Dosage and Administration, Determination of Radiochemical Purity ( 2.5 ) 5/2022

📄 Package Label / Principal Display Panel 14 words ▾

Radioactive Label Radioactive Label

Vial Label Vial Label

30 Vials Carton 30 Vials Carton

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

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 — Not published for this NDC No photo available yet for this listing.
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 Jubilant DraxImage Inc., dba Jubilant Radiopharma. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jubilant DraxImage Inc., dba Jubilant Radiopharma 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.
← 65174-0270-30 · Jubilant 65174-0461-05 · Jubilant →
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.