RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (17 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "65912-002-52",
      "PackageDescription": "50 g in 1 JAR (65912-002-52) ",
      "NDC11Code": "65912-0002-52",
      "ProductNDC": "65912-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dynamic Resurfacing",
      "ProprietaryNameSuffix": "Spf 30",
      "NonProprietaryName": "Avobenzone, Octinoxate, And Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180305",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "ELEMIS Limited",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE",
      "StrengthNumber": "10; 10; 5",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180305",
      "SamplePackage": "Y",
      "IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection."
    },
    {
      "NDCCode": "65912-002-50",
      "PackageDescription": "1 JAR in 1 CARTON (65912-002-50)  / 50 g in 1 JAR",
      "NDC11Code": "65912-0002-50",
      "ProductNDC": "65912-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dynamic Resurfacing",
      "ProprietaryNameSuffix": "Spf 30",
      "NonProprietaryName": "Avobenzone, Octinoxate, And Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180305",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "ELEMIS Limited",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE",
      "StrengthNumber": "10; 10; 5",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180305",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection."
    },
    {
      "NDCCode": "65912-002-51",
      "PackageDescription": "50 g in 1 JAR (65912-002-51) ",
      "NDC11Code": "65912-0002-51",
      "ProductNDC": "65912-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dynamic Resurfacing",
      "ProprietaryNameSuffix": "Spf 30",
      "NonProprietaryName": "Avobenzone, Octinoxate, And Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180305",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "ELEMIS Limited",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE",
      "StrengthNumber": "10; 10; 5",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180305",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection."
    },
    {
      "NDCCode": "65912-001-52",
      "PackageDescription": "50 g in 1 JAR (65912-001-52) ",
      "NDC11Code": "65912-0001-52",
      "ProductNDC": "65912-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pro-collagen Marine",
      "ProprietaryNameSuffix": "Broad Spectrum Spf 30",
      "NonProprietaryName": "Avobenzone, Octinoxate, And Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180119",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "ELEMIS Limited",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE",
      "StrengthNumber": "10; 10; 5",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2026-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180119",
      "SamplePackage": "Y",
      "IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection."
    },
    {
      "NDCCode": "65912-003-52",
      "PackageDescription": "40 g in 1 TUBE (65912-003-52) ",
      "NDC11Code": "65912-0003-52",
      "ProductNDC": "65912-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Daily Defence Shield",
      "ProprietaryNameSuffix": "Spf 30",
      "NonProprietaryName": "Avobenzone, Octinoxate, And Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180604",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "ELEMIS Limited",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE",
      "StrengthNumber": "14; 14; 7",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180604",
      "SamplePackage": "Y",
      "IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection."
    },
    {
      "NDCCode": "51655-002-52",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-002-52)",
      "NDC11Code": "51655-0002-52",
      "ProductNDC": "51655-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carvedilol",
      "NonProprietaryName": "Carvedilol",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140516",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077316",
      "LabelerName": "Northwind Pharmaceuticals",
      "SubstanceName": "CARVEDILOL",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/301",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "58418-002-18",
      "PackageDescription": "52 mL in 1 BOTTLE, DISPENSING (58418-002-18) ",
      "NDC11Code": "58418-0002-18",
      "ProductNDC": "58418-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "2000dl-cl30",
      "NonProprietaryName": "Promo Spf30",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181001",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Tropical Enterprises International, Inc.",
      "SubstanceName": "AVOBENZONE; OCTOCRYLENE",
      "StrengthNumber": ".9; 2.34",
      "StrengthUnit": "g/30mL; g/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk. of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "59579-002-52",
      "PackageDescription": "3 L in 1 DEWAR (59579-002-52) ",
      "NDC11Code": "59579-0002-52",
      "ProductNDC": "59579-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrogen",
      "NonProprietaryName": "Nitrogen",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20071001",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205850",
      "LabelerName": "Linde Gas & Equipment Inc.",
      "SubstanceName": "NITROGEN",
      "StrengthNumber": "990",
      "StrengthUnit": "mL/L",
      "Status": "Active",
      "LastUpdate": "2026-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200109",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69994-002-52",
      "PackageDescription": "52 VIAL, SINGLE-USE in 1 CARTON (69994-002-52)  > .6 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "69994-0002-52",
      "ProductNDC": "69994-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biolle Gel Tears",
      "NonProprietaryName": "Carboxymethylcellulose Sodium, Unspecified Form",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20150601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "SAGE Ethnographic Research, dba Bioll�",
      "SubstanceName": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "-For temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. -May be used as a protectant against further irritation."
    },
    {
      "NDCCode": "73905-002-52",
      "PackageDescription": "260 mL in 1 BOTTLE (73905-002-52) ",
      "NDC11Code": "73905-0002-52",
      "ProductNDC": "73905-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "75% Alcohol Disnfectant",
      "NonProprietaryName": "75% Alcohol Disnfectant",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "EndMarketingDate": "20240423",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200331",
      "EndMarketingDatePackage": "20240423",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "84165-002-52",
      "PackageDescription": "52 BAG in 1 BOX (84165-002-52)  / 21 g in 1 BAG (84165-002-01) ",
      "NDC11Code": "84165-0002-52",
      "ProductNDC": "84165-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lidocaine Pain Relief Gel-patch",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250328",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Guangzhou Zhupuyou E-commerce Co., Ltd",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": ".04",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250328",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows."
    },
    {
      "NDCCode": "84165-006-52",
      "PackageDescription": "52 BAG in 1 BOX (84165-006-52)  / 1 KIT in 1 BAG *  21 g in 1 BAG (84165-002-01)  *  12 g in 1 BAG (84165-005-01)  *  9 g in 1 BAG (84165-107-01) ",
      "NDC11Code": "84165-0006-52",
      "ProductNDC": "84165-006",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lidocaine Pain Relief Gel-patch",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "KIT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250414",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Guangzhou Zhupuyou E-commerce Co., Ltd",
      "Status": "Active",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250414",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shouldcrs,elbows."
