RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "72571-0230-2",
      "PackageDescription": "5 g in 1 POUCH (72571-0230-2) ",
      "NDC11Code": "72571-0230-02",
      "ProductNDC": "72571-0230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ari S-liner",
      "NonProprietaryName": "Garcinia Cambogia Extract Pwd",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190918",
      "EndMarketingDate": "20200917",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "ARI BIOTECHNOLOGY CO., LTD",
      "SubstanceName": "GARCINIA CAMBOGIA FRUIT",
      "StrengthNumber": ".34",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-09-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190918",
      "EndMarketingDatePackage": "20200917",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "72571-0230-1",
      "PackageDescription": "8 g in 1 POUCH (72571-0230-1) ",
      "NDC11Code": "72571-0230-01",
      "ProductNDC": "72571-0230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ari S-liner",
      "NonProprietaryName": "Garcinia Cambogia Extract Pwd",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180919",
      "EndMarketingDate": "20190919",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "ARI BIOTECHNOLOGY CO., LTD",
      "SubstanceName": "GARCINIA CAMBOGIA FRUIT",
      "StrengthNumber": ".34",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180919",
      "EndMarketingDatePackage": "20190919",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "72571-0231-2",
      "PackageDescription": "5 g in 1 POUCH (72571-0231-2) ",
      "NDC11Code": "72571-0231-02",
      "ProductNDC": "72571-0231",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ari S-liner",
      "NonProprietaryName": "Garcinia Cambogia Extract Pwd",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210301",
      "EndMarketingDate": "20220228",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "ARI BIOTECHNOLOGY CO., LTD",
      "SubstanceName": "AMINO ACIDS; GARCINIA CAMBOGIA FRUIT; RICE BRAN",
      "StrengthNumber": ".2; .34; 1.8",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Pharm_Classes": "Amino Acid Hypertonic Solution [EPC], Amino Acids [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210301",
      "EndMarketingDatePackage": "20220228",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "72571-0570-2",
      "PackageDescription": "30 g in 1 DOSE PACK (72571-0570-2) ",
      "NDC11Code": "72571-0570-02",
      "ProductNDC": "72571-0570",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ari Moms Care",
      "NonProprietaryName": "Asian Ginseng, Angelica Dahurica Root, Orange, Licorice",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190313",
      "EndMarketingDate": "20200313",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "ARI BIOTECHNOLOGY CO., LTD",
      "SubstanceName": "ASIAN GINSENG; ANGELICA DAHURICA ROOT; ORANGE; LICORICE",
      "StrengthNumber": "1.2; .8; .8; .4",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-03-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190313",
      "EndMarketingDatePackage": "20200313",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "11014-0230-2",
      "PackageDescription": "1 BAG in 1 DRUM (11014-0230-2)  / 74000 CAPSULE in 1 BAG",
      "NDC11Code": "11014-0230-02",
      "ProductNDC": "11014-0230",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Methylphenidate Hydrochloride",
      "DosageFormName": "CAPSULE",
      "StartMarketingDate": "20170815",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Catalent Pharma Solutions, LLC",
      "SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CII",
      "Status": "Unfinished",
      "LastUpdate": "2025-05-22",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-JAN-25"
    },
    {
      "NDCCode": "15631-0230-2",
      "PackageDescription": "400 PELLET in 1 PACKAGE (15631-0230-2) ",
      "NDC11Code": "15631-0230-02",
      "ProductNDC": "15631-0230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Iberis Amara",
      "NonProprietaryName": "Iberis Amara",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151002",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "IBERIS AMARA SEED",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "17337-0230-2",
      "PackageDescription": "1 BAG in 1 DRUM (17337-0230-2)  > 1 BAG in 1 BAG > 1 kg in 1 BAG",
      "NDC11Code": "17337-0230-02",
      "ProductNDC": "17337-0230",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Glipizide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20101126",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Olon SpA",
      "SubstanceName": "GLIPIZIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2017-12-20",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "37662-0230-2",
      "PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-0230-2) ",
      "NDC11Code": "37662-0230-02",
      "ProductNDC": "37662-0230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Chamomilla",
      "NonProprietaryName": "Chamomilla",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220527",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "MATRICARIA CHAMOMILLA WHOLE",
      "StrengthNumber": "500",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220527",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49288-0230-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0230-1)",
      "NDC11Code": "49288-0230-01",
      "ProductNDC": "49288-0230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Guinea Pig Hair",
      "NonProprietaryName": "Guinea Pig Hair",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "CAVIA PORCELLUS HAIR",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Animal Fur [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": "49288-0230-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0230-2)",
      "NDC11Code": "49288-0230-02",
      "ProductNDC": "49288-0230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Guinea Pig Hair",
      "NonProprietaryName": "Guinea Pig Hair",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "CAVIA PORCELLUS HAIR",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Animal Fur [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": "51141-0230-2",
      "PackageDescription": "1 TUBE in 1 CARTON (51141-0230-2)  > 56 g in 1 TUBE",
      "NDC11Code": "51141-0230-02",
      "ProductNDC": "51141-0230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Atopalm Hemorrhoidal",
      "NonProprietaryName": "Mineral Oil, Petrolatum, Phenylephrine Hydrochloride",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120718",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part346",
      "LabelerName": "NeoPharm USA",
      "SubstanceName": "MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "14; 71.9; .25",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "■ for temporary relief of the local itching and discomfort associated with hemorrhoids. ■ temporarily shrinks hemorrhoidal tissue and relieves burning. ■ temporarily provides a coating for relief of anorectal discomforts. ■ temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful."
