RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (33 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "69945-601-10",
      "PackageDescription": "1 BOTTLE in 1 CAN (69945-601-10)  / 1 CAPSULE, GELATIN COATED in 1 BOTTLE",
      "NDC11Code": "69945-0601-10",
      "ProductNDC": "69945-601",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I 123",
      "NonProprietaryName": "Sodium Iodide I 123",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151104",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071909",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "SODIUM IODIDE I-123",
      "StrengthNumber": "100",
      "StrengthUnit": "uCi/1",
      "Status": "Active",
      "LastUpdate": "2024-10-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20151104",
      "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": "69945-060-10",
      "PackageDescription": "1 INJECTION, SOLUTION in 1 CARTON (69945-060-10) ",
      "NDC11Code": "69945-0060-10",
      "ProductNDC": "69945-060",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ultra-technekow",
      "ProprietaryNameSuffix": "V4",
      "NonProprietaryName": "Technetium Tc-99m",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20140610",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017243",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
      "StrengthNumber": "6",
      "StrengthUnit": "Ci/1",
      "Status": "Active",
      "LastUpdate": "2024-10-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140610",
      "SamplePackage": "N",
      "IndicationAndUsage": "The Ultra-Technekow V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m is used IN ADULTSas an agent for:. Thyroid Imaging Salivary Gland Imaging Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux Nasolacrimal Drainage System Imaging (dacryoscintigraphy). Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTSas an agent for:. Thyroid Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.",
      "Description": "The Ultra-Technekow V4 Generator is prepared with fission-produced molybdenum Mo-99 adsorbed onto alumina in a column shielded by lead, tungsten, or depleted uranium. The column assembly and shielding are encased in a plastic container that is covered with a plastic elution hood.  The elution hood has an opening for the column assembly double inlet needles and an opening for the single outlet needle.  The needles accommodate the sterile eluant vials that contain 0.9% Sodium Chloride Injection and sterile evacuated collection vials.  A sterile vial containing a bacteriostat is supplied with the generator for the customer to aseptically seal the outlet needle after each elution. This terminally sterilized generator provides a closed system for the production of sterile metastable technetium Tc-99m, which is produced by the decay of molybdenum Mo-99. Incorporated between the column outlet and the collection vial is a sterile 0.22 micrometer filter. Sterile, non-pyrogenic isotonic solutions of Sodium Pertechnetate Tc 99m Injection in 0.9% Sodium Chloride Injection can be obtained conveniently by periodic aseptic elution of the generator. These solutions should be clear, colorless, and free from any particulate matter.  The Sodium Pertechnetate Tc 99m Injection is suitable for intravenous injection and direct instillation. The carrier-free solution may be used as is, or diluted to the proper concentration. Over the life of the generator, an elution will contain an amount of technetium Tc-99m in direct proportion to the quantity of Mo-99 decay since the previous elution of the generator. The quantity of Tc-99m in the eluate is determined by quantity of Mo-99 on the column, and the elapsed time between elutions. Each eluate of the generator should not contain more than the USP limit of 0.15 kilobecquerel molybdenum Mo-99 per megabecquerel technetium Tc-99m (0.15 microcurie Mo-99 per millicurie Tc-99m) per administered dose at the time of administration and an aluminum ion concentration of not more than 10 micrograms per milliliter of the generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of generator elution."
    },
    {
      "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": "20271231",
      "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": "69945-092-20",
      "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": "20271231",
      "StartMarketingDatePackage": "20111031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Myocardial Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Kit for the Preparation of Technetium Tc99m Sestamibi Injection is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.",
      "Description": "Each 10 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: 1 Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate – 1 mg, 2 Sodium Citrate Dihydrate - 2.6 mg, 3 L-Cysteine Hydrochloride Monohydrate – 1 mg, 4 Mannitol - 20 mg, 5 Stannous Chloride, Dihydrate, minimum (SnCl22H2O) - 0.025 mg, 6 Stannous Chloride, Dihydrate (SnCl22H2O) - 0.075 mg, 7 Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl22H2O) - 0.086 mg."