    },
    {
      "NDCCode": "0270-1316-52",
      "PackageDescription": "10 BOTTLE in 1 BOX (0270-1316-52)  / 75 mL in 1 BOTTLE",
      "NDC11Code": "00270-1316-52",
      "ProductNDC": "0270-1316",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isovue",
      "ProprietaryNameSuffix": "370",
      "NonProprietaryName": "Iopamidol",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVASCULAR",
      "StartMarketingDate": "19851231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018735",
      "LabelerName": "BRACCO DIAGNOSTICS INC",
      "SubstanceName": "IOPAMIDOL",
      "StrengthNumber": "755",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19851231",
      "SamplePackage": "N",
      "IndicationAndUsage": "ISOVUE is a radiographic contrast agent indicated for. Intra-arterial Procedures † (1.1): 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.",
      "Description": "ISOVUE (iopamidol) injection is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5- lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C17H22I3N3O8, and the following structural formula. ISOVUE is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 ISOVUE 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 ISOVUE 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 ISOVUE 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 ISOVUE 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
    },
    {
      "NDCCode": "22700-002-08",
      "PackageDescription": "1 POUCH in 1 PACKAGE (22700-002-08)  > .8 mL in 1 POUCH",
      "NDC11Code": "22700-0002-08",
      "ProductNDC": "22700-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gucci Face Lustrous Glow Foundation",
      "ProprietaryNameSuffix": "Broadspectrum Spf 25 (all Shades)",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Noxell Corporation",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "3.49; 2.52",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-04-03",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "22700-002-13",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (22700-002-13)  > 13 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "22700-0002-13",
      "ProductNDC": "22700-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gucci Face Lustrous Glow Foundation",
      "ProprietaryNameSuffix": "Broadspectrum Spf 25 (all Shades)",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Noxell Corporation",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "3.49; 2.52",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-04-03",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "22700-002-30",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (22700-002-30)  > 30 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "22700-0002-30",
      "ProductNDC": "22700-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gucci Face Lustrous Glow Foundation",
      "ProprietaryNameSuffix": "Broadspectrum Spf 25 (all Shades)",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Noxell Corporation",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "3.49; 2.52",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20160601",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50771-002-02",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (50771-002-02) ",
      "NDC11Code": "50771-0002-02",
      "ProductNDC": "50771-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venlafaxine Hydrochloride",
      "NonProprietaryName": "Venlafaxine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160906",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202036",
      "LabelerName": "Yaopharma Co., Ltd.",
      "SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
      "StrengthNumber": "37.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160906",
      "SamplePackage": "N",
      "IndicationAndUsage": "Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
      "Description": "Venlafaxine hydrochloride, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17H 27NO 2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride,USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine.Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, ferric oxides yellow, and ferric oxides red."
    },
    {
      "NDCCode": "51144-002-12",
      "PackageDescription": "120 TABLET in 1 BOTTLE (51144-002-12) ",
      "NDC11Code": "51144-0002-12",
      "ProductNDC": "51144-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tukysa",
      "NonProprietaryName": "Tucatinib",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200417",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA213411",
      "LabelerName": "SEAGEN INC.",
      "SubstanceName": "TUCATINIB",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200417",
      "SamplePackage": "N",
      "Description": "Tucatinib is a kinase inhibitor. The chemical name is (N4-(4-([1,2,4]triazolo[1,5-a]pyridin-7-yloxy)-3-methylphenyl)-N6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)quinazoline-4,6-diamine. The molecular formula is C26H24N8O2 and the molecular weight is 480.52 g/mol. The chemical structure is as follows. TUKYSA (tucatinib) is supplied as 50 mg and 150 mg film-coated tablets for oral use and contain the following inactive ingredients. Tablet core: copovidone, crospovidone, sodium chloride, potassium chloride, sodium bicarbonate, colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Coating: yellow film coat: polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol, talc, and yellow iron oxide non-irradiated. Each TUKYSA 50 mg tablet contains 10.10 mg (0.258 mEq) potassium and 9.21 mg (0.401 mEq) sodium. Each TUKYSA 150 mg tablet contains 30.29 mg (0.775 mEq) potassium and 27.64 mg (1.202 mEq) sodium."
    },
    {
      "NDCCode": "51144-002-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (51144-002-60) ",
      "NDC11Code": "51144-0002-60",
      "ProductNDC": "51144-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tukysa",
      "NonProprietaryName": "Tucatinib",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200417",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA213411",
      "LabelerName": "SEAGEN INC.",
      "SubstanceName": "TUCATINIB",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200417",
      "SamplePackage": "N",
      "Description": "Tucatinib is a kinase inhibitor. The chemical name is (N4-(4-([1,2,4]triazolo[1,5-a]pyridin-7-yloxy)-3-methylphenyl)-N6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)quinazoline-4,6-diamine. The molecular formula is C26H24N8O2 and the molecular weight is 480.52 g/mol. The chemical structure is as follows. TUKYSA (tucatinib) is supplied as 50 mg and 150 mg film-coated tablets for oral use and contain the following inactive ingredients. Tablet core: copovidone, crospovidone, sodium chloride, potassium chloride, sodium bicarbonate, colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Coating: yellow film coat: polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol, talc, and yellow iron oxide non-irradiated. Each TUKYSA 50 mg tablet contains 10.10 mg (0.258 mEq) potassium and 9.21 mg (0.401 mEq) sodium. Each TUKYSA 150 mg tablet contains 30.29 mg (0.775 mEq) potassium and 27.64 mg (1.202 mEq) sodium."
    },
    {
      "NDCCode": "52976-002-01",
      "PackageDescription": "75 mL in 1 BOTTLE (52976-002-01) ",
      "NDC11Code": "52976-0002-01",
      "ProductNDC": "52976-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Goldeer Brand Hand Sanitizer",
      "NonProprietaryName": "Gel Disinfectant",
      "DosageFormName": "GEL",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200410",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Fujian Jinlu Daily Chemicals Co.,Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "52.5",
      "StrengthUnit": "mL/75mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200410",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply few drops of hand sanitizer on your hands, genty massage both of your hands fil to drying."
    },
    {
      "NDCCode": "52994-002-01",
      "PackageDescription": "75 mL in 1 BOTTLE (52994-002-01) ",
      "NDC11Code": "52994-0002-01",
      "ProductNDC": "52994-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Goldeer Brand Hand Sanitizer",
      "NonProprietaryName": "Gel Disinfectant",
      "DosageFormName": "GEL",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200406",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Fujian Jinlu Daily Chemicals Co.,Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "52.5",
      "StrengthUnit": "mL/75mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200406",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply few drops of hand sanitizer on your hands, genty massage both of your hands fil to drying."
