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How to Find 69879-104-35 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "69879-104-35",
      "PackageDescription": "35 mL in 1 TUBE (69879-104-35) ",
      "NDC11Code": "69879-0104-35",
      "ProductNDC": "69879-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cover-expert Sunscreen Broad Spectrum Spf 15 No.4 Rosy Beige",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Luxe Art Beaute SAS",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "51; 28",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69879-101-35",
      "PackageDescription": "35 mL in 1 TUBE (69879-101-35) ",
      "NDC11Code": "69879-0101-35",
      "ProductNDC": "69879-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cover-expert Sunscreen Broad Spectrum Spf 15 No.1 Fair Beige",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "EndMarketingDate": "20250129",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Luxe Art Beaute SAS",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "51; 28",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150731",
      "EndMarketingDatePackage": "20250129",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69879-102-35",
      "PackageDescription": "35 mL in 1 TUBE (69879-102-35) ",
      "NDC11Code": "69879-0102-35",
      "ProductNDC": "69879-102",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cover-expert Sunscreen Broad Spectrum Spf 15 No.2 Neutral Beige",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "EndMarketingDate": "20240828",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Luxe Art Beaute SAS",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "51; 28",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-08-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150731",
      "EndMarketingDatePackage": "20240828",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69879-103-35",
      "PackageDescription": "35 mL in 1 TUBE (69879-103-35) ",
      "NDC11Code": "69879-0103-35",
      "ProductNDC": "69879-103",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cover-expert Sunscreen Broad Spectrum Spf 15 No.3 Cream Beige",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Luxe Art Beaute SAS",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "51; 28",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69879-105-35",
      "PackageDescription": "35 mL in 1 TUBE (69879-105-35) ",
      "NDC11Code": "69879-0105-35",
      "ProductNDC": "69879-105",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cover-expert Sunscreen Broad Spectrum Spf 15 No.5 Peach Beige",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Luxe Art Beaute SAS",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "51; 28",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69879-107-35",
      "PackageDescription": "35 mL in 1 TUBE (69879-107-35) ",
      "NDC11Code": "69879-0107-35",
      "ProductNDC": "69879-107",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cover-expert Sunscreen Broad Spectrum Spf 15 No.7 Vanilla Beige",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Luxe Art Beaute SAS",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "51; 28",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69879-108-35",
      "PackageDescription": "35 mL in 1 TUBE (69879-108-35) ",
      "NDC11Code": "69879-0108-35",
      "ProductNDC": "69879-108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Luxe Art Beaute Sas (69879-108-35) Cover-expert Sunscreen Broad Spectrum Spf 15 No.8 Intense Beige, 35ml",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Luxe Art Beaute SAS",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "51; 28",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69879-109-35",
      "PackageDescription": "35 mL in 1 TUBE (69879-109-35) ",
      "NDC11Code": "69879-0109-35",
      "ProductNDC": "69879-109",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cover-expert Sunscreen Broad Spectrum Spf 15 No.9 Honey Beige",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Luxe Art Beaute SAS",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "51; 28",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69879-111-35",
      "PackageDescription": "35 mL in 1 TUBE (69879-111-35) ",
      "NDC11Code": "69879-0111-35",
      "ProductNDC": "69879-111",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cover-expert Sunscreen Broad Spectrum Spf 15 No.11 Amber Brown",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Luxe Art Beaute SAS",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "51; 28",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69879-112-35",
      "PackageDescription": "35 mL in 1 TUBE (69879-112-35) ",
      "NDC11Code": "69879-0112-35",
      "ProductNDC": "69879-112",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cover-expert Sunscreen Broad Spectrum Spf 15 No.12 Warm Copper",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "EndMarketingDate": "20250501",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Luxe Art Beaute SAS",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "51; 28",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150731",
      "EndMarketingDatePackage": "20250501",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49520-104-35",
      "PackageDescription": "150 mL in 1 TUBE (49520-104-35)",
      "NDC11Code": "49520-0104-35",
      "ProductNDC": "49520-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Take Control Calming",
      "ProprietaryNameSuffix": "Cleanser",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120927",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "mybody",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "USE FOR TREATMENT OF ACNE."
