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How to Find 50536-163-08 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "50536-163-08",
      "PackageDescription": "800 mL in 1 BOTTLE (50536-163-08) ",
      "NDC11Code": "50536-0163-08",
      "ProductNDC": "50536-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Super Suds Antibacterial Hand",
      "ProprietaryNameSuffix": "Item 1063",
      "NonProprietaryName": "Chloroxylenol",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140312",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "AMERICAN CHEMICAL AND SANITARY SUPPLY INC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".3",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140312",
      "SamplePackage": "N",
      "IndicationAndUsage": "HANDWASH TO HELP DECREASE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE."
    },
    {
      "NDCCode": "50536-163-01",
      "PackageDescription": "3785 mL in 1 JUG (50536-163-01) ",
      "NDC11Code": "50536-0163-01",
      "ProductNDC": "50536-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Super Suds Antibacterial Hand",
      "ProprietaryNameSuffix": "Item 1063",
      "NonProprietaryName": "Chloroxylenol",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140312",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "AMERICAN CHEMICAL AND SANITARY SUPPLY INC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".3",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140312",
      "SamplePackage": "N",
      "IndicationAndUsage": "HANDWASH TO HELP DECREASE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE."
    },
    {
      "NDCCode": "50536-139-08",
      "PackageDescription": "800 mL in 1 BOTTLE (50536-139-08) ",
      "NDC11Code": "50536-0139-08",
      "ProductNDC": "50536-139",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Soft Touch Plus Antibacterial Hand",
      "ProprietaryNameSuffix": "Item 1039",
      "NonProprietaryName": "Chloroxylenol",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140312",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "AMERICAN CHEMICAL AND SANITARY SUPPLY INC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".3",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140312",
      "SamplePackage": "N",
      "IndicationAndUsage": "Handwash to help decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "50536-181-08",
      "PackageDescription": "800 mL in 1 BOTTLE (50536-181-08) ",
      "NDC11Code": "50536-0181-08",
      "ProductNDC": "50536-181",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Wash Foam",
      "ProprietaryNameSuffix": "Item 1081",
      "NonProprietaryName": "Chloroxylenol",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140312",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "AMERICAN CHEMICAL AND SANITARY SUPPLY INC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".15",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140312",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand washing to reduce bacteria on the skin."
    },
    {
      "NDCCode": "50536-195-08",
      "PackageDescription": "800 mL in 1 BOTTLE (50536-195-08) ",
      "NDC11Code": "50536-0195-08",
      "ProductNDC": "50536-195",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "E-2 Hand",
      "ProprietaryNameSuffix": "Item 1095",
      "NonProprietaryName": "Chloroxylenol",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140312",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "AMERICAN CHEMICAL AND SANITARY SUPPLY INC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".3",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140312",
      "SamplePackage": "N",
      "IndicationAndUsage": "HANDWASH TO HELP DECREASE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE."
    },
    {
      "NDCCode": "20276-163-08",
      "PackageDescription": "237 mL in 1 BOTTLE, PUMP (20276-163-08)",
      "NDC11Code": "20276-0163-08",
      "ProductNDC": "20276-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lucky Antibacterial Hand Soap",
      "ProprietaryNameSuffix": "Supersoft",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100901",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333",
      "LabelerName": "Delta Brands Inc",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".1",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "36800-163-08",
      "PackageDescription": "222 mL in 1 BOTTLE, PUMP (36800-163-08)",
      "NDC11Code": "36800-0163-08",
      "ProductNDC": "36800-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Foaming Antibacterial",
      "ProprietaryNameSuffix": "Pear",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100726",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "For washing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "41163-163-08",
      "PackageDescription": "221 mL in 1 BOTTLE, PUMP (41163-163-08)",
      "NDC11Code": "41163-0163-08",
      "ProductNDC": "41163-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equaline",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120626",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "SUPERVALU INC.",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mg/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "FOR WASHING TO DECREASE BACTERIA ON THE SKIN."
    },
    {
      "NDCCode": "41250-163-08",
      "PackageDescription": "221 mL in 1 BOTTLE, PUMP (41250-163-08)",
      "NDC11Code": "41250-0163-08",
      "ProductNDC": "41250-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Foaming",
      "ProprietaryNameSuffix": "Pear",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111118",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "MEIJER DISTRIBUTION INC",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "HELPS REDUCE BACTERIA ON THE SKIN."
