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How to Find 69968-0904-3 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "69968-0904-3",
      "PackageDescription": "27 mL in 1 BOTTLE (69968-0904-3) ",
      "NDC11Code": "69968-0904-03",
      "ProductNDC": "69968-0904",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241211",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "Kenvue Brands LLC",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251219",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "69968-0904-5",
      "PackageDescription": "500 mL in 1 BOTTLE (69968-0904-5) ",
      "NDC11Code": "69968-0904-05",
      "ProductNDC": "69968-0904",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241211",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "Kenvue Brands LLC",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241211",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "0121-0904-94",
      "PackageDescription": "3 TRAY in 1 CASE (0121-0904-94)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0904-05) ",
      "NDC11Code": "00121-0904-94",
      "ProductNDC": "0121-0904",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170317",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022195",
      "LabelerName": "PAI Holdings, LLC dba PAI Pharma",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2024-11-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201009",
      "SamplePackage": "N",
      "IndicationAndUsage": "Morphine Sulfate Oral Solution 2 mg/mL is indicated for the management of.  adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.  pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients. Limitations of Use:. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:.  Have not been tolerated, or are not expected to be tolerated,  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Morphine Sulfate Oral Solution is an opioid agonist, available in the following concentration for oral administration.  10 mg per 5 mL (2 mg/mL): Each 1 mL of oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3) 2H2SO4,5H2O, and it has the following chemical structure. Morphine sulfate, USP is a white to off-white crystalline powder or a fine white to light yellow powder. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa  is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). For the 10 mg per 5 mL (2 mg/mL) strength: Each 5 mL of oral solution contains 10 mg of morphine sulfate USP and the following inactive ingredients: citric acid anhydrous, disodium edetate, FD&C Green No. 3 (fast green), glycerin, sodium benzoate, sorbitol and purified water."
    },
    {
      "NDCCode": "0904-2995-38",
      "PackageDescription": "1 TUBE in 1 CARTON (0904-2995-38)  > 3.5 g in 1 TUBE",
      "NDC11Code": "00904-2995-38",
      "ProductNDC": "0904-2995",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cortomycin",
      "NonProprietaryName": "Neomycin Sulfate And Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19951030",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA064068",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE",
      "StrengthNumber": "3.5; 10000; 400; 10",
      "StrengthUnit": "mg/g; [USP'U]/g; [USP'U]/g; mg/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-30",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0904-3012-38",
      "PackageDescription": "1 TUBE in 1 CARTON (0904-3012-38)  > 3.5 g in 1 TUBE",
      "NDC11Code": "00904-3012-38",
      "ProductNDC": "0904-3012",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Neocidin",
      "NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19951030",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA064064",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC",
      "StrengthNumber": "3.5; 10000; 400",
      "StrengthUnit": "mg/g; [USP'U]/g; [USP'U]/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2018-08-22",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0904-5168-38",
      "PackageDescription": "3.5 g in 1 TUBE (0904-5168-38)",
      "NDC11Code": "00904-5168-38",
      "ProductNDC": "0904-5168",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lubrifresh P.m.",
      "NonProprietaryName": "White Petrolatum Mineral Oil",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20111209",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "Major Pharaceuticals",
      "SubstanceName": "MINERAL OIL; PETROLATUM",
      "StrengthNumber": "150; 830",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2018-08-22",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0904-5315-38",
      "PackageDescription": "3.5 g in 1 TUBE (0904-5315-38)",
      "NDC11Code": "00904-5315-38",
      "ProductNDC": "0904-5315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sodium Chloride Hypertonicity",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20110101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2018-08-22",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0904-5415-01",
      "PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (0904-5415-01)  *  3 SUPPOSITORY in 1 BLISTER PACK *  9 g in 1 TUBE",
      "NDC11Code": "00904-5415-01",
      "ProductNDC": "0904-5415",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Miconazole 3 Combination Pack",
      "NonProprietaryName": "Miconazole Nitrate",
      "DosageFormName": "KIT",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20021202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074926",
      "LabelerName": "Major Pharmaceuticals",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20021202",
      "SamplePackage": "N",
      "IndicationAndUsage": "treats vaginal yeast infections. relieves external itching and irritation due to a vaginal yeast infection."