    },
    {
      "NDCCode": "69945-092-40",
      "PackageDescription": "30 VIAL in 1 CARTON (69945-092-40)  > 10 mL in 1 VIAL",
      "NDC11Code": "69945-0092-40",
      "ProductNDC": "69945-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Technetium Tc 99m Sestamibi",
      "NonProprietaryName": "Technetium Tc 99m Sestamibi",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20111031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078098",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "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": "69945-094-20",
      "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": "20271231",
      "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": "69945-139-20",
      "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": "20271231",
      "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": "69945-139-40",
      "PackageDescription": "30 VIAL, MULTI-DOSE in 1 CARTON (69945-139-40)  / 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10) ",
      "NDC11Code": "69945-0139-40",
      "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": "20271231",
      "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": "69945-314-05",
      "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": "20271231",
      "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": "20271231",
      "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": "69945-452-10",
      "PackageDescription": "1 CAPSULE in 1 CAN (69945-452-10)  > 10 mL in 1 CAPSULE",
      "NDC11Code": "69945-0452-10",
      "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": "69945-890-10",
      "PackageDescription": "1 INJECTION, SOLUTION in 1 CARTON (69945-890-10) ",
      "NDC11Code": "69945-0890-10",
      "ProductNDC": "69945-890",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ultra-technekow",
      "ProprietaryNameSuffix": "Dte",
      "NonProprietaryName": "Technetium Tc-99m",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20151207",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017243",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
      "StrengthNumber": "6",
      "StrengthUnit": "Ci/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20151207",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10920-601-01",
      "PackageDescription": "10 kg in 1 PACKAGE (10920-601-01)",
      "NDC11Code": "10920-0601-01",
      "ProductNDC": "10920-601",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Doxapram Hydrochloride Monohydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20171025",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Arevipharma GmbH",
      "SubstanceName": "DOXAPRAM HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2021-01-22",
      "ListingRecordCertifiedThrough": "20221231"
    },
    {
      "NDCCode": "12462-601-10",
      "PackageDescription": "1000 mL in 1 BOTTLE (12462-601-10)",
      "NDC11Code": "12462-0601-10",
      "ProductNDC": "12462-601",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Instant Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20020901",
      "EndMarketingDate": "20171231",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Chester Packaging, LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "23155-601-41",
      "PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (23155-601-41)  / 5 mL in 1 VIAL, MULTI-DOSE (23155-601-31) ",
      "NDC11Code": "23155-0601-41",
      "ProductNDC": "23155-601",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Midazolam Hydrochloride",
      "NonProprietaryName": "Midazolam Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20161107",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090850",
      "LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
      "SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2023-04-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161107",
      "SamplePackage": "N",
      "IndicationAndUsage": "Midazolam Injection is indicated: 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;, 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;, 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);, 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.",
      "Description": "Midazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 5 mg midazolam compounded with 0.8% sodium chloride and 0.01% edetate disodium, with 1% benzyl alcohol as preservative; the pH is adjusted to 2.9 to 3.5 with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white or yellowish crystalline powder, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the empirical formula C18H13ClFN3HCl, a calculated molecular weight of 362.25 and the following structural formula.   Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form."
    },
    {
      "NDCCode": "23155-601-42",
      "PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (23155-601-42)  / 10 mL in 1 VIAL, MULTI-DOSE (23155-601-32) ",
      "NDC11Code": "23155-0601-42",
      "ProductNDC": "23155-601",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Midazolam Hydrochloride",
      "NonProprietaryName": "Midazolam Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20161107",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090850",
      "LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
      "SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2023-04-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161107",
      "SamplePackage": "N",
      "IndicationAndUsage": "Midazolam Injection is indicated: 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;, 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;, 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);, 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.",
      "Description": "Midazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 5 mg midazolam compounded with 0.8% sodium chloride and 0.01% edetate disodium, with 1% benzyl alcohol as preservative; the pH is adjusted to 2.9 to 3.5 with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white or yellowish crystalline powder, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the empirical formula C18H13ClFN3HCl, a calculated molecular weight of 362.25 and the following structural formula.   Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form."
    },
    {
      "NDCCode": "24208-601-10",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-601-10)  > 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "24208-0601-10",
      "ProductNDC": "24208-601",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alaway",
      "NonProprietaryName": "Ketotifen Fumarate",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20061201",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021996",
      "LabelerName": "Bausch & Lomb Incorporated",
      "SubstanceName": "KETOTIFEN FUMARATE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-05-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20061201",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander."
    },
    {
      "NDCCode": "24208-601-90",
      "PackageDescription": "2 BOTTLE, DROPPER in 1 CARTON (24208-601-90)  > 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "24208-0601-90",
      "ProductNDC": "24208-601",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alaway",
      "NonProprietaryName": "Ketotifen Fumarate",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20061201",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021996",
      "LabelerName": "Bausch & Lomb Incorporated",
      "SubstanceName": "KETOTIFEN FUMARATE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-05-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20061201",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander."
    },
    {
      "NDCCode": "24909-601-10",
      "PackageDescription": "10 g in 1 JAR (24909-601-10)",
      "NDC11Code": "24909-0601-10",
      "ProductNDC": "24909-601",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fastrin Anti - Fungal Skin Care",
      "NonProprietaryName": "Clotrimazole",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333C",
      "LabelerName": "Aidance Skincare & Topical Solutions, LLC",
      "SubstanceName": "CLOTRIMAZOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Cures most fungal skin infections, including ringworm and tinea. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections."
    },
    {
      "NDCCode": "31722-601-31",
      "PackageDescription": "10 CARTON in 1 BOX (31722-601-31)  / 10 CUP, UNIT-DOSE in 1 CARTON / 10 mL in 1 CUP, UNIT-DOSE",
      "NDC11Code": "31722-0601-31",
      "ProductNDC": "31722-601",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diphenhydramine Hydrochloride",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260617",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219470",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/10mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260617",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diphenhydramine hydrochloride in the oral form is effective for the following indications: Antihistaminic For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctiveto epinephrine and other standard measures after the acute manifestations have been controlled. Motion Sickness For active and prophylactic treatment of motion sickness. Antiparkinsonism For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced) in other age groups; in other cases of parkinsonism (including drug-induced) in combination with centrally acting anticholinergic agents. Nighttime Sleep-aid.",
      "Description": "Diphenhydramine hydrochloride USP is an antihistamine drug having the chemical name 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride and has the molecular formula C 17H 21NOHCl (molecular weight 291.82). It occurs as a white, odorless, crystalline powder. Slowly darkens on exposure to light and is freely soluble in water, alcohol and in chloroform. Sparingly soluble in acetone. Very slightly soluble in benzene and in ether. The structural formula is as follows:.   Each 5 mL contains 12.5 mg of diphenhydramine hydrochloride USP and alcohol 14% for oral administration. Inactive Ingredients: cassia cinnamon flavour (contains cassia bark oil,  cinnamic aldehyde, cinnamon leaf oil, eugenol and glyceryl triacetate), citric acid monohydrate, D&C red No. 33, ethyl alcohol dehydrated, FD&C red No. 40, purified water, sucrose and trisodium citrate dihydrate."
