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TechneLite Technetium Tc99m Generator 250 mCi/mL Injection, Solution — NDC 11994-0090-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TechneLite Technetium Tc99m Generator 250 mCi/mL Injection, Solution — NDC 11994-090-01 (Billing 11994-0090-01)

by Lantheus Medical Imaging, Inc. · 1 VIAL in 1 CARTON / 12 mL in 1 VIAL

This is a package of TechneLite Technetium Tc99m Generator 250 mCi/mL Injection, Solution from Lantheus Medical Imaging, Inc., marketed since Nov 1975 and currently FDA-listed. It is the main listing for this product, which comes in 14 package sizes.

NDC 11994-0090-01
🏷️ FDA NDC (as labeled) 11994-090-01 billing pads the product segment with a zero
This package
Contains12 mL in 1 vial Pack sizes14 compare ↓
Main listing for product 11994-090 · Also comes in: 16 mL 11994-090-03 18 mL 11994-090-04 20 mL 11994-090-05 24 mL 11994-090-06 30 mL 11994-090-07 40 mL 11994-090-09 50 mL 11994-090-10 60 mL 11994-090-11 72 mL 11994-090-12 80 mL 11994-090-13 4 mL 11994-090-36 8 mL 11994-090-73 10 mL 11994-090-92
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 →

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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 11994-090-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
11994 labeler · 090 product · 01 package
Package marketed since
Nov 1, 1975
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1199409001 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11994-090-01
Product NDC 11994-090
11-digit billing NDC 11994009001
NCPDP billing unit EA — each (per item)
UNII A0730CX801
Application # NDA017771
SPL Set ID 3ae14c6b-3daf-4dd1-bbdb-e990fe8100e4
Established class (EPC) Radioactive Diagnostic Agent
Mechanism of action Radiopharmaceutical Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1975-11-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance TECHNETIUM TC-99M SODIUM PERTECHNETATE

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

GPI-14 94359070476420
GPI class TechneLite
GCN Seq No 051337
GCN 18542
HICL code 024552
Ingredient (HICL) Sodium Pertechnetate Tc-99M
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z5
Therapeutic class — intermediate (HIC2) Radiopharmaceuticals/Radiopharmaceutical Adjuvants
HIC3 code Z5B
Therapeutic class — specific (HIC3) Radiopharmaceuticals Elements
AHFS code 36:68.00.00
AHFS class Roentgenography And Other Imaging Agents
FDB label name TECHNELITE TC99M GENERATR 3 CI
FDB brand name Technelite Tc-99M Generator
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 051337
  • GCN: 18542
  • GPI-14 (Medi-Span): 94359070476420
  • HICL (First Databank): 024552
  • AHFS class code: 36:68.00.00
Why two NDCs? The FDA registers this code as 11994-090-01 — 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 → 11994-0090-01. 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 TECHNELITE TC99M GENERATR 3 CI Ingredient Sodium Pertechnetate Tc-99M

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.
Try another pack size: 16 mL 18 mL 20 mL 24 mL 30 mL 40 mL 50 mL 60 mL 72 mL 80 mL 4 mL 8 mL 10 mL
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
11994-0090-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 12 mL in 1 VIAL 1975-11-01 — Active
11994-0090-03 11994-090-03 1 VIAL in 1 CARTON / 16 mL in 1 VIAL 1975-11-01 — Active
11994-0090-04 11994-090-04 1 VIAL in 1 CARTON / 18 mL in 1 VIAL 1975-11-01 — Active
11994-0090-05 11994-090-05 1 VIAL in 1 CARTON / 20 mL in 1 VIAL 1975-11-01 — Active
11994-0090-06 11994-090-06 1 VIAL in 1 CARTON / 24 mL in 1 VIAL 1975-11-01 — Active
11994-0090-07 11994-090-07 1 VIAL in 1 CARTON / 30 mL in 1 VIAL 1975-11-01 — Active
11994-0090-09 11994-090-09 1 VIAL in 1 CARTON / 40 mL in 1 VIAL 1975-11-01 — Active
11994-0090-10 11994-090-10 1 VIAL in 1 CARTON / 50 mL in 1 VIAL 1975-11-01 — Active
11994-0090-11 11994-090-11 1 VIAL in 1 CARTON / 60 mL in 1 VIAL 1975-11-01 — Active
11994-0090-12 11994-090-12 1 VIAL in 1 CARTON / 72 mL in 1 VIAL 1975-11-01 — Active
11994-0090-13 11994-090-13 1 VIAL in 1 CARTON / 80 mL in 1 VIAL 1975-11-01 — Active
11994-0090-36 11994-090-36 1 VIAL in 1 CARTON / 4 mL in 1 VIAL 1975-11-01 — Active
11994-0090-73 11994-090-73 1 VIAL in 1 CARTON / 8 mL in 1 VIAL 1975-11-01 — Active
11994-0090-92 11994-090-92 1 VIAL in 1 CARTON / 10 mL in 1 VIAL 1975-11-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial in 1 carton / 12 ml in 1 vial.
What NDC number is used to bill for this package of TechneLite Technetium Tc99m Generator 250 mCi/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
TechneLite 250 mCi/mLthis 11994-0090-01 Lantheus 1 vial — — FDA listed —
TechneLite 250 mCi/mL 11994-0091-01 Lantheus 1 vial — — 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

