RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>11994-090-06</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-06)  / 24 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-06</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-091-06</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-091-06)  / 24 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0091-06</NDC11Code>
    <ProductNDC>11994-091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-121-06</NDCCode>
    <PackageDescription>3.3 mL in 1 VIAL (11994-121-06) </PackageDescription>
    <NDC11Code>11994-0121-06</NDC11Code>
    <ProductNDC>11994-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gallium</ProprietaryName>
    <NonProprietaryName>Gallium Citrate Ga-67</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19760517</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017478</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>GALLIUM CITRATE GA-67</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19760517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>27241-090-06</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (27241-090-06) </PackageDescription>
    <NDC11Code>27241-0090-06</NDC11Code>
    <ProductNDC>27241-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
    <NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170928</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207797</ApplicationNumber>
    <LabelerName>Ajanta Pharma Limited</LabelerName>
    <SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild to moderate dementia of the Alzheimer’s type (1.1), 2 Mild to moderate dementia associated with Parkinson’s disease (1.2).</IndicationAndUsage>
    <Description>Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)- tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2  C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-090-06</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 BOX, UNIT-DOSE (33342-090-06)  &gt; 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0090-06</NDC11Code>
    <ProductNDC>33342-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
    <NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140902</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203148</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140902</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of:  Mild-to-moderate dementia of the Alzheimers type  (AD) (1.1)  Mild-to-moderate dementia associated with Parkinsons disease (PD) (1.2).</IndicationAndUsage>
    <Description>Rivastigmine tartrate USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate USP is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2  C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (hta salt). Rivastigmine tartrate USP is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine Tartrate Capsules USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, purified water, sodium lauryl sulfate and red and/or yellow iron oxides.</Description>
  </NDC>
  <NDC>
    <NDCCode>42851-090-06</NDCCode>
    <PackageDescription>6 g in 1 PACKET (42851-090-06) </PackageDescription>
    <NDC11Code>42851-0090-06</NDC11Code>
    <ProductNDC>42851-090</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zo Skin Health Astringent Solution</ProprietaryName>
    <NonProprietaryName>Aluminum Acetate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220221</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>ZO Skin Health, Inc.</LabelerName>
    <SubstanceName>ALUMINUM ACETATE</SubstanceName>
    <StrengthNumber>4866</StrengthNumber>
    <StrengthUnit>mg/6g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>When using this product. ■ avoid contact with eyes. If contact occurs, rinse thoroughly with water. ■ do not cover compress or wet dressing with plastic to prevent evaporation. ■ in some skin conditions, soaking too long may overdry.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42851-090-10</NDCCode>
    <PackageDescription>10 PACKET in 1 CARTON (42851-090-10)  &gt; 6 g in 1 PACKET (42851-090-06) </PackageDescription>
    <NDC11Code>42851-0090-10</NDC11Code>
    <ProductNDC>42851-090</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zo Skin Health Astringent Solution</ProprietaryName>
    <NonProprietaryName>Aluminum Acetate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220221</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>ZO Skin Health, Inc.</LabelerName>
    <SubstanceName>ALUMINUM ACETATE</SubstanceName>
    <StrengthNumber>4866</StrengthNumber>
    <StrengthUnit>mg/6g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42851-187-06</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (42851-187-06)  *  6 g in 1 PACKET (42851-090-06)  *  47 mL in 1 TUBE *  60 mL in 1 TUBE *  113 g in 1 TUBE *  50 mL in 1 TUBE</PackageDescription>
    <NDC11Code>42851-0187-06</NDC11Code>
    <ProductNDC>42851-187</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zo Skin Health Post Procedure Program</ProprietaryName>
    <NonProprietaryName>Aluminum Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20190702</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>ZO Skin Health, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-11-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190702</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52584-090-06</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (52584-090-06)  &gt; 6 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>52584-0090-06</NDC11Code>
    <ProductNDC>52584-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20190830</StartMarketingDate>
    <EndMarketingDate>20230630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090108</ApplicationNumber>
    <LabelerName>General Injectables and Vaccines, Inc.</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190830</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>57344-090-06</NDCCode>
    <PackageDescription>2 BOTTLE, PLASTIC in 1 CARTON (57344-090-06)  &gt; 100 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>57344-0090-06</NDC11Code>
    <ProductNDC>57344-090</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diphenhydramine</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>AAA Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68382-090-06</NDCCode>
    <PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-090-06) </PackageDescription>
    <NDC11Code>68382-0090-06</NDC11Code>
    <ProductNDC>68382-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aripiprazole</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090165</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70436-090-06</NDCCode>
    <PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (70436-090-06) </PackageDescription>
    <NDC11Code>70436-0090-06</NDC11Code>
    <ProductNDC>70436-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Montelukast Sodium</ProprietaryName>
    <NonProprietaryName>Montelukast Sodium</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180313</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205695</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC.</LabelerName>
    <SubstanceName>MONTELUKAST SODIUM</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Montelukast sodium chewable tablets are leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 2 to 14 years of age( 1.1). , 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 to 14 years of age( 1.2). , 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 to 14 years of age, and perennial allergic rhinitis (PAR) in patients2 to 14 years of age. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3). .</IndicationAndUsage>
    <Description>Montelukast Sodium, the active ingredient in montelukast sodium chewable tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35ClNNaO 3S, and its molecular weight is 608.18. The structural formula is:. Montelukast Sodium is a hygroscopic, optically active, white to off-white powder. Montelukast Sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 4 mg and 5 mg chewable montelukast sodium tablet contains 4.2 and 5.2 mg montelukast sodium, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: aspartame, cherry flavor, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, ferric oxide red, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulphate.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-01)  / 12 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-01</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-03</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-03)  / 16 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-03</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-04</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-04)  / 18 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-04</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-05</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-05)  / 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-05</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-07</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-07)  / 30 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-07</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-09</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-09)  / 40 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-09</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-10</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-10)  / 50 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-10</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-11</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-11)  / 60 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-11</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-12</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-12)  / 72 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-12</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-13</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-13)  / 80 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-13</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-36</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-36)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-36</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-73</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-73)  / 8 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-73</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-090-92</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-090-92)  / 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0090-92</NDC11Code>
    <ProductNDC>11994-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19751101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-017-16</NDCCode>
    <PackageDescription>16 VIAL, GLASS in 1 CARTON (11994-017-16)  &gt; .35 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>11994-0017-16</NDC11Code>
    <ProductNDC>11994-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Definity Rt</ProprietaryName>
    <NonProprietaryName>Perflutren</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201001</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021064</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>PERFLUTREN</SubstanceName>
    <StrengthNumber>6.52</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Contrast Agent for Ultrasound Imaging [EPC],Ultrasound Contrast Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11994-091-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-091-01)  / 12 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0091-01</NDC11Code>
    <ProductNDC>11994-091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-091-03</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-091-03)  / 16 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0091-03</NDC11Code>
    <ProductNDC>11994-091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-091-04</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-091-04)  / 18 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0091-04</NDC11Code>
    <ProductNDC>11994-091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
  <NDC>
    <NDCCode>11994-091-05</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (11994-091-05)  / 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11994-0091-05</NDC11Code>
    <ProductNDC>11994-091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technelite</ProprietaryName>
    <NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19751101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017771</ApplicationNumber>
    <LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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: 1  Thyroid Imaging, 2  Salivary Gland Imaging, 3  Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4  Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
    <Description>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.</Description>
  </NDC>
</NDCList>