    },
    {
      "NDCCode": "55316-163-08",
      "PackageDescription": "221 mL in 1 BOTTLE, PUMP (55316-163-08)",
      "NDC11Code": "55316-0163-08",
      "ProductNDC": "55316-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Foaming",
      "ProprietaryNameSuffix": "Fresh Pear",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110322",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "DZA BRANDS LLC",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "For washing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "61786-163-08",
      "PackageDescription": "10 CAPSULE in 1 BLISTER PACK (61786-163-08)",
      "NDC11Code": "61786-0163-08",
      "ProductNDC": "61786-163",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151022",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA020998",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-03-14"
    },
    {
      "NDCCode": "71919-163-08",
      "PackageDescription": "30 mL in 1 VIAL, GLASS (71919-163-08) ",
      "NDC11Code": "71919-0163-08",
      "ProductNDC": "71919-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Carbo Vegetabilis",
      "NonProprietaryName": "Activated Charcoal",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100203",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "ACTIVATED CHARCOAL",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100203",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "72036-163-08",
      "PackageDescription": "222 mL in 1 BOTTLE, PUMP (72036-163-08)",
      "NDC11Code": "72036-0163-08",
      "ProductNDC": "72036-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Foaming",
      "ProprietaryNameSuffix": "Pear Scent",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101115",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "HARRIS TEETER",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Helps reduce bacteria on the skin."
    },
    {
      "NDCCode": "79903-163-08",
      "PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (79903-163-08) ",
      "NDC11Code": "79903-0163-08",
      "ProductNDC": "79903-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Wash",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160914",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Walmart Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221215",
      "SamplePackage": "N",
      "IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "83589-163-08",
      "PackageDescription": "100 g in 1 BOTTLE (83589-163-08) ",
      "NDC11Code": "83589-0163-08",
      "ProductNDC": "83589-163",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Abp-7 Acetate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260225",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
      "SubstanceName": "TB-500",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "25-FEB-26"
    },
    {
      "NDCCode": "98132-163-08",
      "PackageDescription": "14 g in 1 TRAY (98132-163-08)",
      "NDC11Code": "98132-0163-08",
      "ProductNDC": "98132-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ready Foundation",
      "ProprietaryNameSuffix": "Fair",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bare Escentuals Beauty Inc.",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "11; 18",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "0178-0900-01",
      "PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (0178-0900-01) ",
      "NDC11Code": "00178-0900-01",
      "ProductNDC": "0178-0900",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Thiola",
      "NonProprietaryName": "Tiopronin",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19880811",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019569",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "TIOPRONIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19880811",
      "SamplePackage": "N",
      "IndicationAndUsage": "THIOLA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.",
      "Description": "THIOLA (tiopronin) immediate-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure:. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each THIOLA tablet contains 100 mg of tiopronin. The inactive ingredients in THIOLA tablets include calcium carbonate, carnauba wax, ethyl cellulose, dimethylaminoethyl methacrylate: butyl methacrylate: methyl methacrylate copolymer (Eudragit E 100), hydroxy-propyl cellulose, lactose monohydrate, magnesium stearate, povidone, sugar, talc, titanium dioxide."
    },
    {
      "NDCCode": "0178-0901-90",
      "PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90) ",
      "NDC11Code": "00178-0901-90",
      "ProductNDC": "0178-0901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Thiola Ec",
      "NonProprietaryName": "Tiopronin",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190628",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA211843",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "TIOPRONIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190628",
      "SamplePackage": "N",
      "IndicationAndUsage": "THIOLA EC is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.",
      "Description": "THIOLA EC (tiopronin) delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N‑(2‑Mercaptopropionyl) glycine and has the following structure. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each THIOLA EC tablet contains 100 or 300 mg of tiopronin. The inactive ingredients in THIOLA EC tablets include lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulose (low substitute), magnesium stearate, hydroxypropyl methylcellulose E5, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate."
    },
    {
      "NDCCode": "0178-0902-01",
      "PackageDescription": "300 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0902-01) ",
      "NDC11Code": "00178-0902-01",
      "ProductNDC": "0178-0902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Thiola Ec",
      "NonProprietaryName": "Tiopronin",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190628",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA211843",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "TIOPRONIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190628",
      "SamplePackage": "N",
      "IndicationAndUsage": "THIOLA EC is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.",
      "Description": "THIOLA EC (tiopronin) delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N‑(2‑Mercaptopropionyl) glycine and has the following structure. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each THIOLA EC tablet contains 100 or 300 mg of tiopronin. The inactive ingredients in THIOLA EC tablets include lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulose (low substitute), magnesium stearate, hydroxypropyl methylcellulose E5, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate."
