RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "0496-0590-02",
      "PackageDescription": "70 g in 1 TUBE (0496-0590-02) ",
      "NDC11Code": "00496-0590-02",
      "ProductNDC": "0496-0590",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr. Mom Butt Balm",
      "NonProprietaryName": "Dimethicone Petrolatum",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20221107",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Ferndale Laboratories, Inc.",
      "SubstanceName": "DIMETHICONE; WHITE PETROLATUM",
      "StrengthNumber": ".28; .48",
      "StrengthUnit": "g/g; g/g",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221107",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin."
    },
    {
      "NDCCode": "13537-496-02",
      "PackageDescription": "1 CARTRIDGE in 1 BOX (13537-496-02)  > 10 g in 1 CARTRIDGE (13537-496-01)",
      "NDC11Code": "13537-0496-02",
      "ProductNDC": "13537-496",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel",
      "ProprietaryNameSuffix": "Divine Polvos Compactos Doble Uso Fps 15 Edicion De Lujo Plateado/double Use Compact Spf 15 Silver Deluxe Edition Medium 6",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide, And Octinoxate",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130527",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD.",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE",
      "StrengthNumber": ".062393; .049; .03",
      "StrengthUnit": "g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "16714-496-02",
      "PackageDescription": "1 TUBE in 1 CARTON (16714-496-02)  / 45 g in 1 TUBE",
      "NDC11Code": "16714-0496-02",
      "ProductNDC": "16714-496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
      "NonProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20010529",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075673",
      "LabelerName": "NORTHSTAR RX LLC",
      "SubstanceName": "CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE",
      "StrengthNumber": "10; .5",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-07-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160815",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.",
      "Description": "Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use. Chemically, clotrimazole is 1–(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C22H17CLN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate has 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula. Betamethasone dipropionate is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, white petrolatum; benzyl alcohol as preservative."
    },
    {
      "NDCCode": "17856-0496-2",
      "PackageDescription": "10 mL in 1 CUP, UNIT-DOSE (17856-0496-2) ",
      "NDC11Code": "17856-0496-02",
      "ProductNDC": "17856-0496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171004",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091348",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "200; 40",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-07-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210827",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37662-0496-2",
      "PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-0496-2) ",
      "NDC11Code": "37662-0496-02",
      "ProductNDC": "37662-0496",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Coccus Cacti",
      "NonProprietaryName": "Coccus Cacti",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220610",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "PROTORTONIA CACTI",
      "StrengthNumber": "10",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2022-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220610",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "41520-496-02",
      "PackageDescription": "59 mL in 1 BOTTLE, PLASTIC (41520-496-02)",
      "NDC11Code": "41520-0496-02",
      "ProductNDC": "41520-496",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Care One",
      "ProprietaryNameSuffix": "Pumpkin Pie",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131027",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "AMERICAN SALES COMPANY",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE."
    },
    {
      "NDCCode": "43333-496-02",
      "PackageDescription": "59 mL in 1 BOTTLE, DISPENSING (43333-496-02) ",
      "NDC11Code": "43333-0496-02",
      "ProductNDC": "43333-496",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200605",
      "EndMarketingDate": "20220605",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Tonic Bath & Body Products Shenzhen Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "65",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200605",
      "EndMarketingDatePackage": "20220605",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49288-0496-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0496-2)",
      "NDC11Code": "49288-0496-02",
      "ProductNDC": "49288-0496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desert Sage",
      "NonProprietaryName": "Desert Sage",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ARTEMISIA TRIDENTATA POLLEN",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49349-496-02",
      "PackageDescription": "30 CAPSULE in 1 BLISTER PACK (49349-496-02)",
      "NDC11Code": "49349-0496-02",
      "ProductNDC": "49349-496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trimethobenzamide Hydrochloride",
      "NonProprietaryName": "Trimethobenzamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110818",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076570",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "TRIMETHOBENZAMIDE HYDROCHLORIDE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC],Emesis Suppression [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "49967-496-02",
      "PackageDescription": "1 TUBE in 1 CARTON (49967-496-02)  / 5 mL in 1 TUBE",
      "NDC11Code": "49967-0496-02",
      "ProductNDC": "49967-496",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate And Octocrylene",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "L'Oreal USA Products Inc",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "30; 100; 50; 70",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "- helps prevent sunburn. - if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "50090-0496-2",
      "PackageDescription": "60 TABLET in 1 BOTTLE (50090-0496-2)",
      "NDC11Code": "50090-0496-02",
      "ProductNDC": "50090-0496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glyburide",
      "NonProprietaryName": "Glyburide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071018",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077537",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "GLYBURIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-08"
    },
    {
      "NDCCode": "51346-496-02",
      "PackageDescription": "1 CONTAINER in 1 CARTON (51346-496-02)  > 55 mL in 1 CONTAINER (51346-496-01) ",
      "NDC11Code": "51346-0496-02",
      "ProductNDC": "51346-496",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cell Power Day",
