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{
  "NDC": [
    {
      "NDCCode": "69945-092-20",
      "PackageDescription": "5 VIAL in 1 CELLO PACK (69945-092-20)  > 10 mL in 1 VIAL",
      "NDC11Code": "69945-0092-20",
      "ProductNDC": "69945-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Technetium Tc 99m Sestamibi",
      "NonProprietaryName": "Technetium Tc 99m Sestamibi",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20111031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078098",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20111031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Myocardial Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Kit for the Preparation of Technetium Tc99m Sestamibi Injection is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.",
      "Description": "Each 10 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: 1 Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate – 1 mg, 2 Sodium Citrate Dihydrate - 2.6 mg, 3 L-Cysteine Hydrochloride Monohydrate – 1 mg, 4 Mannitol - 20 mg, 5 Stannous Chloride, Dihydrate, minimum (SnCl22H2O) - 0.025 mg, 6 Stannous Chloride, Dihydrate (SnCl22H2O) - 0.075 mg, 7 Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl22H2O) - 0.086 mg."
    },
    {
      "NDCCode": "69945-092-40",
      "PackageDescription": "30 VIAL in 1 CARTON (69945-092-40)  > 10 mL in 1 VIAL",
      "NDC11Code": "69945-0092-40",
      "ProductNDC": "69945-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Technetium Tc 99m Sestamibi",
      "NonProprietaryName": "Technetium Tc 99m Sestamibi",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20111031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078098",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20111031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Myocardial Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Kit for the Preparation of Technetium Tc99m Sestamibi Injection is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.",
      "Description": "Each 10 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: 1 Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate – 1 mg, 2 Sodium Citrate Dihydrate - 2.6 mg, 3 L-Cysteine Hydrochloride Monohydrate – 1 mg, 4 Mannitol - 20 mg, 5 Stannous Chloride, Dihydrate, minimum (SnCl22H2O) - 0.025 mg, 6 Stannous Chloride, Dihydrate (SnCl22H2O) - 0.075 mg, 7 Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl22H2O) - 0.086 mg."
    },
    {
      "NDCCode": "69945-068-20",
      "PackageDescription": "5 CELLO PACK in 1 BOX (69945-068-20)  / 1 KIT in 1 CELLO PACK (69945-068-10)  *  .6 mL in 1 SYRINGE, GLASS *  1 mL in 1 SYRINGE, GLASS *  9.5 mg in 1 VIAL, GLASS",
      "NDC11Code": "69945-0068-20",
      "ProductNDC": "69945-068",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ultratag",
      "ProprietaryNameSuffix": "Rbc",
      "NonProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Red Blood Cells",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19910610",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019981",
      "LabelerName": "Curium US LLC",
      "Status": "Active",
      "LastUpdate": "2025-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19910610",
      "SamplePackage": "N",
      "IndicationAndUsage": "Technetium Tc 99m red blood cells are used for blood pool imaging, including cardiac first pass and gated equilibrium imaging and for detection of sites of gastrointestinal bleeding.",
      "Description": "Ultratag RBC (Kit for the Preparation of Technetium Tc 99m Red Blood Cells Injection) is a sterile, nonpyrogenic, diagnostic kit for the in vitro preparation of Technetium Tc 99m Red Blood Cells Injection. Each kit consists of three separate nonradioactive components. 1.      A 10 milliliter reaction vial containing.          Stannous Chloride, Dihydrate (SnCl 22H 2O) – 50 mcg minimum.          Stannous Chloride, Dihydrate (SnCl 22H 2O) – 96 mcg theoretical.          Tin Chloride (Stannous and Stannic), Dihydrate (as SnCl 22H 2O) – 105 mcg maximum.          Sodium Citrate, Dihydrate – 3.67 mg.          Dextrose, Anhydrous – 5.5 mg.          Hydrochloric Acid – 0.47 mg. Prior to lyophilization, the pH is adjusted to 7.1 to 7.2 with sodium hydroxide. The contents of the vial are lyophilized and stored under argon. 2.      Syringe I contains.          Sodium Hypochlorite – 0.6 mg in Sterile Water for Injection. The total volume of this syringe is 0.6 mL. Sodium hydroxide may have been added for pH adjustment. The pH of this solution is 11 to 13. The syringe must be protected from light to prevent degradation of the light-sensitive sodium hypochlorite. 3.      Syringe II contains.          Citric Acid, Monohydrate – 8.7 mg.          Sodium Citrate, Dihydrate – 32.5 mg.          Dextrose, Anhydrous – 12 mg in Sterile Water for Injection. The total volume of this syringe is 1 mL. The pH range of this solution is adjusted to 4.5 to 5.5 with sodium citrate or citric acid as needed."
    },
    {
      "NDCCode": "69945-091-20",
      "PackageDescription": "5 VIAL in 1 CELLO PACK (69945-091-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (69945-091-01) ",
      "NDC11Code": "69945-0091-20",
      "ProductNDC": "69945-091",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Technescan Hdp",
      "NonProprietaryName": "Technetium Tc 99m Oxidronate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20151013",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018321",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "OXIDRONATE DISODIUM",
      "StrengthNumber": "3.15",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151013",
      "SamplePackage": "N",
      "IndicationAndUsage": "Technescan HDP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for skeletal imaging to demonstrate areas of altered osteogenesis in adult and pediatric patients.",
      "Description": "Drug Characteristics. Technescan HDP (kit for the preparation of technetium Tc 99m oxidronate injection) is a radioactive diagnostic drug for intravenous use after radiolabeling with sodium pertechnetate Tc 99m injection. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl 22H 2O), 0.297 mg, theoretical, stannous chloride (SnCl 22H 2O) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl 22H 2O, and the following inactive ingredients: 0.84 mg gentisic acid as a stabilizer and 30 mg sodium chloride. The pH is adjusted with hydrochloric acid and/or sodium hydroxide. The pH of the radiolabeled drug is between 4.0 and 5.5. The vial contains a sterile, non-pyrogenic, lyophilized powder packaged under nitrogen. The chemical structure of oxidronate sodium is. The structure of the technetium Tc 99m oxidronate complex is unknown."
    },
    {
      "NDCCode": "69945-094-20",
      "PackageDescription": "5 VIAL in 1 CELLO PACK (69945-094-20)  / 10 mL in 1 VIAL (69945-094-01) ",
      "NDC11Code": "69945-0094-20",
      "ProductNDC": "69945-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Technescan Pyp",
      "NonProprietaryName": "Technetium Tc 99m Pyrophosphate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20151014",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017538",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "SODIUM PYROPHOSPHATE; STANNOUS CHLORIDE",
      "StrengthNumber": "11.9; 3.2",
      "StrengthUnit": "mg/10mL; mg/10mL",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151014",
      "SamplePackage": "N",
      "IndicationAndUsage": "Technescan PYP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for:  Skeletal imaging to demonstrate areas of altered osteogenesis in adults  Cardiac imaging as an adjunct in the diagnosis of acute myocardial infarction in adults (See WARNINGS). Technescan PYP, in conjunction with sodium pertechnetate Tc 99m injection for red blood cell (RBC) labeling, is indicated for gated cardiac blood pool imaging and for the detection of gastrointestinal bleeding sites in adults.",
      "Description": "Drug Characteristics Technescan PYP (kit for the preparation of technetium Tc 99m pyrophosphate injection) is a radioactive diagnostic drug for intravenous use after radiolabeling with sodium pertechnetate Tc 99m injection or after reconstitution with 0.9% sodium chloride injection in conjunction with sodium pertechnetate Tc 99m injection. Each vial contains 11.9 mg sodium pyrophosphate, 3.2 mg (minimum) stannous chloride (SnCl 22H 2O), and 4.4 mg (maximum) total tin expressed as stannous chloride (SnCl 22H 2O). Prior to lyophilization, the pH is adjusted with hydrochloric acid. The pH of the reconstituted drug is between 4.5 and 7.5. No bacteriostatic preservative is present. The vial contains a sterile, non-pyrogenic, lyophilized powder packaged under nitrogen. The precise structures of the stannous-pyrophosphate and technetium Tc 99m pyrophosphate complexes are not known."
