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RESTful Lookup — Test-Drive (2007 – 2026)

How to Find 55301-780-01 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "55301-780-01",
      "PackageDescription": "43 g in 1 PACKAGE (55301-780-01) ",
      "NDC11Code": "55301-0780-01",
      "ProductNDC": "55301-780",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ultimate Sheer Spf 70",
      "NonProprietaryName": "Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10% Oxybenzone 3%",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20151207",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Your Military Exchanges",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "3; 15; 5; 10; 3",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20151207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses Helps prevent sunburn."
    },
    {
      "NDCCode": "55301-117-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (55301-117-01)  > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
      "NDC11Code": "55301-0117-01",
      "ProductNDC": "55301-117",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Exchange Select Lansoprazole",
      "NonProprietaryName": "Lansoprazole",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120611",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202319",
      "LabelerName": "Army & Air Force Exchange Service",
      "SubstanceName": "LANSOPRAZOLE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "55301-177-01",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (55301-177-01)  / 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "55301-0177-01",
      "ProductNDC": "55301-177",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Exchange Select Eye Drops Advanced Relief Moisturizer",
      "NonProprietaryName": "Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hcl",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20200212",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "Army and Air Force Exchange Service",
      "SubstanceName": "POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE; POVIDONE, UNSPECIFIED; DEXTRAN 70",
      "StrengthNumber": "1; .05; 1; .1",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 relieves redness of the eye due to minor eye irritations, 2 as a lubricant to prevent further irritation or to relieve dryness of the eye."
    },
    {
      "NDCCode": "55301-178-01",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (55301-178-01)  / 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "55301-0178-01",
      "ProductNDC": "55301-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Exchange Select Artificial Tears Lubricant Eye Drops",
      "NonProprietaryName": "Glycerin, Hypromellose, Polyethylene Glycol 400",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20200212",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "Army and Air Force Exchange Service",
      "SubstanceName": "POLYETHYLENE GLYCOL 400; HYPROMELLOSE, UNSPECIFIED; GLYCERIN",
      "StrengthNumber": "1; .2; .2",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 For temporary relief of burning and irritation due to dryness of the eye, 2 for protection against further irritation."
    },
    {
      "NDCCode": "55301-319-01",
      "PackageDescription": "5 POUCH in 1 CARTON (55301-319-01)  > 6 TABLET, CHEWABLE in 1 POUCH",
      "NDC11Code": "55301-0319-01",
      "ProductNDC": "55301-319",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Stomach Relief",
      "NonProprietaryName": "Bismuth Subsalicylate",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980716",
      "EndMarketingDate": "20220807",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part335",
      "LabelerName": "ARMY AND AIR FORCE EXCHANGE SERVICE",
      "SubstanceName": "BISMUTH SUBSALICYLATE",
      "StrengthNumber": "262",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19980716",
      "EndMarketingDatePackage": "20220807",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55301-347-01",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (55301-347-01)  / 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "55301-0347-01",
      "ProductNDC": "55301-347",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Exchange Select High Performance Lubricant Eye Drops",
      "NonProprietaryName": "Polyethylene Glycol 400, Propylene Glycol",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20240101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "Army and Air Force Exchange Service",
      "SubstanceName": "PROPYLENE GLYCOL; POLYETHYLENE GLYCOL 400",
      "StrengthNumber": ".3; .4",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240101",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of burning and irritation due to dryness of the eye."
    },
    {
      "NDCCode": "55301-406-01",
      "PackageDescription": "1 TUBE in 1 PACKAGE (55301-406-01)  > 2 g in 1 TUBE",
      "NDC11Code": "55301-0406-01",
      "ProductNDC": "55301-406",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Exchange Select Cold Sore Treatment",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110804",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Army + Air Force Exchange Service",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "55301-407-01",
      "PackageDescription": "1 TUBE in 1 PACKAGE (55301-407-01)  > 2 g in 1 TUBE",
      "NDC11Code": "55301-0407-01",
      "ProductNDC": "55301-407",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cold Sore Treatment",
      "NonProprietaryName": "Camphor",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141104",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Army & Air Force Exchange Service",
      "SubstanceName": "CAMPHOR (SYNTHETIC); BENZALKONIUM CHLORIDE",
      "StrengthNumber": "30; 1.3",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20141104",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55301-447-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55301-447-01)  > 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
      "NDC11Code": "55301-0447-01",
      "ProductNDC": "55301-447",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen",
      "ProprietaryNameSuffix": "Childrens",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050203",
      "EndMarketingDate": "20201128",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "ARMY AND AIR FORCE EXCHANGE SERVICE",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20050203",
      "EndMarketingDatePackage": "20201128",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55301-506-01",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (55301-506-01)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY",
      "NDC11Code": "55301-0506-01",
      "ProductNDC": "55301-506",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Exchange Select Allergy Relief",
      "NonProprietaryName": "Fluticasone Propionate",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20171027",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207957",
      "LabelerName": "Army & Air Force Exchange Service",
      "SubstanceName": "FLUTICASONE PROPIONATE",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171027",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy nose, 3 runny nose, 4 itchy, watery eyes, 5 sneezing."