    },
    {
      "NDCCode": "0480-7824-98",
      "PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-7824-98) ",
      "NDC11Code": "00480-7824-98",
      "ProductNDC": "0480-7824",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tiopronin",
      "NonProprietaryName": "Tiopronin",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241008",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216456",
      "LabelerName": "Teva Pharmaceuticals, Inc.",
      "SubstanceName": "TIOPRONIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241008",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tiopronin delayed-release tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin delayed-release) tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information.",
      "Description": "Tiopronin delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure. Tiopronin has the empirical formula C5H9NO3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white to off-white crystalline powder, which is freely soluble in water. Each tiopronin delayed-release tablet contains 100 mg or 300 mg of tiopronin. The inactive ingredients in tiopronin delayed-release tablets include ammonium hydroxide, black iron oxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, propylene glycol, shellac glaze, talc, and triethyl citrate."
    },
    {
      "NDCCode": "0480-9227-55",
      "PackageDescription": "300 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-9227-55) ",
      "NDC11Code": "00480-9227-55",
      "ProductNDC": "0480-9227",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tiopronin",
      "NonProprietaryName": "Tiopronin",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241008",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216456",
      "LabelerName": "Teva Pharmaceuticals, Inc.",
      "SubstanceName": "TIOPRONIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241008",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tiopronin delayed-release tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin delayed-release) tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information.",
      "Description": "Tiopronin delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure. Tiopronin has the empirical formula C5H9NO3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white to off-white crystalline powder, which is freely soluble in water. Each tiopronin delayed-release tablet contains 100 mg or 300 mg of tiopronin. The inactive ingredients in tiopronin delayed-release tablets include ammonium hydroxide, black iron oxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, propylene glycol, shellac glaze, talc, and triethyl citrate."
    },
    {
      "NDCCode": "42494-435-25",
      "PackageDescription": "25 VIAL in 1 CARTON (42494-435-25)  / 4 mL in 1 VIAL",
      "NDC11Code": "42494-0435-25",
      "ProductNDC": "42494-435",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetylcysteine",
      "NonProprietaryName": "Acetylcysteine",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250821",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214177",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "ACETYLCYSTEINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250821",
      "SamplePackage": "N",
      "Description": "Acetylcysteine solution is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solutions (not for injection). The solutions contain 20% (Acetylcysteine Solution 20%) or 10% (Acetylcysteine Solution 10%) acetylcysteine, with disodium edetate in water for injection. Sodium hydroxide and/or hydrochloric acid is added to adjust to pH (range 6.0 - 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, L-cysteine. The compound is a white crystalline powder with the molecular formula C5H9NO3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula. This product contains the following inactive ingredients: edetate disodium, sodium hydroxide and water for injection."
    },
    {
      "NDCCode": "42494-436-25",
      "PackageDescription": "25 VIAL in 1 CARTON (42494-436-25)  / 4 mL in 1 VIAL",
      "NDC11Code": "42494-0436-25",
      "ProductNDC": "42494-436",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetylcysteine",
      "NonProprietaryName": "Acetylcysteine",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250821",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214177",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "ACETYLCYSTEINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250821",
      "SamplePackage": "N",
      "Description": "Acetylcysteine solution is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solutions (not for injection). The solutions contain 20% (Acetylcysteine Solution 20%) or 10% (Acetylcysteine Solution 10%) acetylcysteine, with disodium edetate in water for injection. Sodium hydroxide and/or hydrochloric acid is added to adjust to pH (range 6.0 - 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, L-cysteine. The compound is a white crystalline powder with the molecular formula C5H9NO3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula. This product contains the following inactive ingredients: edetate disodium, sodium hydroxide and water for injection."