    },
    {
      "NDCCode": "0904-5832-24",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (0904-5832-24)  > 8 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00904-5832-24",
      "ProductNDC": "0904-5832",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Major Ranitidine",
      "ProprietaryNameSuffix": "Maximum Strength",
      "NonProprietaryName": "Ranitidine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080218",
      "EndMarketingDate": "20181231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078653",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "RANITIDINE HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20080218",
      "EndMarketingDatePackage": "20181231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0904-5834-42",
      "PackageDescription": "3 CARTON in 1 CARTON (0904-5834-42)  > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "00904-5834-42",
      "ProductNDC": "0904-5834",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Omeprazole",
      "NonProprietaryName": "Omeprazole",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080229",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022032",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "OMEPRAZOLE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-11-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20080229",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0904-5834-94",
      "PackageDescription": "3 CARTON in 1 CARTON (0904-5834-94)  > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "00904-5834-94",
      "ProductNDC": "0904-5834",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Omeprazole",
      "NonProprietaryName": "Omeprazole",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080229",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022032",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "OMEPRAZOLE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-06-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20080229",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0904-6214-48",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (0904-6214-48)  > 5 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "00904-6214-48",
      "ProductNDC": "0904-6214",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fexofenadine Hydrochloride",
      "NonProprietaryName": "Fexofenadine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110414",
      "EndMarketingDate": "20191231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076447",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110620",
      "EndMarketingDatePackage": "20191031",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0904-6257-62",
      "PackageDescription": "3 VIAL in 1 CARTON (0904-6257-62)  > 24 LOZENGE in 1 VIAL",
      "NDC11Code": "00904-6257-62",
      "ProductNDC": "0904-6257",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nicorelief",
      "NonProprietaryName": "Nicotine Polacrilex",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077007",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "0904-6258-62",
      "PackageDescription": "3 VIAL in 1 CARTON (0904-6258-62)  > 24 LOZENGE in 1 VIAL",
      "NDC11Code": "00904-6258-62",
      "ProductNDC": "0904-6258",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nicorelief",
      "NonProprietaryName": "Nicotine Polacrilex",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077007",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "0904-6282-42",
      "PackageDescription": "3 BOTTLE in 1 CARTON (0904-6282-42)  > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
      "NDC11Code": "00904-6282-42",
      "ProductNDC": "0904-6282",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lansoprazole",
      "NonProprietaryName": "Lansoprazole",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120329",
      "EndMarketingDate": "20181231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202727",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "LANSOPRAZOLE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120329",
      "EndMarketingDatePackage": "20181231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0904-6488-38",
      "PackageDescription": "1 TUBE in 1 CARTON (0904-6488-38)  / 3.5 g in 1 TUBE",
      "NDC11Code": "00904-6488-38",
      "ProductNDC": "0904-6488",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Major Lubrifresh Pm",
      "NonProprietaryName": "Mineral Oil And White Petrolatum",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20150911",
      "EndMarketingDate": "20261031",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "MINERAL OIL; PETROLATUM",
      "StrengthNumber": "150; 830",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150911",
      "EndMarketingDatePackage": "20261031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions: 1 Wash your hands., 2 Pull down the lower lid of the affected eye(s) and gently apply a small amount (1/4\") of ointment to the inside of the eyelid, every 3-4 hours or as directed by a doctor."
    },
    {
      "NDCCode": "0904-6489-38",
      "PackageDescription": "1 TUBE in 1 CARTON (0904-6489-38)  > 3.5 g in 1 TUBE",
      "NDC11Code": "00904-6489-38",
      "ProductNDC": "0904-6489",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Major Hypertonicity Ophthalmic",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20150914",
      "EndMarketingDate": "20201031",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150914",
      "EndMarketingDatePackage": "20201031",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0904-6711-10",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (0904-6711-10)  / 5 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00904-6711-10",
      "ProductNDC": "0904-6711",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fexofenadine Hydrochloride",
      "NonProprietaryName": "Fexofenadine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180427",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076502",
      "LabelerName": "MAJOR PHARMACEUTICALS",
      "SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180427",
      "SamplePackage": "N",
      "IndicationAndUsage": ". temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. : 1 runny nose , 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "0904-6820-76",
      "PackageDescription": "10 TRAY in 1 CASE (0904-6820-76)  > 10 CUP, UNIT-DOSE in 1 TRAY > 20.3 mL in 1 CUP, UNIT-DOSE",
      "NDC11Code": "00904-6820-76",
      "ProductNDC": "0904-6820",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen Oral Solution",
      "NonProprietaryName": "Acetaminophen Oral Solution",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190408",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/20.3mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190408",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0904-6909-04",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (0904-6909-04)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00904-6909-04",
      "ProductNDC": "0904-6909",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azithromycin Monohydrate",
      "NonProprietaryName": "Azithromycin Monohydrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150818",
      "EndMarketingDate": "20240731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065399",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "AZITHROMYCIN MONOHYDRATE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150818",
      "EndMarketingDatePackage": "20240731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0904-7253-04",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (0904-7253-04)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35) ",
      "NDC11Code": "00904-7253-04",
      "ProductNDC": "0904-7253",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dabigatran Etexilate",
      "NonProprietaryName": "Dabigatran Etexilate",
      "DosageFormName": "CAPSULE, COATED PELLETS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250623",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208040",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250623",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5  For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5)  , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
      "Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&C red #40 & FD&C blue #1 (150 mg and 110 mg), FD&C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide & potassium hydroxide."