    },
    {
      "NDCCode": "55301-533-01",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (55301-533-01)  / 10 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "55301-0533-01",
      "ProductNDC": "55301-533",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucus Relief Dm",
      "NonProprietaryName": "Dextromethorphan Hbr And Guaifenesin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "ARMY AND AIR FORCE EXCHANGE SERVICE",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
      "StrengthNumber": "20; 400",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20051231",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation associated with the common coldthe intensity of coughingthe impulse to cough to help you get to sleep."
    },
    {
      "NDCCode": "55301-874-01",
      "PackageDescription": "130 g in 1 CAN (55301-874-01) ",
      "NDC11Code": "55301-0874-01",
      "ProductNDC": "55301-874",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antifungal Powder",
      "NonProprietaryName": "Tolnaftate",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120103",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "ARMY & AIR FORCE EXCHANGE SERVICE",
      "SubstanceName": "TOLNAFTATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2026-03-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120103",
      "SamplePackage": "N",
      "IndicationAndUsage": "cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris). can prevent recurrence of most athlete's foot. relieves symptoms of athlete's foot, including itching, burning, cracking and chafing associated with jock itch."
    },
    {
      "NDCCode": "55301-898-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (55301-898-01)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
      "NDC11Code": "55301-0898-01",
      "ProductNDC": "55301-898",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Exchange Select Esomeprazole Magnesium",
      "NonProprietaryName": "Esomeprazole",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207193",
      "LabelerName": "Army & Air Force Exchange Service",
      "SubstanceName": "ESOMEPRAZOLE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-08-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20171204",
      "SamplePackage": "N",
      "IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
    },
    {
      "NDCCode": "55301-904-01",
      "PackageDescription": "3 PATCH in 1 POUCH (55301-904-01)  / 4 g in 1 PATCH",
      "NDC11Code": "55301-0904-01",
      "ProductNDC": "55301-904",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Targeted Warming Capsaicin Patch",
      "NonProprietaryName": "Capsaicin",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Army & Air Force Exchange Service",
      "SubstanceName": "CAPSAICIN",
      "StrengthNumber": ".025",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporary relief of minor pain of muscles and joints associated with: arthritis, minor backache, strains, sprains and bruises."
    },
    {
      "NDCCode": "55301-998-01",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (55301-998-01)  / 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "55301-0998-01",
      "ProductNDC": "55301-998",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Exchange Select Maximum Redness Relief Eye Drops",
      "NonProprietaryName": "Glycerin, Naphazoline Hcl",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20240101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "Army and Air Force Exchange Service",
      "SubstanceName": "GLYCERIN; NAPHAZOLINE HYDROCHLORIDE",
      "StrengthNumber": ".5; .03",
      "StrengthUnit": "g/100mL; g/100mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240101",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the relief of redness of the eye due to minor eye irritations. for the temporary relief of burning and irritation due to dryness of the eye. for use as a protectant against further irritation or dryness of the eye."
    },
    {
      "NDCCode": "10135-780-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (10135-780-01) ",
      "NDC11Code": "10135-0780-01",
      "ProductNDC": "10135-780",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Baclofen",
      "NonProprietaryName": "Baclofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212378",
      "LabelerName": "Marlex Pharmaceuticals, Inc.",
      "SubstanceName": "BACLOFEN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20231001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
      "Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate."
    },
    {
      "NDCCode": "12634-780-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (12634-780-01)",
      "NDC11Code": "12634-0780-01",
      "ProductNDC": "12634-780",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluconazole",
      "NonProprietaryName": "Fluconazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081007",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077731",
      "LabelerName": "Apotheca Inc.",
      "SubstanceName": "FLUCONAZOLE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Fluconazole tablets USP are indicated for the treatment of. Prophylaxis. Fluconazole tablets USP are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
      "Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α 1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C 13H 12F 2N 6O and molecular weight of 306.3. The structural formula is:. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "16571-780-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (16571-780-01) ",
      "NDC11Code": "16571-0780-01",
      "ProductNDC": "16571-780",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carisoprodol",
      "NonProprietaryName": "Carisoprodol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161108",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040792",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "CARISOPRODOL",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161108",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.Limitation of UseCarisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].",
      "Description": "Carisoprodol tablets, USP are available as 250 mg and 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in the carisoprodol tablets, USP include pregelatinized starch (maize), crospovidone, povidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate."
    },
    {
      "NDCCode": "16714-780-01",
      "PackageDescription": "30 TABLET in 1 BOTTLE (16714-780-01) ",
      "NDC11Code": "16714-0780-01",
      "ProductNDC": "16714-780",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ezetimibe And Simvastatin",
      "NonProprietaryName": "Ezetimibe And Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190819",
      "EndMarketingDate": "20261031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208699",
      "LabelerName": "NORTHSTAR RX LLC",
      "SubstanceName": "EZETIMIBE; SIMVASTATIN",
      "StrengthNumber": "10; 40",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190819",
      "EndMarketingDatePackage": "20261031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ezetimibe and Simvastatin Tablets. Ezetimibe and Simvastatin Tablets are a combination of simvastatin and ezetimibe indicated: : 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): , 2 In adults with primary hyperlipidemia. , 3 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 4 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .",
      "Description": "Ezetimibe and Simvastatin Tablets contain ezetimibe, a dietary cholesterol absorption inhibitor, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.44 g/mol. Ezetimibe is a white, crystalline powder that is freely soluble in ethanol, methanol and acetone and practically insoluble in water. Its structural formula is. Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7α,8α(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin is a white to off-white, nonhygroscopic powder that is freely soluble in chloroform, methanol and alcohol, sparingly soluble in propylene glycol, very slightly soluble in hexane and practically insoluble in water. Its structural formula is. Ezetimibe and Simvastatin Tablets are available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/10 mg), 20 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/20 mg), 40 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/40 mg), or 80 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate, and sodium lauryl sulfate."