    },
    {
      "NDCCode": "54157-104-03",
      "PackageDescription": "35 g in 1 TUBE (54157-104-03)",
      "NDC11Code": "54157-0104-03",
      "ProductNDC": "54157-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Megafresh",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20140511",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "American Amenities, Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".15",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses: Aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "58159-104-01",
      "PackageDescription": "35 kg in 1 DRUM (58159-104-01) ",
      "NDC11Code": "58159-0104-01",
      "ProductNDC": "58159-104",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nicotinamide Riboside Chloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240821",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "NICOTINAMIDE RIBOSIDE CHLORIDE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-08-30",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "21-AUG-24"
    },
    {
      "NDCCode": "61619-104-32",
      "PackageDescription": "946.35 mL in 1 BOTTLE, PLASTIC (61619-104-32) ",
      "NDC11Code": "61619-0104-32",
      "ProductNDC": "61619-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antimicrobial Cleansing Gel",
      "NonProprietaryName": "Benzethonium Chloride",
      "DosageFormName": "LOTION",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20200220",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "A-Cute Derm, Incorporated",
      "SubstanceName": "BENZETHONIUM CHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200220",
      "SamplePackage": "N",
      "IndicationAndUsage": "B-KLEER is a unique, non-drying cleanser. Designed for all skin types and pH balanced. Excellent for postoperative care. May be used as a topical antimicrobial to help protect against skin infection."
    },
    {
      "NDCCode": "69677-104-35",
      "PackageDescription": "35 TABLET in 1 BOTTLE (69677-104-35) ",
      "NDC11Code": "69677-0104-35",
      "ProductNDC": "69677-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acyclovir",
      "NonProprietaryName": "Acyclovir",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140910",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204314",
      "LabelerName": "MAS MANAGEMENT GROUP, INC.",
      "SubstanceName": "ACYCLOVIR",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Herpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are indicated for the treatment of chickenpox (varicella).",
      "Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations for oral administration. Acyclovir is a white or almost white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.20. It is soluble in diluted hydrochloric acid; slightly soluble in water and insoluble in alcohol. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. Each acyclovir tablet intended for oral administration contains 400 mg and 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate."
    },
    {
      "NDCCode": "70474-104-51",
      "PackageDescription": "1 BOTTLE, DISPENSING in 1 BOX (70474-104-51)  > 35 mL in 1 BOTTLE, DISPENSING (70474-104-01)",
      "NDC11Code": "70474-0104-51",
      "ProductNDC": "70474-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Luminous Moisturizing Foundation",
      "ProprietaryNameSuffix": "Spf-15",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160407",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS)",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": ".9; 12.2",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "84165-104-35",
      "PackageDescription": "35 BAG in 1 BOX (84165-104-35)  / 12 g in 1 BAG (84165-104-01) ",
      "NDC11Code": "84165-0104-35",
      "ProductNDC": "84165-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pain Relief Gel-patch",
      "NonProprietaryName": "Lidocaine, Menthol",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240924",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Guangzhou Zhupuyou E-commerce Co., Ltd",
      "SubstanceName": "MENTHOL; LIDOCAINE",
      "StrengthNumber": ".01; .04",
      "StrengthUnit": "g/g; g/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240924",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back,neck, hips, shoulders,elbows."
    },
    {
      "NDCCode": "85537-104-02",
      "PackageDescription": "35 mL in 1 BOTTLE, SPRAY (85537-104-02) ",
      "NDC11Code": "85537-0104-02",
      "ProductNDC": "85537-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Wish Hand Sanitizer Violet Orchid Sandalwood",
      "NonProprietaryName": "Alcohol Hand Sanitizer",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250424",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "PT. SUPER HOME PRODUCT INDONESIA",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250424",
      "SamplePackage": "N",
      "IndicationAndUsage": "In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin."