    },
    {
      "NDCCode": "55621-002-01",
      "PackageDescription": "9 g in 1 TUBE (55621-002-01)",
      "NDC11Code": "55621-0002-01",
      "ProductNDC": "55621-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Theraplusplus",
      "ProprietaryNameSuffix": "Plus",
      "NonProprietaryName": "Neomycin",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333B",
      "LabelerName": "Zhejiang Jingwei Pharmaceutical Co., Ltd.",
      "SubstanceName": "BACITRACIN; NEOMYCIN; POLYMYXIN B",
      "StrengthNumber": ".41; .0035; .52",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses first aid to help prevent infection in minor. -cuts. -scrapes. -burns."
    },
    {
      "NDCCode": "67979-002-01",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (67979-002-01)  / 1 IMPLANT in 1 VIAL, GLASS",
      "NDC11Code": "67979-0002-01",
      "ProductNDC": "67979-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Supprelin",
      "ProprietaryNameSuffix": "La",
      "NonProprietaryName": "Histrelin Acetate",
      "DosageFormName": "IMPLANT",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20070531",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022058",
      "LabelerName": "Endo USA, Inc.",
      "SubstanceName": "HISTRELIN ACETATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20070531",
      "SamplePackage": "N",
      "IndicationAndUsage": "SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia.",
      "Description": "SUPPRELIN LA is a sterile, non-biodegradable, diffusion-controlled, hydrogel polymer reservoir containing histrelin acetate, a synthetic nonapeptide analog of the naturally occurring gonadotropin releasing hormone (GnRH) possessing a greater potency than the natural sequence hormone. SUPPRELIN LA is designed to deliver approximately 65 mcg histrelin acetate per day over 12 months. The SUPPRELIN LA implant looks like a small thin flexible tube and consists of a 50-mg histrelin acetate drug core inside a 3.5 cm by 3 mm, cylindrical, hydrogel polymer reservoir (Figure 1). The implant may appear partially to completely full with variation in color from off-white to light brown. The color may be uneven within the core. Figure 1: SUPPRELIN LA Implant Diagram (not to scale). The chemical name of histrelin acetate is: L-Pyroglutamyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-N-benzyl-D-histidyl-L-leucyl-L-arginyl-L-proline N-ethylamide, acetate salt. The molecular formula for histrelin acetate is C66H86N18O12 x 2 CH3COOH and its molecular weight is 1443.70 (or 1323.52 as free base). Histrelin is also chemically described as 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-Nt-benzyl-D-histidyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide diacetate. The chemical structure of the free base (histrelin) is represented below in Figure 2.  Figure 2: Structure of Histrelin. The drug core also contains the inactive ingredient stearic acid NF. The hydrogel polymer reservoir is a hydrophilic cartridge composed of 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate, trimethylolpropane trimethacrylate, benzoin methyl ether, Perkadox-16, and Triton X-100. Each implant is packaged hydrated in a glass vial containing 2 mL of sterile 1.8% sodium chloride solution, so that it is primed for immediate release of the drug upon insertion. A single use, sterile, Insertion Tool is provided along with the implant that can be used for the placement of the SUPPRELIN LA implant into the subcutaneous tissue of the inner aspect of the upper arm. The Insertion Tool is enclosed in a sterile bag and is provided separately from the implant in the Implantation Kit [see Recommended Procedure for Implant Insertion and Removal (2.2)]."
    },
    {
      "NDCCode": "70436-127-52",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-52)  / 50 mL in 1 VIAL, SINGLE-DOSE (70436-127-37) ",
      "NDC11Code": "70436-0127-52",
      "ProductNDC": "70436-127",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Iopamidol",
      "NonProprietaryName": "Iopamidol",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVASCULAR",
      "StartMarketingDate": "20240415",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217134",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "IOPAMIDOL",
      "StrengthNumber": "755",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-07-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240415",
      "SamplePackage": "N",
      "IndicationAndUsage": "Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.",
      "Description": "Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
    },
    {
      "NDCCode": "70436-219-52",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-52)  / 30 mL in 1 VIAL, SINGLE-DOSE (70436-219-36) ",
      "NDC11Code": "70436-0219-52",
      "ProductNDC": "70436-219",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Iopamidol",
      "NonProprietaryName": "Iopamidol",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVASCULAR",
      "StartMarketingDate": "20240415",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217134",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "IOPAMIDOL",
      "StrengthNumber": "612",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-07-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240415",
      "SamplePackage": "N",
      "IndicationAndUsage": "Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.",
      "Description": "Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
    },
    {
      "NDCCode": "71332-002-01",
      "PackageDescription": "60 TABLET in 1 BOTTLE (71332-002-01) ",
      "NDC11Code": "71332-0002-01",
      "ProductNDC": "71332-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tavalisse",
      "NonProprietaryName": "Fostamatinib",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180509",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209299",
      "LabelerName": "Rigel Pharmaceuticals, Inc.",
      "SubstanceName": "FOSTAMATINIB",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-11-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180509",
      "SamplePackage": "N",
      "IndicationAndUsage": "TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.",
      "Description": "Fostamatinib is a tyrosine kinase inhibitor. TAVALISSE is formulated with the disodium hexahydrate salt of fostamatinib, a phosphate prodrug that converts to its pharmacologically active metabolite, R406, in vivo. The chemical name for fostamatinib disodium hexahydrate is disodium (6-[[5-fluoro-2-(3,4,5-trimethoxyanilino) pyrimidin-4-yl]amino]-2,2-dimethyl-3-oxo-pyrido[3,2-b][1,4]oxazin-4-yl)methyl phosphate hexahydrate. The molecular formula is C23H24FN6Na2O9P∙6H2O, and the molecular weight is 732.52. The structural formula is. Fostamatinib disodium is a white to off-white powder that is practically insoluble in pH 1.2 aqueous buffer, slightly soluble in water, and soluble in methanol. Each TAVALISSE oral tablet contains 100 mg or 150 mg fostamatinib, equivalent to 126.2 mg or 189.3 mg fostamatinib disodium hexahydrate, respectively. The inactive ingredients in the tablet core are mannitol, sodium bicarbonate, sodium starch glycolate, povidone, and magnesium stearate. The inactive ingredients in the film coating are polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, iron oxide yellow, and iron oxide red."