      "NonProprietaryName": "Niacinamide, Adenosine",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20171201",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "NATURE REPUBLIC CO., LTD.",
      "SubstanceName": "NIACINAMIDE; ADENOSINE",
      "StrengthNumber": "1.1; .02",
      "StrengthUnit": "g/55mL; g/55mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20171201",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51552-0496-2",
      "PackageDescription": "5 g in 1 CONTAINER (51552-0496-2)",
      "NDC11Code": "51552-0496-02",
      "ProductNDC": "51552-0496",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Phentolamine Mesylate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20040901",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Fagron Inc",
      "SubstanceName": "PHENTOLAMINE MESYLATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "61786-496-02",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (61786-496-02) ",
      "NDC11Code": "61786-0496-02",
      "ProductNDC": "61786-496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aripiprazole",
      "NonProprietaryName": "Aripiprazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078583",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "ARIPIPRAZOLE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20151203",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63545-496-02",
      "PackageDescription": "500 PELLET in 1 VIAL, GLASS (63545-496-02) ",
      "NDC11Code": "63545-0496-02",
      "ProductNDC": "63545-496",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bismuthum Subnitricum",
      "NonProprietaryName": "Bismuthum Subnitricum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220502",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "BISMUTH SUBNITRATE",
      "StrengthNumber": "500",
      "StrengthUnit": "[hp_C]/1",
      "Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-05-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220502",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69625-496-02",
      "PackageDescription": "1 TUBE in 1 CARTON (69625-496-02)  / 5 mL in 1 TUBE",
      "NDC11Code": "69625-0496-02",
      "ProductNDC": "69625-496",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate And Octocrylene",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Cosmetique Active Production",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "30; 100; 50; 70",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "- helps prevent sunburn. - if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "70518-0496-2",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (70518-0496-2) ",
      "NDC11Code": "70518-0496-02",
      "ProductNDC": "70518-0496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Chlorzoxazone",
      "NonProprietaryName": "Chlorzoxazone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089859",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "CHLORZOXAZONE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200618",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71335-0496-2",
      "PackageDescription": "15 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0496-2) ",
      "NDC11Code": "71335-0496-02",
      "ProductNDC": "71335-0496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron",
      "NonProprietaryName": "Ondansetron",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100412",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090469",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "ONDANSETRON",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20211227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2, 2 initial and repeat courses of moderately emetogenic cancer chemotherapy, 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen    .",
      "Description": "The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula: The molecular formula is C18H19N3O representing a molecular weight of 293.4 g/mol. Ondansetron is a white to off-white powder. Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet, USP also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which disintegrates on the tongue and does not require water to aid dissolution or swallowing. Meets USP Disintegration Test 2."
    },
    {
      "NDCCode": "72789-496-02",
      "PackageDescription": "2 CAPSULE in 1 BOTTLE, PLASTIC (72789-496-02) ",
      "NDC11Code": "72789-0496-02",
      "ProductNDC": "72789-496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline",
      "NonProprietaryName": "Doxycycline",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205115",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "DOXYCYCLINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250306",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline capsules, USP are indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis,although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia  trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma  urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline capsules, USP are also indicated for the treatment of infections caused by the following gram-negative microorganisms. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis   due to Brucella species(in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella  granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis,including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema  pallidum. Yaws caused by Treponema pallidumsubspecies pertenue. Listeriosis due to Listeria  monocytogenes. Vincent's infection caused by Fusobacterium    fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.",
      "Description": "Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow to pale yellow powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C 22H 24N 2O 8 H 2O           M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each doxycycline capsule, USP intended for oral administration contains 50 mg or 75 mg or 100 mg of doxycycline. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. Additionally, each 50 and 100 mg capsule shell contains iron oxide yellow, each 75 mg and 100 mg capsule shell contains: D & C yellow # 10, FD & C blue # 1, FD & C red # 3 and FD & C yellow # 6 and each 100 mg capsule shell contains iron oxide red. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The Product meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "80425-0496-2",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (80425-0496-2) ",
      "NDC11Code": "80425-0496-02",
      "ProductNDC": "80425-0496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diazepam",
      "NonProprietaryName": "Diazepam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070325",
      "LabelerName": "Advanced Rx of Tennessee, LLC",
      "SubstanceName": "DIAZEPAM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
      "Description": "Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2 H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The molecular formula is C 16H 13ClN 2O and the molecular weight is 284.7. The structural formula is as follows:. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam, USP. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake. The 10 mg tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake."