    },
    {
      "NDCCode": "87660-104-01",
      "PackageDescription": "35 mL in 1 BOTTLE (87660-104-01) ",
      "NDC11Code": "87660-0104-01",
      "ProductNDC": "87660-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260518",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Guangdong Yanze Biotechnology Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "6.2",
      "StrengthUnit": "mL/10mL",
      "Status": "Active",
      "LastUpdate": "2026-06-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260518",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "58159-104-02",
      "PackageDescription": "20 kg in 1 DRUM (58159-104-02) ",
      "NDC11Code": "58159-0104-02",
      "ProductNDC": "58159-104",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nicotinamide Riboside Chloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240821",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "NICOTINAMIDE RIBOSIDE CHLORIDE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-08-30",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "21-AUG-24"
    },
    {
      "NDCCode": "58159-104-03",
      "PackageDescription": "15 kg in 1 DRUM (58159-104-03) ",
      "NDC11Code": "58159-0104-03",
      "ProductNDC": "58159-104",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nicotinamide Riboside Chloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240821",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "NICOTINAMIDE RIBOSIDE CHLORIDE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-08-30",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "21-AUG-24"
    },
    {
      "NDCCode": "58159-104-04",
      "PackageDescription": "10 kg in 1 DRUM (58159-104-04) ",
      "NDC11Code": "58159-0104-04",
      "ProductNDC": "58159-104",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nicotinamide Riboside Chloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240821",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "NICOTINAMIDE RIBOSIDE CHLORIDE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-08-30",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "21-AUG-24"
    },
    {
      "NDCCode": "58159-104-05",
      "PackageDescription": "5 kg in 1 DRUM (58159-104-05) ",
      "NDC11Code": "58159-0104-05",
      "ProductNDC": "58159-104",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nicotinamide Riboside Chloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240821",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "NICOTINAMIDE RIBOSIDE CHLORIDE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-08-30",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "21-AUG-24"
    },
    {
      "NDCCode": "60492-0249-2",
      "PackageDescription": "7 VIAL in 1 CARTON (60492-0249-2)  / 35 mL in 1 VIAL (60492-0249-1) ",
      "NDC11Code": "60492-0249-02",
      "ProductNDC": "60492-0249",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Anthrasil",
      "NonProprietaryName": "Anthrax Immune Globulin (human)",
      "DosageFormName": "LIQUID",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20151005",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125562",
      "LabelerName": "Emergent BioSolutions Canada Inc.",
      "SubstanceName": "ANTHRAX IMMUNE GLOBULIN HUMAN",
      "StrengthNumber": "60",
      "StrengthUnit": "[iU]/35mL",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20151005",
      "SamplePackage": "N",
      "IndicationAndUsage": "ANTHRASIL is an Anthrax Immune Globulin Intravenous (Human) indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs. The effectiveness of ANTHRASIL is based solely on efficacy studies conducted in animal models of inhalational anthrax [See 13.2 Animal Toxicology and/or Pharmacology]. Limitations: 1 ANTHRASIL does not have direct antibacterial activity., 2 ANTHRASIL does not cross the blood-brain barrier and does not prevent or treat meningitis., 3 There have been no studies of ANTHRASIL in the pediatric, geriatric, or obese populations.",
      "Description": "ANTHRASIL, Anthrax Immune Globulin Intravenous (Human), is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that bind the protective antigen (PA) component of Bacillus anthracis lethal and edema toxins. It is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and contains no preservative. The product is a clear or slightly opalescent colorless liquid, free of foreign particles, supplied in a 50 mL vial with variable fill volume. The total protein concentration ranges from 40 to 70 mg per mL. An adult dosage of 420 units (seven vials) of ANTHRASIL contains up to 0.368 g protein per kg body weight, and an adult dosage of 840 units (14 vials) contains up to 0.736 g protein per kg body weight. The protein load exposure to pediatric patients due to ANTHRASIL administration may range from 0.32 to 1.26 g per kg of body weight, depending on the weight-based pediatric dose. ANTHRASIL is prepared using plasma collected from healthy, screened donors who were immunized with BioThrax® (Anthrax Vaccine Adsorbed) to achieve high titers of anti-anthrax antibody (meeting minimum potency specifications) and purified by an anion-exchange column chromatography method. The source plasma is tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV). Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 104 International Units of B19 DNA per mL. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton X-100) is effective in the inactivation of enveloped viruses such as HBV, HCV and HIV. Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 2. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general. The product potency, as determined by an in vitro toxin neutralization assay (TNA), is expressed in arbitrary units by comparison to a standard calibrated against the Centers for Disease Control and Prevention (CDC) Reference Serum standard. Each vial contains approximately 40 to 70 mg per mL total protein and ≥60 units of toxin neutralizing activity. The product contains ≤40 mcg per mL of immune globulin A (IgA) as well as residual amounts of solvent and detergent, which are used to inactivate lipid-enveloped viruses."
    },
    {
      "NDCCode": "61953-0011-1",
      "PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (61953-0011-1)  *  1 mL in 1 SYRINGE, GLASS *  1 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "61953-0011-01",
      "ProductNDC": "61953-0011",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Vistaseal",
      "NonProprietaryName": "Human Fibrinogen, Human Thrombin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20191101",
      "EndMarketingDate": "20270311",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125640",
      "LabelerName": "GRIFOLS USA, LLC",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191101",
      "EndMarketingDatePackage": "20270311",
      "SamplePackage": "N",
      "IndicationAndUsage": "VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.",
      "Description": "VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9."