    },
    {
      "NDCCode": "73218-002-01",
      "PackageDescription": "7 PATCH in 1 PACKAGE (73218-002-01)  > 1.56 g in 1 PATCH",
      "NDC11Code": "73218-0002-01",
      "ProductNDC": "73218-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Flex24 Pain",
      "NonProprietaryName": "Camphor, Menthol",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190828",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "FLEX24 INC",
      "SubstanceName": "CAMPHOR (NATURAL); MENTHOL",
      "StrengthNumber": "3; 2.52",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20190828",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains, cramps, bruises, and sprains."
    },
    {
      "NDCCode": "81962-002-08",
      "PackageDescription": "6 INJECTION in 1 CARTON (81962-002-08) ",
      "NDC11Code": "81962-0002-08",
      "ProductNDC": "81962-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Meropenem",
      "NonProprietaryName": "Meropenem",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250627",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219084",
      "LabelerName": "BROOKS STERISCIENCE LIMITED",
      "SubstanceName": "MEROPENEM ANHYDROUS",
      "StrengthNumber": "2",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250627",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only) Meropenem for Injection is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae, Neisseria meningitidis andpenicillin-susceptible isolates of Streptococcus pneumoniae, in pediatric patients 3 months of age and older. Meropenem for injection has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis. 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Meropenem for Injection, USP contains meropenem a synthetic carbapenem antibacterial. Meropenem is (4R,5S,6S)-3[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection, USP is a white to slight yellow crystalline powder for intravenous administration. Each vial contains meropenem equivalent to 2 grams and 416 mg of sodium bicarbonate, anhydrous. When re-constituted as instructed Meropenem for Injection, USP will deliver 2 grams of meropenem (on anhydrous basis) and approximately 180 mg of sodium as sodium carbonate (7.8 mEq) [see Dosage and Administration (2.2)]. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3."
    },
    {
      "NDCCode": "82113-002-01",
      "PackageDescription": "25000000 mg in 1 DRUM (82113-002-01) ",
      "NDC11Code": "82113-0002-01",
      "ProductNDC": "82113-002",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Thyroid",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260228",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Sichuan Xinchuanyi Biotechnology Co., Ltd",
      "SubstanceName": "LEVOTHYROXINE",
      "StrengthNumber": ".52",
      "StrengthUnit": "mg/.52mg",
      "Status": "Unfinished",
      "LastUpdate": "2026-03-03",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "28-FEB-26"
    },
    {
      "NDCCode": "83154-002-02",
      "PackageDescription": "1 CONTAINER in 1 CARTON (83154-002-02)  > 8 g in 1 CONTAINER (83154-002-01) ",
      "NDC11Code": "83154-0002-02",
      "ProductNDC": "83154-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Elroel Pang Pang Mini Sun Cushion S7",
      "NonProprietaryName": "Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate, Bemotrizinol",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230104",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "MONOGLOT HOLDINGS Inc.",
      "SubstanceName": "BEMOTRIZINOL; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "2.5; 7; 3; 1.52; 9.7",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230104",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"65912-002-52","ProprietaryName":"Dynamic Resurfacing","NonProprietaryName":"Avobenzone, Octinoxate, And Octocrylene"},{"NDCCode":"65912-002-50","ProprietaryName":"Dynamic Resurfacing","NonProprietaryName":"Avobenzone, Octinoxate, And Octocrylene"},{"NDCCode":"65912-002-51","ProprietaryName":"Dynamic Resurfacing","NonProprietaryName":"Avobenzone, Octinoxate, And Octocrylene"},{"NDCCode":"65912-001-52","ProprietaryName":"Pro-collagen Marine","NonProprietaryName":"Avobenzone, Octinoxate, And Octocrylene"},{"NDCCode":"65912-003-52","ProprietaryName":"Daily Defence Shield","NonProprietaryName":"Avobenzone, Octinoxate, And Octocrylene"},{"NDCCode":"51655-002-52","ProprietaryName":"Carvedilol","NonProprietaryName":"Carvedilol"},{"NDCCode":"58418-002-18","ProprietaryName":"2000dl-cl30","NonProprietaryName":"Promo Spf30"},{"NDCCode":"59579-002-52","ProprietaryName":"Nitrogen","NonProprietaryName":"Nitrogen"},{"NDCCode":"69994-002-52","ProprietaryName":"Biolle Gel Tears","NonProprietaryName":"Carboxymethylcellulose Sodium, Unspecified Form"},{"NDCCode":"73905-002-52","ProprietaryName":"75% Alcohol Disnfectant","NonProprietaryName":"75% Alcohol Disnfectant"},{"NDCCode":"84165-002-52","ProprietaryName":"Lidocaine Pain Relief Gel-patch","NonProprietaryName":"Lidocaine"},{"NDCCode":"84165-006-52","ProprietaryName":"Lidocaine Pain Relief Gel-patch","NonProprietaryName":"Lidocaine"},{"NDCCode":"0270-1316-52","ProprietaryName":"Isovue","NonProprietaryName":"Iopamidol"},{"NDCCode":"22700-002-08","ProprietaryName":"Gucci Face Lustrous Glow Foundation","NonProprietaryName":"Octinoxate And Titanium Dioxide"},{"NDCCode":"22700-002-13","ProprietaryName":"Gucci Face Lustrous Glow Foundation","NonProprietaryName":"Octinoxate And Titanium Dioxide"},{"NDCCode":"22700-002-30","ProprietaryName":"Gucci Face Lustrous Glow Foundation","NonProprietaryName":"Octinoxate And Titanium Dioxide"},{"NDCCode":"50771-002-02","ProprietaryName":"Venlafaxine Hydrochloride","NonProprietaryName":"Venlafaxine Hydrochloride"},{"NDCCode":"51144-002-12","ProprietaryName":"Tukysa","NonProprietaryName":"Tucatinib"},{"NDCCode":"51144-002-60","ProprietaryName":"Tukysa","NonProprietaryName":"Tucatinib"},{"NDCCode":"52976-002-01","ProprietaryName":"Goldeer Brand Hand Sanitizer","NonProprietaryName":"Gel Disinfectant"},{"NDCCode":"52994-002-01","ProprietaryName":"Goldeer Brand Hand Sanitizer","NonProprietaryName":"Gel Disinfectant"},{"NDCCode":"55621-002-01","ProprietaryName":"Theraplusplus","NonProprietaryName":"Neomycin"},{"NDCCode":"67979-002-01","ProprietaryName":"Supprelin","NonProprietaryName":"Histrelin Acetate"},{"NDCCode":"70436-127-52","ProprietaryName":"Iopamidol","NonProprietaryName":"Iopamidol"},{"NDCCode":"70436-219-52","ProprietaryName":"Iopamidol","NonProprietaryName":"Iopamidol"},{"NDCCode":"71332-002-01","ProprietaryName":"Tavalisse","NonProprietaryName":"Fostamatinib"},{"NDCCode":"73218-002-01","ProprietaryName":"Flex24 Pain","NonProprietaryName":"Camphor, Menthol"},{"NDCCode":"81962-002-08","ProprietaryName":"Meropenem","NonProprietaryName":"Meropenem"},{"NDCCode":"82113-002-01","NonProprietaryName":"Thyroid"},{"NDCCode":"83154-002-02","ProprietaryName":"Elroel Pang Pang Mini Sun Cushion S7","NonProprietaryName":"Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate, Bemotrizinol"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>65912-002-52</NDCCode>
    <PackageDescription>50 g in 1 JAR (65912-002-52) </PackageDescription>
    <NDC11Code>65912-0002-52</NDC11Code>
    <ProductNDC>65912-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dynamic Resurfacing</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Octinoxate, And Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180305</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>ELEMIS Limited</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>10; 10; 5</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180305</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65912-002-50</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (65912-002-50)  / 50 g in 1 JAR</PackageDescription>