    },
    {
      "NDCCode": "55504-0230-2",
      "PackageDescription": "59 mL in 1 CONTAINER (55504-0230-2)",
      "NDC11Code": "55504-0230-02",
      "ProductNDC": "55504-0230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dawnmist Antiperspirant And Deodorant",
      "NonProprietaryName": "Aluminum Chlorohydrate",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111005",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Donovan Industries, Inc.",
      "SubstanceName": "ALUMINUM CHLOROHYDRATE",
      "StrengthNumber": "7.9",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Reduces underarm perspiration."
    },
    {
      "NDCCode": "68210-0230-2",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (68210-0230-2)  > 24 TABLET in 1 BLISTER PACK",
      "NDC11Code": "68210-0230-02",
      "ProductNDC": "68210-0230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nighttime Sleep Aid",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200212",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part338",
      "LabelerName": "SPIRIT PHARMACEUTICALS LLC",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200212",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70000-0230-1",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (70000-0230-1)  > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "70000-0230-01",
      "ProductNDC": "70000-0230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anti-diarrheal",
      "NonProprietaryName": "Loperamide Hcl",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170131",
      "EndMarketingDate": "20231231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021855",
      "LabelerName": "Cardinal Health (Leader) 70000",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170131",
      "EndMarketingDatePackage": "20231231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71335-0230-2",
      "PackageDescription": "90 TABLET in 1 BOTTLE (71335-0230-2) ",
      "NDC11Code": "71335-0230-02",
      "ProductNDC": "71335-0230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020702",
      "EndMarketingDate": "20220930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076262",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "HYDROCHLOROTHIAZIDE; LISINOPRIL",
      "StrengthNumber": "12.5; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180308",
      "EndMarketingDatePackage": "20220930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "77008-0230-2",
      "PackageDescription": "5 g in 1 POUCH (77008-0230-2) ",
      "NDC11Code": "77008-0230-02",
      "ProductNDC": "77008-0230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ari S-liner",
      "NonProprietaryName": "Garcinia Cambogia Extract Pwd",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200101",
      "EndMarketingDate": "20201231",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "BIOHERB Co., Ltd.",
      "SubstanceName": "GARCINIA CAMBOGIA FRUIT",
      "StrengthNumber": ".34",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200101",
      "EndMarketingDatePackage": "20201231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "84726-0230-2",
      "PackageDescription": "895 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (84726-0230-2) ",
      "NDC11Code": "84726-0230-02",
      "ProductNDC": "84726-0230",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Mineral Oil",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20241031",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Resolute Oil LLC",
      "SubstanceName": "MINERAL OIL",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-15",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "31-OCT-24"
    },
    {
      "NDCCode": "0053-0230-23",
      "PackageDescription": "1 KIT in 1 CARTON (0053-0230-23)  *  1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) ",
      "NDC11Code": "00053-0230-23",
      "ProductNDC": "0053-0230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hemgenix",
      "NonProprietaryName": "Etranacogene Dezaparvovec",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20221122",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125772",
      "LabelerName": "CSL Behring",
      "Status": "Active",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221122",
      "SamplePackage": "N",
      "IndicationAndUsage": "HEMGENIX is indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: 1 Currently use Factor IX prophylaxis therapy, or, 2 Have current or historical life-threatening hemorrhage, or, 3 Have repeated, serious spontaneous bleeding episodes.",
      "Description": "HEMGENIX (etranacogene dezaparvovec-drlb) is an adeno-associated viral vector-based gene therapy for intravenous infusion after dilution. HEMGENIX is a non-replicating recombinant AAV5 containing a codon-optimized DNA sequence of the gain-of-function Padua variant of human Factor IX (variant R338L), under control of a liver-specific promotor 1 (LP1). HEMGENIX has a nominal concentration of 1 × 1013 gc/mL. Each vial contains an extractable volume of no less than 10 mL of HEMGENIX and the following excipients: sucrose (50 mg/mL), polysorbate-20 (0.22 mg/mL), potassium chloride (0.2 mg/mL), potassium phosphate (0.2 mg/mL), sodium chloride (8 mg/mL), and sodium phosphate (1.2 mg/mL). HEMGENIX is sterile, clear and colorless suspension, and contains no preservative. After dilution, HEMGENIX should be clear and colorless suspension."
    },
    {
      "NDCCode": "0054-0230-25",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0054-0230-25) ",
      "NDC11Code": "00054-0230-25",
      "ProductNDC": "0054-0230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quetiapine Fumarate",
      "NonProprietaryName": "Quetiapine Fumarate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090749",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Quetiapine is an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1) , 2 Bipolar I disorder manic episodes (1.2) , 3 Bipolar disorder, depressive episodes (1.2).",
      "Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.10 (fumarate salt). The structural formula is: 1  ."
    },
    {
      "NDCCode": "0832-0230-00",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0230-00) ",
      "NDC11Code": "00832-0230-00",
      "ProductNDC": "0832-0230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202104",
      "LabelerName": "Upsher-Smith Laboratories, LLC",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-07-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.",
      "Description": "Morphine sulfate extended-release capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP. The following inactive ingredients are common to all strengths: hypromellose, microcrystalline cellulose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, and talc. The capsule shells contain gelatin, titanium dioxide, and black ink. In addition, individual capsules contain: FD&C blue #1, FD&C red #40 (10 mg); D&C yellow #10 (20 mg); FD&C blue #1, FD&C red #40 (30 mg); FD&C blue #1, FD&C red #40 (50 mg); FD&C blue #1, FD&C red #40 (60 mg); FD&C red #40, FD&C yellow #6 (80 mg); FD&C yellow #10, FD&C blue #1 (100 mg). The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C 17H 19NO 3) 2∙H 2SO 4∙5H 2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1,000 parts of alcohol but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pK bis 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:."