    },
    {
      "NDCCode": "84522-496-02",
      "PackageDescription": "15 g in 1 BOX (84522-496-02) ",
      "NDC11Code": "84522-0496-02",
      "ProductNDC": "84522-496",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Trstay Dark Spot Corrector Cream",
      "NonProprietaryName": "Trstay Dark Spot Corrector Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241213",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "84756-496-02",
      "PackageDescription": "15 g in 1 BOX (84756-496-02) ",
      "NDC11Code": "84756-0496-02",
      "ProductNDC": "84756-496",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Trstay Dark Spot Corrector Cream",
      "NonProprietaryName": "Trstay Dark Spot Corrector Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241127",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Luoxin E �Commerce Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241127",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "0135-0590-02",
      "PackageDescription": "1 TUBE in 1 CARTON (0135-0590-02)  / 85 g in 1 TUBE",
      "NDC11Code": "00135-0590-02",
      "ProductNDC": "0135-0590",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aquafresh",
      "ProprietaryNameSuffix": "Cavity Protection",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20161001",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Haleon US Holdings LLC",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "1.15",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2026-02-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20161101",
      "SamplePackage": "N",
      "IndicationAndUsage": "aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "10122-590-02",
      "PackageDescription": "1 CANISTER in 1 CARTON (10122-590-02)  / 120 AEROSOL, METERED in 1 CANISTER",
      "NDC11Code": "10122-0590-02",
      "ProductNDC": "10122-590",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trimbow",
      "NonProprietaryName": "Beclomethasone Dipropionate/formoterol Fumarate/glycopyrrolate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20260514",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA219622",
      "LabelerName": "Chiesi USA, Inc.",
      "SubstanceName": "BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE",
      "StrengthNumber": "172; 4.9; 10.6",
      "StrengthUnit": "ug/1; ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260514",
      "SamplePackage": "Y",
      "IndicationAndUsage": "TRIMBOW is indicated for the maintenance treatment of asthma in adult patients aged 18 years and older. Limitations of Use. TRIMBOW is NOT indicated for relief of acute bronchospasm [see Warnings and Precautions (5.2)].",
      "Description": "TRIMBOW (beclomethasone dipropionate, formoterol fumarate and glycopyrrolate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of beclomethasone dipropionate [an inhaled corticosteroid (ICS)], formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] and glycopyrrolate (an anticholinergic) for oral inhalation. Beclomethasone dipropionate, an inhaled corticosteroid [ICS], has the chemical name. [2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-chloro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate. Beclomethasone dipropionate is a white to creamy white, odorless powder, insoluble in water, freely soluble in acetone, and sparingly soluble in alcohol, with a molecular weight of 521.04218 g/mol, and the molecular formula is C28H37ClO7. The structural formula is as follows:. Formoterol fumarate, a long-acting β2 agonist has the chemical name (E)-but-2-enedioic acid; N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-formamide dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. Formoterol fumarate  has a molecular weight of 840.91 g/mol, and the molecular formula is C42H52N4O12. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S) . Glycopyrrolate is a quarternary ammonium bromide salt with the following chemical name: [RS-]-3-[(SR)-(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-Pyrrolidinium bromide. Two asymmetric atoms of carbon are present in the molecule: Glycopyrronium bromide is represented by the (R,S)-(S,R) racemic pair of enantiomers, corresponding to the threo diastereoisomeric structure. Glycopyrrolate is a powder that is freely soluble in water. Glycopyrrolate has a molecular weight of 398.33 g/mol, and the molecular formula is C19H28BrNO3. The structural formula is as follows. Glycopyrrolate contains two chiral centers and is a racemate of a 1;1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. TRIMBOW 86 mcg/4.9 mcg/10.6 mcg and TRIMBOW 172 mcg/4.9 mcg/10.6 mcg are formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized, metered-dose inhalers, each containing 120 actuations.  The canister is supplied with a grey plastic actuator with an integrated dose counter mechanism and mouthpiece, and a red cap (TRIMBOW 86 mcg/4.9 mcg/10.6 mcg) or a green cap (TRIMBOW 172 mcg/4.9 mcg/10.6 mcg). As a solution, TRIMBOW does not need to be shaken before use. TRIMBOW should be “primed” by actuating 2 times prior to using the first dose from a new canister. If the inhaler has not been used for 30 days or longer, re-prime the inhaler [see How Supplied/Storage and Handling (16)]. After priming, each actuation meters 100 or 200 mcg of beclomethasone dipropionate, 6.0 mcg of formoterol fumarate (equivalent to 5.7 mcg of formoterol fumarate anhydrous), and 12.5 mcg of glycopyrrolate (equivalent to 10 mcg of glycopyrronium) in 73.8 mg of solution from the valve and delivers 86 or 172 mcg of beclomethasone dipropionate, 4.9 mcg of formoterol fumarate (equivalent to 4.2 mcg of formoterol fumarate anhydrous), and 10.6 mcg of glycopyrrolate (equivalent to 8.5 mcg of glycopyrronium) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as coordination of the device (metered dose inhaler [MDI]) actuation with the inhalation maneuver, inspiratory flow and peak inspiratory flow through the delivery system, which may vary in patients with asthma and other pulmonary diseases and conditions. Avoid spraying in the eyes or face while using TRIMBOW. TRIMBOW contains dehydrated alcohol (18% v/v), HFA 134a, and hydrochloric acid as excipients in the formulation."