    <NDC11Code>65912-0002-50</NDC11Code>
    <ProductNDC>65912-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dynamic Resurfacing</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Octinoxate, And Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180305</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>ELEMIS Limited</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>10; 10; 5</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180305</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65912-002-51</NDCCode>
    <PackageDescription>50 g in 1 JAR (65912-002-51) </PackageDescription>
    <NDC11Code>65912-0002-51</NDC11Code>
    <ProductNDC>65912-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dynamic Resurfacing</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Octinoxate, And Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180305</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>ELEMIS Limited</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>10; 10; 5</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180305</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65912-001-52</NDCCode>
    <PackageDescription>50 g in 1 JAR (65912-001-52) </PackageDescription>
    <NDC11Code>65912-0001-52</NDC11Code>
    <ProductNDC>65912-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pro-collagen Marine</ProprietaryName>
    <ProprietaryNameSuffix>Broad Spectrum Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Octinoxate, And Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180119</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>ELEMIS Limited</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>10; 10; 5</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180119</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65912-003-52</NDCCode>
    <PackageDescription>40 g in 1 TUBE (65912-003-52) </PackageDescription>
    <NDC11Code>65912-0003-52</NDC11Code>
    <ProductNDC>65912-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Daily Defence Shield</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Octinoxate, And Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180604</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>ELEMIS Limited</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>14; 14; 7</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180604</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51655-002-52</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-002-52)</PackageDescription>
    <NDC11Code>51655-0002-52</NDC11Code>
    <ProductNDC>51655-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol</ProprietaryName>
    <NonProprietaryName>Carvedilol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140516</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077316</ApplicationNumber>
    <LabelerName>Northwind Pharmaceuticals</LabelerName>
    <SubstanceName>CARVEDILOL</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/301</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58418-002-18</NDCCode>
    <PackageDescription>52 mL in 1 BOTTLE, DISPENSING (58418-002-18) </PackageDescription>
    <NDC11Code>58418-0002-18</NDC11Code>
    <ProductNDC>58418-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>2000dl-cl30</ProprietaryName>
    <NonProprietaryName>Promo Spf30</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20181001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Tropical Enterprises International, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>.9; 2.34</StrengthNumber>
    <StrengthUnit>g/30mL; g/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk. of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59579-002-52</NDCCode>
    <PackageDescription>3 L in 1 DEWAR (59579-002-52) </PackageDescription>
    <NDC11Code>59579-0002-52</NDC11Code>
    <ProductNDC>59579-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrogen</ProprietaryName>
    <NonProprietaryName>Nitrogen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20071001</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205850</ApplicationNumber>
    <LabelerName>Linde Gas &amp; Equipment Inc.</LabelerName>
    <SubstanceName>NITROGEN</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69994-002-52</NDCCode>
    <PackageDescription>52 VIAL, SINGLE-USE in 1 CARTON (69994-002-52)  &gt; .6 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>69994-0002-52</NDC11Code>
    <ProductNDC>69994-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biolle Gel Tears</ProprietaryName>
    <NonProprietaryName>Carboxymethylcellulose Sodium, Unspecified Form</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20150601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>SAGE Ethnographic Research, dba Bioll�</LabelerName>
    <SubstanceName>CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>-For temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. -May be used as a protectant against further irritation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73905-002-52</NDCCode>
    <PackageDescription>260 mL in 1 BOTTLE (73905-002-52) </PackageDescription>
    <NDC11Code>73905-0002-52</NDC11Code>
    <ProductNDC>73905-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>75% Alcohol Disnfectant</ProprietaryName>
    <NonProprietaryName>75% Alcohol Disnfectant</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <EndMarketingDate>20240423</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200331</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240423</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84165-002-52</NDCCode>
    <PackageDescription>52 BAG in 1 BOX (84165-002-52)  / 21 g in 1 BAG (84165-002-01) </PackageDescription>
    <NDC11Code>84165-0002-52</NDC11Code>
    <ProductNDC>84165-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250328</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>.04</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84165-006-52</NDCCode>
    <PackageDescription>52 BAG in 1 BOX (84165-006-52)  / 1 KIT in 1 BAG *  21 g in 1 BAG (84165-002-01)  *  12 g in 1 BAG (84165-005-01)  *  9 g in 1 BAG (84165-107-01) </PackageDescription>
    <NDC11Code>84165-0006-52</NDC11Code>
    <ProductNDC>84165-006</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250414</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shouldcrs,elbows.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0270-1316-52</NDCCode>
    <PackageDescription>10 BOTTLE in 1 BOX (0270-1316-52)  / 75 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00270-1316-52</NDC11Code>
    <ProductNDC>0270-1316</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isovue</ProprietaryName>
    <ProprietaryNameSuffix>370</ProprietaryNameSuffix>
    <NonProprietaryName>Iopamidol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVASCULAR</RouteName>
    <StartMarketingDate>19851231</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018735</ApplicationNumber>
    <LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
    <SubstanceName>IOPAMIDOL</SubstanceName>
    <StrengthNumber>755</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19851231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ISOVUE is a radiographic contrast agent indicated for. Intra-arterial Procedures † (1.1): 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