    },
    {
      "NDCCode": "41226-601-10",
      "PackageDescription": "2 BOTTLE in 1 PACKAGE, COMBINATION (41226-601-10)  / 500 TABLET, COATED in 1 BOTTLE (41226-601-53) ",
      "NDC11Code": "41226-0601-10",
      "ProductNDC": "41226-601",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210410",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Kroger Company",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240415",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses temporarily relieves minor aches and pains due to: backache headache menstrual cramps minor pain of arthritis muscular aches the common cold toothache temporarily reduces fever."
    },
    {
      "NDCCode": "42806-601-10",
      "PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-10) ",
      "NDC11Code": "42806-0601-10",
      "ProductNDC": "42806-601",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venlafaxine Hydrochloride",
      "NonProprietaryName": "Venlafaxine Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220907",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214654",
      "LabelerName": "Epic Pharma, LLC",
      "SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
      "StrengthNumber": "37.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220907",
      "SamplePackage": "N",
      "IndicationAndUsage": "Venlafaxine Hydrochloride Extended-Release Capsules, USP are indicated in adults for the treatment of. : 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 Panic Disorder (PD) [see Clinical Studies (14.4)] .",
      "Description": "Venlafaxine Hydrochloride Extended-Release Capsules, USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of empty hard gelatin capsules, ethylcellulose, hypromellose, povidone, sugar spheres (composed of corn starch and sucrose) and talc. The 37.5 mg capsule shell contains red iron oxide, gelatin, and titanium dioxide. The 75 mg capsule shell contains black iron oxide, red iron oxide, gelatin, and titanium dioxide. The 150 mg capsule shell contains FD&C blue 1, FD&C red 3, FD&C yellow 6, gelatin, and titanium dioxide. The imprinting ink contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "43547-601-10",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-601-10) ",
      "NDC11Code": "43547-0601-10",
      "ProductNDC": "43547-601",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ropinirole Hydrochloride",
      "NonProprietaryName": "Ropinirole Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110920",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078110",
      "LabelerName": "SOLCO HEALTHCARE US, LLC",
      "SubstanceName": "ROPINIROLE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110920",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
      "Description": "Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243oC to 250°C and a solubility of 133 mg/mL in water. Each round biconvex film-coated ropinirole tablet contains 0.29, 0.57, 1.14, 2.28, 3.42, 4.56, or 5.70 mg of ropinirole hydrochloride equivalent to ropinirole 0.25, 0.5, 1, 2, 3, 4, or 5 mg, respectively. Inactive ingredients of the core tablets consist of croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Inactive ingredients of the film coats are slightly different among the 7 strengths of tablets and are tabulated below. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "44567-601-04",
      "PackageDescription": "4 VIAL in 1 CARTON (44567-601-04)  / 10 mL in 1 VIAL",
      "NDC11Code": "44567-0601-04",
      "ProductNDC": "44567-601",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexmedetomidine",
      "NonProprietaryName": "Dexmedetomidine",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20160419",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206628",
      "LabelerName": "WG Critical Care, LLC",
      "SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha2 adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours. (1.1) , 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2) .",
      "Description": "Dexmedetomidine Injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine in 5% Dextrose Injection is a sterile ready-to-use, nonpyrogenic solution suitable for intravenous infusion. Dexmedetomidine Injection and Dexmedetomidine in Dextrose Injection contains the dexmedetomidine as active pharmaceutical ingredient in the form of the hydrochloride salt form. Dexmedetomidine hydrochloride is a central alpha-2 adrenergic agonist. Structurally it is the S-enantiomer of medetomidine and is chemically described as 4-[(S)-α,2,3-Trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the empirical formula is C13H16N2  HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 118 mcg of dexmedetomidine hydrochloride USP, equivalent to 100 mcg (0.1 mg) of dexmedetomidine, 1.6 mg of methylparaben NF and 0.2 mg of propylparaben NF, as preservatives and 9 mg of sodium chloride USP, as tonicity agent in water for injection. Dexmedetomidine in 5% Dextrose Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride USP, equivalent to 4 mcg of dexmedetomidine, and 50 mg dextrose monohydrate USP, as tonicity agent, in water for injection."