    },
    {
      "NDCCode": "0904-7265-93",
      "PackageDescription": "3 TRAY in 1 CASE (0904-7265-93)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41) ",
      "NDC11Code": "00904-7265-93",
      "ProductNDC": "0904-7265",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150604",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201157",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221121",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam Oral Solution USP is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam Oral Solution USP is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) .",
      "Description": "Levetiracetam Oral Solution USP is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (–)–(S)–α–ethyl–2–oxo–1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n–hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Oral Solution USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, artificial grape flavor, citric acid, glycerin, maltitol solution, methylparaben, propylparaben, purified water, and sodium citrate."
    },
    {
      "NDCCode": "0904-7321-71",
      "PackageDescription": "10 TRAY in 1 CASE (0904-7321-71)  / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE (0904-7321-03) ",
      "NDC11Code": "00904-7321-71",
      "ProductNDC": "0904-7321",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230605",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/20.3mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230605",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0904-7321-76",
      "PackageDescription": "10 TRAY in 1 CASE (0904-7321-76)  / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE (0904-7321-03) ",
      "NDC11Code": "00904-7321-76",
      "ProductNDC": "0904-7321",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230605",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/20.3mL",
      "Status": "Active",
      "LastUpdate": "2025-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230605",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to: 1  headache, 2  muscular aches, 3  backache, 4  minor pain of arthritis, 5  the common cold, 6  toothache, 7  premenstrual and menstrual cramps."
    },
    {
      "NDCCode": "0904-7397-53",
      "PackageDescription": "3 BOTTLE in 1 CARTON (0904-7397-53)  / 90 TABLET, FILM COATED in 1 BOTTLE (0904-7397-89) ",
      "NDC11Code": "00904-7397-53",
      "ProductNDC": "0904-7397",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pirfenidone",
      "NonProprietaryName": "Pirfenidone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220524",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212772",
      "LabelerName": "MAJOR PHARMACEUTICALS",
      "SubstanceName": "PIRFENIDONE",
      "StrengthNumber": "267",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
      "Status": "Active",
      "LastUpdate": "2024-03-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240302",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
      "Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as film-coated tablets containing 267 mg and 801 mg pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1­ phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is freely soluble in dichloromethane, methanol, soluble in ethanol and practically insoluble in water. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol) and talc."
    },
    {
      "NDCCode": "0904-7459-25",
      "PackageDescription": "3 TRAY in 1 CASE (0904-7459-25)  / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41) ",
      "NDC11Code": "00904-7459-25",
      "ProductNDC": "0904-7459",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atovaquone",
      "NonProprietaryName": "Atovaquone Oral Suspension",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240708",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214272",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "ATOVAQUONE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Antimalarial [EPC], Antiprotozoal [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-08-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240708",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atovaquone oral suspension is a quinone antimicrobial drug indicated for: 1 Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1), 2 Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2).",
      "Description": "Atovaquone oral suspension USP is a quinone antimicrobial drug. The chemical name of atovaquone is trans-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. Atovaquone oral suspension USP is a formulation of micro-fine particles of atovaquone, USP. Each 5 mL of atovaquone oral suspension USP contains 750 mg of atovaquone and the inactive ingredients benzyl alcohol, tutti frutti flavor, poloxamer 188, purified water, saccharin sodium, and xanthan gum."
    },
    {
      "NDCCode": "0904-7540-12",
      "PackageDescription": "1 TUBE in 1 BOX (0904-7540-12)  / 3.5 g in 1 TUBE",
      "NDC11Code": "00904-7540-12",
      "ProductNDC": "0904-7540",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lubrifresh Pm",
      "NonProprietaryName": "Light Mineral Oil, White Petrolatum",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20250721",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "LIGHT MINERAL OIL; WHITE PETROLATUM",
      "StrengthNumber": "150; 830",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2025-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250721",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. may be used as a protectant against further irritation."
    },
    {
      "NDCCode": "0904-7563-04",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (0904-7563-04)  / 10 CAPSULE in 1 BLISTER PACK",
      "NDC11Code": "00904-7563-04",
      "ProductNDC": "0904-7563",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefdinir",
      "NonProprietaryName": "Cefdinir",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251027",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210220",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "CEFDINIR",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251027",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Adults and Adolescents. Community-Acquired Pneumonia. Caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES). Acute Exacerbations of Chronic Bronchitis. Caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Acute Maxillary Sinusitis. Caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). NOTE: For information on use in pediatric patients, see Pediatric Use  and DOSAGE AND ADMINISTRATION. Pharyngitis/Tonsillitis. Caused by Streptococcus pyogenes (see CLINICAL STUDIES). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections. Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Pediatric Patients. Acute Bacterial Otitis Media. Caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Pharyngitis/Tonsillitis. Caused by Streptococcus pyogenes (see CLINICAL STUDIES). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections. Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.",
      "Description": "Cefdinir capsules, USP contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β (Z)]]-7-[[(2-amino-4  thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2- carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer.The empirical formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below. Cefdinir capsules, USP contain 300 mg cefdinir and the following inactive ingredients. carboxymethylcellulose calcium, polyoxyl 40 stearate, colloidal silicone dioxide and magnesium stearate. The capsule shells contain FD&C Blue #2; gelatin, titanium dioxide, gelatin and water. Imprinting ink components shellac, Black Iron Oxide and potassium hydroxide."