    },
    {
      "NDCCode": "42571-163-47",
      "PackageDescription": "100 mL in 1 BOTTLE (42571-163-47) ",
      "NDC11Code": "42571-0163-47",
      "ProductNDC": "42571-163",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205187",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
      "StrengthNumber": "200; 28.5",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below. Limitations of Use. When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium  for oral suspension should not be used. Usage. To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin, USP is ( 2S,5R,6R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium, USP is potassium ( Z)( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Amoxicillin and Clavulanate Potassiumfor Oral Suspension, USP: 1 200 mg/28.5 mg: Following constitution, each 5 mL of oral suspension contains 200 mg of amoxicillin, USP as the trihydrate, and 28.5 mg of clavulanic acid (equivalent to 34 mg of clavulanate potassium, USP). , 2 400 mg/57 mg:Following constitution, each 5 mL of oral suspension contains 400 mg of amoxicillin, USP as the trihydrate, and 57 mg of clavulanic acid (equivalent to 68 mg of clavulanate potassium, USP). ."
    },
    {
      "NDCCode": "51754-0105-8",
      "PackageDescription": "3 VIAL in 1 CARTON (51754-0105-8)  / 30 mL in 1 VIAL",
      "NDC11Code": "51754-0105-08",
      "ProductNDC": "51754-0105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetylcysteine",
      "NonProprietaryName": "Acetylcysteine Solution",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL; RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205643",
      "LabelerName": "Exela Pharma Sciences, LLC",
      "SubstanceName": "ACETYLCYSTEINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "Description": "Acetylcysteine solution, USP is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solution (NOT FOR INJECTION). The solution contains 20% (200 mg/mL) acetylcysteine, with disodium edetate in water for injection. The solution also contains sodium hydroxide and may contain hydrochloric acid to adjust pH (range 6.0 - 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, L-cysteine. The compound is a white crystalline powder with the molecular formula C5H9NO3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula. This product contains the following inactive ingredients: disodium edetate, sodium hydroxide and water for injection."
    },
    {
      "NDCCode": "51991-891-33",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51991-891-33) ",
      "NDC11Code": "51991-0891-33",
      "ProductNDC": "51991-891",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erlotinib",
      "NonProprietaryName": "Erlotinib Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191105",
      "EndMarketingDate": "20250731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208488",
      "LabelerName": "Breckenridge Pharmaceutical, Inc.",
      "SubstanceName": "ERLOTINIB HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191105",
      "EndMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "IndicationAndUsage": "Erlotinib tablets are a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).",
      "Description": "Erlotinib, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. Erlotinib tablets contains erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C22H23N3O4∙HCl and a molecular weight of 429.90. The molecule has a pKa of 5.42 at 25°C. Erlotinib hydrochloride is very slightly soluble in water, slightly soluble in methanol and practically insoluble in acetonitrile, acetone, ethyl acetate and hexane. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.4 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, PEG, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate and titanium dioxide."
    },
    {
      "NDCCode": "51991-892-33",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51991-892-33) ",
      "NDC11Code": "51991-0892-33",
      "ProductNDC": "51991-892",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erlotinib",
      "NonProprietaryName": "Erlotinib Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191105",
      "EndMarketingDate": "20250731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208488",
      "LabelerName": "Breckenridge Pharmaceutical, Inc.",
      "SubstanceName": "ERLOTINIB HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191105",
      "EndMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "IndicationAndUsage": "Erlotinib tablets are a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).",
      "Description": "Erlotinib, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. Erlotinib tablets contains erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C22H23N3O4∙HCl and a molecular weight of 429.90. The molecule has a pKa of 5.42 at 25°C. Erlotinib hydrochloride is very slightly soluble in water, slightly soluble in methanol and practically insoluble in acetonitrile, acetone, ethyl acetate and hexane. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.4 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, PEG, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate and titanium dioxide."