    },
    {
      "NDCCode": "0832-0230-50",
      "PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0230-50) ",
      "NDC11Code": "00832-0230-50",
      "ProductNDC": "0832-0230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202104",
      "LabelerName": "Upsher-Smith Laboratories, LLC",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-07-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.",
      "Description": "Morphine sulfate extended-release capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP. The following inactive ingredients are common to all strengths: hypromellose, microcrystalline cellulose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, and talc. The capsule shells contain gelatin, titanium dioxide, and black ink. In addition, individual capsules contain: FD&C blue #1, FD&C red #40 (10 mg); D&C yellow #10 (20 mg); FD&C blue #1, FD&C red #40 (30 mg); FD&C blue #1, FD&C red #40 (50 mg); FD&C blue #1, FD&C red #40 (60 mg); FD&C red #40, FD&C yellow #6 (80 mg); FD&C yellow #10, FD&C blue #1 (100 mg). The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C 17H 19NO 3) 2∙H 2SO 4∙5H 2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1,000 parts of alcohol but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pK bis 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:."
    },
    {
      "NDCCode": "10544-230-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (10544-230-30)",
      "NDC11Code": "10544-0230-30",
      "ProductNDC": "10544-230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Escitalopram Oxalate",
      "NonProprietaryName": "Escitalopram Oxalate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090939",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "ESCITALOPRAM OXALATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1)Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) .",
      "Description": "Escitalopram oxalate is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1- [3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oxalate, USP is available as tablets. Escitalopram tablets, USP are white to off-white, round, biconvex, film-coated tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, povidone and talc. The film coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "13537-230-62",
      "PackageDescription": "1 BOTTLE in 1 BOX (13537-230-62)  > 30 mL in 1 BOTTLE (13537-230-61)",
      "NDC11Code": "13537-0230-62",
      "ProductNDC": "13537-230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel",
      "ProprietaryNameSuffix": "Effet Parfit",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100815",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "VENTURA INTERNATIONAL LTD.,",
      "SubstanceName": "OCTINOXATE",
      "StrengthNumber": "2.1",
      "StrengthUnit": "g/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides minimal protection against sunburn."
    },
    {
      "NDCCode": "13709-230-01",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (13709-230-01)  / 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "13709-0230-01",
      "ProductNDC": "13709-230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clearcanal Ear Wax Softerner Drops",
      "NonProprietaryName": "Carbamide Peroxide",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "AURICULAR (OTIC)",
      "StartMarketingDate": "20110824",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M014",
      "LabelerName": "NeilMed Pharmaceuticals, Inc.",
      "SubstanceName": "CARBAMIDE PEROXIDE",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-08-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120102",
      "SamplePackage": "N",
      "IndicationAndUsage": "Step 1 Ear Wax Removal Drops Directions: 1 FOR USE IN THE EAR ONLY., 2 Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear., 3 Tip of applicator should not enter ear canal., 4 Keep drops in ear for several minutes by keeping head tilted or placing enclosed ear plugs in ear., 5 Use twice daily for upto 4 days if needed or as directed by a doctor., 6 Any wax remaining after treatment may be removed by gently flushing the ear with NeilMed ClearCanal rinsing system with special ear rinse adapter., 7 Children under 12 years of age: consult a doctor. .",
      "Description": "Ear Wax Removal Complete System. Ear wax is an important part of your body's system for keeping dirt, bacteria and other things from causing hearing problems. When rinsing is necessary, this cleaning system helps to soften, loosen and remove the excessive ear wax. The system consists of kit with 1 bottle carbamide peroxide solution 15mL and 1 can sterile saline spray 177mL (or 125mL)."
    },
    {
      "NDCCode": "13709-230-10",
      "PackageDescription": "1 BOTTLE in 1 KIT (13709-230-10)  / 15 mL in 1 BOTTLE",
      "NDC11Code": "13709-0230-10",
      "ProductNDC": "13709-230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clearcanal Ear Wax Softerner Drops",
      "NonProprietaryName": "Carbamide Peroxide",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "AURICULAR (OTIC)",
      "StartMarketingDate": "20110824",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M014",
      "LabelerName": "NeilMed Pharmaceuticals, Inc.",
      "SubstanceName": "CARBAMIDE PEROXIDE",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-08-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120824",
      "SamplePackage": "N",
      "IndicationAndUsage": "Step 1 Ear Wax Removal Drops Directions: 1 FOR USE IN THE EAR ONLY., 2 Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear., 3 Tip of applicator should not enter ear canal., 4 Keep drops in ear for several minutes by keeping head tilted or placing enclosed ear plugs in ear., 5 Use twice daily for upto 4 days if needed or as directed by a doctor., 6 Any wax remaining after treatment may be removed by gently flushing the ear with NeilMed ClearCanal rinsing system with special ear rinse adapter., 7 Children under 12 years of age: consult a doctor. .",
      "Description": "Ear Wax Removal Complete System. Ear wax is an important part of your body's system for keeping dirt, bacteria and other things from causing hearing problems. When rinsing is necessary, this cleaning system helps to soften, loosen and remove the excessive ear wax. The system consists of kit with 1 bottle carbamide peroxide solution 15mL and 1 can sterile saline spray 177mL (or 125mL)."
    },
    {
      "NDCCode": "14783-230-01",
      "PackageDescription": "30 g in 1 TUBE (14783-230-01) ",
      "NDC11Code": "14783-0230-01",
      "ProductNDC": "14783-230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Claire 4",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201112",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura International LTD",
      "SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "2.44; 6.5; 1.57",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20201112",
      "SamplePackage": "N",
      "IndicationAndUsage": "Stop use and ask a doctorif rash occurs. ."