    },
    {
      "NDCCode": "0904-7938-38",
      "PackageDescription": "1 TUBE in 1 CARTON (0904-7938-38)  > 3.5 g in 1 TUBE",
      "NDC11Code": "00904-7938-38",
      "ProductNDC": "0904-7938",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Neomycin And Polymyxin B Sulfates And Dexamethasone",
      "NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate, And Dexamethasone",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19940725",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA064063",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE",
      "StrengthNumber": "3.5; 10000; 1",
      "StrengthUnit": "mg/g; [USP'U]/g; mg/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "11822-0904-3",
      "PackageDescription": "160 BLISTER PACK in 1 CARTON (11822-0904-3)  / 1 GUM, CHEWING in 1 BLISTER PACK",
      "NDC11Code": "11822-0904-03",
      "ProductNDC": "11822-0904",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nictoine Gum",
      "NonProprietaryName": "Nicotine Polacrilex",
      "DosageFormName": "GUM, CHEWING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170117",
      "EndMarketingDate": "20260930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206394",
      "LabelerName": "Rite Aid Corporation",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170202",
      "EndMarketingDatePackage": "20260401",
      "SamplePackage": "N",
      "IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"69968-0904-3","ProprietaryName":"Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"69968-0904-5","ProprietaryName":"Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"0121-0904-94","ProprietaryName":"Morphine Sulfate","NonProprietaryName":"Morphine Sulfate"},{"NDCCode":"0904-2995-38","ProprietaryName":"Cortomycin","NonProprietaryName":"Neomycin Sulfate And Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone"},{"NDCCode":"0904-3012-38","ProprietaryName":"Neocidin","NonProprietaryName":"Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc"},{"NDCCode":"0904-5168-38","ProprietaryName":"Lubrifresh P.m.","NonProprietaryName":"White Petrolatum Mineral Oil"},{"NDCCode":"0904-5315-38","ProprietaryName":"Sodium Chloride Hypertonicity","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"0904-5415-01","ProprietaryName":"Miconazole 3 Combination Pack","NonProprietaryName":"Miconazole Nitrate"},{"NDCCode":"0904-5832-24","ProprietaryName":"Major Ranitidine","NonProprietaryName":"Ranitidine"},{"NDCCode":"0904-5834-42","ProprietaryName":"Omeprazole","NonProprietaryName":"Omeprazole"},{"NDCCode":"0904-5834-94","ProprietaryName":"Omeprazole","NonProprietaryName":"Omeprazole"},{"NDCCode":"0904-6214-48","ProprietaryName":"Fexofenadine Hydrochloride","NonProprietaryName":"Fexofenadine Hydrochloride"},{"NDCCode":"0904-6257-62","ProprietaryName":"Nicorelief","NonProprietaryName":"Nicotine Polacrilex"},{"NDCCode":"0904-6258-62","ProprietaryName":"Nicorelief","NonProprietaryName":"Nicotine Polacrilex"},{"NDCCode":"0904-6282-42","ProprietaryName":"Lansoprazole","NonProprietaryName":"Lansoprazole"},{"NDCCode":"0904-6488-38","ProprietaryName":"Major Lubrifresh Pm","NonProprietaryName":"Mineral Oil And White Petrolatum"},{"NDCCode":"0904-6489-38","ProprietaryName":"Major Hypertonicity Ophthalmic","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"0904-6711-10","ProprietaryName":"Fexofenadine Hydrochloride","NonProprietaryName":"Fexofenadine Hydrochloride"},{"NDCCode":"0904-6820-76","ProprietaryName":"Acetaminophen Oral Solution","NonProprietaryName":"Acetaminophen Oral Solution"},{"NDCCode":"0904-6909-04","ProprietaryName":"Azithromycin Monohydrate","NonProprietaryName":"Azithromycin Monohydrate"},{"NDCCode":"0904-7253-04","ProprietaryName":"Dabigatran Etexilate","NonProprietaryName":"Dabigatran Etexilate"},{"NDCCode":"0904-7265-93","ProprietaryName":"Levetiracetam","NonProprietaryName":"Levetiracetam"},{"NDCCode":"0904-7321-71","ProprietaryName":"Acetaminophen","NonProprietaryName":"Acetaminophen"},{"NDCCode":"0904-7321-76","ProprietaryName":"Acetaminophen","NonProprietaryName":"Acetaminophen"},{"NDCCode":"0904-7397-53","ProprietaryName":"Pirfenidone","NonProprietaryName":"Pirfenidone"},{"NDCCode":"0904-7459-25","ProprietaryName":"Atovaquone","NonProprietaryName":"Atovaquone Oral Suspension"},{"NDCCode":"0904-7540-12","ProprietaryName":"Lubrifresh Pm","NonProprietaryName":"Light Mineral Oil, White Petrolatum"},{"NDCCode":"0904-7563-04","ProprietaryName":"Cefdinir","NonProprietaryName":"Cefdinir"},{"NDCCode":"0904-7938-38","ProprietaryName":"Neomycin And Polymyxin B Sulfates And Dexamethasone","NonProprietaryName":"Neomycin Sulfate, Polymyxin B Sulfate, And Dexamethasone"},{"NDCCode":"11822-0904-3","ProprietaryName":"Nictoine Gum","NonProprietaryName":"Nicotine Polacrilex"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
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    <NDCCode>69968-0904-3</NDCCode>
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    <NDC11Code>69968-0904-03</NDC11Code>
    <ProductNDC>69968-0904</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>MOUTHWASH</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241211</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>Kenvue Brands LLC</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251219</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
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  <NDC>
    <NDCCode>69968-0904-5</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE (69968-0904-5) </PackageDescription>
    <NDC11Code>69968-0904-05</NDC11Code>
    <ProductNDC>69968-0904</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>MOUTHWASH</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241211</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>Kenvue Brands LLC</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0121-0904-94</NDCCode>
    <PackageDescription>3 TRAY in 1 CASE (0121-0904-94)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0904-05) </PackageDescription>
    <NDC11Code>00121-0904-94</NDC11Code>
    <ProductNDC>0121-0904</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170317</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022195</ApplicationNumber>