    },
    {
      "NDCCode": "69945-096-20",
      "PackageDescription": "5 VIAL in 1 CELLO PACK (69945-096-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
      "NDC11Code": "69945-0096-20",
      "ProductNDC": "69945-096",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Technescan Mag3",
      "NonProprietaryName": "Technescan Tc 99m Mertiatide",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19900615",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019882",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "BETIATIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19900615",
      "SamplePackage": "N",
      "IndicationAndUsage": "Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use.) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.",
      "Description": "Technescan MAG3 is a kit for the preparation of technetium Tc 99m mertiatide, a diagnostic radiopharmaceutical. It is supplied as a sterile, nonpyrogenic, lyophilized powder. Each vial contains betiatide (N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine). After reconstitution with sterile sodium pertechnetate Tc 99m injection, the technetium Tc 99m mertiatide (disodium[N-[N-[N-(mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N′,N″,S′]oxotechnetate (2-)) which is formed is suitable for intravenous administration. Each 10 milliliter vial contains 1 milligram betiatide, 0.05 milligram (minimum) stannous chloride dihydrate (SnCl 22H 2O) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (SnCl 22H 2O), 40 milligrams sodium tartrate dihydrate (Na 2C 4H 2O 62H 2O), and 20 milligrams lactose monohydrate. Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. The contents are sealed under argon. Betiatide is light sensitive and must be protected from light. Betiatide and technetium Tc 99m mertiatide have the following structural formulas:."
    },
    {
      "NDCCode": "69945-139-20",
      "PackageDescription": "5 VIAL, MULTI-DOSE in 1 CELLO PACK (69945-139-20)  / 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10) ",
      "NDC11Code": "69945-0139-20",
      "ProductNDC": "69945-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pulmotech Maa",
      "NonProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
      "RouteName": "INTRAPERITONEAL; INTRAVENOUS",
      "StartMarketingDate": "20200320",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA210089",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "ALBUMIN AGGREGATED",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/15mL",
      "Status": "Active",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200320",
      "SamplePackage": "N",
      "IndicationAndUsage": "PULMOTECH MAA, after radiolabeling with technetium-99m, is indicated for: 1 Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients., 2 Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults.",
      "Description": "PULMOTECH MAA contains albumin aggregated obtained by fractionating material (source blood, plasma, serum, or placentas) from healthy human donors. The macroaggregated albumin (MAA) particles are formed by heat denaturation of stannous chloride treated albumin human under controlled conditions. Each vial contains 2,000,000 to 4,000,000 particles. The particle size distribution of the aggregated albumin is such that not less than 90% are 10 to 90 micrometers in size. There are no aggregated albumin particles greater than 150 micrometers in size as determined by circular equivalents. PULMOTECH MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection provides a sterile, non-pyrogenic, non-radioactive, white lyophilized powder in a multiple-dose reaction vial, sealed under an atmosphere of nitrogen, for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare Technetium Tc 99m Albumin Aggregated Injection, a radioactive diagnostic agent, for intravenous or intraperitoneal use. Each reaction vial contains 2 mg of albumin aggregated, albumin human (7.1 mg), stannous chloride (0.1 mg minimum; 0.22 mg maximum stannous and stannic), sodium chloride (9 mg). Hydrochloric acid may have been added for pH adjustment. The pH is between 5 and 7. It contains no preservatives."
    },
    {
      "NDCCode": "69945-177-01",
      "PackageDescription": "20 mL in 1 VIAL, SINGLE-DOSE (69945-177-01) ",
      "NDC11Code": "69945-0177-01",
      "ProductNDC": "69945-177",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bexlutry",
      "NonProprietaryName": "Lutetium Oxodotreotide Lu-177",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260914",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA218525",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "LUTETIUM OXODOTREOTIDE LU-177",
      "StrengthNumber": "10",
      "StrengthUnit": "mCi/mL",
      "Status": "Active",
      "LastUpdate": "2026-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260914",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69945-452-20",
      "PackageDescription": "1 CAPSULE in 1 CAN (69945-452-20)  > 20 mL in 1 CAPSULE",
      "NDC11Code": "69945-0452-20",
      "ProductNDC": "69945-452",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I 131",
      "NonProprietaryName": "Sodium Iodide I 131",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151027",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016517",
      "LabelerName": "MALLINCKRODT NUCLEAR MEDICINE LLC",
      "SubstanceName": "SODIUM IODIDE I-131",
      "StrengthNumber": "1",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20151027",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69945-602-20",
      "PackageDescription": "1 BOTTLE in 1 CAN (69945-602-20)  / 1 CAPSULE, GELATIN COATED in 1 BOTTLE",
      "NDC11Code": "69945-0602-20",
      "ProductNDC": "69945-602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I 123",
      "NonProprietaryName": "Sodium Iodide I 123",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071910",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "SODIUM IODIDE I-123",
      "StrengthNumber": "200",
      "StrengthUnit": "uCi/1",
      "Status": "Active",
      "LastUpdate": "2024-10-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20070411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.",
      "Description": "Sodium Iodide I 123 (Na 123I) for diagnostic use is supplied in capsules for oral administration. The capsules are available in strengths of 3.7 and 7.4 megabecquerels (MBq) (100 and 200 μCi) I-123 at time of calibration. The radionuclidic composition at calibration is not less than 97.0 percent I-123, not more than 2.9 percent I-125 and not more than 0.1 percent Te-121. The radionuclidic composition at expiration time is not less than 87.2 percent I-123, not more than 12.4 percent I-125 and not more than 0.4 percent Te-121. The ratio of the concentration of I-123 and I-125 changes with time. Graph 1 shows the minimum concentration of I-123 as a function of time and Graph 2 shows the maximum concentration of I-125 as a function of time. Graph 1. Radionuclidic Concentration of I-123. PERCENT OF TOTAL RADIOACTIVITY: IODINE-123. Graph 2. Radionuclidic Concentration of I-125. PERCENT OF TOTAL RADIOACTIVITY: IODINE-125."
    },
    {
      "NDCCode": "16590-092-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE (16590-092-20)",
      "NDC11Code": "16590-0092-20",
      "ProductNDC": "16590-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Etodolac",
      "NonProprietaryName": "Etodolac",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980311",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075074",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ETODOLAC",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.",
      "Description": "Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Polyethylene Glycol, Povidone USP, Sodium Starch Glycolate NF and Titanium Dioxide. Also, each 400 mg tablet contains Iron Oxide Red and Iron Oxide Yellow. Each 500 mg tablet contains D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and FD&C Red #40 Aluminum Lake."
    },
    {
      "NDCCode": "37000-092-20",
      "PackageDescription": "200 mL in 1 BOTTLE, PLASTIC (37000-092-20)",
      "NDC11Code": "37000-0092-20",
      "ProductNDC": "37000-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Head And Shoulders",
      "ProprietaryNameSuffix": "Dry Scalp Care",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "LOTION/SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130901",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358H",
      "LabelerName": "Procter & Gamble Manufacturing Co.",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-09-26"
    },
    {
      "NDCCode": "48433-092-20",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (48433-092-20)  / 1 CAPSULE in 1 BLISTER PACK (48433-092-01) ",
      "NDC11Code": "48433-0092-20",
      "ProductNDC": "48433-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tacrolimus",
      "NonProprietaryName": "Tacrolimus",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260313",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090596",
      "LabelerName": "Safecor Health LLC",
      "SubstanceName": "TACROLIMUS",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260313",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, or heart transplants, in combination with other immunosuppressants. ( 1.1).",
      "Description": "Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5."