    },
    {
      "NDCCode": "16590-230-28",
      "PackageDescription": "28 TABLET, COATED in 1 BOTTLE (16590-230-28)",
      "NDC11Code": "16590-0230-28",
      "ProductNDC": "16590-230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010815",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021123",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "37.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Tramadol HCl 37.5 mg/Acetaminophen 325 mg is indicated for the short-term (five days or less) management of acute pain.",
      "Description": "Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets combine two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax."
    },
    {
      "NDCCode": "16590-230-30",
      "PackageDescription": "30 TABLET, COATED in 1 BOTTLE (16590-230-30)",
      "NDC11Code": "16590-0230-30",
      "ProductNDC": "16590-230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010815",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021123",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "37.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Tramadol HCl 37.5 mg/Acetaminophen 325 mg is indicated for the short-term (five days or less) management of acute pain.",
      "Description": "Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets combine two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax."
    },
    {
      "NDCCode": "16590-230-40",
      "PackageDescription": "40 TABLET, COATED in 1 BOTTLE (16590-230-40)",
      "NDC11Code": "16590-0230-40",
      "ProductNDC": "16590-230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010815",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021123",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "37.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Tramadol HCl 37.5 mg/Acetaminophen 325 mg is indicated for the short-term (five days or less) management of acute pain.",
      "Description": "Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets combine two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax."
    },
    {
      "NDCCode": "16590-230-50",
      "PackageDescription": "50 TABLET, COATED in 1 BOTTLE (16590-230-50)",
      "NDC11Code": "16590-0230-50",
      "ProductNDC": "16590-230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010815",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021123",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "37.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Tramadol HCl 37.5 mg/Acetaminophen 325 mg is indicated for the short-term (five days or less) management of acute pain.",
      "Description": "Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets combine two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"72571-0230-2","ProprietaryName":"Ari S-liner","NonProprietaryName":"Garcinia Cambogia Extract Pwd"},{"NDCCode":"72571-0230-1","ProprietaryName":"Ari S-liner","NonProprietaryName":"Garcinia Cambogia Extract Pwd"},{"NDCCode":"72571-0231-2","ProprietaryName":"Ari S-liner","NonProprietaryName":"Garcinia Cambogia Extract Pwd"},{"NDCCode":"72571-0570-2","ProprietaryName":"Ari Moms Care","NonProprietaryName":"Asian Ginseng, Angelica Dahurica Root, Orange, Licorice"},{"NDCCode":"11014-0230-2","NonProprietaryName":"Methylphenidate Hydrochloride"},{"NDCCode":"15631-0230-2","ProprietaryName":"Iberis Amara","NonProprietaryName":"Iberis Amara"},{"NDCCode":"17337-0230-2","NonProprietaryName":"Glipizide"},{"NDCCode":"37662-0230-2","ProprietaryName":"Chamomilla","NonProprietaryName":"Chamomilla"},{"NDCCode":"49288-0230-1","ProprietaryName":"Guinea Pig Hair","NonProprietaryName":"Guinea Pig Hair"},{"NDCCode":"49288-0230-2","ProprietaryName":"Guinea Pig Hair","NonProprietaryName":"Guinea Pig Hair"},{"NDCCode":"51141-0230-2","ProprietaryName":"Atopalm Hemorrhoidal","NonProprietaryName":"Mineral Oil, Petrolatum, Phenylephrine Hydrochloride"},{"NDCCode":"55504-0230-2","ProprietaryName":"Dawnmist Antiperspirant And Deodorant","NonProprietaryName":"Aluminum Chlorohydrate"},{"NDCCode":"68210-0230-2","ProprietaryName":"Nighttime Sleep Aid","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"70000-0230-1","ProprietaryName":"Anti-diarrheal","NonProprietaryName":"Loperamide Hcl"},{"NDCCode":"71335-0230-2","ProprietaryName":"Lisinopril And Hydrochlorothiazide","NonProprietaryName":"Lisinopril And Hydrochlorothiazide"},{"NDCCode":"77008-0230-2","ProprietaryName":"Ari S-liner","NonProprietaryName":"Garcinia Cambogia Extract Pwd"},{"NDCCode":"84726-0230-2","NonProprietaryName":"Mineral Oil"},{"NDCCode":"0053-0230-23","ProprietaryName":"Hemgenix","NonProprietaryName":"Etranacogene Dezaparvovec"},{"NDCCode":"0054-0230-25","ProprietaryName":"Quetiapine Fumarate","NonProprietaryName":"Quetiapine Fumarate"},{"NDCCode":"0832-0230-00","ProprietaryName":"Morphine Sulfate","NonProprietaryName":"Morphine Sulfate"},{"NDCCode":"0832-0230-50","ProprietaryName":"Morphine Sulfate","NonProprietaryName":"Morphine Sulfate"},{"NDCCode":"10544-230-30","ProprietaryName":"Escitalopram Oxalate","NonProprietaryName":"Escitalopram Oxalate"},{"NDCCode":"13537-230-62","ProprietaryName":"Lbel","NonProprietaryName":"Octinoxate"},{"NDCCode":"13709-230-01","ProprietaryName":"Clearcanal Ear Wax Softerner Drops","NonProprietaryName":"Carbamide Peroxide"},{"NDCCode":"13709-230-10","ProprietaryName":"Clearcanal Ear Wax Softerner Drops","NonProprietaryName":"Carbamide Peroxide"},{"NDCCode":"14783-230-01","ProprietaryName":"Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Claire 4","NonProprietaryName":"Octinoxate, Titanium Dioxide, Zinc Oxide"},{"NDCCode":"16590-230-28","ProprietaryName":"Tramadol Hydrochloride And Acetaminophen","NonProprietaryName":"Tramadol Hydrochloride And Acetaminophen"},{"NDCCode":"16590-230-30","ProprietaryName":"Tramadol Hydrochloride And Acetaminophen","NonProprietaryName":"Tramadol Hydrochloride And Acetaminophen"},{"NDCCode":"16590-230-40","ProprietaryName":"Tramadol Hydrochloride And Acetaminophen","NonProprietaryName":"Tramadol Hydrochloride And Acetaminophen"},{"NDCCode":"16590-230-50","ProprietaryName":"Tramadol Hydrochloride And Acetaminophen","NonProprietaryName":"Tramadol Hydrochloride And Acetaminophen"}]}
                    

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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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    <NonProprietaryName>Garcinia Cambogia Extract Pwd</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
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    <EndMarketingDate>20200917</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>ARI BIOTECHNOLOGY CO., LTD</LabelerName>
    <SubstanceName>GARCINIA CAMBOGIA FRUIT</SubstanceName>
    <StrengthNumber>.34</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190918</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200917</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