    <Description>ISOVUE (iopamidol) injection is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5- lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C17H22I3N3O8, and the following structural formula. ISOVUE is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 ISOVUE 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 ISOVUE 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 ISOVUE 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 ISOVUE 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>22700-002-08</NDCCode>
    <PackageDescription>1 POUCH in 1 PACKAGE (22700-002-08)  &gt; .8 mL in 1 POUCH</PackageDescription>
    <NDC11Code>22700-0002-08</NDC11Code>
    <ProductNDC>22700-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gucci Face Lustrous Glow Foundation</ProprietaryName>
    <ProprietaryNameSuffix>Broadspectrum Spf 25 (all Shades)</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Noxell Corporation</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>3.49; 2.52</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-03</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>22700-002-13</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (22700-002-13)  &gt; 13 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>22700-0002-13</NDC11Code>
    <ProductNDC>22700-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gucci Face Lustrous Glow Foundation</ProprietaryName>
    <ProprietaryNameSuffix>Broadspectrum Spf 25 (all Shades)</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Noxell Corporation</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>3.49; 2.52</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-03</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>22700-002-30</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (22700-002-30)  &gt; 30 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>22700-0002-30</NDC11Code>
    <ProductNDC>22700-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gucci Face Lustrous Glow Foundation</ProprietaryName>
    <ProprietaryNameSuffix>Broadspectrum Spf 25 (all Shades)</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Noxell Corporation</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>3.49; 2.52</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50771-002-02</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (50771-002-02) </PackageDescription>
    <NDC11Code>50771-0002-02</NDC11Code>
    <ProductNDC>50771-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202036</ApplicationNumber>
    <LabelerName>Yaopharma Co., Ltd.</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17H 27NO 2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride,USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine.Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, ferric oxides yellow, and ferric oxides red.</Description>
  </NDC>
  <NDC>
    <NDCCode>51144-002-12</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE (51144-002-12) </PackageDescription>
    <NDC11Code>51144-0002-12</NDC11Code>
    <ProductNDC>51144-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tukysa</ProprietaryName>
    <NonProprietaryName>Tucatinib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200417</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213411</ApplicationNumber>
    <LabelerName>SEAGEN INC.</LabelerName>
    <SubstanceName>TUCATINIB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Tucatinib is a kinase inhibitor. The chemical name is (N4-(4-([1,2,4]triazolo[1,5-a]pyridin-7-yloxy)-3-methylphenyl)-N6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)quinazoline-4,6-diamine. The molecular formula is C26H24N8O2 and the molecular weight is 480.52 g/mol. The chemical structure is as follows. TUKYSA (tucatinib) is supplied as 50 mg and 150 mg film-coated tablets for oral use and contain the following inactive ingredients. Tablet core: copovidone, crospovidone, sodium chloride, potassium chloride, sodium bicarbonate, colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Coating: yellow film coat: polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol, talc, and yellow iron oxide non-irradiated. Each TUKYSA 50 mg tablet contains 10.10 mg (0.258 mEq) potassium and 9.21 mg (0.401 mEq) sodium. Each TUKYSA 150 mg tablet contains 30.29 mg (0.775 mEq) potassium and 27.64 mg (1.202 mEq) sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>51144-002-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (51144-002-60) </PackageDescription>
    <NDC11Code>51144-0002-60</NDC11Code>
    <ProductNDC>51144-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tukysa</ProprietaryName>
    <NonProprietaryName>Tucatinib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200417</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213411</ApplicationNumber>
    <LabelerName>SEAGEN INC.</LabelerName>
    <SubstanceName>TUCATINIB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Tucatinib is a kinase inhibitor. The chemical name is (N4-(4-([1,2,4]triazolo[1,5-a]pyridin-7-yloxy)-3-methylphenyl)-N6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)quinazoline-4,6-diamine. The molecular formula is C26H24N8O2 and the molecular weight is 480.52 g/mol. The chemical structure is as follows. TUKYSA (tucatinib) is supplied as 50 mg and 150 mg film-coated tablets for oral use and contain the following inactive ingredients. Tablet core: copovidone, crospovidone, sodium chloride, potassium chloride, sodium bicarbonate, colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Coating: yellow film coat: polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol, talc, and yellow iron oxide non-irradiated. Each TUKYSA 50 mg tablet contains 10.10 mg (0.258 mEq) potassium and 9.21 mg (0.401 mEq) sodium. Each TUKYSA 150 mg tablet contains 30.29 mg (0.775 mEq) potassium and 27.64 mg (1.202 mEq) sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>52976-002-01</NDCCode>
    <PackageDescription>75 mL in 1 BOTTLE (52976-002-01) </PackageDescription>
    <NDC11Code>52976-0002-01</NDC11Code>
    <ProductNDC>52976-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Goldeer Brand Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Gel Disinfectant</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200410</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Fujian Jinlu Daily Chemicals Co.,Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>52.5</StrengthNumber>
    <StrengthUnit>mL/75mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply few drops of hand sanitizer on your hands, genty massage both of your hands fil to drying.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52994-002-01</NDCCode>
    <PackageDescription>75 mL in 1 BOTTLE (52994-002-01) </PackageDescription>
    <NDC11Code>52994-0002-01</NDC11Code>
    <ProductNDC>52994-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Goldeer Brand Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Gel Disinfectant</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200406</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Fujian Jinlu Daily Chemicals Co.,Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>52.5</StrengthNumber>
    <StrengthUnit>mL/75mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200406</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply few drops of hand sanitizer on your hands, genty massage both of your hands fil to drying.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55621-002-01</NDCCode>
    <PackageDescription>9 g in 1 TUBE (55621-002-01)</PackageDescription>
    <NDC11Code>55621-0002-01</NDC11Code>
    <ProductNDC>55621-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Theraplusplus</ProprietaryName>