🏛️
1975
On the market since
Nov 1975
📍
2026
Currently FDA-listed
51 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerLantheus Medical Imaging, Inc.
Application holderSHINE SPECT USA LLC
FDA applicationNDA017771 (NDA)
Labeler code11994
First marketedNov 1975
Product typeHuman Prescription Drug
Portfolio9 products on file

More NDCs from Lantheus Medical Imaging, Inc. labeler code 11994

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 94 words ▾

INDICATIONS AND USAGE: The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: Thyroid Imaging Salivary Gland Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux. Nasolacrimal Drainage System Imaging Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for: Thyroid Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION: Sodium Pertechnetate Tc 99m Injection is usually administered by intravascular injection. For imaging the urinary bladder and ureters (direct isotopic cystography), the Sodium Pertechnetate Tc 99m Injection is administered by direct instillation aseptically into the bladder via a urethral catheter, following which the catheter is flushed with approximately 200 mL of 0.9% Sodium Chloride Injection, USP directly into the bladder. The dosage employed varies with each diagnostic procedure.

When imaging the nasolacrimal drainage system, instill the Sodium Pertechnetate Tc 99m Injection by the use of a device such as a micropipette or similar method which will ensure the accuracy of the dose. The suggested dose range employed for various diagnostic indications in the average ADULT PATIENT (70kg) is: Vesico-ureteral Imaging 18.5 to 37MBq (0.5 to 1mCi) Thyroid Gland Imaging 37 to 370MBq (1 to 10mCi) Salivary Gland Imaging 37 to 185MBq (1 to 5mCi) Nasolacrimal Drainage System Maximum 3.7MBq (100µCi) The recommended dosage range in PEDIATRIC PATIENTS is: Vesico-ureteral Imaging 18.5 to 37MBq (0.5 to 1mCi) Thyroid Gland Imaging 2.22 to 2.96MBq (60 to 80µCi)/kg body weight The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration of the dose.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The solution to be administered as the patient dose should be clear and contain no particulate matter. Do not use an eluate of the TECHNELITE ® , Technetium Tc 99m Generator later than one (1) working day after elution (12 hours).

Radiation Dosimetry The estimated absorbed radiation doses to an average ADULT and Pediatric patient from an intravenous injection of a maximum dose of 1110MBq (30 millicuries) of Sodium Pertechnetate Tc 99m Injection distributed uniformly in the total body are shown in Tables 5 and 6. Table 5. Adult Absorbed Radiation Doses (mGy) from Intravenous Injection Organ Absorbed Radiation Dose (mGy) for a 1110 MBq (30mCi) dose To obtain radiation absorbed dose in rads (30 mCi dose) from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose).