    },
    {
      "NDCCode": "59779-163-77",
      "PackageDescription": "500 mL in 1 BOTTLE, PLASTIC (59779-163-77) ",
      "NDC11Code": "59779-0163-77",
      "ProductNDC": "59779-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anticavity Fluoride Rinse",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080915",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "CVS Pharmacy, Inc",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20080915",
      "SamplePackage": "N",
      "IndicationAndUsage": "aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "62673-163-01",
      "PackageDescription": "1 TUBE in 1 CARTON (62673-163-01)  / 28 g in 1 TUBE",
      "NDC11Code": "62673-0163-01",
      "ProductNDC": "62673-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Enhanced Facial Moisturizer",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20050101",
      "EndMarketingDate": "20241231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Neoteric Cosmetics, Inc.",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": ".08; .05",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20050101",
      "EndMarketingDatePackage": "20241231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63323-690-30",
      "PackageDescription": "3 VIAL in 1 CARTON (63323-690-30)  / 30 mL in 1 VIAL (63323-690-22) ",
      "NDC11Code": "63323-0690-30",
      "ProductNDC": "63323-690",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetylcysteine",
      "NonProprietaryName": "Acetylcysteine",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL; RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20120901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203853",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "ACETYLCYSTEINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-08-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120901",
      "SamplePackage": "N",
      "Description": "Acetylcysteine Solution, USP is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solution (NOT FOR INJECTION). The solutions contain 20% (200 mg/mL) or 10% (100 mg/mL) acetylcysteine, with disodium edetate in purified water. Sodium hydroxide and/or hydrochloric acid is added to adjust pH (range 6.0 to 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, cysteine. The compound is a white crystalline powder with the molecular formula C 5H 9NO 3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula:. This product contains the following inactive ingredients: disodium edetate, sodium hydroxide, purified water, and hydrochloric acid, if necessary. ACETYLCYSTEINE AS A MUCOLYTIC AGENT."
    }
  ]
}
                    
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    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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    <LabelerName>MEIJER DISTRIBUTION INC</LabelerName>
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    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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    <LabelerName>DZA BRANDS LLC</LabelerName>
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    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020998</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
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    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100203</StartMarketingDatePackage>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>HARRIS TEETER</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
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    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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    <LabelerName>Walmart Inc.</LabelerName>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221215</StartMarketingDatePackage>
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    <NDCCode>83589-163-08</NDCCode>
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    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>TB-500</SubstanceName>
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    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>25-FEB-26</StartMarketingDatePackage>
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    <NDCCode>98132-163-08</NDCCode>
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    <ProductNDC>98132-163</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ready Foundation</ProprietaryName>
    <ProprietaryNameSuffix>Fair</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bare Escentuals Beauty Inc.</LabelerName>
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    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0178-0900-01</NDCCode>
    <PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (0178-0900-01) </PackageDescription>
    <NDC11Code>00178-0900-01</NDC11Code>
    <ProductNDC>0178-0900</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thiola</ProprietaryName>
    <NonProprietaryName>Tiopronin</NonProprietaryName>
    <DosageFormName>TABLET, SUGAR COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19880811</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019569</ApplicationNumber>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>TIOPRONIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19880811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>THIOLA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.</IndicationAndUsage>
    <Description>THIOLA (tiopronin) immediate-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure:. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each THIOLA tablet contains 100 mg of tiopronin. The inactive ingredients in THIOLA tablets include calcium carbonate, carnauba wax, ethyl cellulose, dimethylaminoethyl methacrylate: butyl methacrylate: methyl methacrylate copolymer (Eudragit E 100), hydroxy-propyl cellulose, lactose monohydrate, magnesium stearate, povidone, sugar, talc, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0178-0901-90</NDCCode>
    <PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90) </PackageDescription>
    <NDC11Code>00178-0901-90</NDC11Code>
    <ProductNDC>0178-0901</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thiola Ec</ProprietaryName>