    },
    {
      "NDCCode": "50268-092-12",
      "PackageDescription": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-092-12)  / 1 TABLET in 1 BLISTER PACK (50268-092-11) ",
      "NDC11Code": "50268-0092-12",
      "ProductNDC": "50268-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aripiprazole",
      "NonProprietaryName": "Aripiprazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160428",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205064",
      "LabelerName": "AvPAK",
      "SubstanceName": "ARIPIPRAZOLE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160428",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of:  Schizophrenia  Treatment of Tourette’s Disorder.",
      "Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
    },
    {
      "NDCCode": "55289-092-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (55289-092-20) ",
      "NDC11Code": "55289-0092-20",
      "ProductNDC": "55289-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diazepam",
      "NonProprietaryName": "Diazepam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19850904",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070325",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "DIAZEPAM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
      "Description": "Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2 H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The molecular formula is C 16H 13ClN 2O and the molecular weight is 284.7. The structural formula is as follows:. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam, USP. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake. The 10 mg tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake."
    },
    {
      "NDCCode": "58159-092-02",
      "PackageDescription": "20 kg in 1 DRUM (58159-092-02) ",
      "NDC11Code": "58159-0092-02",
      "ProductNDC": "58159-092",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Pitolisant Hydrochloride Sd",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20220929",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "PITOLISANT HYDROCHLORIDE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-12",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "29-SEP-22"
    },
    {
      "NDCCode": "62135-092-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE (62135-092-20) ",
      "NDC11Code": "62135-0092-20",
      "ProductNDC": "62135-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20021031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065096",
      "LabelerName": "Chartwell RX, LLC",
      "SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
      "StrengthNumber": "875; 125",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260721",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below. : 1 Lower Respiratory Tract Infections – caused by beta–lactamase–producing isolates of  Haemophilus influenzae and  Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media – caused by beta–lactamase–producing isolates of  H. influenzae and  M. catarrhalis. , 3 Sinusitis – caused by beta–lactamase–producing isolates of  H. influenzae and  M. catarrhalis., 4 Skin and Skin Structure Infections – caused by beta–lactamase–producing isolates of  Staphylococcus aureus, Escherichia coli, and  Klebsiella species. , 5 Urinary Tract Infections – caused by beta–lactamase–producing isolates of  E.coli, Klebsiella species, and  Enterobacter species. .",
      "Description": "Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are oral antibacterial combinations consisting of the semisynthetic antibiotic amoxicillin, USP and the beta–lactamase inhibitor, clavulanate potassium, USP (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6–aminopenicillanic acid. Chemically, amoxicillin, USP is (2S,5R,6R)–6–[(R)–(–)–2–Amino–2–(p–hydroxyphenyl)acetamido]–3,3–dimethyl–7–oxo–4–thia–1–azabicyclo[3.2.0]heptane–2–carboxylic acid trihydrate and has the following structural formula. C 16H 19N 3O 5S3H 2O M.W. 419.45. Clavulanic acid is produced by the fermentation of  Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. Chemically, clavulanate potassium, USP is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and has the following structural formula:. C 8H 8KNO 5  M.W. 237.25. Amoxicillin and Clavulanate Potassium Tablets, USP. : 1 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). , 2 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). ."
    },
    {
      "NDCCode": "64543-092-20",
      "PackageDescription": "12 POUCH in 1 CARTON (64543-092-20)  > 1 TABLET in 1 POUCH",
      "NDC11Code": "64543-0092-20",
      "ProductNDC": "64543-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rescon Mx",
      "NonProprietaryName": "Dexchlorpheniramine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111228",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Capellon Pharmaceuticals, LLC",
      "SubstanceName": "DEXCHLORPHENIRAMINE MALEATE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-03-12"
    },
    {
      "NDCCode": "64661-092-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE (64661-092-20)",
      "NDC11Code": "64661-0092-20",
      "ProductNDC": "64661-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Drymax",
      "ProprietaryNameSuffix": "Af",
      "NonProprietaryName": "Chlophedianol Hydrochloride, Chlorpheniramine Maleate, Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130219",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "JayMac Pharmaceuticals",
      "SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "25; 4; 15",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "84010-092-01",
      "PackageDescription": "20 g in 1 TUBE (84010-092-01) ",
      "NDC11Code": "84010-0092-01",
      "ProductNDC": "84010-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Healmusz Fast Natural Wart Removal",
      "NonProprietaryName": "Salicylic Acid 17% Fast Natural Wart Removal",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250327",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M028",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "17",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250327",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the removal of common warts, which have a rough,cauliflower-like appearance."
    },
    {
      "NDCCode": "85766-092-20",
      "PackageDescription": "20 TABLET, COATED in 1 BOTTLE (85766-092-20) ",
      "NDC11Code": "85766-0092-20",
      "ProductNDC": "85766-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Geri-dryl Allergy Relief",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Sportpharm LLC",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251008",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:. runny nose."
    },
    {
      "NDCCode": "69945-097-11",
      "PackageDescription": "1 CAN in 1 CONTAINER (69945-097-11)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE",
      "NDC11Code": "69945-0097-11",
      "ProductNDC": "69945-097",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Xenon, Xe-133",
      "NonProprietaryName": "Xenon",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20160330",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018327",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "XENON XE-133",
      "StrengthNumber": "5",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.",
      "Description": "Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition."
    },
    {
      "NDCCode": "69945-097-13",
      "PackageDescription": "3 CAN in 1 CONTAINER (69945-097-13)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE",
      "NDC11Code": "69945-0097-13",
      "ProductNDC": "69945-097",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Xenon, Xe-133",
      "NonProprietaryName": "Xenon",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20160330",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018327",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "XENON XE-133",
      "StrengthNumber": "5",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.",
      "Description": "Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition."
    },
    {
      "NDCCode": "69945-097-15",
      "PackageDescription": "5 CAN in 1 CONTAINER (69945-097-15)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE",
      "NDC11Code": "69945-0097-15",
      "ProductNDC": "69945-097",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Xenon, Xe-133",
      "NonProprietaryName": "Xenon",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20160330",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018327",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "XENON XE-133",
      "StrengthNumber": "5",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.",
      "Description": "Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition."
    },
    {
      "NDCCode": "69945-098-21",
      "PackageDescription": "1 CAN in 1 CONTAINER (69945-098-21)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE",
      "NDC11Code": "69945-0098-21",
      "ProductNDC": "69945-098",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Xenon, Xe-133",
      "NonProprietaryName": "Xenon",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20160330",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018327",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "XENON XE-133",
      "StrengthNumber": "10",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.",
      "Description": "Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition."
    },
    {
      "NDCCode": "69945-098-23",
      "PackageDescription": "3 CAN in 1 CONTAINER (69945-098-23)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE",
      "NDC11Code": "69945-0098-23",
      "ProductNDC": "69945-098",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Xenon, Xe-133",
      "NonProprietaryName": "Xenon",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20160330",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018327",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "XENON XE-133",
      "StrengthNumber": "10",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.",
      "Description": "Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition."
    },
    {
      "NDCCode": "69945-098-25",
      "PackageDescription": "5 CAN in 1 CONTAINER (69945-098-25)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE",
      "NDC11Code": "69945-0098-25",
      "ProductNDC": "69945-098",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Xenon, Xe-133",
      "NonProprietaryName": "Xenon",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20160330",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018327",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "XENON XE-133",
      "StrengthNumber": "10",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.",
      "Description": "Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition."