    },
    {
      "NDCCode": "61953-0012-1",
      "PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (61953-0012-1)  *  2 mL in 1 SYRINGE, GLASS *  2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "61953-0012-01",
      "ProductNDC": "61953-0012",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Vistaseal",
      "NonProprietaryName": "Human Fibrinogen, Human Thrombin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20191101",
      "EndMarketingDate": "20270318",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125640",
      "LabelerName": "GRIFOLS USA, LLC",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191101",
      "EndMarketingDatePackage": "20270318",
      "SamplePackage": "N",
      "IndicationAndUsage": "VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.",
      "Description": "VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9."
    },
    {
      "NDCCode": "61953-0013-1",
      "PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (61953-0013-1)  *  3 mL in 1 SYRINGE, GLASS *  3 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "61953-0013-01",
      "ProductNDC": "61953-0013",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Vistaseal",
      "NonProprietaryName": "Human Fibrinogen, Human Thrombin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20191101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125640",
      "LabelerName": "GRIFOLS USA, LLC",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20191101",
      "SamplePackage": "N",
      "IndicationAndUsage": "VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.",
      "Description": "VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9."
    },
    {
      "NDCCode": "61953-0014-1",
      "PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (61953-0014-1)  *  5 mL in 1 SYRINGE, GLASS *  5 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "61953-0014-01",
      "ProductNDC": "61953-0014",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Vistaseal",
      "NonProprietaryName": "Human Fibrinogen, Human Thrombin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20191101",
      "EndMarketingDate": "20270209",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125640",
      "LabelerName": "GRIFOLS USA, LLC",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191101",
      "EndMarketingDatePackage": "20270209",
      "SamplePackage": "N",
      "IndicationAndUsage": "VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.",
      "Description": "VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9."
    },
    {
      "NDCCode": "61953-0020-1",
      "PackageDescription": "1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-1)  / 2 mL in 1 SYRINGE, GLASS (61953-0020-2) ",
      "NDC11Code": "61953-0020-01",
      "ProductNDC": "61953-0020",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Vistaseal",
      "NonProprietaryName": "Human Fibrinogen, Human Thrombin",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20191101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125640",
      "LabelerName": "GRIFOLS USA, LLC",
      "SubstanceName": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
      "StrengthNumber": "80; 500",
      "StrengthUnit": "mg/mL; [iU]/mL",
      "Pharm_Classes": "Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191101",
      "SamplePackage": "N",
      "IndicationAndUsage": "VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.",
      "Description": "VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9."
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      "IndicationAndUsage": "VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.",
      "Description": "VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9."
    }
  ]
}
                    
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    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>51; 28</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69879-112-35</NDCCode>
    <PackageDescription>35 mL in 1 TUBE (69879-112-35) </PackageDescription>
    <NDC11Code>69879-0112-35</NDC11Code>
    <ProductNDC>69879-112</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.12 Warm Copper</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150731</StartMarketingDate>
    <EndMarketingDate>20250501</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Luxe Art Beaute SAS</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>51; 28</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150731</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250501</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49520-104-35</NDCCode>
    <PackageDescription>150 mL in 1 TUBE (49520-104-35)</PackageDescription>
    <NDC11Code>49520-0104-35</NDC11Code>
    <ProductNDC>49520-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Take Control Calming</ProprietaryName>
    <ProprietaryNameSuffix>Cleanser</ProprietaryNameSuffix>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120927</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>mybody</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>USE FOR TREATMENT OF ACNE.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54157-104-03</NDCCode>
    <PackageDescription>35 g in 1 TUBE (54157-104-03)</PackageDescription>
    <NDC11Code>54157-0104-03</NDC11Code>
    <ProductNDC>54157-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Megafresh</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>GEL, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20140511</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>American Amenities, Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.15</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses: Aids in the prevention of dental cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58159-104-01</NDCCode>
    <PackageDescription>35 kg in 1 DRUM (58159-104-01) </PackageDescription>
    <NDC11Code>58159-0104-01</NDC11Code>