    <NonProprietaryName>Tiopronin</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190628</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA211843</ApplicationNumber>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>TIOPRONIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>THIOLA EC is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.</IndicationAndUsage>
    <Description>THIOLA EC (tiopronin) delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N‑(2‑Mercaptopropionyl) glycine and has the following structure. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each THIOLA EC tablet contains 100 or 300 mg of tiopronin. The inactive ingredients in THIOLA EC tablets include lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulose (low substitute), magnesium stearate, hydroxypropyl methylcellulose E5, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0178-0902-01</NDCCode>
    <PackageDescription>300 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0902-01) </PackageDescription>
    <NDC11Code>00178-0902-01</NDC11Code>
    <ProductNDC>0178-0902</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thiola Ec</ProprietaryName>
    <NonProprietaryName>Tiopronin</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190628</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA211843</ApplicationNumber>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>TIOPRONIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>THIOLA EC is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.</IndicationAndUsage>
    <Description>THIOLA EC (tiopronin) delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N‑(2‑Mercaptopropionyl) glycine and has the following structure. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each THIOLA EC tablet contains 100 or 300 mg of tiopronin. The inactive ingredients in THIOLA EC tablets include lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulose (low substitute), magnesium stearate, hydroxypropyl methylcellulose E5, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0480-7824-98</NDCCode>
    <PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-7824-98) </PackageDescription>
    <NDC11Code>00480-7824-98</NDC11Code>
    <ProductNDC>0480-7824</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tiopronin</ProprietaryName>
    <NonProprietaryName>Tiopronin</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241008</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216456</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TIOPRONIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tiopronin delayed-release tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin delayed-release) tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Tiopronin delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure. Tiopronin has the empirical formula C5H9NO3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white to off-white crystalline powder, which is freely soluble in water. Each tiopronin delayed-release tablet contains 100 mg or 300 mg of tiopronin. The inactive ingredients in tiopronin delayed-release tablets include ammonium hydroxide, black iron oxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, propylene glycol, shellac glaze, talc, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0480-9227-55</NDCCode>
    <PackageDescription>300 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-9227-55) </PackageDescription>
    <NDC11Code>00480-9227-55</NDC11Code>
    <ProductNDC>0480-9227</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tiopronin</ProprietaryName>
    <NonProprietaryName>Tiopronin</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241008</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216456</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TIOPRONIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tiopronin delayed-release tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin delayed-release) tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Tiopronin delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure. Tiopronin has the empirical formula C5H9NO3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white to off-white crystalline powder, which is freely soluble in water. Each tiopronin delayed-release tablet contains 100 mg or 300 mg of tiopronin. The inactive ingredients in tiopronin delayed-release tablets include ammonium hydroxide, black iron oxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, propylene glycol, shellac glaze, talc, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42494-435-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (42494-435-25)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>42494-0435-25</NDC11Code>
    <ProductNDC>42494-435</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetylcysteine</ProprietaryName>
    <NonProprietaryName>Acetylcysteine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250821</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214177</ApplicationNumber>
    <LabelerName>Cameron Pharmaceuticals</LabelerName>
    <SubstanceName>ACETYLCYSTEINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250821</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Acetylcysteine solution is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solutions (not for injection). The solutions contain 20% (Acetylcysteine Solution 20%) or 10% (Acetylcysteine Solution 10%) acetylcysteine, with disodium edetate in water for injection. Sodium hydroxide and/or hydrochloric acid is added to adjust to pH (range 6.0 - 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, L-cysteine. The compound is a white crystalline powder with the molecular formula C5H9NO3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula. This product contains the following inactive ingredients: edetate disodium, sodium hydroxide and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>42494-436-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (42494-436-25)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>42494-0436-25</NDC11Code>
    <ProductNDC>42494-436</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetylcysteine</ProprietaryName>
    <NonProprietaryName>Acetylcysteine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250821</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214177</ApplicationNumber>
    <LabelerName>Cameron Pharmaceuticals</LabelerName>