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    <PackageDescription>8 g in 1 POUCH (72571-0230-1) </PackageDescription>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>ARI BIOTECHNOLOGY CO., LTD</LabelerName>
    <SubstanceName>GARCINIA CAMBOGIA FRUIT</SubstanceName>
    <StrengthNumber>.34</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180919</StartMarketingDatePackage>
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    <NDCCode>72571-0231-2</NDCCode>
    <PackageDescription>5 g in 1 POUCH (72571-0231-2) </PackageDescription>
    <NDC11Code>72571-0231-02</NDC11Code>
    <ProductNDC>72571-0231</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ari S-liner</ProprietaryName>
    <NonProprietaryName>Garcinia Cambogia Extract Pwd</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210301</StartMarketingDate>
    <EndMarketingDate>20220228</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>ARI BIOTECHNOLOGY CO., LTD</LabelerName>
    <SubstanceName>AMINO ACIDS; GARCINIA CAMBOGIA FRUIT; RICE BRAN</SubstanceName>
    <StrengthNumber>.2; .34; 1.8</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Amino Acid Hypertonic Solution [EPC], Amino Acids [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210301</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>72571-0570-2</NDCCode>
    <PackageDescription>30 g in 1 DOSE PACK (72571-0570-2) </PackageDescription>
    <NDC11Code>72571-0570-02</NDC11Code>
    <ProductNDC>72571-0570</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ari Moms Care</ProprietaryName>
    <NonProprietaryName>Asian Ginseng, Angelica Dahurica Root, Orange, Licorice</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190313</StartMarketingDate>
    <EndMarketingDate>20200313</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>ARI BIOTECHNOLOGY CO., LTD</LabelerName>
    <SubstanceName>ASIAN GINSENG; ANGELICA DAHURICA ROOT; ORANGE; LICORICE</SubstanceName>
    <StrengthNumber>1.2; .8; .8; .4</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-03-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190313</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200313</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>11014-0230-2</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (11014-0230-2)  / 74000 CAPSULE in 1 BAG</PackageDescription>
    <NDC11Code>11014-0230-02</NDC11Code>
    <ProductNDC>11014-0230</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20170815</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
    <SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2025-05-22</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>15631-0230-2</NDCCode>
    <PackageDescription>400 PELLET in 1 PACKAGE (15631-0230-2) </PackageDescription>
    <NDC11Code>15631-0230-02</NDC11Code>
    <ProductNDC>15631-0230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Iberis Amara</ProprietaryName>
    <NonProprietaryName>Iberis Amara</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151002</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>IBERIS AMARA SEED</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>17337-0230-2</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (17337-0230-2)  &gt; 1 BAG in 1 BAG &gt; 1 kg in 1 BAG</PackageDescription>
    <NDC11Code>17337-0230-02</NDC11Code>
    <ProductNDC>17337-0230</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Glipizide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20101126</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Olon SpA</LabelerName>
    <SubstanceName>GLIPIZIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>37662-0230-2</NDCCode>
    <PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-0230-2) </PackageDescription>
    <NDC11Code>37662-0230-02</NDC11Code>
    <ProductNDC>37662-0230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chamomilla</ProprietaryName>
    <NonProprietaryName>Chamomilla</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220527</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>MATRICARIA CHAMOMILLA WHOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49288-0230-1</NDCCode>
    <PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0230-1)</PackageDescription>
    <NDC11Code>49288-0230-01</NDC11Code>
    <ProductNDC>49288-0230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Guinea Pig Hair</ProprietaryName>
    <NonProprietaryName>Guinea Pig Hair</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>CAVIA PORCELLUS HAIR</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Animal Fur [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>49288-0230-2</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0230-2)</PackageDescription>
    <NDC11Code>49288-0230-02</NDC11Code>
    <ProductNDC>49288-0230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Guinea Pig Hair</ProprietaryName>
    <NonProprietaryName>Guinea Pig Hair</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>CAVIA PORCELLUS HAIR</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Animal Fur [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>51141-0230-2</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (51141-0230-2)  &gt; 56 g in 1 TUBE</PackageDescription>
    <NDC11Code>51141-0230-02</NDC11Code>
    <ProductNDC>51141-0230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Atopalm Hemorrhoidal</ProprietaryName>
    <NonProprietaryName>Mineral Oil, Petrolatum, Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120718</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part346</ApplicationNumber>
    <LabelerName>NeoPharm USA</LabelerName>
    <SubstanceName>MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>14; 71.9; .25</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>■ for temporary relief of the local itching and discomfort associated with hemorrhoids. ■ temporarily shrinks hemorrhoidal tissue and relieves burning. ■ temporarily provides a coating for relief of anorectal discomforts. ■ temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55504-0230-2</NDCCode>
    <PackageDescription>59 mL in 1 CONTAINER (55504-0230-2)</PackageDescription>
    <NDC11Code>55504-0230-02</NDC11Code>
    <ProductNDC>55504-0230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dawnmist Antiperspirant And Deodorant</ProprietaryName>
    <NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111005</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Donovan Industries, Inc.</LabelerName>
    <SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
    <StrengthNumber>7.9</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Reduces underarm perspiration.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68210-0230-2</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (68210-0230-2)  &gt; 24 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68210-0230-02</NDC11Code>