    <ProductNDC>58159-104</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nicotinamide Riboside Chloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20240821</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>NICOTINAMIDE RIBOSIDE CHLORIDE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-08-30</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-AUG-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>61619-104-32</NDCCode>
    <PackageDescription>946.35 mL in 1 BOTTLE, PLASTIC (61619-104-32) </PackageDescription>
    <NDC11Code>61619-0104-32</NDC11Code>
    <ProductNDC>61619-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antimicrobial Cleansing Gel</ProprietaryName>
    <NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20200220</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>A-Cute Derm, Incorporated</LabelerName>
    <SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>B-KLEER is a unique, non-drying cleanser. Designed for all skin types and pH balanced. Excellent for postoperative care. May be used as a topical antimicrobial to help protect against skin infection.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69677-104-35</NDCCode>
    <PackageDescription>35 TABLET in 1 BOTTLE (69677-104-35) </PackageDescription>
    <NDC11Code>69677-0104-35</NDC11Code>
    <ProductNDC>69677-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140910</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204314</ApplicationNumber>
    <LabelerName>MAS MANAGEMENT GROUP, INC.</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Herpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
    <Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations for oral administration. Acyclovir is a white or almost white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.20. It is soluble in diluted hydrochloric acid; slightly soluble in water and insoluble in alcohol. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. Each acyclovir tablet intended for oral administration contains 400 mg and 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70474-104-51</NDCCode>
    <PackageDescription>1 BOTTLE, DISPENSING in 1 BOX (70474-104-51)  &gt; 35 mL in 1 BOTTLE, DISPENSING (70474-104-01)</PackageDescription>
    <NDC11Code>70474-0104-51</NDC11Code>
    <ProductNDC>70474-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Luminous Moisturizing Foundation</ProprietaryName>
    <ProprietaryNameSuffix>Spf-15</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160407</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS)</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>.9; 12.2</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>84165-104-35</NDCCode>
    <PackageDescription>35 BAG in 1 BOX (84165-104-35)  / 12 g in 1 BAG (84165-104-01) </PackageDescription>
    <NDC11Code>84165-0104-35</NDC11Code>
    <ProductNDC>84165-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pain Relief Gel-patch</ProprietaryName>
    <NonProprietaryName>Lidocaine, Menthol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240924</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
    <SubstanceName>MENTHOL; LIDOCAINE</SubstanceName>
    <StrengthNumber>.01; .04</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back,neck, hips, shoulders,elbows.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85537-104-02</NDCCode>
    <PackageDescription>35 mL in 1 BOTTLE, SPRAY (85537-104-02) </PackageDescription>
    <NDC11Code>85537-0104-02</NDC11Code>
    <ProductNDC>85537-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Wish Hand Sanitizer Violet Orchid Sandalwood</ProprietaryName>
    <NonProprietaryName>Alcohol Hand Sanitizer</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250424</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>PT. SUPER HOME PRODUCT INDONESIA</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>87660-104-01</NDCCode>
    <PackageDescription>35 mL in 1 BOTTLE (87660-104-01) </PackageDescription>
    <NDC11Code>87660-0104-01</NDC11Code>
    <ProductNDC>87660-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260518</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Guangdong Yanze Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>6.2</StrengthNumber>
    <StrengthUnit>mL/10mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58159-104-02</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (58159-104-02) </PackageDescription>
    <NDC11Code>58159-0104-02</NDC11Code>
    <ProductNDC>58159-104</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nicotinamide Riboside Chloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20240821</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>NICOTINAMIDE RIBOSIDE CHLORIDE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-08-30</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-AUG-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>58159-104-03</NDCCode>
    <PackageDescription>15 kg in 1 DRUM (58159-104-03) </PackageDescription>
    <NDC11Code>58159-0104-03</NDC11Code>
    <ProductNDC>58159-104</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nicotinamide Riboside Chloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20240821</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>NICOTINAMIDE RIBOSIDE CHLORIDE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-08-30</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-AUG-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>58159-104-04</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (58159-104-04) </PackageDescription>
    <NDC11Code>58159-0104-04</NDC11Code>
    <ProductNDC>58159-104</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nicotinamide Riboside Chloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20240821</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>NICOTINAMIDE RIBOSIDE CHLORIDE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-08-30</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-AUG-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>58159-104-05</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (58159-104-05) </PackageDescription>
    <NDC11Code>58159-0104-05</NDC11Code>