    },
    {
      "NDCCode": "69945-273-00",
      "PackageDescription": "800 g in 1 BOTTLE (69945-273-00) ",
      "NDC11Code": "69945-0273-00",
      "ProductNDC": "69945-273",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Diethylenetriaminepentaacetic Acid",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20160120",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "PENTETIC ACID",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-26",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20-JAN-16"
    },
    {
      "NDCCode": "69945-314-05",
      "PackageDescription": "5 VIAL in 1 KIT (69945-314-05)  / 10 mL in 1 VIAL (69945-314-01) ",
      "NDC11Code": "69945-0314-05",
      "ProductNDC": "69945-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Pentetate",
      "NonProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Pentetate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS; RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250408",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215146",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "PENTETIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Lead Chelating Activity [MoA], Lead Chelator [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250408",
      "SamplePackage": "N",
      "IndicationAndUsage": "Kit for the Preparation of Technetium Tc 99m Pentetate Injection, after radiolabeling with Technetium Tc 99m, is indicated for.",
      "Description": "Kit for the Preparation of Technetium Tc 99m pentetate injection, a radioactive diagnostic agent, for intravenous or inhalation use. Each multiple-dose 10 mL glass vial contains a sterile, non-pyrogenic, non-radioactive lyophilized powder of 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg maximum tin expressed as stannous chloride dihydrate. The lyophilized product is sealed under an atmosphere of nitrogen. No bacteriostatic preservative is present. Its chemical name is. Technetate (1-)99mTc,[N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato(5-)]-, sodium. The structure of the technetium labeled form is. The pH is adjusted with HCl and/or NaOH prior to lyophilization so that the pH range of the reconstituted radiopharmaceutical is 6.5 to 7.5."
    },
    {
      "NDCCode": "69945-314-30",
      "PackageDescription": "30 VIAL in 1 CARTON (69945-314-30)  / 10 mL in 1 VIAL (69945-314-01) ",
      "NDC11Code": "69945-0314-30",
      "ProductNDC": "69945-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Pentetate",
      "NonProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Pentetate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS; RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250408",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215146",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "PENTETIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Lead Chelating Activity [MoA], Lead Chelator [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250408",
      "SamplePackage": "N",
      "IndicationAndUsage": "Kit for the Preparation of Technetium Tc 99m Pentetate Injection, after radiolabeling with Technetium Tc 99m, is indicated for.",
      "Description": "Kit for the Preparation of Technetium Tc 99m pentetate injection, a radioactive diagnostic agent, for intravenous or inhalation use. Each multiple-dose 10 mL glass vial contains a sterile, non-pyrogenic, non-radioactive lyophilized powder of 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg maximum tin expressed as stannous chloride dihydrate. The lyophilized product is sealed under an atmosphere of nitrogen. No bacteriostatic preservative is present. Its chemical name is. Technetate (1-)99mTc,[N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato(5-)]-, sodium. The structure of the technetium labeled form is. The pH is adjusted with HCl and/or NaOH prior to lyophilization so that the pH range of the reconstituted radiopharmaceutical is 6.5 to 7.5."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"69945-092-20","ProprietaryName":"Technetium Tc 99m Sestamibi","NonProprietaryName":"Technetium Tc 99m Sestamibi"},{"NDCCode":"69945-092-40","ProprietaryName":"Technetium Tc 99m Sestamibi","NonProprietaryName":"Technetium Tc 99m Sestamibi"},{"NDCCode":"69945-068-20","ProprietaryName":"Ultratag","NonProprietaryName":"Kit For The Preparation Of Technetium Tc 99m Red Blood Cells"},{"NDCCode":"69945-091-20","ProprietaryName":"Technescan Hdp","NonProprietaryName":"Technetium Tc 99m Oxidronate"},{"NDCCode":"69945-094-20","ProprietaryName":"Technescan Pyp","NonProprietaryName":"Technetium Tc 99m Pyrophosphate"},{"NDCCode":"69945-096-20","ProprietaryName":"Technescan Mag3","NonProprietaryName":"Technescan Tc 99m Mertiatide"},{"NDCCode":"69945-139-20","ProprietaryName":"Pulmotech Maa","NonProprietaryName":"Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated"},{"NDCCode":"69945-177-01","ProprietaryName":"Bexlutry","NonProprietaryName":"Lutetium Oxodotreotide Lu-177"},{"NDCCode":"69945-452-20","ProprietaryName":"Sodium Iodide I 131","NonProprietaryName":"Sodium Iodide I 131"},{"NDCCode":"69945-602-20","ProprietaryName":"Sodium Iodide I 123","NonProprietaryName":"Sodium Iodide I 123"},{"NDCCode":"16590-092-20","ProprietaryName":"Etodolac","NonProprietaryName":"Etodolac"},{"NDCCode":"37000-092-20","ProprietaryName":"Head And Shoulders","NonProprietaryName":"Pyrithione Zinc"},{"NDCCode":"48433-092-20","ProprietaryName":"Tacrolimus","NonProprietaryName":"Tacrolimus"},{"NDCCode":"50268-092-12","ProprietaryName":"Aripiprazole","NonProprietaryName":"Aripiprazole"},{"NDCCode":"55289-092-20","ProprietaryName":"Diazepam","NonProprietaryName":"Diazepam"},{"NDCCode":"58159-092-02","NonProprietaryName":"Pitolisant Hydrochloride Sd"},{"NDCCode":"62135-092-20","ProprietaryName":"Amoxicillin And Clavulanate Potassium","NonProprietaryName":"Amoxicillin And Clavulanate Potassium"},{"NDCCode":"64543-092-20","ProprietaryName":"Rescon Mx","NonProprietaryName":"Dexchlorpheniramine Maleate"},{"NDCCode":"64661-092-20","ProprietaryName":"Drymax","NonProprietaryName":"Chlophedianol Hydrochloride, Chlorpheniramine Maleate, Phenylephrine Hydrochloride"},{"NDCCode":"84010-092-01","ProprietaryName":"Healmusz Fast Natural Wart Removal","NonProprietaryName":"Salicylic Acid 17% Fast Natural Wart Removal"},{"NDCCode":"85766-092-20","ProprietaryName":"Geri-dryl Allergy Relief","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"69945-097-11","ProprietaryName":"Xenon, Xe-133","NonProprietaryName":"Xenon"},{"NDCCode":"69945-097-13","ProprietaryName":"Xenon, Xe-133","NonProprietaryName":"Xenon"},{"NDCCode":"69945-097-15","ProprietaryName":"Xenon, Xe-133","NonProprietaryName":"Xenon"},{"NDCCode":"69945-098-21","ProprietaryName":"Xenon, Xe-133","NonProprietaryName":"Xenon"},{"NDCCode":"69945-098-23","ProprietaryName":"Xenon, Xe-133","NonProprietaryName":"Xenon"},{"NDCCode":"69945-098-25","ProprietaryName":"Xenon, Xe-133","NonProprietaryName":"Xenon"},{"NDCCode":"69945-273-00","NonProprietaryName":"Diethylenetriaminepentaacetic Acid"},{"NDCCode":"69945-314-05","ProprietaryName":"Kit For The Preparation Of Technetium Tc 99m Pentetate","NonProprietaryName":"Kit For The Preparation Of Technetium Tc 99m Pentetate"},{"NDCCode":"69945-314-30","ProprietaryName":"Kit For The Preparation Of Technetium Tc 99m Pentetate","NonProprietaryName":"Kit For The Preparation Of Technetium Tc 99m Pentetate"}]}
                    
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<NDCList>
  <NDC>
    <NDCCode>69945-092-20</NDCCode>
    <PackageDescription>5 VIAL in 1 CELLO PACK (69945-092-20)  &gt; 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>69945-0092-20</NDC11Code>
    <ProductNDC>69945-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technetium Tc 99m Sestamibi</ProprietaryName>
    <NonProprietaryName>Technetium Tc 99m Sestamibi</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20111031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078098</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Myocardial Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Kit for the Preparation of Technetium Tc99m Sestamibi Injection is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.</IndicationAndUsage>
    <Description>Each 10 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: 1 Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate – 1 mg, 2 Sodium Citrate Dihydrate - 2.6 mg, 3 L-Cysteine Hydrochloride Monohydrate – 1 mg, 4 Mannitol - 20 mg, 5 Stannous Chloride, Dihydrate, minimum (SnCl22H2O) - 0.025 mg, 6 Stannous Chloride, Dihydrate (SnCl22H2O) - 0.075 mg, 7 Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl22H2O) - 0.086 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-092-40</NDCCode>
    <PackageDescription>30 VIAL in 1 CARTON (69945-092-40)  &gt; 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>69945-0092-40</NDC11Code>
    <ProductNDC>69945-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technetium Tc 99m Sestamibi</ProprietaryName>
    <NonProprietaryName>Technetium Tc 99m Sestamibi</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20111031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078098</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Myocardial Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Kit for the Preparation of Technetium Tc99m Sestamibi Injection is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.</IndicationAndUsage>