Adrenals

4.1 Urinary Bladder Wall 20 Bone Surfaces

6.2 Brain

2.2 Breasts 2 Gallbladder Wall

8.3 Stomach Wall 29 Small Intestine 18 ULI Wall 63 LLI Wall 23 Heart Wall

3.5 Kidneys 6 Liver

4.7 Lungs

2.9 Muscle

3.6 Ovaries 11 Pancreas

6.3 Red Marrow

4.1 Skin 2 Spleen

4.8 Testes

3.1 Thymus

2.7 Thyroid 24 Uterus 9 Remaining Tissues

3.9Effective Dose (mSv) 14 Table 6. Pediatric Absorbed Radiation Doses (mGy) from Intravenous Injection Age 15 years 10 years 5 years 1 year To obtain radiation absorbed dose in rads (30 mCi dose) from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose). Administered activity in MBq (mCi) 1110 (30) 740 (20) 555 (15) 370 (10) Organ Adrenals 5.3 5.4 6.2

7.1Urinary Bladder Wall 26 22 18 22 Bone Surfaces 7.6 7.5 8.1 10 Brain 2.8 3.1 3.7

4.5Breasts 2.6 2.6 3.2

4.1Gallbladder Wall 11 12 13 13 Stomach Wall 38 36 43 59 Small Intestine 22 23 26 30 ULI Wall 81 89 110 140 LLI Wall 31 33 40 48 Heart Wall 4.5 4.6 5.2

6.4Kidneys 7.2 6.9 7.8

8.5Liver 6 6.7 8

9.1Lungs 3.8 3.8 4.4

5.3Muscle 4.5 4.5 5 6 Ovaries 14 13 14 17 Pancreas 8.1 8.2 8.9 10 Red Marrow 5.1 5 5.2 6 Skin 2.5 2.6 3.2

3.8Spleen 6 6 6.7

7.8Testes 4.1 4.3 4.9 6 Thymus 3.6 3.5 4.2

5.3Thyroid 40 41 67 81 Uterus 11 11 12 14 Remaining Tissues 4.8 4.8 5.4

6.4Effective Dose (mSv) 19 19 23 29 The estimated absorbed radiation doses to an average ADULT from the instillation of Sodium Pertechnetate Tc 99m Injection for imaging the nasolacrimal drainage system are shown in Table 7. Table 7. Absorbed Radiation Dose from Dacryoscintigraphy Using Sodium Pertechnetate Tc 99m Absorbed Dose Target Organ mGy/ 3.7MBq (rad/ 100µCi) * Assuming n… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS: None known.

⚠️ Warnings 68 words ▾

WARNINGS: Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life-expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.

🤒 Adverse Reactions 19 words ▾

ADVERSE REACTIONS: Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m Injection.

🤰 Pregnancy 84 words ▾

Pregnancy Animal reproductive studies have not been conducted with Sodium Pertechnetate Tc 99m. It is also not known whether Sodium Pertechnetate Tc 99m can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Pertechnetate Tc 99m Injection should be given to a pregnant woman only if clearly needed.

Ideally examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

🧒 Pediatric Use 18 words ▾

Pediatric Use See INDICATIONS and DOSAGE AND ADMINISTRATION sections. Also see the description of additional risks under WARNINGS.

🧓 Geriatric Use 83 words ▾

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

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY: The pertechnetate ion distributes in the body similarly to the iodide ion but is not organified when trapped in the thyroid gland. It also concentrates in the choroid plexus, thyroid gland, salivary glands, and stomach. However, in contrast to the iodide ion, the pertechnetate ion is released unchanged from the thyroid gland.

After intravascular administration the pertechnetate ion gradually equilibrates with the extracellular space. A fraction is promptly excreted via the kidneys. Following the administration of Sodium Pertechnetate Tc 99m Injection as an eye drop, the drug mixes with tears within the conjunctival space.

Within seconds to minutes it leaves the conjunctival space and escapes into the inferior meatus of the nose through the nasolacrimal drainage system. During this process the pertechnetate ion passes through the canaliculi, the lacrimal sac and the nasolacrimal duct. In the event of any anatomical or functional blockage of the drainage system there will be a backflow resulting in tearing (epiphora).

