RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (21 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "84167-332-23",
      "PackageDescription": "5 BAG in 1 BOX (84167-332-23)  / 1 PATCH in 1 BAG",
      "NDC11Code": "84167-0332-23",
      "ProductNDC": "84167-332",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Apuree Pure Nailtific Extra-strength Fungal Nail Patches",
      "NonProprietaryName": "Apuree Pure Nailtific Extra-strength Fungal Nail Patches",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251124",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "TOLNAFTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/1",
      "Status": "Active",
      "LastUpdate": "2025-11-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251124",
      "SamplePackage": "N",
      "IndicationAndUsage": "PUREE Pure Nailtific Extra-Strength Fungal Nail Patches."
    },
    {
      "NDCCode": "84167-662-23",
      "PackageDescription": "5 BOTTLE, PLASTIC in 1 BOX (84167-662-23)  / 1 LIQUID in 1 BOTTLE, PLASTIC",
      "NDC11Code": "84167-0662-23",
      "ProductNDC": "84167-662",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Apuree Nailtific Extra-max Strength Antigungal",
      "NonProprietaryName": "Apuree Nailtific Extra-max Strength Antigungal",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260209",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "UNDECYLENIC ACID; TOLNAFTATE",
      "StrengthNumber": ".25; .01",
      "StrengthUnit": "g/1; g/1",
      "Status": "Active",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260209",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sterilization."
    },
    {
      "NDCCode": "37000-332-23",
      "PackageDescription": "700 mL in 1 BOTTLE, PLASTIC (37000-332-23)",
      "NDC11Code": "37000-0332-23",
      "ProductNDC": "37000-332",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Head And Shoulders 2in1",
      "ProprietaryNameSuffix": "Itchy Scalp Care",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "LOTION/SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110101",
      "EndMarketingDate": "20151026",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358H",
      "LabelerName": "Procter & Gamble Manufacturing Company",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": "1",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "42571-332-23",
      "PackageDescription": "80 TABLET in 1 CARTON (42571-332-23) ",
      "NDC11Code": "42571-0332-23",
      "ProductNDC": "42571-332",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methenamine Hippurate",
      "NonProprietaryName": "Methenamine Hippurate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190815",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212172",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "METHENAMINE HIPPURATE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-05-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190815",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methenamine hippurate tablets USP are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate and other antibacterial drugs, methenamine hippurate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Each white to off-white capsule-shaped tablet contains 1 g Methenamine Hippurate USP which is the Hippuric Acid Salt of Methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients Colloidal silicon dioxide, magnesium stearate and povidone K90."
    },
    {
      "NDCCode": "69230-332-23",
      "PackageDescription": "1 BOTTLE in 1 CARTON (69230-332-23)  / 237 mL in 1 BOTTLE",
      "NDC11Code": "69230-0332-23",
      "ProductNDC": "69230-332",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Adult Tussin",
      "NonProprietaryName": "Guaifenesin",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250519",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Camber Consumer Care",
      "SubstanceName": "GUAIFENESIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/10mL",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
      "Status": "Active",
      "LastUpdate": "2025-05-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250520",
      "SamplePackage": "N",
      "IndicationAndUsage": "UsesHelps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive."