    },
    {
      "NDCCode": "46144-601-10",
      "PackageDescription": "1 g in 1 BOTTLE, GLASS (46144-601-10)",
      "NDC11Code": "46144-0601-10",
      "ProductNDC": "46144-601",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Hydroxocobalamin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20120615",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "A.P.I. Solutions, Inc.",
      "SubstanceName": "HYDROXOCOBALAMIN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "47781-601-91",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (47781-601-91)  > 10 mL in 1 VIAL, SINGLE-DOSE (47781-601-22) ",
      "NDC11Code": "47781-0601-91",
      "ProductNDC": "47781-601",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tranexamic Acid",
      "NonProprietaryName": "Tranexamic Acid",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207239",
      "LabelerName": "Alvogen Inc.",
      "SubstanceName": "TRANEXAMIC ACID",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20170901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49035-601-10",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49035-601-10)  / 30 mL in 1 BOTTLE",
      "NDC11Code": "49035-0601-10",
      "ProductNDC": "49035-601",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Parents Choice Infants Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170712",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075217",
      "LabelerName": "Wal-Mart Stores Inc",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1.25mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170712",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily: 1 reduces fever, 2 relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches."
    },
    {
      "NDCCode": "49483-601-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (49483-601-10) ",
      "NDC11Code": "49483-0601-10",
      "ProductNDC": "49483-601",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160322",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091239",
      "LabelerName": "TIME CAP LABORATORIES,INC",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-08-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20160322",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51407-601-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (51407-601-10) ",
      "NDC11Code": "51407-0601-10",
      "ProductNDC": "51407-601",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Captopril",
      "NonProprietaryName": "Captopril",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074505",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "CAPTOPRIL",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210913",
      "EndMarketingDatePackage": "20260228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Captopril Tablets, USP are indicated for the treatment of hypertension. In using Captopril Tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril Tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril Tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.",
      "Description": "Captopril Tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline and has the following structural formula.                                                                                                                         MW 217.29. Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate (derived from potato), starch (derived from corn), and stearic acid."
    },
    {
      "NDCCode": "51645-601-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (51645-601-10)",
      "NDC11Code": "51645-0601-10",
      "ProductNDC": "51645-601",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120330",
      "EndMarketingDate": "20171130",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"69945-601-10","ProprietaryName":"Sodium Iodide I 123","NonProprietaryName":"Sodium Iodide I 123"},{"NDCCode":"69945-060-10","ProprietaryName":"Ultra-technekow","NonProprietaryName":"Technetium Tc-99m"},{"NDCCode":"69945-068-20","ProprietaryName":"Ultratag","NonProprietaryName":"Kit For The Preparation Of Technetium Tc 99m Red Blood Cells"},{"NDCCode":"69945-092-20","ProprietaryName":"Technetium Tc 99m Sestamibi","NonProprietaryName":"Technetium Tc 99m Sestamibi"},{"NDCCode":"69945-092-40","ProprietaryName":"Technetium Tc 99m Sestamibi","NonProprietaryName":"Technetium Tc 99m Sestamibi"},{"NDCCode":"69945-094-20","ProprietaryName":"Technescan Pyp","NonProprietaryName":"Technetium Tc 99m Pyrophosphate"},{"NDCCode":"69945-139-20","ProprietaryName":"Pulmotech Maa","NonProprietaryName":"Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated"},{"NDCCode":"69945-139-40","ProprietaryName":"Pulmotech Maa","NonProprietaryName":"Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated"},{"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"},{"NDCCode":"69945-452-10","ProprietaryName":"Sodium Iodide I 131","NonProprietaryName":"Sodium Iodide I 131"},{"NDCCode":"69945-890-10","ProprietaryName":"Ultra-technekow","NonProprietaryName":"Technetium Tc-99m"},{"NDCCode":"10920-601-01","NonProprietaryName":"Doxapram Hydrochloride Monohydrate"},{"NDCCode":"12462-601-10","ProprietaryName":"Instant Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"23155-601-41","ProprietaryName":"Midazolam Hydrochloride","NonProprietaryName":"Midazolam Hydrochloride"},{"NDCCode":"23155-601-42","ProprietaryName":"Midazolam Hydrochloride","NonProprietaryName":"Midazolam Hydrochloride"},{"NDCCode":"24208-601-10","ProprietaryName":"Alaway","NonProprietaryName":"Ketotifen Fumarate"},{"NDCCode":"24208-601-90","ProprietaryName":"Alaway","NonProprietaryName":"Ketotifen Fumarate"},{"NDCCode":"24909-601-10","ProprietaryName":"Fastrin Anti - Fungal Skin Care","NonProprietaryName":"Clotrimazole"},{"NDCCode":"31722-601-31","ProprietaryName":"Diphenhydramine Hydrochloride","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"41226-601-10","ProprietaryName":"Ibuprofen","NonProprietaryName":"Ibuprofen"},{"NDCCode":"42806-601-10","ProprietaryName":"Venlafaxine Hydrochloride","NonProprietaryName":"Venlafaxine Hydrochloride"},{"NDCCode":"43547-601-10","ProprietaryName":"Ropinirole Hydrochloride","NonProprietaryName":"Ropinirole Hydrochloride"},{"NDCCode":"44567-601-04","ProprietaryName":"Dexmedetomidine","NonProprietaryName":"Dexmedetomidine"},{"NDCCode":"46144-601-10","NonProprietaryName":"Hydroxocobalamin"},{"NDCCode":"47781-601-91","ProprietaryName":"Tranexamic Acid","NonProprietaryName":"Tranexamic Acid"},{"NDCCode":"49035-601-10","ProprietaryName":"Parents Choice Infants Ibuprofen","NonProprietaryName":"Ibuprofen"},{"NDCCode":"49483-601-10","ProprietaryName":"Ibuprofen","NonProprietaryName":"Ibuprofen"},{"NDCCode":"51407-601-10","ProprietaryName":"Captopril","NonProprietaryName":"Captopril"},{"NDCCode":"51645-601-10","ProprietaryName":"Acetaminophen","NonProprietaryName":"Acetaminophen"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>69945-601-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CAN (69945-601-10)  / 1 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>69945-0601-10</NDC11Code>