    <SubstanceName>ACETYLCYSTEINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250821</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Acetylcysteine solution is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solutions (not for injection). The solutions contain 20% (Acetylcysteine Solution 20%) or 10% (Acetylcysteine Solution 10%) acetylcysteine, with disodium edetate in water for injection. Sodium hydroxide and/or hydrochloric acid is added to adjust to pH (range 6.0 - 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, L-cysteine. The compound is a white crystalline powder with the molecular formula C5H9NO3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula. This product contains the following inactive ingredients: edetate disodium, sodium hydroxide and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-163-47</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (42571-163-47) </PackageDescription>
    <NDC11Code>42571-0163-47</NDC11Code>
    <ProductNDC>42571-163</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
    <NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205187</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
    <StrengthNumber>200; 28.5</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below. Limitations of Use. When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium  for oral suspension should not be used. Usage. To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin, USP is ( 2S,5R,6R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium, USP is potassium ( Z)( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Amoxicillin and Clavulanate Potassiumfor Oral Suspension, USP: 1 200 mg/28.5 mg: Following constitution, each 5 mL of oral suspension contains 200 mg of amoxicillin, USP as the trihydrate, and 28.5 mg of clavulanic acid (equivalent to 34 mg of clavulanate potassium, USP). , 2 400 mg/57 mg:Following constitution, each 5 mL of oral suspension contains 400 mg of amoxicillin, USP as the trihydrate, and 57 mg of clavulanic acid (equivalent to 68 mg of clavulanate potassium, USP). .</Description>
  </NDC>
  <NDC>
    <NDCCode>51754-0105-8</NDCCode>
    <PackageDescription>3 VIAL in 1 CARTON (51754-0105-8)  / 30 mL in 1 VIAL</PackageDescription>
    <NDC11Code>51754-0105-08</NDC11Code>
    <ProductNDC>51754-0105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetylcysteine</ProprietaryName>
    <NonProprietaryName>Acetylcysteine Solution</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20231113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205643</ApplicationNumber>
    <LabelerName>Exela Pharma Sciences, LLC</LabelerName>
    <SubstanceName>ACETYLCYSTEINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Acetylcysteine solution, USP is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solution (NOT FOR INJECTION). The solution contains 20% (200 mg/mL) acetylcysteine, with disodium edetate in water for injection. The solution also contains sodium hydroxide and may contain hydrochloric acid to adjust pH (range 6.0 - 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, L-cysteine. The compound is a white crystalline powder with the molecular formula C5H9NO3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula. This product contains the following inactive ingredients: disodium edetate, sodium hydroxide and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>51991-891-33</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51991-891-33) </PackageDescription>
    <NDC11Code>51991-0891-33</NDC11Code>
    <ProductNDC>51991-891</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Erlotinib</ProprietaryName>
    <NonProprietaryName>Erlotinib Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191105</StartMarketingDate>
    <EndMarketingDate>20250731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208488</ApplicationNumber>
    <LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>ERLOTINIB HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20191105</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Erlotinib tablets are a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).</IndicationAndUsage>
    <Description>Erlotinib, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. Erlotinib tablets contains erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C22H23N3O4∙HCl and a molecular weight of 429.90. The molecule has a pKa of 5.42 at 25°C. Erlotinib hydrochloride is very slightly soluble in water, slightly soluble in methanol and practically insoluble in acetonitrile, acetone, ethyl acetate and hexane. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.4 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, PEG, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>51991-892-33</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51991-892-33) </PackageDescription>
    <NDC11Code>51991-0892-33</NDC11Code>
    <ProductNDC>51991-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Erlotinib</ProprietaryName>
    <NonProprietaryName>Erlotinib Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191105</StartMarketingDate>
    <EndMarketingDate>20250731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208488</ApplicationNumber>
    <LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>ERLOTINIB HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20191105</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Erlotinib tablets are a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).</IndicationAndUsage>
    <Description>Erlotinib, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. Erlotinib tablets contains erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C22H23N3O4∙HCl and a molecular weight of 429.90. The molecule has a pKa of 5.42 at 25°C. Erlotinib hydrochloride is very slightly soluble in water, slightly soluble in methanol and practically insoluble in acetonitrile, acetone, ethyl acetate and hexane. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.4 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, PEG, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>59779-163-77</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE, PLASTIC (59779-163-77) </PackageDescription>
    <NDC11Code>59779-0163-77</NDC11Code>