    },
    {
      "NDCCode": "84167-001-01",
      "PackageDescription": "30 mL in 1 BOTTLE (84167-001-01) ",
      "NDC11Code": "84167-0001-01",
      "ProductNDC": "84167-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quarxery Quarxery Physical Sunscreen",
      "NonProprietaryName": "Quarxery Physical Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240313",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240313",
      "SamplePackage": "N",
      "IndicationAndUsage": "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": "84167-001-02",
      "PackageDescription": "50 mL in 1 BOTTLE (84167-001-02) ",
      "NDC11Code": "84167-0001-02",
      "ProductNDC": "84167-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quarxery Quarxery Physical Sunscreen",
      "NonProprietaryName": "Quarxery Physical Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240313",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240313",
      "SamplePackage": "N",
      "IndicationAndUsage": "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": "84167-001-03",
      "PackageDescription": "60 mL in 1 BOTTLE (84167-001-03) ",
      "NDC11Code": "84167-0001-03",
      "ProductNDC": "84167-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quarxery Quarxery Physical Sunscreen",
      "NonProprietaryName": "Quarxery Physical Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240313",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240313",
      "SamplePackage": "N",
      "IndicationAndUsage": "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": "84167-001-04",
      "PackageDescription": "90 mL in 1 BOTTLE (84167-001-04) ",
      "NDC11Code": "84167-0001-04",
      "ProductNDC": "84167-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quarxery Quarxery Physical Sunscreen",
      "NonProprietaryName": "Quarxery Physical Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240313",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240313",
      "SamplePackage": "N",
      "IndicationAndUsage": "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": "84167-001-05",
      "PackageDescription": "100 mL in 1 BOTTLE (84167-001-05) ",
      "NDC11Code": "84167-0001-05",
      "ProductNDC": "84167-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quarxery Quarxery Physical Sunscreen",
      "NonProprietaryName": "Quarxery Physical Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240313",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240313",
      "SamplePackage": "N",
      "IndicationAndUsage": "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": "84167-001-06",
      "PackageDescription": "120 mL in 1 BOTTLE (84167-001-06) ",
      "NDC11Code": "84167-0001-06",
      "ProductNDC": "84167-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quarxery Quarxery Physical Sunscreen",
      "NonProprietaryName": "Quarxery Physical Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240313",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240313",
      "SamplePackage": "N",
      "IndicationAndUsage": "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": "84167-001-07",
      "PackageDescription": "150 mL in 1 BOTTLE (84167-001-07) ",
      "NDC11Code": "84167-0001-07",
      "ProductNDC": "84167-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quarxery Quarxery Physical Sunscreen",
      "NonProprietaryName": "Quarxery Physical Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240313",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240313",
      "SamplePackage": "N",
      "IndicationAndUsage": "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": "84167-001-08",
      "PackageDescription": "200 mL in 1 BOTTLE (84167-001-08) ",
      "NDC11Code": "84167-0001-08",
      "ProductNDC": "84167-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quarxery Quarxery Physical Sunscreen",
      "NonProprietaryName": "Quarxery Physical Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240313",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240313",
      "SamplePackage": "N",
      "IndicationAndUsage": "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": "84167-002-01",
      "PackageDescription": "30 g in 1 BOTTLE (84167-002-01) ",
      "NDC11Code": "84167-0002-01",
      "ProductNDC": "84167-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Doood Liquid Foundation Neutral With Broad Spectrum Spf50",
      "NonProprietaryName": "Liquid Foundation Neutral With Broad Spectrum Spf50",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240710",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240710",
      "SamplePackage": "N",
      "IndicationAndUsage": "Provides broad-spectrum protection against UVA and UVB rays. Helps prevent sunburn and photodamage."
    },
    {
      "NDCCode": "84167-003-01",
      "PackageDescription": "35 g in 1 TUBE (84167-003-01) ",
      "NDC11Code": "84167-0003-01",
      "ProductNDC": "84167-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Urose Full Coverage Cream",
      "NonProprietaryName": "Full Coverage Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240912",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "7; 2; 6.65",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240912",
      "SamplePackage": "N",
      "IndicationAndUsage": "Product features: touch the skin as smooth as cream mousse, and facial integration to make the entire makeup naturally flawless, more texture, just the right amount of gloss, as if born with flawless skin, to create the exclusive elegant fog makeup feeling."