    },
    {
      "NDCCode": "10920-590-02",
      "PackageDescription": "25 kg in 1 DRUM (10920-590-02) ",
      "NDC11Code": "10920-0590-02",
      "ProductNDC": "10920-590",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Buprenorphine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20110302",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Arevipharma GmbH",
      "SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "DEASchedule": "CIII",
      "Status": "Unfinished",
      "LastUpdate": "2024-10-09",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "02-MAR-11"
    },
    {
      "NDCCode": "13537-590-02",
      "PackageDescription": "1 TUBE in 1 BOX (13537-590-02)  > 4 g in 1 TUBE (13537-590-01)",
      "NDC11Code": "13537-0590-02",
      "ProductNDC": "13537-590",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esika Hydracolor 2 In 1 Spf 25",
      "ProprietaryNameSuffix": "(marron Glamour) - Brown",
      "NonProprietaryName": "Octinoxate And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20151123",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
      "StrengthNumber": ".0664; .0151",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "13668-590-02",
      "PackageDescription": "100 TABLET in 1 BOTTLE (13668-590-02) ",
      "NDC11Code": "13668-0590-02",
      "ProductNDC": "13668-590",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100415",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079191",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20100415",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "15631-0590-2",
      "PackageDescription": "50 TABLET in 1 CONTAINER (15631-0590-2)",
      "NDC11Code": "15631-0590-02",
      "ProductNDC": "15631-0590",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ginkgo Biloba",
      "NonProprietaryName": "Ginkgo Biloba",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160107",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "GINKGO",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "16714-590-02",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (16714-590-02) ",
      "NDC11Code": "16714-0590-02",
      "ProductNDC": "16714-590",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Digoxin",
      "NonProprietaryName": "Digoxin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160912",
      "EndMarketingDate": "20260430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076363",
      "LabelerName": "Northstar Rx LLC",
      "SubstanceName": "DIGOXIN",
      "StrengthNumber": "125",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160912",
      "EndMarketingDatePackage": "20260430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults (1.1). , 2 Increasing myocardial contractility in pediatric patients with heart failure (1.2)., 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults (1.3).",
      "Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O-2,6-dideoxy-β- D- ribo-hexopyranosyl-(1→4)- O-2,6-dideoxy-β- D- ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β- D- ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41H 64O 14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: lactose monohydrate, hydroxypropyl methylcellulose, magnesium stearate. In addition, the dye used in the 0.125 mg tablets is D&C Yellow No. 10 aluminum lake."
    },
    {
      "NDCCode": "21839-590-02",
      "PackageDescription": "1 BOTTLE in 1 CARTON (21839-590-02)  > 25 mL in 1 BOTTLE (21839-590-01) ",
      "NDC11Code": "21839-0590-02",
      "ProductNDC": "21839-590",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Coola Refreshing Water Mist Sunscreen",
      "ProprietaryNameSuffix": "Spf 30",
      "NonProprietaryName": "Avobenzone,homosalate, Octisalate,octocrylene",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Gordon Laboratories, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "20; 100; 50; 55",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20181231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. * helps prevent sunburn. * if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun."
    }
  ]
}
                    

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<NDCList>
  <NDC>
    <NDCCode>0496-0590-02</NDCCode>
    <PackageDescription>70 g in 1 TUBE (0496-0590-02) </PackageDescription>
    <NDC11Code>00496-0590-02</NDC11Code>
    <ProductNDC>0496-0590</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr. Mom Butt Balm</ProprietaryName>
    <NonProprietaryName>Dimethicone Petrolatum</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20221107</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Ferndale Laboratories, Inc.</LabelerName>
    <SubstanceName>DIMETHICONE; WHITE PETROLATUM</SubstanceName>
    <StrengthNumber>.28; .48</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13537-496-02</NDCCode>
    <PackageDescription>1 CARTRIDGE in 1 BOX (13537-496-02)  &gt; 10 g in 1 CARTRIDGE (13537-496-01)</PackageDescription>
    <NDC11Code>13537-0496-02</NDC11Code>
    <ProductNDC>13537-496</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel</ProprietaryName>
    <ProprietaryNameSuffix>Divine Polvos Compactos Doble Uso Fps 15 Edicion De Lujo Plateado/double Use Compact Spf 15 Silver Deluxe Edition Medium 6</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide, And Octinoxate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130527</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE</SubstanceName>
    <StrengthNumber>.062393; .049; .03</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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  <NDC>
    <NDCCode>16714-496-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (16714-496-02)  / 45 g in 1 TUBE</PackageDescription>
    <NDC11Code>16714-0496-02</NDC11Code>
    <ProductNDC>16714-496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
    <NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20010529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075673</ApplicationNumber>
    <LabelerName>NORTHSTAR RX LLC</LabelerName>
    <SubstanceName>CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE</SubstanceName>
    <StrengthNumber>10; .5</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.</IndicationAndUsage>
    <Description>Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use. Chemically, clotrimazole is 1–(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C22H17CLN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate has 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula. Betamethasone dipropionate is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, white petrolatum; benzyl alcohol as preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>17856-0496-2</NDCCode>