    <ProductNDC>58159-104</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nicotinamide Riboside Chloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20240821</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>NICOTINAMIDE RIBOSIDE CHLORIDE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-08-30</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-AUG-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>60492-0249-2</NDCCode>
    <PackageDescription>7 VIAL in 1 CARTON (60492-0249-2)  / 35 mL in 1 VIAL (60492-0249-1) </PackageDescription>
    <NDC11Code>60492-0249-02</NDC11Code>
    <ProductNDC>60492-0249</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Anthrasil</ProprietaryName>
    <NonProprietaryName>Anthrax Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20151005</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125562</ApplicationNumber>
    <LabelerName>Emergent BioSolutions Canada Inc.</LabelerName>
    <SubstanceName>ANTHRAX IMMUNE GLOBULIN HUMAN</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>[iU]/35mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151005</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ANTHRASIL is an Anthrax Immune Globulin Intravenous (Human) indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs. The effectiveness of ANTHRASIL is based solely on efficacy studies conducted in animal models of inhalational anthrax [See 13.2 Animal Toxicology and/or Pharmacology]. Limitations: 1 ANTHRASIL does not have direct antibacterial activity., 2 ANTHRASIL does not cross the blood-brain barrier and does not prevent or treat meningitis., 3 There have been no studies of ANTHRASIL in the pediatric, geriatric, or obese populations.</IndicationAndUsage>
    <Description>ANTHRASIL, Anthrax Immune Globulin Intravenous (Human), is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that bind the protective antigen (PA) component of Bacillus anthracis lethal and edema toxins. It is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and contains no preservative. The product is a clear or slightly opalescent colorless liquid, free of foreign particles, supplied in a 50 mL vial with variable fill volume. The total protein concentration ranges from 40 to 70 mg per mL. An adult dosage of 420 units (seven vials) of ANTHRASIL contains up to 0.368 g protein per kg body weight, and an adult dosage of 840 units (14 vials) contains up to 0.736 g protein per kg body weight. The protein load exposure to pediatric patients due to ANTHRASIL administration may range from 0.32 to 1.26 g per kg of body weight, depending on the weight-based pediatric dose. ANTHRASIL is prepared using plasma collected from healthy, screened donors who were immunized with BioThrax® (Anthrax Vaccine Adsorbed) to achieve high titers of anti-anthrax antibody (meeting minimum potency specifications) and purified by an anion-exchange column chromatography method. The source plasma is tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV). Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 104 International Units of B19 DNA per mL. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton X-100) is effective in the inactivation of enveloped viruses such as HBV, HCV and HIV. Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 2. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general. The product potency, as determined by an in vitro toxin neutralization assay (TNA), is expressed in arbitrary units by comparison to a standard calibrated against the Centers for Disease Control and Prevention (CDC) Reference Serum standard. Each vial contains approximately 40 to 70 mg per mL total protein and ≥60 units of toxin neutralizing activity. The product contains ≤40 mcg per mL of immune globulin A (IgA) as well as residual amounts of solvent and detergent, which are used to inactivate lipid-enveloped viruses.</Description>
  </NDC>
  <NDC>
    <NDCCode>61953-0011-1</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (61953-0011-1)  *  1 mL in 1 SYRINGE, GLASS *  1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>61953-0011-01</NDC11Code>
    <ProductNDC>61953-0011</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Vistaseal</ProprietaryName>
    <NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20191101</StartMarketingDate>
    <EndMarketingDate>20270311</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125640</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20191101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270311</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.</IndicationAndUsage>
    <Description>VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9.</Description>
  </NDC>
  <NDC>
    <NDCCode>61953-0012-1</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (61953-0012-1)  *  2 mL in 1 SYRINGE, GLASS *  2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>61953-0012-01</NDC11Code>
    <ProductNDC>61953-0012</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Vistaseal</ProprietaryName>
    <NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20191101</StartMarketingDate>
    <EndMarketingDate>20270318</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
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    <LabelerName>GRIFOLS USA, LLC</LabelerName>
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    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20191101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270318</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.</IndicationAndUsage>
    <Description>VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9.</Description>
  </NDC>
  <NDC>
    <NDCCode>61953-0013-1</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (61953-0013-1)  *  3 mL in 1 SYRINGE, GLASS *  3 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>61953-0013-01</NDC11Code>
    <ProductNDC>61953-0013</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Vistaseal</ProprietaryName>
    <NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20191101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125640</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.</IndicationAndUsage>
    <Description>VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9.</Description>
  </NDC>
  <NDC>