    },
    {
      "NDCCode": "24658-780-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (24658-780-01) ",
      "NDC11Code": "24658-0780-01",
      "ProductNDC": "24658-780",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ursodiol",
      "NonProprietaryName": "Ursodiol",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075517",
      "LabelerName": "PuraCap Laboratories, LLC",
      "SubstanceName": "URSODIOL",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Bile Acid [EPC], Bile Acids and Salts [CS]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.",
      "Description": "Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol, USP (ursodeoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. The chemical name for ursodiol is 3α, 7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below. Inactive Ingredients: Corn starch, magnesium stearate, silicon dioxide and the capsule shell contain the following ingredients, gelatin, titanium dioxide, D&C Red #28, FD&C Blue #1 and FD&C Red #40. The imprinting ink contains the following: black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, propylene glycol and shellac glaze."
    },
    {
      "NDCCode": "28595-780-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (28595-780-01)",
      "NDC11Code": "28595-0780-01",
      "ProductNDC": "28595-780",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Histaflex",
      "NonProprietaryName": "Acetaminophen And Pyrilamine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140522",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Allegis Pharmaceuticals, LLC",
      "SubstanceName": "ACETAMINOPHEN; PYRILAMINE MALEATE",
      "StrengthNumber": "325; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "33261-780-01",
      "PackageDescription": "21 TABLET in 1 BOX, UNIT-DOSE (33261-780-01)",
      "NDC11Code": "33261-0780-01",
      "ProductNDC": "33261-780",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020712",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040256",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis, 4 Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
      "Description": "PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg."
    },
    {
      "NDCCode": "41226-780-01",
      "PackageDescription": "354 mL in 1 BOTTLE (41226-780-01) ",
      "NDC11Code": "41226-0780-01",
      "ProductNDC": "41226-780",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Severe Cold And Flu Daytime",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240430",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "KROGER COMPANY",
      "SubstanceName": "GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "400; 10; 650; 20",
      "StrengthUnit": "mg/30mL; mg/30mL; mg/30mL; mg/30mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240430",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves common cold/flu symptoms:."
    },
    {
      "NDCCode": "41250-780-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (41250-780-01)  / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC",
      "NDC11Code": "41250-0780-01",
      "ProductNDC": "41250-780",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aspirin 81 Mg",
      "NonProprietaryName": "Aspirin",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110301",
      "EndMarketingDate": "20261231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Meijer",
      "SubstanceName": "ASPIRIN",
      "StrengthNumber": "81",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110301",
      "EndMarketingDatePackage": "20260930",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for this product."
    },
    {
      "NDCCode": "52346-011-01",
      "PackageDescription": "780 L in 1 DEWAR (52346-011-01)",
      "NDC11Code": "52346-0011-01",
      "ProductNDC": "52346-011",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrogen",
      "NonProprietaryName": "Nitrogen",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19851201",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205866",
      "LabelerName": "Scott-Gross Company, Inc.",
      "SubstanceName": "NITROGEN",
      "StrengthNumber": "990",
      "StrengthUnit": "mL/L",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "55319-780-01",
      "PackageDescription": "30 mL in 1 BOTTLE (55319-780-01) ",
      "NDC11Code": "55319-0780-01",
      "ProductNDC": "55319-780",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fb Hydrating Hand Sanitizer",
      "NonProprietaryName": "Fb Hydrating Hand Sanitizer",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250607",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "FAMILY DOLLAR SERVICES, LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250607",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use hand sanitizer to help reduce bacteria on the skin."
    },
    {
      "NDCCode": "55648-780-01",
      "PackageDescription": "1 VIAL in 1 CARTON (55648-780-01)  > 18 mL in 1 VIAL",
      "NDC11Code": "55648-0780-01",
      "ProductNDC": "55648-780",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amiodarone Hydrochloride",
      "NonProprietaryName": "Amiodarone Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20081030",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077834",
      "LabelerName": "Wockhardt Limited",
      "SubstanceName": "AMIODARONE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Amiodarone injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. (1).",
      "Description": "Amiodarone injection contains amiodarone HCl (C25H29I2NO3HCl), a class III antiarrhythmic drug. Amiodarone HCl is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone HCl has the following structural formula:. Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone injection is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the amiodarone formulation contains 50 mg of amiodarone HCl USP, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone injection contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [(see Dosage and Administration (2)]."