    <PackageDescription>10 mL in 1 CUP, UNIT-DOSE (17856-0496-2) </PackageDescription>
    <NDC11Code>17856-0496-02</NDC11Code>
    <ProductNDC>17856-0496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171004</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091348</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>200; 40</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-07-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210827</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>37662-0496-2</NDCCode>
    <PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-0496-2) </PackageDescription>
    <NDC11Code>37662-0496-02</NDC11Code>
    <ProductNDC>37662-0496</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coccus Cacti</ProprietaryName>
    <NonProprietaryName>Coccus Cacti</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220610</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>PROTORTONIA CACTI</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>[hp_M]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>41520-496-02</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, PLASTIC (41520-496-02)</PackageDescription>
    <NDC11Code>41520-0496-02</NDC11Code>
    <ProductNDC>41520-496</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Care One</ProprietaryName>
    <ProprietaryNameSuffix>Pumpkin Pie</ProprietaryNameSuffix>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131027</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>AMERICAN SALES COMPANY</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43333-496-02</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DISPENSING (43333-496-02) </PackageDescription>
    <NDC11Code>43333-0496-02</NDC11Code>
    <ProductNDC>43333-496</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200605</StartMarketingDate>
    <EndMarketingDate>20220605</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Tonic Bath &amp; Body Products Shenzhen Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200605</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220605</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49288-0496-2</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0496-2)</PackageDescription>
    <NDC11Code>49288-0496-02</NDC11Code>
    <ProductNDC>49288-0496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desert Sage</ProprietaryName>
    <NonProprietaryName>Desert Sage</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19920413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>ARTEMISIA TRIDENTATA POLLEN</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>49349-496-02</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BLISTER PACK (49349-496-02)</PackageDescription>
    <NDC11Code>49349-0496-02</NDC11Code>
    <ProductNDC>49349-496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trimethobenzamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Trimethobenzamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110818</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076570</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>TRIMETHOBENZAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiemetic [EPC],Emesis Suppression [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49967-496-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (49967-496-02)  / 5 mL in 1 TUBE</PackageDescription>
    <NDC11Code>49967-0496-02</NDC11Code>
    <ProductNDC>49967-496</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate And Octocrylene</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>L'Oreal USA Products Inc</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>30; 100; 50; 70</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>- helps prevent sunburn. - if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50090-0496-2</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (50090-0496-2)</PackageDescription>
    <NDC11Code>50090-0496-02</NDC11Code>
    <ProductNDC>50090-0496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glyburide</ProprietaryName>
    <NonProprietaryName>Glyburide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077537</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>GLYBURIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-08</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>51346-496-02</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (51346-496-02)  &gt; 55 mL in 1 CONTAINER (51346-496-01) </PackageDescription>
    <NDC11Code>51346-0496-02</NDC11Code>
    <ProductNDC>51346-496</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cell Power Day</ProprietaryName>
    <NonProprietaryName>Niacinamide, Adenosine</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20171201</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
    <SubstanceName>NIACINAMIDE; ADENOSINE</SubstanceName>
    <StrengthNumber>1.1; .02</StrengthNumber>
    <StrengthUnit>g/55mL; g/55mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51552-0496-2</NDCCode>
    <PackageDescription>5 g in 1 CONTAINER (51552-0496-2)</PackageDescription>
    <NDC11Code>51552-0496-02</NDC11Code>
    <ProductNDC>51552-0496</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Phentolamine Mesylate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20040901</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Fagron Inc</LabelerName>
    <SubstanceName>PHENTOLAMINE MESYLATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61786-496-02</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (61786-496-02) </PackageDescription>
    <NDC11Code>61786-0496-02</NDC11Code>
    <ProductNDC>61786-496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aripiprazole</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078583</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63545-496-02</NDCCode>
    <PackageDescription>500 PELLET in 1 VIAL, GLASS (63545-496-02) </PackageDescription>
    <NDC11Code>63545-0496-02</NDC11Code>
    <ProductNDC>63545-496</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bismuthum Subnitricum</ProprietaryName>
    <NonProprietaryName>Bismuthum Subnitricum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220502</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>BISMUTH SUBNITRATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69625-496-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (69625-496-02)  / 5 mL in 1 TUBE</PackageDescription>