Thus the pertechnetate escapes the conjunctival space in the tears. While the major part of the pertechnetate escapes within a few minutes of normal drainage and tearing, it has been documented that there is some degree of transconjunctival absorption with a fractional turnover rate of 0.015/min in normal individuals, 0.021/min in patients without any sac and 0.027/min in patients with inflamed conjunctiva due to chronic dacryocystitis. Individual values may vary but these rates are probably representative and indicate that the maximum possible pertechnetate absorbed will remain below one thousandth of that used in other routine diagnostic procedures.

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

HOW SUPPLIED: Lantheus Medical Imaging TechneLite ® , (Technetium Tc 99m Generator) for the Production of Sodium Pertechnetate Tc 99m Injection is supplied in a multi-dose container and is available in the following quantities of radioactivity of Mo99 on the calibration date (date of manufacture) as specified on the product lot identification label affixed to the generator: Table 9 Available Quantities of Radioactivity High Enriched Uranium (HEU) Low Enriched Uranium (LEU) NDC # GBq of Mo99 Ci of Mo99 NDC # GBq of Mo99 Ci of Mo99 11994-090-36 37.0 1 11994-091-36 37.0 1 11994-090-73 74.0 2 11994-091-73 74.0 2 11994-090-92 92.5 2.5 11994-091-92 92.5 2.5 11994-090-01 111.0 3 11994-091-01 111.0 3 11994-090-03 148.0 4 11994-091-03 148.0 4 11994-090-04 166.5 4.5 11994-091-04 166.5 4.5 11994-090-05 185.0 5 11994-091-05 185.0 5 11994-090-06 222.0 6 11994-091-06 222.0 6 11994-090-07 277.5 7.5 11994-091-07 277.5 7.5 11994-090-09 370.0 10 11994-091-09 370.0 10 11994-090-10 462.5 12.5 11994-091-10 462.5 12.5 11994-090-11 555.0 15 11994-091-11 555.0 15 11994-090-12 666.0 18 11994-091-12 666.0 18 11994-090-13 740.0 20 11994-091-13 740.0 20 Each generator is supplied with the following standard components: Collect Needle Seal Eluant Charge Vials (may be supplied separately) Eluate Collection Vials (may be supplied separately) 1 Package Insert 6 Radiation Labels (Collection Vial) 6 Radiation Labels (Eluting Shield) First order generators are shipped with the following accessory components: 2 Eluting Shields Additional quantities of these components may be obtained at the customer's request.

📦 Storage and Handling 21 words ▾

STORAGE: Store generator and Sodium Pertechnetate Tc 99m Injection at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description ~3 min read ▾

DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE ® , Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5.

The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE ® , Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours).

Lantheus Medical Imaging, Inc. TECHNELITE ® , Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle.

Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic.

The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield.

The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution. Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.

1 Photons that are useful for imaging studies are listed in Table 1. Table 1. Principal Radiation Emission Data - Technetium Tc 99m Radiation Mean %/Disintegration Mean Energy (keV) Gamma-2 89.07 140.5 External Radiation The specific gamma ray constant for Technetium Tc 99m is 5.4 microcoulombs/Kg-MBq-hr (0.795 R/mCi-hr) at 1cm.

The first half-value thickness is 0.023cm of lead (Pb). To facilitate control of radiation exposure from millicurie amounts of Technetium Tc 99m, for example, the use of a 0.27 cm thick standard radiation elution lead shield will attenuate the radiation emitted by a factor of about 1000. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead is shown in Table 2.

NOTE : Because the generator is well contained and essentially dry, there is little likelihood of contamination due to damage in transit. Table 2. Radiation Attenuation of Technetium Tc 99m by Lead Shielding Shield Thickness lead (Pb) cm Coefficient of Attenuation 0.023 0.5 0.09 10 -1 0.18 10 -2 0.27 10 -3 0.33 10 -4 Molybdenum Mo99 decays to Technetium Tc 99m with a Molybdenum Mo99 half-life of 66 hours.

This means that only 78% of the activity remains after 24 hours; 60% remains after 48 hours, etc. (see Table 3). All units have a minimum of 38 mm, 1.5 inches (~ 6 half-value layers) of lead surrounding the activity.