    <ProductNDC>59779-163</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Anticavity Fluoride Rinse</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>MOUTHWASH</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080915</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>CVS Pharmacy, Inc</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62673-163-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (62673-163-01)  / 28 g in 1 TUBE</PackageDescription>
    <NDC11Code>62673-0163-01</NDC11Code>
    <ProductNDC>62673-163</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Enhanced Facial Moisturizer</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20050101</StartMarketingDate>
    <EndMarketingDate>20241231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Neoteric Cosmetics, Inc.</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.08; .05</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20050101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63323-690-30</NDCCode>
    <PackageDescription>3 VIAL in 1 CARTON (63323-690-30)  / 30 mL in 1 VIAL (63323-690-22) </PackageDescription>
    <NDC11Code>63323-0690-30</NDC11Code>
    <ProductNDC>63323-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetylcysteine</ProprietaryName>
    <NonProprietaryName>Acetylcysteine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20120901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203853</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ACETYLCYSTEINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Acetylcysteine Solution, USP is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solution (NOT FOR INJECTION). The solutions contain 20% (200 mg/mL) or 10% (100 mg/mL) acetylcysteine, with disodium edetate in purified water. Sodium hydroxide and/or hydrochloric acid is added to adjust pH (range 6.0 to 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, cysteine. The compound is a white crystalline powder with the molecular formula C 5H 9NO 3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula:. This product contains the following inactive ingredients: disodium edetate, sodium hydroxide, purified water, and hydrochloric acid, if necessary. ACETYLCYSTEINE AS A MUCOLYTIC AGENT.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>50536-163-08</NDCCode><ProprietaryName>Super Suds Antibacterial Hand</ProprietaryName><NonProprietaryName>Chloroxylenol</NonProprietaryName></NDC><NDC><NDCCode>50536-163-01</NDCCode><ProprietaryName>Super Suds Antibacterial Hand</ProprietaryName><NonProprietaryName>Chloroxylenol</NonProprietaryName></NDC><NDC><NDCCode>50536-139-08</NDCCode><ProprietaryName>Soft Touch Plus Antibacterial Hand</ProprietaryName><NonProprietaryName>Chloroxylenol</NonProprietaryName></NDC><NDC><NDCCode>50536-181-08</NDCCode><ProprietaryName>Antibacterial Wash Foam</ProprietaryName><NonProprietaryName>Chloroxylenol</NonProprietaryName></NDC><NDC><NDCCode>50536-195-08</NDCCode><ProprietaryName>E-2 Hand</ProprietaryName><NonProprietaryName>Chloroxylenol</NonProprietaryName></NDC><NDC><NDCCode>20276-163-08</NDCCode><ProprietaryName>Lucky Antibacterial Hand Soap</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>36800-163-08</NDCCode><ProprietaryName>Foaming Antibacterial</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>41163-163-08</NDCCode><ProprietaryName>Equaline</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>41250-163-08</NDCCode><ProprietaryName>Antibacterial Foaming</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>55316-163-08</NDCCode><ProprietaryName>Antibacterial Foaming</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>61786-163-08</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>71919-163-08</NDCCode><ProprietaryName>Carbo Vegetabilis</ProprietaryName><NonProprietaryName>Activated Charcoal</NonProprietaryName></NDC><NDC><NDCCode>72036-163-08</NDCCode><ProprietaryName>Antibacterial Foaming</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>79903-163-08</NDCCode><ProprietaryName>Hand Wash</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>83589-163-08</NDCCode><NonProprietaryName>Abp-7 Acetate</NonProprietaryName></NDC><NDC><NDCCode>98132-163-08</NDCCode><ProprietaryName>Ready Foundation</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>0178-0900-01</NDCCode><ProprietaryName>Thiola</ProprietaryName><NonProprietaryName>Tiopronin</NonProprietaryName></NDC><NDC><NDCCode>0178-0901-90</NDCCode><ProprietaryName>Thiola Ec</ProprietaryName><NonProprietaryName>Tiopronin</NonProprietaryName></NDC><NDC><NDCCode>0178-0902-01</NDCCode><ProprietaryName>Thiola Ec</ProprietaryName><NonProprietaryName>Tiopronin</NonProprietaryName></NDC><NDC><NDCCode>0480-7824-98</NDCCode><ProprietaryName>Tiopronin</ProprietaryName><NonProprietaryName>Tiopronin</NonProprietaryName></NDC><NDC><NDCCode>0480-9227-55</NDCCode><ProprietaryName>Tiopronin</ProprietaryName><NonProprietaryName>Tiopronin</NonProprietaryName></NDC><NDC><NDCCode>42494-435-25</NDCCode><ProprietaryName>Acetylcysteine</ProprietaryName><NonProprietaryName>Acetylcysteine</NonProprietaryName></NDC><NDC><NDCCode>42494-436-25</NDCCode><ProprietaryName>Acetylcysteine</ProprietaryName><NonProprietaryName>Acetylcysteine</NonProprietaryName></NDC><NDC><NDCCode>42571-163-47</NDCCode><ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName><NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName></NDC><NDC><NDCCode>51754-0105-8</NDCCode><ProprietaryName>Acetylcysteine</ProprietaryName><NonProprietaryName>Acetylcysteine Solution</NonProprietaryName></NDC><NDC><NDCCode>51991-891-33</NDCCode><ProprietaryName>Erlotinib</ProprietaryName><NonProprietaryName>Erlotinib Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51991-892-33</NDCCode><ProprietaryName>Erlotinib</ProprietaryName><NonProprietaryName>Erlotinib Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>59779-163-77</NDCCode><ProprietaryName>Anticavity Fluoride Rinse</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>62673-163-01</NDCCode><ProprietaryName>Enhanced Facial Moisturizer</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>63323-690-30</NDCCode><ProprietaryName>Acetylcysteine</ProprietaryName><NonProprietaryName>Acetylcysteine</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.",
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      "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",
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}
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