    <LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201009</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution 2 mg/mL is indicated for the management of.  adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.  pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients. Limitations of Use:. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:.  Have not been tolerated, or are not expected to be tolerated,  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available in the following concentration for oral administration.  10 mg per 5 mL (2 mg/mL): Each 1 mL of oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3) 2H2SO4,5H2O, and it has the following chemical structure. Morphine sulfate, USP is a white to off-white crystalline powder or a fine white to light yellow powder. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa  is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). For the 10 mg per 5 mL (2 mg/mL) strength: Each 5 mL of oral solution contains 10 mg of morphine sulfate USP and the following inactive ingredients: citric acid anhydrous, disodium edetate, FD&amp;C Green No. 3 (fast green), glycerin, sodium benzoate, sorbitol and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-2995-38</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0904-2995-38)  &gt; 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>00904-2995-38</NDC11Code>
    <ProductNDC>0904-2995</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cortomycin</ProprietaryName>
    <NonProprietaryName>Neomycin Sulfate And Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19951030</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064068</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE</SubstanceName>
    <StrengthNumber>3.5; 10000; 400; 10</StrengthNumber>
    <StrengthUnit>mg/g; [USP'U]/g; [USP'U]/g; mg/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis &amp;amp; Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-30</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0904-3012-38</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0904-3012-38)  &gt; 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>00904-3012-38</NDC11Code>
    <ProductNDC>0904-3012</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neocidin</ProprietaryName>
    <NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19951030</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064064</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC</SubstanceName>
    <StrengthNumber>3.5; 10000; 400</StrengthNumber>
    <StrengthUnit>mg/g; [USP'U]/g; [USP'U]/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis &amp;amp; Repair [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-08-22</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0904-5168-38</NDCCode>
    <PackageDescription>3.5 g in 1 TUBE (0904-5168-38)</PackageDescription>
    <NDC11Code>00904-5168-38</NDC11Code>
    <ProductNDC>0904-5168</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lubrifresh P.m.</ProprietaryName>
    <NonProprietaryName>White Petrolatum Mineral Oil</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20111209</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>Major Pharaceuticals</LabelerName>
    <SubstanceName>MINERAL OIL; PETROLATUM</SubstanceName>
    <StrengthNumber>150; 830</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-08-22</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0904-5315-38</NDCCode>
    <PackageDescription>3.5 g in 1 TUBE (0904-5315-38)</PackageDescription>
    <NDC11Code>00904-5315-38</NDC11Code>
    <ProductNDC>0904-5315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride Hypertonicity</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20110101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-08-22</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0904-5415-01</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (0904-5415-01)  *  3 SUPPOSITORY in 1 BLISTER PACK *  9 g in 1 TUBE</PackageDescription>
    <NDC11Code>00904-5415-01</NDC11Code>
    <ProductNDC>0904-5415</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Miconazole 3 Combination Pack</ProprietaryName>
    <NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20021202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074926</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20021202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats vaginal yeast infections. relieves external itching and irritation due to a vaginal yeast infection.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0904-5832-24</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (0904-5832-24)  &gt; 8 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-5832-24</NDC11Code>
    <ProductNDC>0904-5832</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Major Ranitidine</ProprietaryName>
    <ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Ranitidine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080218</StartMarketingDate>
    <EndMarketingDate>20181231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078653</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20080218</StartMarketingDatePackage>
    <EndMarketingDatePackage>20181231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0904-5834-42</NDCCode>
    <PackageDescription>3 CARTON in 1 CARTON (0904-5834-42)  &gt; 14 BLISTER PACK in 1 CARTON &gt; 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-5834-42</NDC11Code>
    <ProductNDC>0904-5834</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080229</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022032</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0904-5834-94</NDCCode>
    <PackageDescription>3 CARTON in 1 CARTON (0904-5834-94)  &gt; 14 BLISTER PACK in 1 CARTON &gt; 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-5834-94</NDC11Code>
    <ProductNDC>0904-5834</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080229</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022032</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0904-6214-48</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (0904-6214-48)  &gt; 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-6214-48</NDC11Code>
    <ProductNDC>0904-6214</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110414</StartMarketingDate>