    <ProductNDC>68210-0230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nighttime Sleep Aid</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200212</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part338</ApplicationNumber>
    <LabelerName>SPIRIT PHARMACEUTICALS LLC</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70000-0230-1</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (70000-0230-1)  &gt; 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>70000-0230-01</NDC11Code>
    <ProductNDC>70000-0230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Anti-diarrheal</ProprietaryName>
    <NonProprietaryName>Loperamide Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170131</StartMarketingDate>
    <EndMarketingDate>20231231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021855</ApplicationNumber>
    <LabelerName>Cardinal Health (Leader) 70000</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170131</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71335-0230-2</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (71335-0230-2) </PackageDescription>
    <NDC11Code>71335-0230-02</NDC11Code>
    <ProductNDC>71335-0230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020702</StartMarketingDate>
    <EndMarketingDate>20220930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076262</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE; LISINOPRIL</SubstanceName>
    <StrengthNumber>12.5; 20</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180308</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>77008-0230-2</NDCCode>
    <PackageDescription>5 g in 1 POUCH (77008-0230-2) </PackageDescription>
    <NDC11Code>77008-0230-02</NDC11Code>
    <ProductNDC>77008-0230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ari S-liner</ProprietaryName>
    <NonProprietaryName>Garcinia Cambogia Extract Pwd</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200101</StartMarketingDate>
    <EndMarketingDate>20201231</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>BIOHERB Co., Ltd.</LabelerName>
    <SubstanceName>GARCINIA CAMBOGIA FRUIT</SubstanceName>
    <StrengthNumber>.34</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84726-0230-2</NDCCode>
    <PackageDescription>895 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (84726-0230-2) </PackageDescription>
    <NDC11Code>84726-0230-02</NDC11Code>
    <ProductNDC>84726-0230</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Mineral Oil</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20241031</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Resolute Oil LLC</LabelerName>
    <SubstanceName>MINERAL OIL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-15</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-OCT-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0053-0230-23</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0053-0230-23)  *  1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) </PackageDescription>
    <NDC11Code>00053-0230-23</NDC11Code>
    <ProductNDC>0053-0230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hemgenix</ProprietaryName>
    <NonProprietaryName>Etranacogene Dezaparvovec</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20221122</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125772</ApplicationNumber>
    <LabelerName>CSL Behring</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HEMGENIX is indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: 1 Currently use Factor IX prophylaxis therapy, or, 2 Have current or historical life-threatening hemorrhage, or, 3 Have repeated, serious spontaneous bleeding episodes.</IndicationAndUsage>
    <Description>HEMGENIX (etranacogene dezaparvovec-drlb) is an adeno-associated viral vector-based gene therapy for intravenous infusion after dilution. HEMGENIX is a non-replicating recombinant AAV5 containing a codon-optimized DNA sequence of the gain-of-function Padua variant of human Factor IX (variant R338L), under control of a liver-specific promotor 1 (LP1). HEMGENIX has a nominal concentration of 1 × 1013 gc/mL. Each vial contains an extractable volume of no less than 10 mL of HEMGENIX and the following excipients: sucrose (50 mg/mL), polysorbate-20 (0.22 mg/mL), potassium chloride (0.2 mg/mL), potassium phosphate (0.2 mg/mL), sodium chloride (8 mg/mL), and sodium phosphate (1.2 mg/mL). HEMGENIX is sterile, clear and colorless suspension, and contains no preservative. After dilution, HEMGENIX should be clear and colorless suspension.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0230-25</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0054-0230-25) </PackageDescription>
    <NDC11Code>00054-0230-25</NDC11Code>
    <ProductNDC>0054-0230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090749</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1) , 2 Bipolar I disorder manic episodes (1.2) , 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.10 (fumarate salt). The structural formula is: 1  .</Description>
  </NDC>
  <NDC>
    <NDCCode>0832-0230-00</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0230-00) </PackageDescription>
    <NDC11Code>00832-0230-00</NDC11Code>
    <ProductNDC>0832-0230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202104</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-07-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.</IndicationAndUsage>
    <Description>Morphine sulfate extended-release capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP. The following inactive ingredients are common to all strengths: hypromellose, microcrystalline cellulose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, and talc. The capsule shells contain gelatin, titanium dioxide, and black ink. In addition, individual capsules contain: FD&amp;C blue #1, FD&amp;C red #40 (10 mg); D&amp;C yellow #10 (20 mg); FD&amp;C blue #1, FD&amp;C red #40 (30 mg); FD&amp;C blue #1, FD&amp;C red #40 (50 mg); FD&amp;C blue #1, FD&amp;C red #40 (60 mg); FD&amp;C red #40, FD&amp;C yellow #6 (80 mg); FD&amp;C yellow #10, FD&amp;C blue #1 (100 mg). The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C 17H 19NO 3) 2∙H 2SO 4∙5H 2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1,000 parts of alcohol but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pK bis 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>0832-0230-50</NDCCode>
    <PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0230-50) </PackageDescription>
    <NDC11Code>00832-0230-50</NDC11Code>
    <ProductNDC>0832-0230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202104</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-07-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.</IndicationAndUsage>