    <ProductNDC>69945-601</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>20151104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071909</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>SODIUM IODIDE I-123</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>uCi/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151104</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>69945-060-10</NDCCode>
    <PackageDescription>1 INJECTION, SOLUTION in 1 CARTON (69945-060-10) </PackageDescription>
    <NDC11Code>69945-0060-10</NDC11Code>
    <ProductNDC>69945-060</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ultra-technekow</ProprietaryName>
    <ProprietaryNameSuffix>V4</ProprietaryNameSuffix>
    <NonProprietaryName>Technetium Tc-99m</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20140610</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017243</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>Ci/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>The Ultra-Technekow V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m is used IN ADULTSas an agent for:. Thyroid Imaging Salivary Gland Imaging Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux Nasolacrimal Drainage System Imaging (dacryoscintigraphy). Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTSas an agent for:. Thyroid Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.</IndicationAndUsage>
    <Description>The Ultra-Technekow V4 Generator is prepared with fission-produced molybdenum Mo-99 adsorbed onto alumina in a column shielded by lead, tungsten, or depleted uranium. The column assembly and shielding are encased in a plastic container that is covered with a plastic elution hood.  The elution hood has an opening for the column assembly double inlet needles and an opening for the single outlet needle.  The needles accommodate the sterile eluant vials that contain 0.9% Sodium Chloride Injection and sterile evacuated collection vials.  A sterile vial containing a bacteriostat is supplied with the generator for the customer to aseptically seal the outlet needle after each elution. This terminally sterilized generator provides a closed system for the production of sterile metastable technetium Tc-99m, which is produced by the decay of molybdenum Mo-99. Incorporated between the column outlet and the collection vial is a sterile 0.22 micrometer filter. Sterile, non-pyrogenic isotonic solutions of Sodium Pertechnetate Tc 99m Injection in 0.9% Sodium Chloride Injection can be obtained conveniently by periodic aseptic elution of the generator. These solutions should be clear, colorless, and free from any particulate matter.  The Sodium Pertechnetate Tc 99m Injection is suitable for intravenous injection and direct instillation. The carrier-free solution may be used as is, or diluted to the proper concentration. Over the life of the generator, an elution will contain an amount of technetium Tc-99m in direct proportion to the quantity of Mo-99 decay since the previous elution of the generator. The quantity of Tc-99m in the eluate is determined by quantity of Mo-99 on the column, and the elapsed time between elutions. Each eluate of the generator should not contain more than the USP limit of 0.15 kilobecquerel molybdenum Mo-99 per megabecquerel technetium Tc-99m (0.15 microcurie Mo-99 per millicurie Tc-99m) per administered dose at the time of administration and an aluminum ion concentration of not more than 10 micrograms per milliliter of the generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of generator elution.</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>20271231</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>69945-092-20</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>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Myocardial Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Kit for the Preparation of Technetium Tc99m Sestamibi Injection is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Kit for the Preparation of Technetium Tc99m Sestamibi Injection is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.</IndicationAndUsage>
    <Description>Each 10 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: 1 Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate – 1 mg, 2 Sodium Citrate Dihydrate - 2.6 mg, 3 L-Cysteine Hydrochloride Monohydrate – 1 mg, 4 Mannitol - 20 mg, 5 Stannous Chloride, Dihydrate, minimum (SnCl22H2O) - 0.025 mg, 6 Stannous Chloride, Dihydrate (SnCl22H2O) - 0.075 mg, 7 Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl22H2O) - 0.086 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>69945-092-40</NDCCode>
    <PackageDescription>30 VIAL in 1 CARTON (69945-092-40)  &gt; 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>69945-0092-40</NDC11Code>
    <ProductNDC>69945-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Technetium Tc 99m Sestamibi</ProprietaryName>
    <NonProprietaryName>Technetium Tc 99m Sestamibi</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20111031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078098</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</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>69945-094-20</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>20271231</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>69945-139-20</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>20271231</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>69945-139-40</NDCCode>
    <PackageDescription>30 VIAL, MULTI-DOSE in 1 CARTON (69945-139-40)  / 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10) </PackageDescription>
    <NDC11Code>69945-0139-40</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>20271231</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>69945-314-05</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>20271231</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>20271231</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>69945-452-10</NDCCode>
    <PackageDescription>1 CAPSULE in 1 CAN (69945-452-10)  &gt; 10 mL in 1 CAPSULE</PackageDescription>
    <NDC11Code>69945-0452-10</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>69945-890-10</NDCCode>
    <PackageDescription>1 INJECTION, SOLUTION in 1 CARTON (69945-890-10) </PackageDescription>
    <NDC11Code>69945-0890-10</NDC11Code>