    <Description>Each 10 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: 1 Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate – 1 mg, 2 Sodium Citrate Dihydrate - 2.6 mg, 3 L-Cysteine Hydrochloride Monohydrate – 1 mg, 4 Mannitol - 20 mg, 5 Stannous Chloride, Dihydrate, minimum (SnCl22H2O) - 0.025 mg, 6 Stannous Chloride, Dihydrate (SnCl22H2O) - 0.075 mg, 7 Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl22H2O) - 0.086 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-068-20</NDCCode>
    <PackageDescription>5 CELLO PACK in 1 BOX (69945-068-20)  / 1 KIT in 1 CELLO PACK (69945-068-10)  *  .6 mL in 1 SYRINGE, GLASS *  1 mL in 1 SYRINGE, GLASS *  9.5 mg in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>69945-0068-20</NDC11Code>
    <ProductNDC>69945-068</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ultratag</ProprietaryName>
    <ProprietaryNameSuffix>Rbc</ProprietaryNameSuffix>
    <NonProprietaryName>Kit For The Preparation Of Technetium Tc 99m Red Blood Cells</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19910610</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019981</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19910610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Technetium Tc 99m red blood cells are used for blood pool imaging, including cardiac first pass and gated equilibrium imaging and for detection of sites of gastrointestinal bleeding.</IndicationAndUsage>
    <Description>Ultratag RBC (Kit for the Preparation of Technetium Tc 99m Red Blood Cells Injection) is a sterile, nonpyrogenic, diagnostic kit for the in vitro preparation of Technetium Tc 99m Red Blood Cells Injection. Each kit consists of three separate nonradioactive components. 1.      A 10 milliliter reaction vial containing.          Stannous Chloride, Dihydrate (SnCl 22H 2O) – 50 mcg minimum.          Stannous Chloride, Dihydrate (SnCl 22H 2O) – 96 mcg theoretical.          Tin Chloride (Stannous and Stannic), Dihydrate (as SnCl 22H 2O) – 105 mcg maximum.          Sodium Citrate, Dihydrate – 3.67 mg.          Dextrose, Anhydrous – 5.5 mg.          Hydrochloric Acid – 0.47 mg. Prior to lyophilization, the pH is adjusted to 7.1 to 7.2 with sodium hydroxide. The contents of the vial are lyophilized and stored under argon. 2.      Syringe I contains.          Sodium Hypochlorite – 0.6 mg in Sterile Water for Injection. The total volume of this syringe is 0.6 mL. Sodium hydroxide may have been added for pH adjustment. The pH of this solution is 11 to 13. The syringe must be protected from light to prevent degradation of the light-sensitive sodium hypochlorite. 3.      Syringe II contains.          Citric Acid, Monohydrate – 8.7 mg.          Sodium Citrate, Dihydrate – 32.5 mg.          Dextrose, Anhydrous – 12 mg in Sterile Water for Injection. The total volume of this syringe is 1 mL. The pH range of this solution is adjusted to 4.5 to 5.5 with sodium citrate or citric acid as needed.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-091-20</NDCCode>
    <PackageDescription>5 VIAL in 1 CELLO PACK (69945-091-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (69945-091-01) </PackageDescription>
    <NDC11Code>69945-0091-20</NDC11Code>
    <ProductNDC>69945-091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technescan Hdp</ProprietaryName>
    <NonProprietaryName>Technetium Tc 99m Oxidronate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20151013</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018321</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>OXIDRONATE DISODIUM</SubstanceName>
    <StrengthNumber>3.15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Technescan HDP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for skeletal imaging to demonstrate areas of altered osteogenesis in adult and pediatric patients.</IndicationAndUsage>
    <Description>Drug Characteristics. Technescan HDP (kit for the preparation of technetium Tc 99m oxidronate injection) is a radioactive diagnostic drug for intravenous use after radiolabeling with sodium pertechnetate Tc 99m injection. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl 22H 2O), 0.297 mg, theoretical, stannous chloride (SnCl 22H 2O) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl 22H 2O, and the following inactive ingredients: 0.84 mg gentisic acid as a stabilizer and 30 mg sodium chloride. The pH is adjusted with hydrochloric acid and/or sodium hydroxide. The pH of the radiolabeled drug is between 4.0 and 5.5. The vial contains a sterile, non-pyrogenic, lyophilized powder packaged under nitrogen. The chemical structure of oxidronate sodium is. The structure of the technetium Tc 99m oxidronate complex is unknown.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-094-20</NDCCode>
    <PackageDescription>5 VIAL in 1 CELLO PACK (69945-094-20)  / 10 mL in 1 VIAL (69945-094-01) </PackageDescription>
    <NDC11Code>69945-0094-20</NDC11Code>
    <ProductNDC>69945-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technescan Pyp</ProprietaryName>
    <NonProprietaryName>Technetium Tc 99m Pyrophosphate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20151014</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017538</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>SODIUM PYROPHOSPHATE; STANNOUS CHLORIDE</SubstanceName>
    <StrengthNumber>11.9; 3.2</StrengthNumber>
    <StrengthUnit>mg/10mL; mg/10mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Technescan PYP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for:  Skeletal imaging to demonstrate areas of altered osteogenesis in adults  Cardiac imaging as an adjunct in the diagnosis of acute myocardial infarction in adults (See WARNINGS). Technescan PYP, in conjunction with sodium pertechnetate Tc 99m injection for red blood cell (RBC) labeling, is indicated for gated cardiac blood pool imaging and for the detection of gastrointestinal bleeding sites in adults.</IndicationAndUsage>
    <Description>Drug Characteristics Technescan PYP (kit for the preparation of technetium Tc 99m pyrophosphate injection) is a radioactive diagnostic drug for intravenous use after radiolabeling with sodium pertechnetate Tc 99m injection or after reconstitution with 0.9% sodium chloride injection in conjunction with sodium pertechnetate Tc 99m injection. Each vial contains 11.9 mg sodium pyrophosphate, 3.2 mg (minimum) stannous chloride (SnCl 22H 2O), and 4.4 mg (maximum) total tin expressed as stannous chloride (SnCl 22H 2O). Prior to lyophilization, the pH is adjusted with hydrochloric acid. The pH of the reconstituted drug is between 4.5 and 7.5. No bacteriostatic preservative is present. The vial contains a sterile, non-pyrogenic, lyophilized powder packaged under nitrogen. The precise structures of the stannous-pyrophosphate and technetium Tc 99m pyrophosphate complexes are not known.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-096-20</NDCCode>
    <PackageDescription>5 VIAL in 1 CELLO PACK (69945-096-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>69945-0096-20</NDC11Code>
    <ProductNDC>69945-096</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technescan Mag3</ProprietaryName>
    <NonProprietaryName>Technescan Tc 99m Mertiatide</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19900615</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019882</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>BETIATIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use.) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.</IndicationAndUsage>
    <Description>Technescan MAG3 is a kit for the preparation of technetium Tc 99m mertiatide, a diagnostic radiopharmaceutical. It is supplied as a sterile, nonpyrogenic, lyophilized powder. Each vial contains betiatide (N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine). After reconstitution with sterile sodium pertechnetate Tc 99m injection, the technetium Tc 99m mertiatide (disodium[N-[N-[N-(mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N′,N″,S′]oxotechnetate (2-)) which is formed is suitable for intravenous administration. Each 10 milliliter vial contains 1 milligram betiatide, 0.05 milligram (minimum) stannous chloride dihydrate (SnCl 22H 2O) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (SnCl 22H 2O), 40 milligrams sodium tartrate dihydrate (Na 2C 4H 2O 62H 2O), and 20 milligrams lactose monohydrate. Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. The contents are sealed under argon. Betiatide is light sensitive and must be protected from light. Betiatide and technetium Tc 99m mertiatide have the following structural formulas:.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-139-20</NDCCode>
    <PackageDescription>5 VIAL, MULTI-DOSE in 1 CELLO PACK (69945-139-20)  / 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10) </PackageDescription>
    <NDC11Code>69945-0139-20</NDC11Code>
    <ProductNDC>69945-139</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pulmotech Maa</ProprietaryName>
    <NonProprietaryName>Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION</DosageFormName>
    <RouteName>INTRAPERITONEAL; INTRAVENOUS</RouteName>
    <StartMarketingDate>20200320</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA210089</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>ALBUMIN AGGREGATED</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/15mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PULMOTECH MAA, after radiolabeling with technetium-99m, is indicated for: 1 Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients., 2 Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults.</IndicationAndUsage>