    },
    {
      "NDCCode": "59746-780-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (59746-780-01) ",
      "NDC11Code": "59746-0780-01",
      "ProductNDC": "59746-780",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydroxychloroquine Sulfate",
      "ProprietaryNameSuffix": "Film Coated",
      "NonProprietaryName": "Hydroxychloroquine Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200722",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212902",
      "LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
      "SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200725",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59779-780-01",
      "PackageDescription": "1 CYLINDER in 1 BLISTER PACK (59779-780-01)  > 4.5 g in 1 CYLINDER",
      "NDC11Code": "59779-0780-01",
      "ProductNDC": "59779-780",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Health Medicated Lip Care",
      "NonProprietaryName": "Avobenzone, Dimethicone, Octinoxate, Octisalate",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150901",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "AVOBENZONE; DIMETHICONE; OCTINOXATE; OCTISALATE",
      "StrengthNumber": "30; 10; 75; 50",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-06-02",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "60274-780-01",
      "PackageDescription": "52000 CAPSULE, EXTENDED RELEASE in 1 DRUM (60274-780-01) ",
      "NDC11Code": "60274-0780-01",
      "ProductNDC": "60274-780",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Dexmethylphenidate Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "StartMarketingDate": "20231023",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Societal CDMO Gainesville, LLC",
      "SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CII",
      "Status": "Unfinished",
      "LastUpdate": "2023-10-25",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "23-OCT-23"
    }
  ]
}
                    
{"NDC":[{"NDCCode":"55301-780-01","ProprietaryName":"Ultimate Sheer Spf 70","NonProprietaryName":"Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10% Oxybenzone 3%"},{"NDCCode":"55301-117-01","ProprietaryName":"Exchange Select Lansoprazole","NonProprietaryName":"Lansoprazole"},{"NDCCode":"55301-177-01","ProprietaryName":"Exchange Select Eye Drops Advanced Relief Moisturizer","NonProprietaryName":"Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hcl"},{"NDCCode":"55301-178-01","ProprietaryName":"Exchange Select Artificial Tears Lubricant Eye Drops","NonProprietaryName":"Glycerin, Hypromellose, Polyethylene Glycol 400"},{"NDCCode":"55301-319-01","ProprietaryName":"Stomach Relief","NonProprietaryName":"Bismuth Subsalicylate"},{"NDCCode":"55301-347-01","ProprietaryName":"Exchange Select High Performance Lubricant Eye Drops","NonProprietaryName":"Polyethylene Glycol 400, Propylene Glycol"},{"NDCCode":"55301-406-01","ProprietaryName":"Exchange Select Cold Sore Treatment","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"55301-407-01","ProprietaryName":"Cold Sore Treatment","NonProprietaryName":"Camphor"},{"NDCCode":"55301-447-01","ProprietaryName":"Acetaminophen","NonProprietaryName":"Acetaminophen"},{"NDCCode":"55301-506-01","ProprietaryName":"Exchange Select Allergy Relief","NonProprietaryName":"Fluticasone Propionate"},{"NDCCode":"55301-533-01","ProprietaryName":"Mucus Relief Dm","NonProprietaryName":"Dextromethorphan Hbr And Guaifenesin"},{"NDCCode":"55301-874-01","ProprietaryName":"Antifungal Powder","NonProprietaryName":"Tolnaftate"},{"NDCCode":"55301-898-01","ProprietaryName":"Exchange Select Esomeprazole Magnesium","NonProprietaryName":"Esomeprazole"},{"NDCCode":"55301-904-01","ProprietaryName":"Targeted Warming Capsaicin Patch","NonProprietaryName":"Capsaicin"},{"NDCCode":"55301-998-01","ProprietaryName":"Exchange Select Maximum Redness Relief Eye Drops","NonProprietaryName":"Glycerin, Naphazoline Hcl"},{"NDCCode":"10135-780-01","ProprietaryName":"Baclofen","NonProprietaryName":"Baclofen"},{"NDCCode":"12634-780-01","ProprietaryName":"Fluconazole","NonProprietaryName":"Fluconazole"},{"NDCCode":"16571-780-01","ProprietaryName":"Carisoprodol","NonProprietaryName":"Carisoprodol"},{"NDCCode":"16714-780-01","ProprietaryName":"Ezetimibe And Simvastatin","NonProprietaryName":"Ezetimibe And Simvastatin"},{"NDCCode":"24658-780-01","ProprietaryName":"Ursodiol","NonProprietaryName":"Ursodiol"},{"NDCCode":"28595-780-01","ProprietaryName":"Histaflex","NonProprietaryName":"Acetaminophen And Pyrilamine Maleate"},{"NDCCode":"33261-780-01","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"41226-780-01","ProprietaryName":"Severe Cold And Flu Daytime","NonProprietaryName":"Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"},{"NDCCode":"41250-780-01","ProprietaryName":"Aspirin 81 Mg","NonProprietaryName":"Aspirin"},{"NDCCode":"52346-011-01","ProprietaryName":"Nitrogen","NonProprietaryName":"Nitrogen"},{"NDCCode":"55319-780-01","ProprietaryName":"Fb Hydrating Hand Sanitizer","NonProprietaryName":"Fb Hydrating Hand Sanitizer"},{"NDCCode":"55648-780-01","ProprietaryName":"Amiodarone Hydrochloride","NonProprietaryName":"Amiodarone Hydrochloride"},{"NDCCode":"59746-780-01","ProprietaryName":"Hydroxychloroquine Sulfate","NonProprietaryName":"Hydroxychloroquine Sulfate"},{"NDCCode":"59779-780-01","ProprietaryName":"Cvs Health Medicated Lip Care","NonProprietaryName":"Avobenzone, Dimethicone, Octinoxate, Octisalate"},{"NDCCode":"60274-780-01","NonProprietaryName":"Dexmethylphenidate Hydrochloride"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>55301-780-01</NDCCode>
    <PackageDescription>43 g in 1 PACKAGE (55301-780-01) </PackageDescription>
    <NDC11Code>55301-0780-01</NDC11Code>
    <ProductNDC>55301-780</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ultimate Sheer Spf 70</ProprietaryName>
    <NonProprietaryName>Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10% Oxybenzone 3%</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20151207</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Your Military Exchanges</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>3; 15; 5; 10; 3</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55301-117-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (55301-117-01)  &gt; 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>55301-0117-01</NDC11Code>
    <ProductNDC>55301-117</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Exchange Select Lansoprazole</ProprietaryName>
    <NonProprietaryName>Lansoprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120611</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202319</ApplicationNumber>