    <EndMarketingDate>20191231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076447</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110620</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0904-6257-62</NDCCode>
    <PackageDescription>3 VIAL in 1 CARTON (0904-6257-62)  &gt; 24 LOZENGE in 1 VIAL</PackageDescription>
    <NDC11Code>00904-6257-62</NDC11Code>
    <ProductNDC>0904-6257</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicorelief</ProprietaryName>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071023</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077007</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0904-6258-62</NDCCode>
    <PackageDescription>3 VIAL in 1 CARTON (0904-6258-62)  &gt; 24 LOZENGE in 1 VIAL</PackageDescription>
    <NDC11Code>00904-6258-62</NDC11Code>
    <ProductNDC>0904-6258</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicorelief</ProprietaryName>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077007</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0904-6282-42</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (0904-6282-42)  &gt; 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>00904-6282-42</NDC11Code>
    <ProductNDC>0904-6282</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lansoprazole</ProprietaryName>
    <NonProprietaryName>Lansoprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120329</StartMarketingDate>
    <EndMarketingDate>20181231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202727</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>LANSOPRAZOLE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120329</StartMarketingDatePackage>
    <EndMarketingDatePackage>20181231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0904-6488-38</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0904-6488-38)  / 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>00904-6488-38</NDC11Code>
    <ProductNDC>0904-6488</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Major Lubrifresh Pm</ProprietaryName>
    <NonProprietaryName>Mineral Oil And White Petrolatum</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20150911</StartMarketingDate>
    <EndMarketingDate>20261031</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>MINERAL OIL; PETROLATUM</SubstanceName>
    <StrengthNumber>150; 830</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150911</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions: 1 Wash your hands., 2 Pull down the lower lid of the affected eye(s) and gently apply a small amount (1/4") of ointment to the inside of the eyelid, every 3-4 hours or as directed by a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0904-6489-38</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0904-6489-38)  &gt; 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>00904-6489-38</NDC11Code>
    <ProductNDC>0904-6489</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Major Hypertonicity Ophthalmic</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20150914</StartMarketingDate>
    <EndMarketingDate>20201031</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150914</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0904-6711-10</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (0904-6711-10)  / 5 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-6711-10</NDC11Code>
    <ProductNDC>0904-6711</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180427</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076502</ApplicationNumber>
    <LabelerName>MAJOR PHARMACEUTICALS</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. : 1 runny nose , 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0904-6820-76</NDCCode>
    <PackageDescription>10 TRAY in 1 CASE (0904-6820-76)  &gt; 10 CUP, UNIT-DOSE in 1 TRAY &gt; 20.3 mL in 1 CUP, UNIT-DOSE</PackageDescription>
    <NDC11Code>00904-6820-76</NDC11Code>
    <ProductNDC>0904-6820</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen Oral Solution</ProprietaryName>
    <NonProprietaryName>Acetaminophen Oral Solution</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190408</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/20.3mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190408</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0904-6909-04</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (0904-6909-04)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-6909-04</NDC11Code>
    <ProductNDC>0904-6909</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin Monohydrate</ProprietaryName>
    <NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150818</StartMarketingDate>
    <EndMarketingDate>20240731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065399</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150818</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0904-7253-04</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (0904-7253-04)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35) </PackageDescription>
    <NDC11Code>00904-7253-04</NDC11Code>
    <ProductNDC>0904-7253</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dabigatran Etexilate</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250623</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208040</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5  For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5)  , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&amp;C red #40 &amp; FD&amp;C blue #1 (150 mg and 110 mg), FD&amp;C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide &amp; potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7265-93</NDCCode>
    <PackageDescription>3 TRAY in 1 CASE (0904-7265-93)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41) </PackageDescription>
    <NDC11Code>00904-7265-93</NDC11Code>
    <ProductNDC>0904-7265</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201157</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam Oral Solution USP is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam Oral Solution USP is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) .</IndicationAndUsage>