    <NDCCode>61953-0014-1</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (61953-0014-1)  *  5 mL in 1 SYRINGE, GLASS *  5 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>61953-0014-01</NDC11Code>
    <ProductNDC>61953-0014</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Vistaseal</ProprietaryName>
    <NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20191101</StartMarketingDate>
    <EndMarketingDate>20270209</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125640</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20191101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270209</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.</IndicationAndUsage>
    <Description>VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9.</Description>
  </NDC>
  <NDC>
    <NDCCode>61953-0020-1</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-1)  / 2 mL in 1 SYRINGE, GLASS (61953-0020-2) </PackageDescription>
    <NDC11Code>61953-0020-01</NDC11Code>
    <ProductNDC>61953-0020</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Vistaseal</ProprietaryName>
    <NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125640</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>80; 500</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.</IndicationAndUsage>
    <Description>VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9.</Description>
  </NDC>
  <NDC>
    <NDCCode>61953-0020-3</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-3)  / 4 mL in 1 SYRINGE, GLASS (61953-0020-4) </PackageDescription>
    <NDC11Code>61953-0020-03</NDC11Code>
    <ProductNDC>61953-0020</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Vistaseal</ProprietaryName>
    <NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125640</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>80; 500</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.</IndicationAndUsage>
    <Description>VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder. VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives. Fibrinogen. Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:Active ingredient: human fibrinogen (80 mg/mL)Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection. Thrombin. Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:Active ingredient: human thrombin (500 IU/mL)Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection. The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. Viral safety Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative). The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and  a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin. The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>69879-104-35</NDCCode><ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.4 Rosy Beige</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69879-101-35</NDCCode><ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.1 Fair Beige</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69879-102-35</NDCCode><ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.2 Neutral Beige</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69879-103-35</NDCCode><ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.3 Cream Beige</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69879-105-35</NDCCode><ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.5 Peach Beige</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69879-107-35</NDCCode><ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.7 Vanilla Beige</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69879-108-35</NDCCode><ProprietaryName>Luxe Art Beaute Sas (69879-108-35) Cover-expert Sunscreen Broad Spectrum Spf 15 No.8 Intense Beige, 35ml</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69879-109-35</NDCCode><ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.9 Honey Beige</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69879-111-35</NDCCode><ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.11 Amber Brown</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69879-112-35</NDCCode><ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.12 Warm Copper</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>49520-104-35</NDCCode><ProprietaryName>Take Control Calming</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>54157-104-03</NDCCode><ProprietaryName>Megafresh</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>58159-104-01</NDCCode><NonProprietaryName>Nicotinamide Riboside Chloride</NonProprietaryName></NDC><NDC><NDCCode>61619-104-32</NDCCode><ProprietaryName>Antimicrobial Cleansing Gel</ProprietaryName><NonProprietaryName>Benzethonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>69677-104-35</NDCCode><ProprietaryName>Acyclovir</ProprietaryName><NonProprietaryName>Acyclovir</NonProprietaryName></NDC><NDC><NDCCode>70474-104-51</NDCCode><ProprietaryName>Luminous Moisturizing Foundation</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>84165-104-35</NDCCode><ProprietaryName>Pain Relief Gel-patch</ProprietaryName><NonProprietaryName>Lidocaine, Menthol</NonProprietaryName></NDC><NDC><NDCCode>85537-104-02</NDCCode><ProprietaryName>Wish Hand Sanitizer Violet Orchid Sandalwood</ProprietaryName><NonProprietaryName>Alcohol Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>87660-104-01</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>58159-104-02</NDCCode><NonProprietaryName>Nicotinamide Riboside Chloride</NonProprietaryName></NDC><NDC><NDCCode>58159-104-03</NDCCode><NonProprietaryName>Nicotinamide Riboside Chloride</NonProprietaryName></NDC><NDC><NDCCode>58159-104-04</NDCCode><NonProprietaryName>Nicotinamide Riboside Chloride</NonProprietaryName></NDC><NDC><NDCCode>58159-104-05</NDCCode><NonProprietaryName>Nicotinamide Riboside Chloride</NonProprietaryName></NDC><NDC><NDCCode>60492-0249-2</NDCCode><ProprietaryName>Anthrasil</ProprietaryName><NonProprietaryName>Anthrax Immune Globulin (human)</NonProprietaryName></NDC><NDC><NDCCode>61953-0011-1</NDCCode><ProprietaryName>Vistaseal</ProprietaryName><NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName></NDC><NDC><NDCCode>61953-0012-1</NDCCode><ProprietaryName>Vistaseal</ProprietaryName><NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName></NDC><NDC><NDCCode>61953-0013-1</NDCCode><ProprietaryName>Vistaseal</ProprietaryName><NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName></NDC><NDC><NDCCode>61953-0014-1</NDCCode><ProprietaryName>Vistaseal</ProprietaryName><NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName></NDC><NDC><NDCCode>61953-0020-1</NDCCode><ProprietaryName>Vistaseal</ProprietaryName><NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName></NDC><NDC><NDCCode>61953-0020-3</NDCCode><ProprietaryName>Vistaseal</ProprietaryName><NonProprietaryName>Human Fibrinogen, Human Thrombin</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