    <LabelerName>Army &amp; Air Force Exchange Service</LabelerName>
    <SubstanceName>LANSOPRAZOLE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55301-177-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (55301-177-01)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>55301-0177-01</NDC11Code>
    <ProductNDC>55301-177</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Exchange Select Eye Drops Advanced Relief Moisturizer</ProprietaryName>
    <NonProprietaryName>Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hcl</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20200212</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>Army and Air Force Exchange Service</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE; POVIDONE, UNSPECIFIED; DEXTRAN 70</SubstanceName>
    <StrengthNumber>1; .05; 1; .1</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 relieves redness of the eye due to minor eye irritations, 2 as a lubricant to prevent further irritation or to relieve dryness of the eye.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55301-178-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (55301-178-01)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>55301-0178-01</NDC11Code>
    <ProductNDC>55301-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Exchange Select Artificial Tears Lubricant Eye Drops</ProprietaryName>
    <NonProprietaryName>Glycerin, Hypromellose, Polyethylene Glycol 400</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20200212</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>Army and Air Force Exchange Service</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 400; HYPROMELLOSE, UNSPECIFIED; GLYCERIN</SubstanceName>
    <StrengthNumber>1; .2; .2</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 For temporary relief of burning and irritation due to dryness of the eye, 2 for protection against further irritation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55301-319-01</NDCCode>
    <PackageDescription>5 POUCH in 1 CARTON (55301-319-01)  &gt; 6 TABLET, CHEWABLE in 1 POUCH</PackageDescription>
    <NDC11Code>55301-0319-01</NDC11Code>
    <ProductNDC>55301-319</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stomach Relief</ProprietaryName>
    <NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980716</StartMarketingDate>
    <EndMarketingDate>20220807</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part335</ApplicationNumber>
    <LabelerName>ARMY AND AIR FORCE EXCHANGE SERVICE</LabelerName>
    <SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
    <StrengthNumber>262</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19980716</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220807</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55301-347-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 BOX (55301-347-01)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>55301-0347-01</NDC11Code>
    <ProductNDC>55301-347</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Exchange Select High Performance Lubricant Eye Drops</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol 400, Propylene Glycol</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>Army and Air Force Exchange Service</LabelerName>
    <SubstanceName>PROPYLENE GLYCOL; POLYETHYLENE GLYCOL 400</SubstanceName>
    <StrengthNumber>.3; .4</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-04-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of burning and irritation due to dryness of the eye.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55301-406-01</NDCCode>
    <PackageDescription>1 TUBE in 1 PACKAGE (55301-406-01)  &gt; 2 g in 1 TUBE</PackageDescription>
    <NDC11Code>55301-0406-01</NDC11Code>
    <ProductNDC>55301-406</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Exchange Select Cold Sore Treatment</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110804</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Army + Air Force Exchange Service</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55301-407-01</NDCCode>
    <PackageDescription>1 TUBE in 1 PACKAGE (55301-407-01)  &gt; 2 g in 1 TUBE</PackageDescription>
    <NDC11Code>55301-0407-01</NDC11Code>
    <ProductNDC>55301-407</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cold Sore Treatment</ProprietaryName>
    <NonProprietaryName>Camphor</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141104</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Army &amp; Air Force Exchange Service</LabelerName>
    <SubstanceName>CAMPHOR (SYNTHETIC); BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>30; 1.3</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55301-447-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (55301-447-01)  &gt; 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>55301-0447-01</NDC11Code>
    <ProductNDC>55301-447</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <ProprietaryNameSuffix>Childrens</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050203</StartMarketingDate>
    <EndMarketingDate>20201128</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>ARMY AND AIR FORCE EXCHANGE SERVICE</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20050203</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201128</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55301-506-01</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (55301-506-01)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>55301-0506-01</NDC11Code>
    <ProductNDC>55301-506</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Exchange Select Allergy Relief</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20171027</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207957</ApplicationNumber>
    <LabelerName>Army &amp; Air Force Exchange Service</LabelerName>
    <SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171027</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy nose, 3 runny nose, 4 itchy, watery eyes, 5 sneezing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55301-533-01</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (55301-533-01)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55301-0533-01</NDC11Code>
    <ProductNDC>55301-533</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucus Relief Dm</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hbr And Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20051231</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>ARMY AND AIR FORCE EXCHANGE SERVICE</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
