RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "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": "69945-068-20",
      "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": "69945-092-20",
      "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": "69945-096-20",
      "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": "10544-094-20",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (10544-094-20)",
      "NDC11Code": "10544-0094-20",
      "ProductNDC": "10544-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benzonatate",
      "NonProprietaryName": "Benzonatate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040749",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "BENZONATATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Benzonatate USP is indicated for the symptomatic relief of cough.",
      "Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, purified water, methylparaben, propylparaben and titanium dioxide."
    },
    {
      "NDCCode": "10631-094-20",
      "PackageDescription": "1 TUBE in 1 CARTON (10631-094-20)  > 30 g in 1 TUBE",
      "NDC11Code": "10631-0094-20",
      "ProductNDC": "10631-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Halog",
      "NonProprietaryName": "Halcinonide Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090210",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017556",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "HALCINONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2019-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090210",
      "SamplePackage": "N",
      "IndicationAndUsage": "HALOG (Halcinonide Cream, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula. Each gram of 0.1% HALOG (Halcinonide Cream, USP) contains 1 mg halcinonide, USP in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide."
    },
    {
      "NDCCode": "48433-094-20",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (48433-094-20)  / 1 CAPSULE in 1 BLISTER PACK (48433-094-01) ",
      "NDC11Code": "48433-0094-20",
      "ProductNDC": "48433-094",
      "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": "52584-094-20",
      "PackageDescription": "1 BLISTER PACK in 1 BAG (52584-094-20)  > 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "52584-0094-20",
      "ProductNDC": "52584-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine Hydrochloride",
      "NonProprietaryName": "Clonidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191010",
      "EndMarketingDate": "20200930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070317",
      "LabelerName": "General Injectables & Vaccines, Inc.",
      "SubstanceName": "CLONIDINE HYDROCHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191010",
      "EndMarketingDatePackage": "20200930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55289-094-20",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (55289-094-20)",
      "NDC11Code": "55289-0094-20",
      "ProductNDC": "55289-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicloxacillin Sodium",
      "NonProprietaryName": "Dicloxacillin Sodium",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19710401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061454",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "DICLOXACILLIN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "58159-094-02",
      "PackageDescription": "20 kg in 1 DRUM (58159-094-02) ",
      "NDC11Code": "58159-0094-02",
      "ProductNDC": "58159-094",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Levoketoconazole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20221128",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "LEVOKETOCONAZOLE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-12-06",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "28-NOV-22"
    },
    {
      "NDCCode": "61649-094-20",
      "PackageDescription": "20 g in 1 CARTON (61649-094-20) ",
      "NDC11Code": "61649-0094-20",
      "ProductNDC": "61649-094",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Attitude Sunly Mineral Sunscreen Face Stick Unscented Spf 30",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240215",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "9055-7588 Quebec Inc. DBA Attitude",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "67046-094-20",
      "PackageDescription": "20 TABLET in 1 BLISTER PACK (67046-094-20)",
      "NDC11Code": "67046-0094-20",
      "ProductNDC": "67046-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine Hydrochloride",
      "NonProprietaryName": "Clonidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170928",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070974",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "CLONIDINE HYDROCHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.",
      "Description": "Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg, and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The following inactive ingredients are contained in these products: corn starch, D&C yellow #10 Aluminum Lake, FD&C yellow #6 Aluminum Lake (Sunset Yellow Lake), lactose monohydrate, magnesium stearate, and sodium starch glycolate. Clonidine hydrochloride, USP is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride, USP is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
    },
    {
      "NDCCode": "71656-094-20",
      "PackageDescription": "20 mL in 1 BOTTLE (71656-094-20) ",
      "NDC11Code": "71656-0094-20",
      "ProductNDC": "71656-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluocinonide",
      "NonProprietaryName": "Fluocinonide",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260511",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207554",
      "LabelerName": "Saptalis Pharmaceuticals, LLC.",
      "SubstanceName": "FLUOCINONIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260511",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "Fluocinonide Topical Solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21- (acetyloxy)-6,9- difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α, 11β, 16α)-. It has the following chemical structure. Fluocinonide Topical Solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a solution of citric acid, ethyl alcohol (35%), diisopropyl adipate, propylene glycol and purified water. In this formulation, the active ingredient is totally in solution."