    <ProductNDC>69945-890</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ultra-technekow</ProprietaryName>
    <ProprietaryNameSuffix>Dte</ProprietaryNameSuffix>
    <NonProprietaryName>Technetium Tc-99m</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20151207</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017243</ApplicationNumber>
    <LabelerName>Curium US LLC</LabelerName>
    <SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>Ci/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10920-601-01</NDCCode>
    <PackageDescription>10 kg in 1 PACKAGE (10920-601-01)</PackageDescription>
    <NDC11Code>10920-0601-01</NDC11Code>
    <ProductNDC>10920-601</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Doxapram Hydrochloride Monohydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20171025</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Arevipharma GmbH</LabelerName>
    <SubstanceName>DOXAPRAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2021-01-22</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>12462-601-10</NDCCode>
    <PackageDescription>1000 mL in 1 BOTTLE (12462-601-10)</PackageDescription>
    <NDC11Code>12462-0601-10</NDC11Code>
    <ProductNDC>12462-601</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instant Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20020901</StartMarketingDate>
    <EndMarketingDate>20171231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Chester Packaging, LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>23155-601-41</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (23155-601-41)  / 5 mL in 1 VIAL, MULTI-DOSE (23155-601-31) </PackageDescription>
    <NDC11Code>23155-0601-41</NDC11Code>
    <ProductNDC>23155-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Midazolam Hydrochloride</ProprietaryName>
    <NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20161107</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090850</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-04-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Midazolam Injection is indicated: 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;, 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;, 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);, 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.</IndicationAndUsage>
    <Description>Midazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 5 mg midazolam compounded with 0.8% sodium chloride and 0.01% edetate disodium, with 1% benzyl alcohol as preservative; the pH is adjusted to 2.9 to 3.5 with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white or yellowish crystalline powder, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the empirical formula C18H13ClFN3HCl, a calculated molecular weight of 362.25 and the following structural formula.   Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form.</Description>
  </NDC>
  <NDC>
    <NDCCode>23155-601-42</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (23155-601-42)  / 10 mL in 1 VIAL, MULTI-DOSE (23155-601-32) </PackageDescription>
    <NDC11Code>23155-0601-42</NDC11Code>
    <ProductNDC>23155-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Midazolam Hydrochloride</ProprietaryName>
    <NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20161107</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090850</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-04-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Midazolam Injection is indicated: 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;, 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;, 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);, 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.</IndicationAndUsage>
    <Description>Midazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 5 mg midazolam compounded with 0.8% sodium chloride and 0.01% edetate disodium, with 1% benzyl alcohol as preservative; the pH is adjusted to 2.9 to 3.5 with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white or yellowish crystalline powder, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the empirical formula C18H13ClFN3HCl, a calculated molecular weight of 362.25 and the following structural formula.   Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form.</Description>
  </NDC>
  <NDC>
    <NDCCode>24208-601-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-601-10)  &gt; 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>24208-0601-10</NDC11Code>
    <ProductNDC>24208-601</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alaway</ProprietaryName>
    <NonProprietaryName>Ketotifen Fumarate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20061201</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021996</ApplicationNumber>
    <LabelerName>Bausch &amp; Lomb Incorporated</LabelerName>
    <SubstanceName>KETOTIFEN FUMARATE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>24208-601-90</NDCCode>
    <PackageDescription>2 BOTTLE, DROPPER in 1 CARTON (24208-601-90)  &gt; 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>24208-0601-90</NDC11Code>
    <ProductNDC>24208-601</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alaway</ProprietaryName>
    <NonProprietaryName>Ketotifen Fumarate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20061201</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021996</ApplicationNumber>
    <LabelerName>Bausch &amp; Lomb Incorporated</LabelerName>
    <SubstanceName>KETOTIFEN FUMARATE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>24909-601-10</NDCCode>
    <PackageDescription>10 g in 1 JAR (24909-601-10)</PackageDescription>
    <NDC11Code>24909-0601-10</NDC11Code>
    <ProductNDC>24909-601</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fastrin Anti - Fungal Skin Care</ProprietaryName>
    <NonProprietaryName>Clotrimazole</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333C</ApplicationNumber>
    <LabelerName>Aidance Skincare &amp; Topical Solutions, LLC</LabelerName>
    <SubstanceName>CLOTRIMAZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Cures most fungal skin infections, including ringworm and tinea. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>31722-601-31</NDCCode>
    <PackageDescription>10 CARTON in 1 BOX (31722-601-31)  / 10 CUP, UNIT-DOSE in 1 CARTON / 10 mL in 1 CUP, UNIT-DOSE</PackageDescription>
    <NDC11Code>31722-0601-31</NDC11Code>