    <NDC11Code>69625-0496-02</NDC11Code>
    <ProductNDC>69625-496</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate And Octocrylene</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Cosmetique Active Production</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>30; 100; 50; 70</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>- helps prevent sunburn. - if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70518-0496-2</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (70518-0496-2) </PackageDescription>
    <NDC11Code>70518-0496-02</NDC11Code>
    <ProductNDC>70518-0496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chlorzoxazone</ProprietaryName>
    <NonProprietaryName>Chlorzoxazone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089859</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>CHLORZOXAZONE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-09-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200618</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71335-0496-2</NDCCode>
    <PackageDescription>15 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0496-2) </PackageDescription>
    <NDC11Code>71335-0496-02</NDC11Code>
    <ProductNDC>71335-0496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron</ProprietaryName>
    <NonProprietaryName>Ondansetron</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090469</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>ONDANSETRON</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2, 2 initial and repeat courses of moderately emetogenic cancer chemotherapy, 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen    .</IndicationAndUsage>
    <Description>The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula: The molecular formula is C18H19N3O representing a molecular weight of 293.4 g/mol. Ondansetron is a white to off-white powder. Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet, USP also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which disintegrates on the tongue and does not require water to aid dissolution or swallowing. Meets USP Disintegration Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>72789-496-02</NDCCode>
    <PackageDescription>2 CAPSULE in 1 BOTTLE, PLASTIC (72789-496-02) </PackageDescription>
    <NDC11Code>72789-0496-02</NDC11Code>
    <ProductNDC>72789-496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160314</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205115</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline capsules, USP are indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis,although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia  trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma  urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline capsules, USP are also indicated for the treatment of infections caused by the following gram-negative microorganisms. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis   due to Brucella species(in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella  granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis,including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema  pallidum. Yaws caused by Treponema pallidumsubspecies pertenue. Listeriosis due to Listeria  monocytogenes. Vincent's infection caused by Fusobacterium    fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.</IndicationAndUsage>
    <Description>Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow to pale yellow powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C 22H 24N 2O 8 H 2O           M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each doxycycline capsule, USP intended for oral administration contains 50 mg or 75 mg or 100 mg of doxycycline. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. Additionally, each 50 and 100 mg capsule shell contains iron oxide yellow, each 75 mg and 100 mg capsule shell contains: D &amp; C yellow # 10, FD &amp; C blue # 1, FD &amp; C red # 3 and FD &amp; C yellow # 6 and each 100 mg capsule shell contains iron oxide red. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The Product meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0496-2</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (80425-0496-2) </PackageDescription>
    <NDC11Code>80425-0496-02</NDC11Code>
    <ProductNDC>80425-0496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070325</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2 H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The molecular formula is C 16H 13ClN 2O and the molecular weight is 284.7. The structural formula is as follows:. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam, USP. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 5 mg tablets also contain FD&amp;C Yellow No. 6 Aluminum Lake. The 10 mg tablets also contain D&amp;C Yellow No. 10 Aluminum Lake and FD&amp;C Blue No. 1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>84522-496-02</NDCCode>
    <PackageDescription>15 g in 1 BOX (84522-496-02) </PackageDescription>
    <NDC11Code>84522-0496-02</NDC11Code>
    <ProductNDC>84522-496</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trstay Dark Spot Corrector Cream</ProprietaryName>
    <NonProprietaryName>Trstay Dark Spot Corrector Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241213</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84756-496-02</NDCCode>
    <PackageDescription>15 g in 1 BOX (84756-496-02) </PackageDescription>
    <NDC11Code>84756-0496-02</NDC11Code>
    <ProductNDC>84756-496</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trstay Dark Spot Corrector Cream</ProprietaryName>
    <NonProprietaryName>Trstay Dark Spot Corrector Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241127</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Luoxin E �Commerce Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0135-0590-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0135-0590-02)  / 85 g in 1 TUBE</PackageDescription>
    <NDC11Code>00135-0590-02</NDC11Code>
    <ProductNDC>0135-0590</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aquafresh</ProprietaryName>
    <ProprietaryNameSuffix>Cavity Protection</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20161001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Haleon US Holdings LLC</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>1.15</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10122-590-02</NDCCode>