    <ProprietaryNameSuffix>Plus</ProprietaryNameSuffix>
    <NonProprietaryName>Neomycin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333B</ApplicationNumber>
    <LabelerName>Zhejiang Jingwei Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>BACITRACIN; NEOMYCIN; POLYMYXIN B</SubstanceName>
    <StrengthNumber>.41; .0035; .52</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses first aid to help prevent infection in minor. -cuts. -scrapes. -burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67979-002-01</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (67979-002-01)  / 1 IMPLANT in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>67979-0002-01</NDC11Code>
    <ProductNDC>67979-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Supprelin</ProprietaryName>
    <ProprietaryNameSuffix>La</ProprietaryNameSuffix>
    <NonProprietaryName>Histrelin Acetate</NonProprietaryName>
    <DosageFormName>IMPLANT</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20070531</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022058</ApplicationNumber>
    <LabelerName>Endo USA, Inc.</LabelerName>
    <SubstanceName>HISTRELIN ACETATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia.</IndicationAndUsage>
    <Description>SUPPRELIN LA is a sterile, non-biodegradable, diffusion-controlled, hydrogel polymer reservoir containing histrelin acetate, a synthetic nonapeptide analog of the naturally occurring gonadotropin releasing hormone (GnRH) possessing a greater potency than the natural sequence hormone. SUPPRELIN LA is designed to deliver approximately 65 mcg histrelin acetate per day over 12 months. The SUPPRELIN LA implant looks like a small thin flexible tube and consists of a 50-mg histrelin acetate drug core inside a 3.5 cm by 3 mm, cylindrical, hydrogel polymer reservoir (Figure 1). The implant may appear partially to completely full with variation in color from off-white to light brown. The color may be uneven within the core. Figure 1: SUPPRELIN LA Implant Diagram (not to scale). The chemical name of histrelin acetate is: L-Pyroglutamyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-N-benzyl-D-histidyl-L-leucyl-L-arginyl-L-proline N-ethylamide, acetate salt. The molecular formula for histrelin acetate is C66H86N18O12 x 2 CH3COOH and its molecular weight is 1443.70 (or 1323.52 as free base). Histrelin is also chemically described as 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-Nt-benzyl-D-histidyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide diacetate. The chemical structure of the free base (histrelin) is represented below in Figure 2.  Figure 2: Structure of Histrelin. The drug core also contains the inactive ingredient stearic acid NF. The hydrogel polymer reservoir is a hydrophilic cartridge composed of 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate, trimethylolpropane trimethacrylate, benzoin methyl ether, Perkadox-16, and Triton X-100. Each implant is packaged hydrated in a glass vial containing 2 mL of sterile 1.8% sodium chloride solution, so that it is primed for immediate release of the drug upon insertion. A single use, sterile, Insertion Tool is provided along with the implant that can be used for the placement of the SUPPRELIN LA implant into the subcutaneous tissue of the inner aspect of the upper arm. The Insertion Tool is enclosed in a sterile bag and is provided separately from the implant in the Implantation Kit [see Recommended Procedure for Implant Insertion and Removal (2.2)].</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-127-52</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-52)  / 50 mL in 1 VIAL, SINGLE-DOSE (70436-127-37) </PackageDescription>
    <NDC11Code>70436-0127-52</NDC11Code>
    <ProductNDC>70436-127</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iopamidol</ProprietaryName>
    <NonProprietaryName>Iopamidol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVASCULAR</RouteName>
    <StartMarketingDate>20240415</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217134</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>IOPAMIDOL</SubstanceName>
    <StrengthNumber>755</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
    <Description>Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-219-52</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-52)  / 30 mL in 1 VIAL, SINGLE-DOSE (70436-219-36) </PackageDescription>
    <NDC11Code>70436-0219-52</NDC11Code>
    <ProductNDC>70436-219</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iopamidol</ProprietaryName>
    <NonProprietaryName>Iopamidol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVASCULAR</RouteName>
    <StartMarketingDate>20240415</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217134</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>IOPAMIDOL</SubstanceName>
    <StrengthNumber>612</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
    <Description>Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>71332-002-01</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (71332-002-01) </PackageDescription>
    <NDC11Code>71332-0002-01</NDC11Code>
    <ProductNDC>71332-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tavalisse</ProprietaryName>
    <NonProprietaryName>Fostamatinib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180509</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209299</ApplicationNumber>
    <LabelerName>Rigel Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FOSTAMATINIB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180509</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.</IndicationAndUsage>
    <Description>Fostamatinib is a tyrosine kinase inhibitor. TAVALISSE is formulated with the disodium hexahydrate salt of fostamatinib, a phosphate prodrug that converts to its pharmacologically active metabolite, R406, in vivo. The chemical name for fostamatinib disodium hexahydrate is disodium (6-[[5-fluoro-2-(3,4,5-trimethoxyanilino) pyrimidin-4-yl]amino]-2,2-dimethyl-3-oxo-pyrido[3,2-b][1,4]oxazin-4-yl)methyl phosphate hexahydrate. The molecular formula is C23H24FN6Na2O9P∙6H2O, and the molecular weight is 732.52. The structural formula is. Fostamatinib disodium is a white to off-white powder that is practically insoluble in pH 1.2 aqueous buffer, slightly soluble in water, and soluble in methanol. Each TAVALISSE oral tablet contains 100 mg or 150 mg fostamatinib, equivalent to 126.2 mg or 189.3 mg fostamatinib disodium hexahydrate, respectively. The inactive ingredients in the tablet core are mannitol, sodium bicarbonate, sodium starch glycolate, povidone, and magnesium stearate. The inactive ingredients in the film coating are polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, iron oxide yellow, and iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>73218-002-01</NDCCode>
    <PackageDescription>7 PATCH in 1 PACKAGE (73218-002-01)  &gt; 1.56 g in 1 PATCH</PackageDescription>
    <NDC11Code>73218-0002-01</NDC11Code>
    <ProductNDC>73218-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Flex24 Pain</ProprietaryName>
    <NonProprietaryName>Camphor, Menthol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190828</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>FLEX24 INC</LabelerName>
    <SubstanceName>CAMPHOR (NATURAL); MENTHOL</SubstanceName>
    <StrengthNumber>3; 2.52</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190828</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains, cramps, bruises, and sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>81962-002-08</NDCCode>