    <Description>Levetiracetam Oral Solution USP is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (–)–(S)–α–ethyl–2–oxo–1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n–hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Oral Solution USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, artificial grape flavor, citric acid, glycerin, maltitol solution, methylparaben, propylparaben, purified water, and sodium citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7321-71</NDCCode>
    <PackageDescription>10 TRAY in 1 CASE (0904-7321-71)  / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE (0904-7321-03) </PackageDescription>
    <NDC11Code>00904-7321-71</NDC11Code>
    <ProductNDC>0904-7321</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230605</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/20.3mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0904-7321-76</NDCCode>
    <PackageDescription>10 TRAY in 1 CASE (0904-7321-76)  / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE (0904-7321-03) </PackageDescription>
    <NDC11Code>00904-7321-76</NDC11Code>
    <ProductNDC>0904-7321</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230605</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/20.3mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: 1  headache, 2  muscular aches, 3  backache, 4  minor pain of arthritis, 5  the common cold, 6  toothache, 7  premenstrual and menstrual cramps.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0904-7397-53</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (0904-7397-53)  / 90 TABLET, FILM COATED in 1 BOTTLE (0904-7397-89) </PackageDescription>
    <NDC11Code>00904-7397-53</NDC11Code>
    <ProductNDC>0904-7397</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212772</ApplicationNumber>
    <LabelerName>MAJOR PHARMACEUTICALS</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240302</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as film-coated tablets containing 267 mg and 801 mg pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1­ phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is freely soluble in dichloromethane, methanol, soluble in ethanol and practically insoluble in water. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol) and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7459-25</NDCCode>
    <PackageDescription>3 TRAY in 1 CASE (0904-7459-25)  / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41) </PackageDescription>
    <NDC11Code>00904-7459-25</NDC11Code>
    <ProductNDC>0904-7459</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atovaquone</ProprietaryName>
    <NonProprietaryName>Atovaquone Oral Suspension</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240708</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214272</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>ATOVAQUONE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC], Antiprotozoal [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240708</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atovaquone oral suspension is a quinone antimicrobial drug indicated for: 1 Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1), 2 Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2).</IndicationAndUsage>
    <Description>Atovaquone oral suspension USP is a quinone antimicrobial drug. The chemical name of atovaquone is trans-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. Atovaquone oral suspension USP is a formulation of micro-fine particles of atovaquone, USP. Each 5 mL of atovaquone oral suspension USP contains 750 mg of atovaquone and the inactive ingredients benzyl alcohol, tutti frutti flavor, poloxamer 188, purified water, saccharin sodium, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7540-12</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (0904-7540-12)  / 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>00904-7540-12</NDC11Code>
    <ProductNDC>0904-7540</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lubrifresh Pm</ProprietaryName>
    <NonProprietaryName>Light Mineral Oil, White Petrolatum</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250721</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>LIGHT MINERAL OIL; WHITE PETROLATUM</SubstanceName>
    <StrengthNumber>150; 830</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250721</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. may be used as a protectant against further irritation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0904-7563-04</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (0904-7563-04)  / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-7563-04</NDC11Code>
    <ProductNDC>0904-7563</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefdinir</ProprietaryName>
    <NonProprietaryName>Cefdinir</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251027</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210220</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>CEFDINIR</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251027</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Adults and Adolescents. Community-Acquired Pneumonia. Caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES). Acute Exacerbations of Chronic Bronchitis. Caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Acute Maxillary Sinusitis. Caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). NOTE: For information on use in pediatric patients, see Pediatric Use  and DOSAGE AND ADMINISTRATION. Pharyngitis/Tonsillitis. Caused by Streptococcus pyogenes (see CLINICAL STUDIES). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections. Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Pediatric Patients. Acute Bacterial Otitis Media. Caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Pharyngitis/Tonsillitis. Caused by Streptococcus pyogenes (see CLINICAL STUDIES). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections. Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.</IndicationAndUsage>