    <Description>PULMOTECH MAA contains albumin aggregated obtained by fractionating material (source blood, plasma, serum, or placentas) from healthy human donors. The macroaggregated albumin (MAA) particles are formed by heat denaturation of stannous chloride treated albumin human under controlled conditions. Each vial contains 2,000,000 to 4,000,000 particles. The particle size distribution of the aggregated albumin is such that not less than 90% are 10 to 90 micrometers in size. There are no aggregated albumin particles greater than 150 micrometers in size as determined by circular equivalents. PULMOTECH MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection provides a sterile, non-pyrogenic, non-radioactive, white lyophilized powder in a multiple-dose reaction vial, sealed under an atmosphere of nitrogen, for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare Technetium Tc 99m Albumin Aggregated Injection, a radioactive diagnostic agent, for intravenous or intraperitoneal use. Each reaction vial contains 2 mg of albumin aggregated, albumin human (7.1 mg), stannous chloride (0.1 mg minimum; 0.22 mg maximum stannous and stannic), sodium chloride (9 mg). Hydrochloric acid may have been added for pH adjustment. The pH is between 5 and 7. It contains no preservatives.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-177-01</NDCCode>
    <PackageDescription>20 mL in 1 VIAL, SINGLE-DOSE (69945-177-01) </PackageDescription>
    <NDC11Code>69945-0177-01</NDC11Code>
    <ProductNDC>69945-177</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bexlutry</ProprietaryName>
    <NonProprietaryName>Lutetium Oxodotreotide Lu-177</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260914</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218525</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>LUTETIUM OXODOTREOTIDE LU-177</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260914</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69945-452-20</NDCCode>
    <PackageDescription>1 CAPSULE in 1 CAN (69945-452-20)  &gt; 20 mL in 1 CAPSULE</PackageDescription>
    <NDC11Code>69945-0452-20</NDC11Code>
    <ProductNDC>69945-452</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Iodide I 131</ProprietaryName>
    <NonProprietaryName>Sodium Iodide I 131</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151027</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016517</ApplicationNumber>
    <LabelerName>MALLINCKRODT NUCLEAR MEDICINE LLC</LabelerName>
    <SubstanceName>SODIUM IODIDE I-131</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151027</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69945-602-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CAN (69945-602-20)  / 1 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>69945-0602-20</NDC11Code>
    <ProductNDC>69945-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Iodide I 123</ProprietaryName>
    <NonProprietaryName>Sodium Iodide I 123</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071910</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>SODIUM IODIDE I-123</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>uCi/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070411</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.</IndicationAndUsage>
    <Description>Sodium Iodide I 123 (Na 123I) for diagnostic use is supplied in capsules for oral administration. The capsules are available in strengths of 3.7 and 7.4 megabecquerels (MBq) (100 and 200 μCi) I-123 at time of calibration. The radionuclidic composition at calibration is not less than 97.0 percent I-123, not more than 2.9 percent I-125 and not more than 0.1 percent Te-121. The radionuclidic composition at expiration time is not less than 87.2 percent I-123, not more than 12.4 percent I-125 and not more than 0.4 percent Te-121. The ratio of the concentration of I-123 and I-125 changes with time. Graph 1 shows the minimum concentration of I-123 as a function of time and Graph 2 shows the maximum concentration of I-125 as a function of time. Graph 1. Radionuclidic Concentration of I-123. PERCENT OF TOTAL RADIOACTIVITY: IODINE-123. Graph 2. Radionuclidic Concentration of I-125. PERCENT OF TOTAL RADIOACTIVITY: IODINE-125.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-092-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (16590-092-20)</PackageDescription>
    <NDC11Code>16590-0092-20</NDC11Code>
    <ProductNDC>16590-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Etodolac</ProprietaryName>
    <NonProprietaryName>Etodolac</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980311</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075074</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>ETODOLAC</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
    <Description>Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Polyethylene Glycol, Povidone USP, Sodium Starch Glycolate NF and Titanium Dioxide. Also, each 400 mg tablet contains Iron Oxide Red and Iron Oxide Yellow. Each 500 mg tablet contains D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake, and FD&amp;C Red #40 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>37000-092-20</NDCCode>
    <PackageDescription>200 mL in 1 BOTTLE, PLASTIC (37000-092-20)</PackageDescription>
    <NDC11Code>37000-0092-20</NDC11Code>
    <ProductNDC>37000-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Head And Shoulders</ProprietaryName>
    <ProprietaryNameSuffix>Dry Scalp Care</ProprietaryNameSuffix>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>LOTION/SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358H</ApplicationNumber>
    <LabelerName>Procter &amp; Gamble Manufacturing Co.</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-09-26</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>48433-092-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (48433-092-20)  / 1 CAPSULE in 1 BLISTER PACK (48433-092-01) </PackageDescription>
    <NDC11Code>48433-0092-20</NDC11Code>
    <ProductNDC>48433-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tacrolimus</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260313</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090596</ApplicationNumber>
    <LabelerName>Safecor Health LLC</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, or heart transplants, in combination with other immunosuppressants. ( 1.1).</IndicationAndUsage>
    <Description>Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&amp;C Red No. 28, D&amp;C Yellow No. 10 and FD&amp;C Red No. 40, the 1 mg capsules also contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3 and the 5 mg capsules also contain D&amp;C Red No. 33, D&amp;C Red No. 28 and D&amp;C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5.</Description>
  </NDC>
  <NDC>
    <NDCCode>50268-092-12</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-092-12)  / 1 TABLET in 1 BLISTER PACK (50268-092-11) </PackageDescription>
    <NDC11Code>50268-0092-12</NDC11Code>
    <ProductNDC>50268-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aripiprazole</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160428</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205064</ApplicationNumber>
    <LabelerName>AvPAK</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160428</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of:  Schizophrenia  Treatment of Tourette’s Disorder.</IndicationAndUsage>
    <Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&amp;C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-092-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (55289-092-20) </PackageDescription>
    <NDC11Code>55289-0092-20</NDC11Code>
    <ProductNDC>55289-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19850904</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070325</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2 H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The molecular formula is C 16H 13ClN 2O and the molecular weight is 284.7. The structural formula is as follows:. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam, USP. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 5 mg tablets also contain FD&amp;C Yellow No. 6 Aluminum Lake. The 10 mg tablets also contain D&amp;C Yellow No. 10 Aluminum Lake and FD&amp;C Blue No. 1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>58159-092-02</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (58159-092-02) </PackageDescription>
    <NDC11Code>58159-0092-02</NDC11Code>
    <ProductNDC>58159-092</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Pitolisant Hydrochloride Sd</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20220929</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>PITOLISANT HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-12</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-SEP-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>62135-092-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (62135-092-20) </PackageDescription>
    <NDC11Code>62135-0092-20</NDC11Code>
    <ProductNDC>62135-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
    <NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065096</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