    <PackageDescription>1 CANISTER in 1 CARTON (10122-590-02)  / 120 AEROSOL, METERED in 1 CANISTER</PackageDescription>
    <NDC11Code>10122-0590-02</NDC11Code>
    <ProductNDC>10122-590</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trimbow</ProprietaryName>
    <NonProprietaryName>Beclomethasone Dipropionate/formoterol Fumarate/glycopyrrolate</NonProprietaryName>
    <DosageFormName>AEROSOL, METERED</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20260514</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219622</ApplicationNumber>
    <LabelerName>Chiesi USA, Inc.</LabelerName>
    <SubstanceName>BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>172; 4.9; 10.6</StrengthNumber>
    <StrengthUnit>ug/1; ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260514</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>TRIMBOW is indicated for the maintenance treatment of asthma in adult patients aged 18 years and older. Limitations of Use. TRIMBOW is NOT indicated for relief of acute bronchospasm [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>TRIMBOW (beclomethasone dipropionate, formoterol fumarate and glycopyrrolate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of beclomethasone dipropionate [an inhaled corticosteroid (ICS)], formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] and glycopyrrolate (an anticholinergic) for oral inhalation. Beclomethasone dipropionate, an inhaled corticosteroid [ICS], has the chemical name. [2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-chloro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate. Beclomethasone dipropionate is a white to creamy white, odorless powder, insoluble in water, freely soluble in acetone, and sparingly soluble in alcohol, with a molecular weight of 521.04218 g/mol, and the molecular formula is C28H37ClO7. The structural formula is as follows:. Formoterol fumarate, a long-acting β2 agonist has the chemical name (E)-but-2-enedioic acid; N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-formamide dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. Formoterol fumarate  has a molecular weight of 840.91 g/mol, and the molecular formula is C42H52N4O12. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S) . Glycopyrrolate is a quarternary ammonium bromide salt with the following chemical name: [RS-]-3-[(SR)-(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-Pyrrolidinium bromide. Two asymmetric atoms of carbon are present in the molecule: Glycopyrronium bromide is represented by the (R,S)-(S,R) racemic pair of enantiomers, corresponding to the threo diastereoisomeric structure. Glycopyrrolate is a powder that is freely soluble in water. Glycopyrrolate has a molecular weight of 398.33 g/mol, and the molecular formula is C19H28BrNO3. The structural formula is as follows. Glycopyrrolate contains two chiral centers and is a racemate of a 1;1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. TRIMBOW 86 mcg/4.9 mcg/10.6 mcg and TRIMBOW 172 mcg/4.9 mcg/10.6 mcg are formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized, metered-dose inhalers, each containing 120 actuations.  The canister is supplied with a grey plastic actuator with an integrated dose counter mechanism and mouthpiece, and a red cap (TRIMBOW 86 mcg/4.9 mcg/10.6 mcg) or a green cap (TRIMBOW 172 mcg/4.9 mcg/10.6 mcg). As a solution, TRIMBOW does not need to be shaken before use. TRIMBOW should be “primed” by actuating 2 times prior to using the first dose from a new canister. If the inhaler has not been used for 30 days or longer, re-prime the inhaler [see How Supplied/Storage and Handling (16)]. After priming, each actuation meters 100 or 200 mcg of beclomethasone dipropionate, 6.0 mcg of formoterol fumarate (equivalent to 5.7 mcg of formoterol fumarate anhydrous), and 12.5 mcg of glycopyrrolate (equivalent to 10 mcg of glycopyrronium) in 73.8 mg of solution from the valve and delivers 86 or 172 mcg of beclomethasone dipropionate, 4.9 mcg of formoterol fumarate (equivalent to 4.2 mcg of formoterol fumarate anhydrous), and 10.6 mcg of glycopyrrolate (equivalent to 8.5 mcg of glycopyrronium) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as coordination of the device (metered dose inhaler [MDI]) actuation with the inhalation maneuver, inspiratory flow and peak inspiratory flow through the delivery system, which may vary in patients with asthma and other pulmonary diseases and conditions. Avoid spraying in the eyes or face while using TRIMBOW. TRIMBOW contains dehydrated alcohol (18% v/v), HFA 134a, and hydrochloric acid as excipients in the formulation.</Description>
  </NDC>
  <NDC>
    <NDCCode>10920-590-02</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (10920-590-02) </PackageDescription>
    <NDC11Code>10920-0590-02</NDC11Code>
    <ProductNDC>10920-590</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20110302</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Arevipharma GmbH</LabelerName>
    <SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <DEASchedule>CIII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2024-10-09</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>02-MAR-11</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>13537-590-02</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13537-590-02)  &gt; 4 g in 1 TUBE (13537-590-01)</PackageDescription>
    <NDC11Code>13537-0590-02</NDC11Code>
    <ProductNDC>13537-590</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Esika Hydracolor 2 In 1 Spf 25</ProprietaryName>
    <ProprietaryNameSuffix>(marron Glamour) - Brown</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20151123</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.0664; .0151</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13668-590-02</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (13668-590-02) </PackageDescription>
    <NDC11Code>13668-0590-02</NDC11Code>
    <ProductNDC>13668-590</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100415</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079191</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>15631-0590-2</NDCCode>
    <PackageDescription>50 TABLET in 1 CONTAINER (15631-0590-2)</PackageDescription>
    <NDC11Code>15631-0590-02</NDC11Code>
    <ProductNDC>15631-0590</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ginkgo Biloba</ProprietaryName>