    },
    {
      "NDCCode": "84010-094-01",
      "PackageDescription": "20 g in 1 TUBE (84010-094-01) ",
      "NDC11Code": "84010-0094-01",
      "ProductNDC": "84010-094",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Reinreude Wart Removaer",
      "NonProprietaryName": "Salicylic Acid 17% Wart Removaer",
      "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": "85766-094-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE (85766-094-20) ",
      "NDC11Code": "85766-0094-20",
      "ProductNDC": "85766-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sumatriptan",
      "NonProprietaryName": "Sumatriptan Succinate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090817",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078327",
      "LabelerName": "Sportpharm LLC",
      "SubstanceName": "SUMATRIPTAN SUCCINATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251010",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks., 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.",
      "Description": "Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT 1B/1Dreceptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole­-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C 14H 21N 3O 2SC 4H 6O 4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate."
    },
    {
      "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": "69945-097-11",
      "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":"69945-094-20","ProprietaryName":"Technescan Pyp","NonProprietaryName":"Technetium Tc 99m Pyrophosphate"},{"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":"69945-092-20","ProprietaryName":"Technetium Tc 99m Sestamibi","NonProprietaryName":"Technetium Tc 99m Sestamibi"},{"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":"10544-094-20","ProprietaryName":"Benzonatate","NonProprietaryName":"Benzonatate"},{"NDCCode":"10631-094-20","ProprietaryName":"Halog","NonProprietaryName":"Halcinonide Cream"},{"NDCCode":"48433-094-20","ProprietaryName":"Tacrolimus","NonProprietaryName":"Tacrolimus"},{"NDCCode":"52584-094-20","ProprietaryName":"Clonidine Hydrochloride","NonProprietaryName":"Clonidine Hydrochloride"},{"NDCCode":"55289-094-20","ProprietaryName":"Dicloxacillin Sodium","NonProprietaryName":"Dicloxacillin Sodium"},{"NDCCode":"58159-094-02","NonProprietaryName":"Levoketoconazole"},{"NDCCode":"61649-094-20","ProprietaryName":"Attitude Sunly Mineral Sunscreen Face Stick Unscented Spf 30","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"67046-094-20","ProprietaryName":"Clonidine Hydrochloride","NonProprietaryName":"Clonidine Hydrochloride"},{"NDCCode":"71656-094-20","ProprietaryName":"Fluocinonide","NonProprietaryName":"Fluocinonide"},{"NDCCode":"84010-094-01","ProprietaryName":"Reinreude Wart Removaer","NonProprietaryName":"Salicylic Acid 17% Wart Removaer"},{"NDCCode":"85766-094-20","ProprietaryName":"Sumatriptan","NonProprietaryName":"Sumatriptan Succinate"},{"NDCCode":"69945-092-40","ProprietaryName":"Technetium Tc 99m Sestamibi","NonProprietaryName":"Technetium Tc 99m Sestamibi"},{"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"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <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>69945-068-20</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>69945-092-20</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>69945-096-20</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>10544-094-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE (10544-094-20)</PackageDescription>
    <NDC11Code>10544-0094-20</NDC11Code>
    <ProductNDC>10544-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benzonatate</ProprietaryName>
    <NonProprietaryName>Benzonatate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040749</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>BENZONATATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Benzonatate USP is indicated for the symptomatic relief of cough.</IndicationAndUsage>
    <Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&amp;C Yellow #10, gelatin, glycerin, purified water, methylparaben, propylparaben and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10631-094-20</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10631-094-20)  &gt; 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>10631-0094-20</NDC11Code>
    <ProductNDC>10631-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Halog</ProprietaryName>
    <NonProprietaryName>Halcinonide Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090210</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017556</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>HALCINONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-01-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HALOG (Halcinonide Cream, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula. Each gram of 0.1% HALOG (Halcinonide Cream, USP) contains 1 mg halcinonide, USP in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>48433-094-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (48433-094-20)  / 1 CAPSULE in 1 BLISTER PACK (48433-094-01) </PackageDescription>
    <NDC11Code>48433-0094-20</NDC11Code>
    <ProductNDC>48433-094</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>52584-094-20</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 BAG (52584-094-20)  &gt; 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>52584-0094-20</NDC11Code>
    <ProductNDC>52584-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191010</StartMarketingDate>
    <EndMarketingDate>20200930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070317</ApplicationNumber>
    <LabelerName>General Injectables &amp; Vaccines, Inc.</LabelerName>
    <SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20191010</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55289-094-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (55289-094-20)</PackageDescription>
    <NDC11Code>55289-0094-20</NDC11Code>
    <ProductNDC>55289-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dicloxacillin Sodium</ProprietaryName>