    <StrengthNumber>875; 125</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260721</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below. : 1 Lower Respiratory Tract Infections – caused by beta–lactamase–producing isolates of  Haemophilus influenzae and  Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media – caused by beta–lactamase–producing isolates of  H. influenzae and  M. catarrhalis. , 3 Sinusitis – caused by beta–lactamase–producing isolates of  H. influenzae and  M. catarrhalis., 4 Skin and Skin Structure Infections – caused by beta–lactamase–producing isolates of  Staphylococcus aureus, Escherichia coli, and  Klebsiella species. , 5 Urinary Tract Infections – caused by beta–lactamase–producing isolates of  E.coli, Klebsiella species, and  Enterobacter species. .</IndicationAndUsage>
    <Description>Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are oral antibacterial combinations consisting of the semisynthetic antibiotic amoxicillin, USP and the beta–lactamase inhibitor, clavulanate potassium, USP (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6–aminopenicillanic acid. Chemically, amoxicillin, USP is (2S,5R,6R)–6–[(R)–(–)–2–Amino–2–(p–hydroxyphenyl)acetamido]–3,3–dimethyl–7–oxo–4–thia–1–azabicyclo[3.2.0]heptane–2–carboxylic acid trihydrate and has the following structural formula. C 16H 19N 3O 5S3H 2O M.W. 419.45. Clavulanic acid is produced by the fermentation of  Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. Chemically, clavulanate potassium, USP is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and has the following structural formula:. C 8H 8KNO 5  M.W. 237.25. Amoxicillin and Clavulanate Potassium Tablets, USP. : 1 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). , 2 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). .</Description>
  </NDC>
  <NDC>
    <NDCCode>64543-092-20</NDCCode>
    <PackageDescription>12 POUCH in 1 CARTON (64543-092-20)  &gt; 1 TABLET in 1 POUCH</PackageDescription>
    <NDC11Code>64543-0092-20</NDC11Code>
    <ProductNDC>64543-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rescon Mx</ProprietaryName>
    <NonProprietaryName>Dexchlorpheniramine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111228</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Capellon Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>DEXCHLORPHENIRAMINE MALEATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-03-12</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>64661-092-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (64661-092-20)</PackageDescription>
    <NDC11Code>64661-0092-20</NDC11Code>
    <ProductNDC>64661-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Drymax</ProprietaryName>
    <ProprietaryNameSuffix>Af</ProprietaryNameSuffix>
    <NonProprietaryName>Chlophedianol Hydrochloride, Chlorpheniramine Maleate, Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130219</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>JayMac Pharmaceuticals</LabelerName>
    <SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25; 4; 15</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>84010-092-01</NDCCode>
    <PackageDescription>20 g in 1 TUBE (84010-092-01) </PackageDescription>
    <NDC11Code>84010-0092-01</NDC11Code>
    <ProductNDC>84010-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Healmusz Fast Natural Wart Removal</ProprietaryName>
    <NonProprietaryName>Salicylic Acid 17% Fast Natural Wart Removal</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250327</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M028</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the removal of common warts, which have a rough,cauliflower-like appearance.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85766-092-20</NDCCode>
    <PackageDescription>20 TABLET, COATED in 1 BOTTLE (85766-092-20) </PackageDescription>
    <NDC11Code>85766-0092-20</NDC11Code>
    <ProductNDC>85766-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Geri-dryl Allergy Relief</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Sportpharm LLC</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:. runny nose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69945-097-11</NDCCode>
    <PackageDescription>1 CAN in 1 CONTAINER (69945-097-11)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>69945-0097-11</NDC11Code>
    <ProductNDC>69945-097</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xenon, Xe-133</ProprietaryName>
    <NonProprietaryName>Xenon</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20160330</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018327</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>XENON XE-133</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.</IndicationAndUsage>
    <Description>Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-097-13</NDCCode>
    <PackageDescription>3 CAN in 1 CONTAINER (69945-097-13)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>69945-0097-13</NDC11Code>
    <ProductNDC>69945-097</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xenon, Xe-133</ProprietaryName>
    <NonProprietaryName>Xenon</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20160330</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018327</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>XENON XE-133</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.</IndicationAndUsage>
    <Description>Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-097-15</NDCCode>
    <PackageDescription>5 CAN in 1 CONTAINER (69945-097-15)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>69945-0097-15</NDC11Code>
    <ProductNDC>69945-097</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xenon, Xe-133</ProprietaryName>
    <NonProprietaryName>Xenon</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20160330</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018327</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>XENON XE-133</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.</IndicationAndUsage>
    <Description>Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-098-21</NDCCode>
    <PackageDescription>1 CAN in 1 CONTAINER (69945-098-21)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>69945-0098-21</NDC11Code>
    <ProductNDC>69945-098</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xenon, Xe-133</ProprietaryName>
    <NonProprietaryName>Xenon</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20160330</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018327</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>XENON XE-133</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.</IndicationAndUsage>
    <Description>Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-098-23</NDCCode>
    <PackageDescription>3 CAN in 1 CONTAINER (69945-098-23)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>69945-0098-23</NDC11Code>
    <ProductNDC>69945-098</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xenon, Xe-133</ProprietaryName>
    <NonProprietaryName>Xenon</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20160330</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018327</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>XENON XE-133</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.</IndicationAndUsage>
    <Description>Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-098-25</NDCCode>
    <PackageDescription>5 CAN in 1 CONTAINER (69945-098-25)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>69945-0098-25</NDC11Code>
    <ProductNDC>69945-098</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xenon, Xe-133</ProprietaryName>
    <NonProprietaryName>Xenon</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20160330</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018327</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>XENON XE-133</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.</IndicationAndUsage>
    <Description>Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-273-00</NDCCode>
    <PackageDescription>800 g in 1 BOTTLE (69945-273-00) </PackageDescription>
    <NDC11Code>69945-0273-00</NDC11Code>
    <ProductNDC>69945-273</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Diethylenetriaminepentaacetic Acid</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20160120</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>PENTETIC ACID</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-26</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20-JAN-16</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>69945-314-05</NDCCode>
    <PackageDescription>5 VIAL in 1 KIT (69945-314-05)  / 10 mL in 1 VIAL (69945-314-01) </PackageDescription>
    <NDC11Code>69945-0314-05</NDC11Code>
    <ProductNDC>69945-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kit For The Preparation Of Technetium Tc 99m Pentetate</ProprietaryName>
    <NonProprietaryName>Kit For The Preparation Of Technetium Tc 99m Pentetate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250408</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215146</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>PENTETIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Lead Chelating Activity [MoA], Lead Chelator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250408</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Kit for the Preparation of Technetium Tc 99m Pentetate Injection, after radiolabeling with Technetium Tc 99m, is indicated for.</IndicationAndUsage>
    <Description>Kit for the Preparation of Technetium Tc 99m pentetate injection, a radioactive diagnostic agent, for intravenous or inhalation use. Each multiple-dose 10 mL glass vial contains a sterile, non-pyrogenic, non-radioactive lyophilized powder of 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg maximum tin expressed as stannous chloride dihydrate. The lyophilized product is sealed under an atmosphere of nitrogen. No bacteriostatic preservative is present. Its chemical name is. Technetate (1-)99mTc,[N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato(5-)]-, sodium. The structure of the technetium labeled form is. The pH is adjusted with HCl and/or NaOH prior to lyophilization so that the pH range of the reconstituted radiopharmaceutical is 6.5 to 7.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-314-30</NDCCode>