    <StrengthNumber>20; 400</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20051231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation associated with the common coldthe intensity of coughingthe impulse to cough to help you get to sleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55301-874-01</NDCCode>
    <PackageDescription>130 g in 1 CAN (55301-874-01) </PackageDescription>
    <NDC11Code>55301-0874-01</NDC11Code>
    <ProductNDC>55301-874</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antifungal Powder</ProprietaryName>
    <NonProprietaryName>Tolnaftate</NonProprietaryName>
    <DosageFormName>AEROSOL, SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120103</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>ARMY &amp; AIR FORCE EXCHANGE SERVICE</LabelerName>
    <SubstanceName>TOLNAFTATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris). can prevent recurrence of most athlete's foot. relieves symptoms of athlete's foot, including itching, burning, cracking and chafing associated with jock itch.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55301-898-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (55301-898-01)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>55301-0898-01</NDC11Code>
    <ProductNDC>55301-898</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Exchange Select Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Esomeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207193</ApplicationNumber>
    <LabelerName>Army &amp; Air Force Exchange Service</LabelerName>
    <SubstanceName>ESOMEPRAZOLE</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>Active</Status>
    <LastUpdate>2024-08-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55301-904-01</NDCCode>
    <PackageDescription>3 PATCH in 1 POUCH (55301-904-01)  / 4 g in 1 PATCH</PackageDescription>
    <NDC11Code>55301-0904-01</NDC11Code>
    <ProductNDC>55301-904</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Targeted Warming Capsaicin Patch</ProprietaryName>
    <NonProprietaryName>Capsaicin</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Army &amp; Air Force Exchange Service</LabelerName>
    <SubstanceName>CAPSAICIN</SubstanceName>
    <StrengthNumber>.025</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporary relief of minor pain of muscles and joints associated with: arthritis, minor backache, strains, sprains and bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55301-998-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 BOX (55301-998-01)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>55301-0998-01</NDC11Code>
    <ProductNDC>55301-998</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Exchange Select Maximum Redness Relief Eye Drops</ProprietaryName>
    <NonProprietaryName>Glycerin, Naphazoline Hcl</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>Army and Air Force Exchange Service</LabelerName>
    <SubstanceName>GLYCERIN; NAPHAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.5; .03</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the relief of redness of the eye due to minor eye irritations. for the temporary relief of burning and irritation due to dryness of the eye. for use as a protectant against further irritation or dryness of the eye.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10135-780-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (10135-780-01) </PackageDescription>
    <NDC11Code>10135-0780-01</NDC11Code>
    <ProductNDC>10135-780</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Baclofen</ProprietaryName>
    <NonProprietaryName>Baclofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212378</ApplicationNumber>
    <LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>BACLOFEN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
    <Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>12634-780-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (12634-780-01)</PackageDescription>
    <NDC11Code>12634-0780-01</NDC11Code>
    <ProductNDC>12634-780</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081007</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077731</ApplicationNumber>
    <LabelerName>Apotheca Inc.</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Fluconazole tablets USP are indicated for the treatment of. Prophylaxis. Fluconazole tablets USP are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
    <Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α 1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C 13H 12F 2N 6O and molecular weight of 306.3. The structural formula is:. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&amp;C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-780-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (16571-780-01) </PackageDescription>
    <NDC11Code>16571-0780-01</NDC11Code>
    <ProductNDC>16571-780</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carisoprodol</ProprietaryName>
    <NonProprietaryName>Carisoprodol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040792</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>CARISOPRODOL</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-01-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.Limitation of UseCarisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].</IndicationAndUsage>
    <Description>Carisoprodol tablets, USP are available as 250 mg and 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in the carisoprodol tablets, USP include pregelatinized starch (maize), crospovidone, povidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-780-01</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (16714-780-01) </PackageDescription>
    <NDC11Code>16714-0780-01</NDC11Code>
    <ProductNDC>16714-780</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190819</StartMarketingDate>
    <EndMarketingDate>20261031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208699</ApplicationNumber>
    <LabelerName>NORTHSTAR RX LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190819</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and Simvastatin Tablets are a combination of simvastatin and ezetimibe indicated: : 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): , 2 In adults with primary hyperlipidemia. , 3 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 4 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .</IndicationAndUsage>