    <ProductNDC>31722-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260617</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219470</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260617</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diphenhydramine hydrochloride in the oral form is effective for the following indications: Antihistaminic For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctiveto epinephrine and other standard measures after the acute manifestations have been controlled. Motion Sickness For active and prophylactic treatment of motion sickness. Antiparkinsonism For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced) in other age groups; in other cases of parkinsonism (including drug-induced) in combination with centrally acting anticholinergic agents. Nighttime Sleep-aid.</IndicationAndUsage>
    <Description>Diphenhydramine hydrochloride USP is an antihistamine drug having the chemical name 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride and has the molecular formula C 17H 21NOHCl (molecular weight 291.82). It occurs as a white, odorless, crystalline powder. Slowly darkens on exposure to light and is freely soluble in water, alcohol and in chloroform. Sparingly soluble in acetone. Very slightly soluble in benzene and in ether. The structural formula is as follows:.   Each 5 mL contains 12.5 mg of diphenhydramine hydrochloride USP and alcohol 14% for oral administration. Inactive Ingredients: cassia cinnamon flavour (contains cassia bark oil,  cinnamic aldehyde, cinnamon leaf oil, eugenol and glyceryl triacetate), citric acid monohydrate, D&amp;C red No. 33, ethyl alcohol dehydrated, FD&amp;C red No. 40, purified water, sucrose and trisodium citrate dihydrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>41226-601-10</NDCCode>
    <PackageDescription>2 BOTTLE in 1 PACKAGE, COMBINATION (41226-601-10)  / 500 TABLET, COATED in 1 BOTTLE (41226-601-53) </PackageDescription>
    <NDC11Code>41226-0601-10</NDC11Code>
    <ProductNDC>41226-601</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210410</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Kroger Company</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses temporarily relieves minor aches and pains due to: backache headache menstrual cramps minor pain of arthritis muscular aches the common cold toothache temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42806-601-10</NDCCode>
    <PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-10) </PackageDescription>
    <NDC11Code>42806-0601-10</NDC11Code>
    <ProductNDC>42806-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220907</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214654</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220907</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine Hydrochloride Extended-Release Capsules, USP are indicated in adults for the treatment of. : 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 Panic Disorder (PD) [see Clinical Studies (14.4)] .</IndicationAndUsage>
    <Description>Venlafaxine Hydrochloride Extended-Release Capsules, USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of empty hard gelatin capsules, ethylcellulose, hypromellose, povidone, sugar spheres (composed of corn starch and sucrose) and talc. The 37.5 mg capsule shell contains red iron oxide, gelatin, and titanium dioxide. The 75 mg capsule shell contains black iron oxide, red iron oxide, gelatin, and titanium dioxide. The 150 mg capsule shell contains FD&amp;C blue 1, FD&amp;C red 3, FD&amp;C yellow 6, gelatin, and titanium dioxide. The imprinting ink contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-601-10</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-601-10) </PackageDescription>
    <NDC11Code>43547-0601-10</NDC11Code>
    <ProductNDC>43547-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078110</ApplicationNumber>
    <LabelerName>SOLCO HEALTHCARE US, LLC</LabelerName>
    <SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
    <Description>Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243oC to 250°C and a solubility of 133 mg/mL in water. Each round biconvex film-coated ropinirole tablet contains 0.29, 0.57, 1.14, 2.28, 3.42, 4.56, or 5.70 mg of ropinirole hydrochloride equivalent to ropinirole 0.25, 0.5, 1, 2, 3, 4, or 5 mg, respectively. Inactive ingredients of the core tablets consist of croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Inactive ingredients of the film coats are slightly different among the 7 strengths of tablets and are tabulated below. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-601-04</NDCCode>
    <PackageDescription>4 VIAL in 1 CARTON (44567-601-04)  / 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>44567-0601-04</NDC11Code>
    <ProductNDC>44567-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmedetomidine</ProprietaryName>
    <NonProprietaryName>Dexmedetomidine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206628</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha2 adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours. (1.1) , 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2) .</IndicationAndUsage>
    <Description>Dexmedetomidine Injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine in 5% Dextrose Injection is a sterile ready-to-use, nonpyrogenic solution suitable for intravenous infusion. Dexmedetomidine Injection and Dexmedetomidine in Dextrose Injection contains the dexmedetomidine as active pharmaceutical ingredient in the form of the hydrochloride salt form. Dexmedetomidine hydrochloride is a central alpha-2 adrenergic agonist. Structurally it is the S-enantiomer of medetomidine and is chemically described as 4-[(S)-α,2,3-Trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the empirical formula is C13H16N2  HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 118 mcg of dexmedetomidine hydrochloride USP, equivalent to 100 mcg (0.1 mg) of dexmedetomidine, 1.6 mg of methylparaben NF and 0.2 mg of propylparaben NF, as preservatives and 9 mg of sodium chloride USP, as tonicity agent in water for injection. Dexmedetomidine in 5% Dextrose Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride USP, equivalent to 4 mcg of dexmedetomidine, and 50 mg dextrose monohydrate USP, as tonicity agent, in water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>46144-601-10</NDCCode>
    <PackageDescription>1 g in 1 BOTTLE, GLASS (46144-601-10)</PackageDescription>
    <NDC11Code>46144-0601-10</NDC11Code>
    <ProductNDC>46144-601</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Hydroxocobalamin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120615</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>A.P.I. Solutions, Inc.</LabelerName>
    <SubstanceName>HYDROXOCOBALAMIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>47781-601-91</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (47781-601-91)  &gt; 10 mL in 1 VIAL, SINGLE-DOSE (47781-601-22) </PackageDescription>