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      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1447771951",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "JEFF BINSTOCK, DVM, OD, FAAO, PLLC",
      "OtherOrgName": "REDMOND EYE CLINIC",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "(425) 885-3574",
      "EnumerationDate": "07/05/2017",
      "LastUpdateDate": "12/27/2017",
      "AuthorizedOfficialLastName": "BINSTOCK",
      "AuthorizedOfficialFirstName": "JEFF",
      "AuthorizedOfficialTitle": "MEMBER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "DVM, OD, FAAO",
      "AuthorizedOfficialTelephoneNumber": "818-620-7641",
      "TaxonomyCode1": "152WC0802X",
      "Taxonomy1": "Corneal and Contact Management",
      "LicenseNumber1": "60553429",
      "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": "1689189151",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "PERSONALEYES, LLC",
      "OtherOrgName": "WILLOW CREEK EYE CARE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "1000 SW INDIAN AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3039",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-2488",
      "MailingAddressFaxNumber": "541-548-5334",
      "FirstLinePracticeLocationAddress": "14740 NW CORNELL RD",
      "PracticeLocationAddressCityName": "PORTLAND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97229-5496",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "503-645-8002",
      "PracticeLocationAddressFaxNumber": "503-645-9455",
      "EnumerationDate": "12/06/2017",
      "LastUpdateDate": "12/06/2017",
      "AuthorizedOfficialLastName": "SHELDON",
      "AuthorizedOfficialFirstName": "TODD",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialCredential": "OD, MBA, FAAO",
      "AuthorizedOfficialTelephoneNumber": "541-548-2488",
      "TaxonomyCode1": "261QM2500X",
      "Taxonomy1": "Medical Specialty ",
      "LicenseNumber1": "2823ATI",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1225534910",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MAZHAR",
      "FirstName": "SAHAR",
      "MiddleName": "RANIA",
      "FirstLineMailingAddress": "1108 ROSS CLARK CIR",
      "MailingAddressCityName": "DOTHAN",
      "MailingAddressStateName": "AL",
      "MailingAddressPostalCode": "36301-3022",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "334-712-3329",
      "FirstLinePracticeLocationAddress": "1108 ROSS CLARK CIR",
      "PracticeLocationAddressCityName": "DOTHAN",
      "PracticeLocationAddressStateName": "AL",
      "PracticeLocationAddressPostalCode": "36301-3022",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "334-712-3329",
      "EnumerationDate": "04/02/2018",
      "LastUpdateDate": "04/02/2018",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "390200000X",
      "Taxonomy1": "Student in an Organized Health Care Education/Training Program",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1922502889",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "FADLALLA",
      "FirstName": "RANIA",
      "MiddleName": "ABDALLA DAW ELBEIT",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 BAY AVE",
      "MailingAddressCityName": "MONTCLAIR",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "07042-4837",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "973-429-6196",
      "FirstLinePracticeLocationAddress": "1 BAY AVE",
      "PracticeLocationAddressCityName": "MONTCLAIR",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "07042-4837",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "973-429-6196",
      "EnumerationDate": "03/23/2018",
      "LastUpdateDate": "03/23/2018",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "390200000X",
      "Taxonomy1": "Student in an Organized Health Care Education/Training Program",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1629068499",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "FAHOURY",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLineMailingAddress": "SUITE 201",
      "MailingAddressCityName": "TOLEDO",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "43623-3525",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "419-843-3627",
      "MailingAddressFaxNumber": "419-843-9697",
      "FirstLinePracticeLocationAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLinePracticeLocationAddress": "SUITE 201",
      "PracticeLocationAddressCityName": "TOLEDO",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "43623-3525",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "419-843-3627",
      "PracticeLocationAddressFaxNumber": "419-843-9697",
      "EnumerationDate": "10/24/2005",
      "LastUpdateDate": "09/02/2011",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "35086663",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2621621",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH",
      "OtherIdentifier2": "P00401238",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OH",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE"
    },
    {
      "NPI": "1033186986",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "NICOLA",
      "FirstName": "RANIA",
      "MiddleName": "SOLIMAN",
      "NamePrefix": "DR.",
      "Credential": "DDS",
      "FirstLineMailingAddress": "110 S WOODLAND ST",
      "MailingAddressCityName": "WINTER GARDEN",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "34787-3546",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
Done. Press any key to exit ...
                
            

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