    <NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19710401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA061454</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DICLOXACILLIN SODIUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58159-094-02</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (58159-094-02) </PackageDescription>
    <NDC11Code>58159-0094-02</NDC11Code>
    <ProductNDC>58159-094</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Levoketoconazole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20221128</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>LEVOKETOCONAZOLE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-12-06</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>28-NOV-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>61649-094-20</NDCCode>
    <PackageDescription>20 g in 1 CARTON (61649-094-20) </PackageDescription>
    <NDC11Code>61649-0094-20</NDC11Code>
    <ProductNDC>61649-094</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Attitude Sunly Mineral Sunscreen Face Stick Unscented Spf 30</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240215</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>9055-7588 Quebec Inc. DBA Attitude</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67046-094-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BLISTER PACK (67046-094-20)</PackageDescription>
    <NDC11Code>67046-0094-20</NDC11Code>
    <ProductNDC>67046-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170928</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070974</ApplicationNumber>
    <LabelerName>Contract Pharmacy Services-PA</LabelerName>
    <SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
    <Description>Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg, and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The following inactive ingredients are contained in these products: corn starch, D&amp;C yellow #10 Aluminum Lake, FD&amp;C yellow #6 Aluminum Lake (Sunset Yellow Lake), lactose monohydrate, magnesium stearate, and sodium starch glycolate. Clonidine hydrochloride, USP is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride, USP is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>71656-094-20</NDCCode>
    <PackageDescription>20 mL in 1 BOTTLE (71656-094-20) </PackageDescription>
    <NDC11Code>71656-0094-20</NDC11Code>
    <ProductNDC>71656-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluocinonide</ProprietaryName>
    <NonProprietaryName>Fluocinonide</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207554</ApplicationNumber>
    <LabelerName>Saptalis Pharmaceuticals, LLC.</LabelerName>
    <SubstanceName>FLUOCINONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Fluocinonide Topical Solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21- (acetyloxy)-6,9- difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α, 11β, 16α)-. It has the following chemical structure. Fluocinonide Topical Solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a solution of citric acid, ethyl alcohol (35%), diisopropyl adipate, propylene glycol and purified water. In this formulation, the active ingredient is totally in solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>84010-094-01</NDCCode>
    <PackageDescription>20 g in 1 TUBE (84010-094-01) </PackageDescription>
    <NDC11Code>84010-0094-01</NDC11Code>
    <ProductNDC>84010-094</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Reinreude Wart Removaer</ProprietaryName>
    <NonProprietaryName>Salicylic Acid 17% Wart Removaer</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>85766-094-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (85766-094-20) </PackageDescription>
    <NDC11Code>85766-0094-20</NDC11Code>
    <ProductNDC>85766-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078327</ApplicationNumber>
    <LabelerName>Sportpharm LLC</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks., 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT 1B/1Dreceptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole­-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C 14H 21N 3O 2SC 4H 6O 4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate.</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>69945-097-11</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>69945-094-20</NDCCode><ProprietaryName>Technescan Pyp</ProprietaryName><NonProprietaryName>Technetium Tc 99m Pyrophosphate</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>69945-092-20</NDCCode><ProprietaryName>Technetium Tc 99m Sestamibi</ProprietaryName><NonProprietaryName>Technetium Tc 99m Sestamibi</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>10544-094-20</NDCCode><ProprietaryName>Benzonatate</ProprietaryName><NonProprietaryName>Benzonatate</NonProprietaryName></NDC><NDC><NDCCode>10631-094-20</NDCCode><ProprietaryName>Halog</ProprietaryName><NonProprietaryName>Halcinonide Cream</NonProprietaryName></NDC><NDC><NDCCode>48433-094-20</NDCCode><ProprietaryName>Tacrolimus</ProprietaryName><NonProprietaryName>Tacrolimus</NonProprietaryName></NDC><NDC><NDCCode>52584-094-20</NDCCode><ProprietaryName>Clonidine Hydrochloride</ProprietaryName><NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55289-094-20</NDCCode><ProprietaryName>Dicloxacillin Sodium</ProprietaryName><NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName></NDC><NDC><NDCCode>58159-094-02</NDCCode><NonProprietaryName>Levoketoconazole</NonProprietaryName></NDC><NDC><NDCCode>61649-094-20</NDCCode><ProprietaryName>Attitude Sunly Mineral Sunscreen Face Stick Unscented Spf 30</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>67046-094-20</NDCCode><ProprietaryName>Clonidine Hydrochloride</ProprietaryName><NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71656-094-20</NDCCode><ProprietaryName>Fluocinonide</ProprietaryName><NonProprietaryName>Fluocinonide</NonProprietaryName></NDC><NDC><NDCCode>84010-094-01</NDCCode><ProprietaryName>Reinreude Wart Removaer</ProprietaryName><NonProprietaryName>Salicylic Acid 17% Wart Removaer</NonProprietaryName></NDC><NDC><NDCCode>85766-094-20</NDCCode><ProprietaryName>Sumatriptan</ProprietaryName><NonProprietaryName>Sumatriptan Succinate</NonProprietaryName></NDC><NDC><NDCCode>69945-092-40</NDCCode><ProprietaryName>Technetium Tc 99m Sestamibi</ProprietaryName><NonProprietaryName>Technetium Tc 99m Sestamibi</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.