    <Description>Ezetimibe and Simvastatin Tablets contain ezetimibe, a dietary cholesterol absorption inhibitor, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.44 g/mol. Ezetimibe is a white, crystalline powder that is freely soluble in ethanol, methanol and acetone and practically insoluble in water. Its structural formula is. Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7α,8α(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin is a white to off-white, nonhygroscopic powder that is freely soluble in chloroform, methanol and alcohol, sparingly soluble in propylene glycol, very slightly soluble in hexane and practically insoluble in water. Its structural formula is. Ezetimibe and Simvastatin Tablets are available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/10 mg), 20 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/20 mg), 40 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/40 mg), or 80 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate, and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>24658-780-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (24658-780-01) </PackageDescription>
    <NDC11Code>24658-0780-01</NDC11Code>
    <ProductNDC>24658-780</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ursodiol</ProprietaryName>
    <NonProprietaryName>Ursodiol</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075517</ApplicationNumber>
    <LabelerName>PuraCap Laboratories, LLC</LabelerName>
    <SubstanceName>URSODIOL</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bile Acid [EPC], Bile Acids and Salts [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones &lt; 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.</IndicationAndUsage>
    <Description>Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol, USP (ursodeoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. The chemical name for ursodiol is 3α, 7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below. Inactive Ingredients: Corn starch, magnesium stearate, silicon dioxide and the capsule shell contain the following ingredients, gelatin, titanium dioxide, D&amp;C Red #28, FD&amp;C Blue #1 and FD&amp;C Red #40. The imprinting ink contains the following: black iron oxide, D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake, FD&amp;C Blue #2 Aluminum Lake, FD&amp;C Red #40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>28595-780-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (28595-780-01)</PackageDescription>
    <NDC11Code>28595-0780-01</NDC11Code>
    <ProductNDC>28595-780</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Histaflex</ProprietaryName>
    <NonProprietaryName>Acetaminophen And Pyrilamine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140522</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Allegis Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; PYRILAMINE MALEATE</SubstanceName>
    <StrengthNumber>325; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>33261-780-01</NDCCode>
    <PackageDescription>21 TABLET in 1 BOX, UNIT-DOSE (33261-780-01)</PackageDescription>
    <NDC11Code>33261-0780-01</NDC11Code>
    <ProductNDC>33261-780</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020712</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040256</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis, 4 Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>41226-780-01</NDCCode>
    <PackageDescription>354 mL in 1 BOTTLE (41226-780-01) </PackageDescription>
    <NDC11Code>41226-0780-01</NDC11Code>
    <ProductNDC>41226-780</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Severe Cold And Flu Daytime</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240430</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>KROGER COMPANY</LabelerName>
    <SubstanceName>GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>400; 10; 650; 20</StrengthNumber>
    <StrengthUnit>mg/30mL; mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves common cold/flu symptoms:.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41250-780-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (41250-780-01)  / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>41250-0780-01</NDC11Code>
    <ProductNDC>41250-780</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aspirin 81 Mg</ProprietaryName>
    <NonProprietaryName>Aspirin</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110301</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Meijer</LabelerName>
    <SubstanceName>ASPIRIN</SubstanceName>
    <StrengthNumber>81</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110301</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for this product.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52346-011-01</NDCCode>
    <PackageDescription>780 L in 1 DEWAR (52346-011-01)</PackageDescription>
    <NDC11Code>52346-0011-01</NDC11Code>
    <ProductNDC>52346-011</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrogen</ProprietaryName>
    <NonProprietaryName>Nitrogen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19851201</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205866</ApplicationNumber>
    <LabelerName>Scott-Gross Company, Inc.</LabelerName>
    <SubstanceName>NITROGEN</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55319-780-01</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (55319-780-01) </PackageDescription>
    <NDC11Code>55319-0780-01</NDC11Code>
    <ProductNDC>55319-780</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fb Hydrating Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Fb Hydrating Hand Sanitizer</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250607</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>FAMILY DOLLAR SERVICES, LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55648-780-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (55648-780-01)  &gt; 18 mL in 1 VIAL</PackageDescription>
    <NDC11Code>55648-0780-01</NDC11Code>
    <ProductNDC>55648-780</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amiodarone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20081030</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077834</ApplicationNumber>
    <LabelerName>Wockhardt Limited</LabelerName>
    <SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Amiodarone injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. (1).</IndicationAndUsage>
    <Description>Amiodarone injection contains amiodarone HCl (C25H29I2NO3HCl), a class III antiarrhythmic drug. Amiodarone HCl is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone HCl has the following structural formula:. Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone injection is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the amiodarone formulation contains 50 mg of amiodarone HCl USP, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone injection contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [(see Dosage and Administration (2)].</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-780-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-780-01) </PackageDescription>