    <NonProprietaryName>Ginkgo Biloba</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160107</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>GINKGO</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-590-02</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (16714-590-02) </PackageDescription>
    <NDC11Code>16714-0590-02</NDC11Code>
    <ProductNDC>16714-590</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Digoxin</ProprietaryName>
    <NonProprietaryName>Digoxin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160912</StartMarketingDate>
    <EndMarketingDate>20260430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076363</ApplicationNumber>
    <LabelerName>Northstar Rx LLC</LabelerName>
    <SubstanceName>DIGOXIN</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160912</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults (1.1). , 2 Increasing myocardial contractility in pediatric patients with heart failure (1.2)., 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults (1.3).</IndicationAndUsage>
    <Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O-2,6-dideoxy-β- D- ribo-hexopyranosyl-(1→4)- O-2,6-dideoxy-β- D- ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β- D- ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41H 64O 14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: lactose monohydrate, hydroxypropyl methylcellulose, magnesium stearate. In addition, the dye used in the 0.125 mg tablets is D&amp;C Yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>21839-590-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21839-590-02)  &gt; 25 mL in 1 BOTTLE (21839-590-01) </PackageDescription>
    <NDC11Code>21839-0590-02</NDC11Code>
    <ProductNDC>21839-590</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coola Refreshing Water Mist Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone,homosalate, Octisalate,octocrylene</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20181231</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Gordon Laboratories, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>20; 100; 50; 55</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. * helps prevent sunburn. * if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0496-0590-02</NDCCode><ProprietaryName>Dr. Mom Butt Balm</ProprietaryName><NonProprietaryName>Dimethicone Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>13537-496-02</NDCCode><ProprietaryName>Lbel</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide, And Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>16714-496-02</NDCCode><ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName><NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>17856-0496-2</NDCCode><ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>37662-0496-2</NDCCode><ProprietaryName>Coccus Cacti</ProprietaryName><NonProprietaryName>Coccus Cacti</NonProprietaryName></NDC><NDC><NDCCode>41520-496-02</NDCCode><ProprietaryName>Care One</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>43333-496-02</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>49288-0496-2</NDCCode><ProprietaryName>Desert Sage</ProprietaryName><NonProprietaryName>Desert Sage</NonProprietaryName></NDC><NDC><NDCCode>49349-496-02</NDCCode><ProprietaryName>Trimethobenzamide Hydrochloride</ProprietaryName><NonProprietaryName>Trimethobenzamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49967-496-02</NDCCode><ProprietaryName>La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>50090-0496-2</NDCCode><ProprietaryName>Glyburide</ProprietaryName><NonProprietaryName>Glyburide</NonProprietaryName></NDC><NDC><NDCCode>51346-496-02</NDCCode><ProprietaryName>Cell Power Day</ProprietaryName><NonProprietaryName>Niacinamide, Adenosine</NonProprietaryName></NDC><NDC><NDCCode>51552-0496-2</NDCCode><NonProprietaryName>Phentolamine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>61786-496-02</NDCCode><ProprietaryName>Aripiprazole</ProprietaryName><NonProprietaryName>Aripiprazole</NonProprietaryName></NDC><NDC><NDCCode>63545-496-02</NDCCode><ProprietaryName>Bismuthum Subnitricum</ProprietaryName><NonProprietaryName>Bismuthum Subnitricum</NonProprietaryName></NDC><NDC><NDCCode>69625-496-02</NDCCode><ProprietaryName>La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>70518-0496-2</NDCCode><ProprietaryName>Chlorzoxazone</ProprietaryName><NonProprietaryName>Chlorzoxazone</NonProprietaryName></NDC><NDC><NDCCode>71335-0496-2</NDCCode><ProprietaryName>Ondansetron</ProprietaryName><NonProprietaryName>Ondansetron</NonProprietaryName></NDC><NDC><NDCCode>72789-496-02</NDCCode><ProprietaryName>Doxycycline</ProprietaryName><NonProprietaryName>Doxycycline</NonProprietaryName></NDC><NDC><NDCCode>80425-0496-2</NDCCode><ProprietaryName>Diazepam</ProprietaryName><NonProprietaryName>Diazepam</NonProprietaryName></NDC><NDC><NDCCode>84522-496-02</NDCCode><ProprietaryName>Trstay Dark Spot Corrector Cream</ProprietaryName><NonProprietaryName>Trstay Dark Spot Corrector Cream</NonProprietaryName></NDC><NDC><NDCCode>84756-496-02</NDCCode><ProprietaryName>Trstay Dark Spot Corrector Cream</ProprietaryName><NonProprietaryName>Trstay Dark Spot Corrector Cream</NonProprietaryName></NDC><NDC><NDCCode>0135-0590-02</NDCCode><ProprietaryName>Aquafresh</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>10122-590-02</NDCCode><ProprietaryName>Trimbow</ProprietaryName><NonProprietaryName>Beclomethasone Dipropionate/formoterol Fumarate/glycopyrrolate</NonProprietaryName></NDC><NDC><NDCCode>10920-590-02</NDCCode><NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>13537-590-02</NDCCode><ProprietaryName>Esika Hydracolor 2 In 1 Spf 25</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>13668-590-02</NDCCode><ProprietaryName>Cetirizine Hydrochloride</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>15631-0590-2</NDCCode><ProprietaryName>Ginkgo Biloba</ProprietaryName><NonProprietaryName>Ginkgo Biloba</NonProprietaryName></NDC><NDC><NDCCode>16714-590-02</NDCCode><ProprietaryName>Digoxin</ProprietaryName><NonProprietaryName>Digoxin</NonProprietaryName></NDC><NDC><NDCCode>21839-590-02</NDCCode><ProprietaryName>Coola Refreshing Water Mist Sunscreen</ProprietaryName><NonProprietaryName>Avobenzone,homosalate, Octisalate,octocrylene</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

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

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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