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();
    }
}
            
        

            
{
  "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",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "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."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "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",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "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."
    },
    {
      "NPI": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
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      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "334-712-3329",
      "EnumerationDate": "04/02/2018",
      "LastUpdateDate": "04/02/2018",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "390200000X",
      "Taxonomy1": "Student in an Organized Health Care Education/Training Program",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1922502889",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "FADLALLA",
      "FirstName": "RANIA",
      "MiddleName": "ABDALLA DAW ELBEIT",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 BAY AVE",
      "MailingAddressCityName": "MONTCLAIR",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "07042-4837",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "973-429-6196",
      "FirstLinePracticeLocationAddress": "1 BAY AVE",
      "PracticeLocationAddressCityName": "MONTCLAIR",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "07042-4837",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "973-429-6196",
      "EnumerationDate": "03/23/2018",
      "LastUpdateDate": "03/23/2018",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "390200000X",
      "Taxonomy1": "Student in an Organized Health Care Education/Training Program",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1629068499",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "FAHOURY",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLineMailingAddress": "SUITE 201",
      "MailingAddressCityName": "TOLEDO",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "43623-3525",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "419-843-3627",
      "MailingAddressFaxNumber": "419-843-9697",
      "FirstLinePracticeLocationAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLinePracticeLocationAddress": "SUITE 201",
      "PracticeLocationAddressCityName": "TOLEDO",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "43623-3525",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "419-843-3627",
      "PracticeLocationAddressFaxNumber": "419-843-9697",
      "EnumerationDate": "10/24/2005",
      "LastUpdateDate": "09/02/2011",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "35086663",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2621621",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH",
      "OtherIdentifier2": "P00401238",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OH",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE"
    },
    {
      "NPI": "1033186986",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "NICOLA",
      "FirstName": "RANIA",
      "MiddleName": "SOLIMAN",
      "NamePrefix": "DR.",
      "Credential": "DDS",
      "FirstLineMailingAddress": "110 S WOODLAND ST",
      "MailingAddressCityName": "WINTER GARDEN",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "34787-3546",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "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 ...
            
        

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();
        }
    }
                
            

                
    {
      "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();
        }
    }
                
            

                
    {
      "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();
        }
    }
                
            

                
    {
      "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();
        }
    }
                
            

                
{
  "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",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "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": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
Done. Press any key to exit ...