    <NDC11Code>59746-0780-01</NDC11Code>
    <ProductNDC>59746-780</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
    <ProprietaryNameSuffix>Film Coated</ProprietaryNameSuffix>
    <NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200722</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212902</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59779-780-01</NDCCode>
    <PackageDescription>1 CYLINDER in 1 BLISTER PACK (59779-780-01)  &gt; 4.5 g in 1 CYLINDER</PackageDescription>
    <NDC11Code>59779-0780-01</NDC11Code>
    <ProductNDC>59779-780</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cvs Health Medicated Lip Care</ProprietaryName>
    <NonProprietaryName>Avobenzone, Dimethicone, Octinoxate, Octisalate</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <SubstanceName>AVOBENZONE; DIMETHICONE; OCTINOXATE; OCTISALATE</SubstanceName>
    <StrengthNumber>30; 10; 75; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-06-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>60274-780-01</NDCCode>
    <PackageDescription>52000 CAPSULE, EXTENDED RELEASE in 1 DRUM (60274-780-01) </PackageDescription>
    <NDC11Code>60274-0780-01</NDC11Code>
    <ProductNDC>60274-780</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <StartMarketingDate>20231023</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Societal CDMO Gainesville, LLC</LabelerName>
    <SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2023-10-25</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>23-OCT-23</StartMarketingDatePackage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>55301-780-01</NDCCode><ProprietaryName>Ultimate Sheer Spf 70</ProprietaryName><NonProprietaryName>Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10% Oxybenzone 3%</NonProprietaryName></NDC><NDC><NDCCode>55301-117-01</NDCCode><ProprietaryName>Exchange Select Lansoprazole</ProprietaryName><NonProprietaryName>Lansoprazole</NonProprietaryName></NDC><NDC><NDCCode>55301-177-01</NDCCode><ProprietaryName>Exchange Select Eye Drops Advanced Relief Moisturizer</ProprietaryName><NonProprietaryName>Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hcl</NonProprietaryName></NDC><NDC><NDCCode>55301-178-01</NDCCode><ProprietaryName>Exchange Select Artificial Tears Lubricant Eye Drops</ProprietaryName><NonProprietaryName>Glycerin, Hypromellose, Polyethylene Glycol 400</NonProprietaryName></NDC><NDC><NDCCode>55301-319-01</NDCCode><ProprietaryName>Stomach Relief</ProprietaryName><NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName></NDC><NDC><NDCCode>55301-347-01</NDCCode><ProprietaryName>Exchange Select High Performance Lubricant Eye Drops</ProprietaryName><NonProprietaryName>Polyethylene Glycol 400, Propylene Glycol</NonProprietaryName></NDC><NDC><NDCCode>55301-406-01</NDCCode><ProprietaryName>Exchange Select Cold Sore Treatment</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>55301-407-01</NDCCode><ProprietaryName>Cold Sore Treatment</ProprietaryName><NonProprietaryName>Camphor</NonProprietaryName></NDC><NDC><NDCCode>55301-447-01</NDCCode><ProprietaryName>Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>55301-506-01</NDCCode><ProprietaryName>Exchange Select Allergy Relief</ProprietaryName><NonProprietaryName>Fluticasone Propionate</NonProprietaryName></NDC><NDC><NDCCode>55301-533-01</NDCCode><ProprietaryName>Mucus Relief Dm</ProprietaryName><NonProprietaryName>Dextromethorphan Hbr And Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>55301-874-01</NDCCode><ProprietaryName>Antifungal Powder</ProprietaryName><NonProprietaryName>Tolnaftate</NonProprietaryName></NDC><NDC><NDCCode>55301-898-01</NDCCode><ProprietaryName>Exchange Select Esomeprazole Magnesium</ProprietaryName><NonProprietaryName>Esomeprazole</NonProprietaryName></NDC><NDC><NDCCode>55301-904-01</NDCCode><ProprietaryName>Targeted Warming Capsaicin Patch</ProprietaryName><NonProprietaryName>Capsaicin</NonProprietaryName></NDC><NDC><NDCCode>55301-998-01</NDCCode><ProprietaryName>Exchange Select Maximum Redness Relief Eye Drops</ProprietaryName><NonProprietaryName>Glycerin, Naphazoline Hcl</NonProprietaryName></NDC><NDC><NDCCode>10135-780-01</NDCCode><ProprietaryName>Baclofen</ProprietaryName><NonProprietaryName>Baclofen</NonProprietaryName></NDC><NDC><NDCCode>12634-780-01</NDCCode><ProprietaryName>Fluconazole</ProprietaryName><NonProprietaryName>Fluconazole</NonProprietaryName></NDC><NDC><NDCCode>16571-780-01</NDCCode><ProprietaryName>Carisoprodol</ProprietaryName><NonProprietaryName>Carisoprodol</NonProprietaryName></NDC><NDC><NDCCode>16714-780-01</NDCCode><ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName><NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>24658-780-01</NDCCode><ProprietaryName>Ursodiol</ProprietaryName><NonProprietaryName>Ursodiol</NonProprietaryName></NDC><NDC><NDCCode>28595-780-01</NDCCode><ProprietaryName>Histaflex</ProprietaryName><NonProprietaryName>Acetaminophen And Pyrilamine Maleate</NonProprietaryName></NDC><NDC><NDCCode>33261-780-01</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>41226-780-01</NDCCode><ProprietaryName>Severe Cold And Flu Daytime</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>41250-780-01</NDCCode><ProprietaryName>Aspirin 81 Mg</ProprietaryName><NonProprietaryName>Aspirin</NonProprietaryName></NDC><NDC><NDCCode>52346-011-01</NDCCode><ProprietaryName>Nitrogen</ProprietaryName><NonProprietaryName>Nitrogen</NonProprietaryName></NDC><NDC><NDCCode>55319-780-01</NDCCode><ProprietaryName>Fb Hydrating Hand Sanitizer</ProprietaryName><NonProprietaryName>Fb Hydrating Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>55648-780-01</NDCCode><ProprietaryName>Amiodarone Hydrochloride</ProprietaryName><NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>59746-780-01</NDCCode><ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName><NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>59779-780-01</NDCCode><ProprietaryName>Cvs Health Medicated Lip Care</ProprietaryName><NonProprietaryName>Avobenzone, Dimethicone, Octinoxate, Octisalate</NonProprietaryName></NDC><NDC><NDCCode>60274-780-01</NDCCode><NonProprietaryName>Dexmethylphenidate Hydrochloride</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",
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      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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