(See Table 3.) Table 3. Molybdenum Mo99 Decay Chart Half-Life

66.0Hours Days Percent Remaining Days Percent Remaining 0 100 10 8 1 78 11 6 2 60 12 5 3 47 13 4 4 37 14 3 5 28 15 2 6 22 20 0.6 7 17 25 0.2 8 13 30 0.05 9 10 The physical decay characteris… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~2 min read ▾

PRECAUTIONS: General As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers. Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of TECHNELITE ® , Technetium Tc 99m Generator elution. After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Carcinogenesis, Mutagenesis, Impairment of Fertility No animal studies have been performed to evaluate carcinogenic potential or whether Sodium Pertechnetate Tc 99m affects fertility in males or females. Pregnancy Animal reproductive studies have not been conducted with Sodium Pertechnetate Tc 99m.

It is also not known whether Sodium Pertechnetate Tc 99m can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Pertechnetate Tc 99m Injection should be given to a pregnant woman only if clearly needed. Ideally examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers Sodium Pertechnetate Tc 99m is excreted in human milk during lactation; therefore formula feedings should be substituted for breast feeding. This radiopharmaceutical preparation should not be administered to pregnant or lactating women unless expected benefits to be gained outweigh the potential risks. Pediatric Use See INDICATIONS and DOSAGE AND ADMINISTRATION sections.

Also see the description of additional risks under WARNINGS. Geriatric Use Clinical studies of TechneLite ® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🍼 Nursing Mothers 44 words ▾

Nursing Mothers Sodium Pertechnetate Tc 99m is excreted in human milk during lactation; therefore formula feedings should be substituted for breast feeding. This radiopharmaceutical preparation should not be administered to pregnant or lactating women unless expected benefits to be gained outweigh the potential risks.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 27 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No animal studies have been performed to evaluate carcinogenic potential or whether Sodium Pertechnetate Tc 99m affects fertility in males or females.

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - Generator Label - NDC 11994-090 Sterile, Non-Pyrogenic Diagnostic Agent for Intravenous Injection TechneLite ® Technetium Tc 99m Generator for the Production of Sodium Pertechnetate Tc 99m Injection Rx only. See Package Insert for dosing information. DIN 02328550 AUSTR R 130301 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Eluate must be used within 12 hours of elution. CAUTION: This generator should not be dismantled. Manufacturer: Lantheus Medical Imaging ® N.

Billerica, Massachusetts 01862 USA Canadian License Holder: Lantheus MI Canada, Inc. Montréal, Canada H4M 2X6 Australian Sponsor: Global Medical Solutions Australia Pty Ltd. 515128-1023 CAUTION: RADIOACTIVE MATERIAL PRINCIPAL DISPLAY PANEL - Generator Label - NDC 11994-090

PRINCIPAL DISPLAY PANEL - Generator Label - NDC 11994-091 Sterile, Non-Pyrogenic Diagnostic Agent for Intravenous Injection TechneLite ® Technetium Tc 99m Generator for the Production of Sodium Pertechnetate Tc 99m Injection Rx only. See Package Insert for dosing information. DIN 02328550 AUSTR R 130301 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Eluate must be used within 12 hours of elution. CAUTION: This generator should not be dismantled. Manufacturer: Lantheus Medical Imaging ® N.

Billerica, Massachusetts 01862 USA Canadian License Holder: Lantheus MI Canada, Inc. Montréal, Canada H4M 2X6 Australian Sponsor: Global Medical Solutions Australia Pty Ltd. 515128-1023 CAUTION: RADIOACTIVE MATERIAL PRINCIPAL DISPLAY PANEL - Generator Label - NDC 11994-091

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

Reported adverse events (FAERS)

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

Top reported reactions

Dyspnoea2
Pruritus2
Hot Flush1
Incorrect Route Of Product Administration1
Nausea1
Occupational Exposure To Product1
Occupational Exposure To Radiation1

Reporter sex

14 reports
Male · 57%
Female · 43%

Serious outcomes

Hospitalization2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Lantheus Medical Imaging, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 13 other package presentations of this same product, including 1 vial (11994-0090-03), 1 vial (11994-0090-04), 1 vial (11994-0090-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Lantheus Medical Imaging, 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.
← 11994-0017-01 · Lantheus 11994-0091-01 · Lantheus →
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.