    <PackageDescription>6 INJECTION in 1 CARTON (81962-002-08) </PackageDescription>
    <NDC11Code>81962-0002-08</NDC11Code>
    <ProductNDC>81962-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250627</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219084</ApplicationNumber>
    <LabelerName>BROOKS STERISCIENCE LIMITED</LabelerName>
    <SubstanceName>MEROPENEM ANHYDROUS</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250627</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only) Meropenem for Injection is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae, Neisseria meningitidis andpenicillin-susceptible isolates of Streptococcus pneumoniae, in pediatric patients 3 months of age and older. Meropenem for injection has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis. 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Meropenem for Injection, USP contains meropenem a synthetic carbapenem antibacterial. Meropenem is (4R,5S,6S)-3[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection, USP is a white to slight yellow crystalline powder for intravenous administration. Each vial contains meropenem equivalent to 2 grams and 416 mg of sodium bicarbonate, anhydrous. When re-constituted as instructed Meropenem for Injection, USP will deliver 2 grams of meropenem (on anhydrous basis) and approximately 180 mg of sodium as sodium carbonate (7.8 mEq) [see Dosage and Administration (2.2)]. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>82113-002-01</NDCCode>
    <PackageDescription>25000000 mg in 1 DRUM (82113-002-01) </PackageDescription>
    <NDC11Code>82113-0002-01</NDC11Code>
    <ProductNDC>82113-002</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Thyroid</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260228</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Sichuan Xinchuanyi Biotechnology Co., Ltd</LabelerName>
    <SubstanceName>LEVOTHYROXINE</SubstanceName>
    <StrengthNumber>.52</StrengthNumber>
    <StrengthUnit>mg/.52mg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>28-FEB-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>83154-002-02</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (83154-002-02)  &gt; 8 g in 1 CONTAINER (83154-002-01) </PackageDescription>
    <NDC11Code>83154-0002-02</NDC11Code>
    <ProductNDC>83154-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Elroel Pang Pang Mini Sun Cushion S7</ProprietaryName>
    <NonProprietaryName>Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate, Bemotrizinol</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230104</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>MONOGLOT HOLDINGS Inc.</LabelerName>
    <SubstanceName>BEMOTRIZINOL; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>2.5; 7; 3; 1.52; 9.7</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>65912-002-52</NDCCode><ProprietaryName>Dynamic Resurfacing</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate, And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>65912-002-50</NDCCode><ProprietaryName>Dynamic Resurfacing</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate, And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>65912-002-51</NDCCode><ProprietaryName>Dynamic Resurfacing</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate, And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>65912-001-52</NDCCode><ProprietaryName>Pro-collagen Marine</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate, And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>65912-003-52</NDCCode><ProprietaryName>Daily Defence Shield</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate, And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>51655-002-52</NDCCode><ProprietaryName>Carvedilol</ProprietaryName><NonProprietaryName>Carvedilol</NonProprietaryName></NDC><NDC><NDCCode>58418-002-18</NDCCode><ProprietaryName>2000dl-cl30</ProprietaryName><NonProprietaryName>Promo Spf30</NonProprietaryName></NDC><NDC><NDCCode>59579-002-52</NDCCode><ProprietaryName>Nitrogen</ProprietaryName><NonProprietaryName>Nitrogen</NonProprietaryName></NDC><NDC><NDCCode>69994-002-52</NDCCode><ProprietaryName>Biolle Gel Tears</ProprietaryName><NonProprietaryName>Carboxymethylcellulose Sodium, Unspecified Form</NonProprietaryName></NDC><NDC><NDCCode>73905-002-52</NDCCode><ProprietaryName>75% Alcohol Disnfectant</ProprietaryName><NonProprietaryName>75% Alcohol Disnfectant</NonProprietaryName></NDC><NDC><NDCCode>84165-002-52</NDCCode><ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName><NonProprietaryName>Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>84165-006-52</NDCCode><ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName><NonProprietaryName>Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>0270-1316-52</NDCCode><ProprietaryName>Isovue</ProprietaryName><NonProprietaryName>Iopamidol</NonProprietaryName></NDC><NDC><NDCCode>22700-002-08</NDCCode><ProprietaryName>Gucci Face Lustrous Glow Foundation</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>22700-002-13</NDCCode><ProprietaryName>Gucci Face Lustrous Glow Foundation</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>22700-002-30</NDCCode><ProprietaryName>Gucci Face Lustrous Glow Foundation</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>50771-002-02</NDCCode><ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName><NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51144-002-12</NDCCode><ProprietaryName>Tukysa</ProprietaryName><NonProprietaryName>Tucatinib</NonProprietaryName></NDC><NDC><NDCCode>51144-002-60</NDCCode><ProprietaryName>Tukysa</ProprietaryName><NonProprietaryName>Tucatinib</NonProprietaryName></NDC><NDC><NDCCode>52976-002-01</NDCCode><ProprietaryName>Goldeer Brand Hand Sanitizer</ProprietaryName><NonProprietaryName>Gel Disinfectant</NonProprietaryName></NDC><NDC><NDCCode>52994-002-01</NDCCode><ProprietaryName>Goldeer Brand Hand Sanitizer</ProprietaryName><NonProprietaryName>Gel Disinfectant</NonProprietaryName></NDC><NDC><NDCCode>55621-002-01</NDCCode><ProprietaryName>Theraplusplus</ProprietaryName><NonProprietaryName>Neomycin</NonProprietaryName></NDC><NDC><NDCCode>67979-002-01</NDCCode><ProprietaryName>Supprelin</ProprietaryName><NonProprietaryName>Histrelin Acetate</NonProprietaryName></NDC><NDC><NDCCode>70436-127-52</NDCCode><ProprietaryName>Iopamidol</ProprietaryName><NonProprietaryName>Iopamidol</NonProprietaryName></NDC><NDC><NDCCode>70436-219-52</NDCCode><ProprietaryName>Iopamidol</ProprietaryName><NonProprietaryName>Iopamidol</NonProprietaryName></NDC><NDC><NDCCode>71332-002-01</NDCCode><ProprietaryName>Tavalisse</ProprietaryName><NonProprietaryName>Fostamatinib</NonProprietaryName></NDC><NDC><NDCCode>73218-002-01</NDCCode><ProprietaryName>Flex24 Pain</ProprietaryName><NonProprietaryName>Camphor, Menthol</NonProprietaryName></NDC><NDC><NDCCode>81962-002-08</NDCCode><ProprietaryName>Meropenem</ProprietaryName><NonProprietaryName>Meropenem</NonProprietaryName></NDC><NDC><NDCCode>82113-002-01</NDCCode><NonProprietaryName>Thyroid</NonProprietaryName></NDC><NDC><NDCCode>83154-002-02</NDCCode><ProprietaryName>Elroel Pang Pang Mini Sun Cushion S7</ProprietaryName><NonProprietaryName>Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate, Bemotrizinol</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",
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      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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",
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}
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