    <Description>Cefdinir capsules, USP contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β (Z)]]-7-[[(2-amino-4  thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2- carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer.The empirical formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below. Cefdinir capsules, USP contain 300 mg cefdinir and the following inactive ingredients. carboxymethylcellulose calcium, polyoxyl 40 stearate, colloidal silicone dioxide and magnesium stearate. The capsule shells contain FD&amp;C Blue #2; gelatin, titanium dioxide, gelatin and water. Imprinting ink components shellac, Black Iron Oxide and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7938-38</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0904-7938-38)  &gt; 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>00904-7938-38</NDC11Code>
    <ProductNDC>0904-7938</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neomycin And Polymyxin B Sulfates And Dexamethasone</ProprietaryName>
    <NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate, And Dexamethasone</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19940725</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064063</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE</SubstanceName>
    <StrengthNumber>3.5; 10000; 1</StrengthNumber>
    <StrengthUnit>mg/g; [USP'U]/g; mg/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11822-0904-3</NDCCode>
    <PackageDescription>160 BLISTER PACK in 1 CARTON (11822-0904-3)  / 1 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>11822-0904-03</NDC11Code>
    <ProductNDC>11822-0904</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nictoine Gum</ProprietaryName>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>GUM, CHEWING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170117</StartMarketingDate>
    <EndMarketingDate>20260930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206394</ApplicationNumber>
    <LabelerName>Rite Aid Corporation</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170202</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260401</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>69968-0904-3</NDCCode><ProprietaryName>Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>69968-0904-5</NDCCode><ProprietaryName>Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>0121-0904-94</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0904-2995-38</NDCCode><ProprietaryName>Cortomycin</ProprietaryName><NonProprietaryName>Neomycin Sulfate And Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>0904-3012-38</NDCCode><ProprietaryName>Neocidin</ProprietaryName><NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc</NonProprietaryName></NDC><NDC><NDCCode>0904-5168-38</NDCCode><ProprietaryName>Lubrifresh P.m.</ProprietaryName><NonProprietaryName>White Petrolatum Mineral Oil</NonProprietaryName></NDC><NDC><NDCCode>0904-5315-38</NDCCode><ProprietaryName>Sodium Chloride Hypertonicity</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0904-5415-01</NDCCode><ProprietaryName>Miconazole 3 Combination Pack</ProprietaryName><NonProprietaryName>Miconazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>0904-5832-24</NDCCode><ProprietaryName>Major Ranitidine</ProprietaryName><NonProprietaryName>Ranitidine</NonProprietaryName></NDC><NDC><NDCCode>0904-5834-42</NDCCode><ProprietaryName>Omeprazole</ProprietaryName><NonProprietaryName>Omeprazole</NonProprietaryName></NDC><NDC><NDCCode>0904-5834-94</NDCCode><ProprietaryName>Omeprazole</ProprietaryName><NonProprietaryName>Omeprazole</NonProprietaryName></NDC><NDC><NDCCode>0904-6214-48</NDCCode><ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName><NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0904-6257-62</NDCCode><ProprietaryName>Nicorelief</ProprietaryName><NonProprietaryName>Nicotine Polacrilex</NonProprietaryName></NDC><NDC><NDCCode>0904-6258-62</NDCCode><ProprietaryName>Nicorelief</ProprietaryName><NonProprietaryName>Nicotine Polacrilex</NonProprietaryName></NDC><NDC><NDCCode>0904-6282-42</NDCCode><ProprietaryName>Lansoprazole</ProprietaryName><NonProprietaryName>Lansoprazole</NonProprietaryName></NDC><NDC><NDCCode>0904-6488-38</NDCCode><ProprietaryName>Major Lubrifresh Pm</ProprietaryName><NonProprietaryName>Mineral Oil And White Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>0904-6489-38</NDCCode><ProprietaryName>Major Hypertonicity Ophthalmic</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0904-6711-10</NDCCode><ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName><NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0904-6820-76</NDCCode><ProprietaryName>Acetaminophen Oral Solution</ProprietaryName><NonProprietaryName>Acetaminophen Oral Solution</NonProprietaryName></NDC><NDC><NDCCode>0904-6909-04</NDCCode><ProprietaryName>Azithromycin Monohydrate</ProprietaryName><NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0904-7253-04</NDCCode><ProprietaryName>Dabigatran Etexilate</ProprietaryName><NonProprietaryName>Dabigatran Etexilate</NonProprietaryName></NDC><NDC><NDCCode>0904-7265-93</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>0904-7321-71</NDCCode><ProprietaryName>Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>0904-7321-76</NDCCode><ProprietaryName>Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>0904-7397-53</NDCCode><ProprietaryName>Pirfenidone</ProprietaryName><NonProprietaryName>Pirfenidone</NonProprietaryName></NDC><NDC><NDCCode>0904-7459-25</NDCCode><ProprietaryName>Atovaquone</ProprietaryName><NonProprietaryName>Atovaquone Oral Suspension</NonProprietaryName></NDC><NDC><NDCCode>0904-7540-12</NDCCode><ProprietaryName>Lubrifresh Pm</ProprietaryName><NonProprietaryName>Light Mineral Oil, White Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>0904-7563-04</NDCCode><ProprietaryName>Cefdinir</ProprietaryName><NonProprietaryName>Cefdinir</NonProprietaryName></NDC><NDC><NDCCode>0904-7938-38</NDCCode><ProprietaryName>Neomycin And Polymyxin B Sulfates And Dexamethasone</ProprietaryName><NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate, And Dexamethasone</NonProprietaryName></NDC><NDC><NDCCode>11822-0904-3</NDCCode><ProprietaryName>Nictoine Gum</ProprietaryName><NonProprietaryName>Nicotine Polacrilex</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
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      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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