    <Description>Morphine sulfate extended-release capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP. The following inactive ingredients are common to all strengths: hypromellose, microcrystalline cellulose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, and talc. The capsule shells contain gelatin, titanium dioxide, and black ink. In addition, individual capsules contain: FD&amp;C blue #1, FD&amp;C red #40 (10 mg); D&amp;C yellow #10 (20 mg); FD&amp;C blue #1, FD&amp;C red #40 (30 mg); FD&amp;C blue #1, FD&amp;C red #40 (50 mg); FD&amp;C blue #1, FD&amp;C red #40 (60 mg); FD&amp;C red #40, FD&amp;C yellow #6 (80 mg); FD&amp;C yellow #10, FD&amp;C blue #1 (100 mg). The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C 17H 19NO 3) 2∙H 2SO 4∙5H 2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1,000 parts of alcohol but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pK bis 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-230-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (10544-230-30)</PackageDescription>
    <NDC11Code>10544-0230-30</NDC11Code>
    <ProductNDC>10544-230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram Oxalate</ProprietaryName>
    <NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090939</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1)Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) .</IndicationAndUsage>
    <Description>Escitalopram oxalate is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1- [3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oxalate, USP is available as tablets. Escitalopram tablets, USP are white to off-white, round, biconvex, film-coated tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, povidone and talc. The film coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>13537-230-62</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (13537-230-62)  &gt; 30 mL in 1 BOTTLE (13537-230-61)</PackageDescription>
    <NDC11Code>13537-0230-62</NDC11Code>
    <ProductNDC>13537-230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel</ProprietaryName>
    <ProprietaryNameSuffix>Effet Parfit</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100815</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>VENTURA INTERNATIONAL LTD.,</LabelerName>
    <SubstanceName>OCTINOXATE</SubstanceName>
    <StrengthNumber>2.1</StrengthNumber>
    <StrengthUnit>g/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides minimal protection against sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13709-230-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 BOX (13709-230-01)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>13709-0230-01</NDC11Code>
    <ProductNDC>13709-230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clearcanal Ear Wax Softerner Drops</ProprietaryName>
    <NonProprietaryName>Carbamide Peroxide</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>AURICULAR (OTIC)</RouteName>
    <StartMarketingDate>20110824</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M014</ApplicationNumber>
    <LabelerName>NeilMed Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CARBAMIDE PEROXIDE</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Step 1 Ear Wax Removal Drops Directions: 1 FOR USE IN THE EAR ONLY., 2 Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear., 3 Tip of applicator should not enter ear canal., 4 Keep drops in ear for several minutes by keeping head tilted or placing enclosed ear plugs in ear., 5 Use twice daily for upto 4 days if needed or as directed by a doctor., 6 Any wax remaining after treatment may be removed by gently flushing the ear with NeilMed ClearCanal rinsing system with special ear rinse adapter., 7 Children under 12 years of age: consult a doctor. .</IndicationAndUsage>
    <Description>Ear Wax Removal Complete System. Ear wax is an important part of your body's system for keeping dirt, bacteria and other things from causing hearing problems. When rinsing is necessary, this cleaning system helps to soften, loosen and remove the excessive ear wax. The system consists of kit with 1 bottle carbamide peroxide solution 15mL and 1 can sterile saline spray 177mL (or 125mL).</Description>
  </NDC>
  <NDC>
    <NDCCode>13709-230-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 KIT (13709-230-10)  / 15 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>13709-0230-10</NDC11Code>
    <ProductNDC>13709-230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clearcanal Ear Wax Softerner Drops</ProprietaryName>
    <NonProprietaryName>Carbamide Peroxide</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>AURICULAR (OTIC)</RouteName>
    <StartMarketingDate>20110824</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M014</ApplicationNumber>
    <LabelerName>NeilMed Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CARBAMIDE PEROXIDE</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120824</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Step 1 Ear Wax Removal Drops Directions: 1 FOR USE IN THE EAR ONLY., 2 Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear., 3 Tip of applicator should not enter ear canal., 4 Keep drops in ear for several minutes by keeping head tilted or placing enclosed ear plugs in ear., 5 Use twice daily for upto 4 days if needed or as directed by a doctor., 6 Any wax remaining after treatment may be removed by gently flushing the ear with NeilMed ClearCanal rinsing system with special ear rinse adapter., 7 Children under 12 years of age: consult a doctor. .</IndicationAndUsage>
    <Description>Ear Wax Removal Complete System. Ear wax is an important part of your body's system for keeping dirt, bacteria and other things from causing hearing problems. When rinsing is necessary, this cleaning system helps to soften, loosen and remove the excessive ear wax. The system consists of kit with 1 bottle carbamide peroxide solution 15mL and 1 can sterile saline spray 177mL (or 125mL).</Description>
  </NDC>
  <NDC>
    <NDCCode>14783-230-01</NDCCode>
    <PackageDescription>30 g in 1 TUBE (14783-230-01) </PackageDescription>
    <NDC11Code>14783-0230-01</NDC11Code>
    <ProductNDC>14783-230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Claire 4</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201112</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura International LTD</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>2.44; 6.5; 1.57</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Stop use and ask a doctorif rash occurs. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16590-230-28</NDCCode>
    <PackageDescription>28 TABLET, COATED in 1 BOTTLE (16590-230-28)</PackageDescription>
    <NDC11Code>16590-0230-28</NDC11Code>
    <ProductNDC>16590-230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010815</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021123</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>37.5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Tramadol HCl 37.5 mg/Acetaminophen 325 mg is indicated for the short-term (five days or less) management of acute pain.</IndicationAndUsage>