    <PackageDescription>30 VIAL in 1 CARTON (69945-314-30)  / 10 mL in 1 VIAL (69945-314-01) </PackageDescription>
    <NDC11Code>69945-0314-30</NDC11Code>
    <ProductNDC>69945-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kit For The Preparation Of Technetium Tc 99m Pentetate</ProprietaryName>
    <NonProprietaryName>Kit For The Preparation Of Technetium Tc 99m Pentetate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250408</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215146</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>PENTETIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Lead Chelating Activity [MoA], Lead Chelator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250408</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Kit for the Preparation of Technetium Tc 99m Pentetate Injection, after radiolabeling with Technetium Tc 99m, is indicated for.</IndicationAndUsage>
    <Description>Kit for the Preparation of Technetium Tc 99m pentetate injection, a radioactive diagnostic agent, for intravenous or inhalation use. Each multiple-dose 10 mL glass vial contains a sterile, non-pyrogenic, non-radioactive lyophilized powder of 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg maximum tin expressed as stannous chloride dihydrate. The lyophilized product is sealed under an atmosphere of nitrogen. No bacteriostatic preservative is present. Its chemical name is. Technetate (1-)99mTc,[N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato(5-)]-, sodium. The structure of the technetium labeled form is. The pH is adjusted with HCl and/or NaOH prior to lyophilization so that the pH range of the reconstituted radiopharmaceutical is 6.5 to 7.5.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>69945-092-20</NDCCode><ProprietaryName>Technetium Tc 99m Sestamibi</ProprietaryName><NonProprietaryName>Technetium Tc 99m Sestamibi</NonProprietaryName></NDC><NDC><NDCCode>69945-092-40</NDCCode><ProprietaryName>Technetium Tc 99m Sestamibi</ProprietaryName><NonProprietaryName>Technetium Tc 99m Sestamibi</NonProprietaryName></NDC><NDC><NDCCode>69945-068-20</NDCCode><ProprietaryName>Ultratag</ProprietaryName><NonProprietaryName>Kit For The Preparation Of Technetium Tc 99m Red Blood Cells</NonProprietaryName></NDC><NDC><NDCCode>69945-091-20</NDCCode><ProprietaryName>Technescan Hdp</ProprietaryName><NonProprietaryName>Technetium Tc 99m Oxidronate</NonProprietaryName></NDC><NDC><NDCCode>69945-094-20</NDCCode><ProprietaryName>Technescan Pyp</ProprietaryName><NonProprietaryName>Technetium Tc 99m Pyrophosphate</NonProprietaryName></NDC><NDC><NDCCode>69945-096-20</NDCCode><ProprietaryName>Technescan Mag3</ProprietaryName><NonProprietaryName>Technescan Tc 99m Mertiatide</NonProprietaryName></NDC><NDC><NDCCode>69945-139-20</NDCCode><ProprietaryName>Pulmotech Maa</ProprietaryName><NonProprietaryName>Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated</NonProprietaryName></NDC><NDC><NDCCode>69945-177-01</NDCCode><ProprietaryName>Bexlutry</ProprietaryName><NonProprietaryName>Lutetium Oxodotreotide Lu-177</NonProprietaryName></NDC><NDC><NDCCode>69945-452-20</NDCCode><ProprietaryName>Sodium Iodide I 131</ProprietaryName><NonProprietaryName>Sodium Iodide I 131</NonProprietaryName></NDC><NDC><NDCCode>69945-602-20</NDCCode><ProprietaryName>Sodium Iodide I 123</ProprietaryName><NonProprietaryName>Sodium Iodide I 123</NonProprietaryName></NDC><NDC><NDCCode>16590-092-20</NDCCode><ProprietaryName>Etodolac</ProprietaryName><NonProprietaryName>Etodolac</NonProprietaryName></NDC><NDC><NDCCode>37000-092-20</NDCCode><ProprietaryName>Head And Shoulders</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>48433-092-20</NDCCode><ProprietaryName>Tacrolimus</ProprietaryName><NonProprietaryName>Tacrolimus</NonProprietaryName></NDC><NDC><NDCCode>50268-092-12</NDCCode><ProprietaryName>Aripiprazole</ProprietaryName><NonProprietaryName>Aripiprazole</NonProprietaryName></NDC><NDC><NDCCode>55289-092-20</NDCCode><ProprietaryName>Diazepam</ProprietaryName><NonProprietaryName>Diazepam</NonProprietaryName></NDC><NDC><NDCCode>58159-092-02</NDCCode><NonProprietaryName>Pitolisant Hydrochloride Sd</NonProprietaryName></NDC><NDC><NDCCode>62135-092-20</NDCCode><ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName><NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName></NDC><NDC><NDCCode>64543-092-20</NDCCode><ProprietaryName>Rescon Mx</ProprietaryName><NonProprietaryName>Dexchlorpheniramine Maleate</NonProprietaryName></NDC><NDC><NDCCode>64661-092-20</NDCCode><ProprietaryName>Drymax</ProprietaryName><NonProprietaryName>Chlophedianol Hydrochloride, Chlorpheniramine Maleate, Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>84010-092-01</NDCCode><ProprietaryName>Healmusz Fast Natural Wart Removal</ProprietaryName><NonProprietaryName>Salicylic Acid 17% Fast Natural Wart Removal</NonProprietaryName></NDC><NDC><NDCCode>85766-092-20</NDCCode><ProprietaryName>Geri-dryl Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>69945-097-11</NDCCode><ProprietaryName>Xenon, Xe-133</ProprietaryName><NonProprietaryName>Xenon</NonProprietaryName></NDC><NDC><NDCCode>69945-097-13</NDCCode><ProprietaryName>Xenon, Xe-133</ProprietaryName><NonProprietaryName>Xenon</NonProprietaryName></NDC><NDC><NDCCode>69945-097-15</NDCCode><ProprietaryName>Xenon, Xe-133</ProprietaryName><NonProprietaryName>Xenon</NonProprietaryName></NDC><NDC><NDCCode>69945-098-21</NDCCode><ProprietaryName>Xenon, Xe-133</ProprietaryName><NonProprietaryName>Xenon</NonProprietaryName></NDC><NDC><NDCCode>69945-098-23</NDCCode><ProprietaryName>Xenon, Xe-133</ProprietaryName><NonProprietaryName>Xenon</NonProprietaryName></NDC><NDC><NDCCode>69945-098-25</NDCCode><ProprietaryName>Xenon, Xe-133</ProprietaryName><NonProprietaryName>Xenon</NonProprietaryName></NDC><NDC><NDCCode>69945-273-00</NDCCode><NonProprietaryName>Diethylenetriaminepentaacetic Acid</NonProprietaryName></NDC><NDC><NDCCode>69945-314-05</NDCCode><ProprietaryName>Kit For The Preparation Of Technetium Tc 99m Pentetate</ProprietaryName><NonProprietaryName>Kit For The Preparation Of Technetium Tc 99m Pentetate</NonProprietaryName></NDC><NDC><NDCCode>69945-314-30</NDCCode><ProprietaryName>Kit For The Preparation Of Technetium Tc 99m Pentetate</ProprietaryName><NonProprietaryName>Kit For The Preparation Of Technetium Tc 99m Pentetate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

  • Use the domain parameter to specify required data domain.
  • Use the operation parameter to specify “format_check” operation.
  • Use the q (query) parameter to specify your query.
  • Use the token (API key) query parameter to identify your application.

Optional parameter:

  • Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

  • Use the domain parameter to specify required data domain.
  • Use the operation parameter to specify “format_check” operation.
  • Use the q (query) parameter to specify your query.
  • Use the token (API key) query parameter to identify your application.
  • Use the tin (tin number) parameter to specify your query about tin number.
  • Use the tinname (tin name) parameter to specify your query about tin name.
  • Use the zipcode (zip code) parameter to specify your query about zip code.
  • Use the radius (radius) parameter to specify your query about radius.
  • Use the fromdate (fromdate) parameter to specify your query about from date.
  • Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

  • check_status — this method allows to get current code status.
  • getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
  • getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
  • search — allows retrieval of set of items based on the free-form lookup query.
  • search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

  • validate — allows to determine whether provider's information is valid based on data in the CMS database.
  • paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
  • search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
  • zipradius — allows to get npis by zipcode & radius.
  • npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) based on the free-form lookup query.
    • search_and_keywords - returns not only free-form lookup results but also keywords relevant to the original query.
    • getcode - this method allows retrieval of full infrormation regarding one item based on the provided key.
    • getcodes - this method allows retrieval of full infrormation regarding number of items based on the provided keys.
  • NPI-specific operations:
    • validate — allows to determine whether provider's information is valid based on data in the CMS database.
    • paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
    • search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
    • zipradius — allows to get npis by zipcode & radius.
    • npideactivated — allows to get deactivated npis between two dates.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
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      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
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}
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