    <NDC11Code>47781-0601-91</NDC11Code>
    <ProductNDC>47781-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tranexamic Acid</ProprietaryName>
    <NonProprietaryName>Tranexamic Acid</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207239</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>TRANEXAMIC ACID</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49035-601-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49035-601-10)  / 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>49035-0601-10</NDC11Code>
    <ProductNDC>49035-601</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Parents Choice Infants Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170712</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075217</ApplicationNumber>
    <LabelerName>Wal-Mart Stores Inc</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1.25mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170712</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49483-601-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (49483-601-10) </PackageDescription>
    <NDC11Code>49483-0601-10</NDC11Code>
    <ProductNDC>49483-601</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091239</ApplicationNumber>
    <LabelerName>TIME CAP LABORATORIES,INC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-08-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51407-601-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (51407-601-10) </PackageDescription>
    <NDC11Code>51407-0601-10</NDC11Code>
    <ProductNDC>51407-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Captopril</ProprietaryName>
    <NonProprietaryName>Captopril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074505</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>CAPTOPRIL</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210913</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Captopril Tablets, USP are indicated for the treatment of hypertension. In using Captopril Tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril Tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril Tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.</IndicationAndUsage>
    <Description>Captopril Tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline and has the following structural formula.                                                                                                                         MW 217.29. Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate (derived from potato), starch (derived from corn), and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>51645-601-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (51645-601-10)</PackageDescription>
    <NDC11Code>51645-0601-10</NDC11Code>
    <ProductNDC>51645-601</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120330</StartMarketingDate>
    <EndMarketingDate>20171130</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>69945-601-10</NDCCode><ProprietaryName>Sodium Iodide I 123</ProprietaryName><NonProprietaryName>Sodium Iodide I 123</NonProprietaryName></NDC><NDC><NDCCode>69945-060-10</NDCCode><ProprietaryName>Ultra-technekow</ProprietaryName><NonProprietaryName>Technetium Tc-99m</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>69945-092-20</NDCCode><ProprietaryName>Technetium Tc 99m Sestamibi</ProprietaryName><NonProprietaryName>Technetium Tc 99m Sestamibi</NonProprietaryName></NDC><NDC><NDCCode>69945-092-40</NDCCode><ProprietaryName>Technetium Tc 99m Sestamibi</ProprietaryName><NonProprietaryName>Technetium Tc 99m Sestamibi</NonProprietaryName></NDC><NDC><NDCCode>69945-094-20</NDCCode><ProprietaryName>Technescan Pyp</ProprietaryName><NonProprietaryName>Technetium Tc 99m Pyrophosphate</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>69945-139-40</NDCCode><ProprietaryName>Pulmotech Maa</ProprietaryName><NonProprietaryName>Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated</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><NDC><NDCCode>69945-452-10</NDCCode><ProprietaryName>Sodium Iodide I 131</ProprietaryName><NonProprietaryName>Sodium Iodide I 131</NonProprietaryName></NDC><NDC><NDCCode>69945-890-10</NDCCode><ProprietaryName>Ultra-technekow</ProprietaryName><NonProprietaryName>Technetium Tc-99m</NonProprietaryName></NDC><NDC><NDCCode>10920-601-01</NDCCode><NonProprietaryName>Doxapram Hydrochloride Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>12462-601-10</NDCCode><ProprietaryName>Instant Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>23155-601-41</NDCCode><ProprietaryName>Midazolam Hydrochloride</ProprietaryName><NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>23155-601-42</NDCCode><ProprietaryName>Midazolam Hydrochloride</ProprietaryName><NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>24208-601-10</NDCCode><ProprietaryName>Alaway</ProprietaryName><NonProprietaryName>Ketotifen Fumarate</NonProprietaryName></NDC><NDC><NDCCode>24208-601-90</NDCCode><ProprietaryName>Alaway</ProprietaryName><NonProprietaryName>Ketotifen Fumarate</NonProprietaryName></NDC><NDC><NDCCode>24909-601-10</NDCCode><ProprietaryName>Fastrin Anti - Fungal Skin Care</ProprietaryName><NonProprietaryName>Clotrimazole</NonProprietaryName></NDC><NDC><NDCCode>31722-601-31</NDCCode><ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>41226-601-10</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>42806-601-10</NDCCode><ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName><NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43547-601-10</NDCCode><ProprietaryName>Ropinirole Hydrochloride</ProprietaryName><NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>44567-601-04</NDCCode><ProprietaryName>Dexmedetomidine</ProprietaryName><NonProprietaryName>Dexmedetomidine</NonProprietaryName></NDC><NDC><NDCCode>46144-601-10</NDCCode><NonProprietaryName>Hydroxocobalamin</NonProprietaryName></NDC><NDC><NDCCode>47781-601-91</NDCCode><ProprietaryName>Tranexamic Acid</ProprietaryName><NonProprietaryName>Tranexamic Acid</NonProprietaryName></NDC><NDC><NDCCode>49035-601-10</NDCCode><ProprietaryName>Parents Choice Infants Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>49483-601-10</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>51407-601-10</NDCCode><ProprietaryName>Captopril</ProprietaryName><NonProprietaryName>Captopril</NonProprietaryName></NDC><NDC><NDCCode>51645-601-10</NDCCode><ProprietaryName>Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</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",
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      "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"
    }
  ]
}
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