    <Description>Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets combine two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-230-30</NDCCode>
    <PackageDescription>30 TABLET, COATED in 1 BOTTLE (16590-230-30)</PackageDescription>
    <NDC11Code>16590-0230-30</NDC11Code>
    <ProductNDC>16590-230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010815</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021123</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>37.5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Tramadol HCl 37.5 mg/Acetaminophen 325 mg is indicated for the short-term (five days or less) management of acute pain.</IndicationAndUsage>
    <Description>Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets combine two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-230-40</NDCCode>
    <PackageDescription>40 TABLET, COATED in 1 BOTTLE (16590-230-40)</PackageDescription>
    <NDC11Code>16590-0230-40</NDC11Code>
    <ProductNDC>16590-230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010815</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021123</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>37.5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Tramadol HCl 37.5 mg/Acetaminophen 325 mg is indicated for the short-term (five days or less) management of acute pain.</IndicationAndUsage>
    <Description>Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets combine two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-230-50</NDCCode>
    <PackageDescription>50 TABLET, COATED in 1 BOTTLE (16590-230-50)</PackageDescription>
    <NDC11Code>16590-0230-50</NDC11Code>
    <ProductNDC>16590-230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010815</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021123</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>37.5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Tramadol HCl 37.5 mg/Acetaminophen 325 mg is indicated for the short-term (five days or less) management of acute pain.</IndicationAndUsage>
    <Description>Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets combine two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>72571-0230-2</NDCCode><ProprietaryName>Ari S-liner</ProprietaryName><NonProprietaryName>Garcinia Cambogia Extract Pwd</NonProprietaryName></NDC><NDC><NDCCode>72571-0230-1</NDCCode><ProprietaryName>Ari S-liner</ProprietaryName><NonProprietaryName>Garcinia Cambogia Extract Pwd</NonProprietaryName></NDC><NDC><NDCCode>72571-0231-2</NDCCode><ProprietaryName>Ari S-liner</ProprietaryName><NonProprietaryName>Garcinia Cambogia Extract Pwd</NonProprietaryName></NDC><NDC><NDCCode>72571-0570-2</NDCCode><ProprietaryName>Ari Moms Care</ProprietaryName><NonProprietaryName>Asian Ginseng, Angelica Dahurica Root, Orange, Licorice</NonProprietaryName></NDC><NDC><NDCCode>11014-0230-2</NDCCode><NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>15631-0230-2</NDCCode><ProprietaryName>Iberis Amara</ProprietaryName><NonProprietaryName>Iberis Amara</NonProprietaryName></NDC><NDC><NDCCode>17337-0230-2</NDCCode><NonProprietaryName>Glipizide</NonProprietaryName></NDC><NDC><NDCCode>37662-0230-2</NDCCode><ProprietaryName>Chamomilla</ProprietaryName><NonProprietaryName>Chamomilla</NonProprietaryName></NDC><NDC><NDCCode>49288-0230-1</NDCCode><ProprietaryName>Guinea Pig Hair</ProprietaryName><NonProprietaryName>Guinea Pig Hair</NonProprietaryName></NDC><NDC><NDCCode>49288-0230-2</NDCCode><ProprietaryName>Guinea Pig Hair</ProprietaryName><NonProprietaryName>Guinea Pig Hair</NonProprietaryName></NDC><NDC><NDCCode>51141-0230-2</NDCCode><ProprietaryName>Atopalm Hemorrhoidal</ProprietaryName><NonProprietaryName>Mineral Oil, Petrolatum, Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55504-0230-2</NDCCode><ProprietaryName>Dawnmist Antiperspirant And Deodorant</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>68210-0230-2</NDCCode><ProprietaryName>Nighttime Sleep Aid</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70000-0230-1</NDCCode><ProprietaryName>Anti-diarrheal</ProprietaryName><NonProprietaryName>Loperamide Hcl</NonProprietaryName></NDC><NDC><NDCCode>71335-0230-2</NDCCode><ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>77008-0230-2</NDCCode><ProprietaryName>Ari S-liner</ProprietaryName><NonProprietaryName>Garcinia Cambogia Extract Pwd</NonProprietaryName></NDC><NDC><NDCCode>84726-0230-2</NDCCode><NonProprietaryName>Mineral Oil</NonProprietaryName></NDC><NDC><NDCCode>0053-0230-23</NDCCode><ProprietaryName>Hemgenix</ProprietaryName><NonProprietaryName>Etranacogene Dezaparvovec</NonProprietaryName></NDC><NDC><NDCCode>0054-0230-25</NDCCode><ProprietaryName>Quetiapine Fumarate</ProprietaryName><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0832-0230-00</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0832-0230-50</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>10544-230-30</NDCCode><ProprietaryName>Escitalopram Oxalate</ProprietaryName><NonProprietaryName>Escitalopram Oxalate</NonProprietaryName></NDC><NDC><NDCCode>13537-230-62</NDCCode><ProprietaryName>Lbel</ProprietaryName><NonProprietaryName>Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>13709-230-01</NDCCode><ProprietaryName>Clearcanal Ear Wax Softerner Drops</ProprietaryName><NonProprietaryName>Carbamide Peroxide</NonProprietaryName></NDC><NDC><NDCCode>13709-230-10</NDCCode><ProprietaryName>Clearcanal Ear Wax Softerner Drops</ProprietaryName><NonProprietaryName>Carbamide Peroxide</NonProprietaryName></NDC><NDC><NDCCode>14783-230-01</NDCCode><ProprietaryName>Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Claire 4</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>16590-230-28</NDCCode><ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>16590-230-30</NDCCode><ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>16590-230-40</NDCCode><ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>16590-230-50</NDCCode><ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</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",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
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      "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",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
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    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
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      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
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      "MailingAddressStateName": "OR",
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      "MailingAddressCountryCode": "US",
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      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
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      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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