    },
    {
      "NDCCode": "84167-004-01",
      "PackageDescription": "25 mL in 1 BOTTLE, DROPPER (84167-004-01) ",
      "NDC11Code": "84167-0004-01",
      "ProductNDC": "84167-004",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Urose Anti-acne Beauty Serum",
      "NonProprietaryName": "Anti-acne Beauty Serum",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240912",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": ".5",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240912",
      "SamplePackage": "N",
      "IndicationAndUsage": "This product is specially designed for acne-prone skin and can effectively improve or slow down the acne skin condition, accelerate the reduction of acne, pimples, acne marks, and restore the delicate, smooth and beautiful skin."
    },
    {
      "NDCCode": "84167-005-01",
      "PackageDescription": "30 g in 1 BOTTLE (84167-005-01) ",
      "NDC11Code": "84167-0005-01",
      "ProductNDC": "84167-005",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aceast Clear Concealer Sunscreen Liquid Foundation Spf50 Pa",
      "NonProprietaryName": "Clear Concealer Sunscreen Liquid Foundation Spf50 Pa",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241010",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "7.5; 2; 11; 1",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241010",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunbum. lf used as directed with other sun protectionmeasures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "84167-170-02",
      "PackageDescription": "5 BAG in 1 BOX (84167-170-02)  / 1 CREAM in 1 BAG",
      "NDC11Code": "84167-0170-02",
      "ProductNDC": "84167-170",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Apuree Maximum Strength Athletes Foot Antifungal",
      "NonProprietaryName": "Apuree Maximum Strength Athletes Foot Antifungal",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260817",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": ".02",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260817",
      "SamplePackage": "N",
      "IndicationAndUsage": "Net Wt. 4.23 oz (120 g)."
    },
    {
      "NDCCode": "84167-175-01",
      "PackageDescription": "5 BAG in 1 BOX (84167-175-01)  / 1 CREAM in 1 BAG",
      "NDC11Code": "84167-0175-01",
      "ProductNDC": "84167-175",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Apuree Maximum Strength Ringworm Antifungal",
      "NonProprietaryName": "Apuree Maximum Strength Ringworm Antifungal",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260817",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": ".02",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260817",
      "SamplePackage": "N",
      "IndicationAndUsage": "Net Wt. 4.23 oz (120 g)."
    },
    {
      "NDCCode": "84167-177-01",
      "PackageDescription": "5 BAG in 1 BOX (84167-177-01)  / 1 CREAM in 1 BAG",
      "NDC11Code": "84167-0177-01",
      "ProductNDC": "84167-177",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Apuree Maximum Strength Jock Itch Antifungal",
      "NonProprietaryName": "Apuree Maximum Strength Jock Itch Antifungal",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260817",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Guangzhou Meixi Biotechnology Co., Ltd.",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": ".02",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260817",
      "SamplePackage": "N",
      "IndicationAndUsage": "Net Wt. 4.23 oz (120 g)."
    },
    {
      "NDCCode": "0641-6274-25",
      "PackageDescription": "25 VIAL in 1 CARTON (0641-6274-25)  / 1 mL in 1 VIAL (0641-6274-01) ",
      "NDC11Code": "00641-6274-25",
      "ProductNDC": "0641-6274",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atropine Sulfate",
      "NonProprietaryName": "Atropine Sulfate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVASCULAR",
      "StartMarketingDate": "20251107",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217345",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "ATROPINE SULFATE",
      "StrengthNumber": ".4",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251107",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atropine sulfate injection is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.",
      "Description": "Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.4 mg or 1 mg of atropine sulfate monohydrate equivalent to 0.332 mg or 0.83 mg of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 5.0. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 H2SO4 H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d-and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug."
    },
    {
      "NDCCode": "0641-6275-25",
      "PackageDescription": "25 VIAL in 1 CARTON (0641-6275-25)  / 1 mL in 1 VIAL (0641-6275-01) ",
      "NDC11Code": "00641-6275-25",
      "ProductNDC": "0641-6275",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atropine Sulfate",
      "NonProprietaryName": "Atropine Sulfate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20251107",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217345",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "ATROPINE SULFATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251107",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atropine sulfate injection is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.",
      "Description": "Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.4 mg or 1 mg of atropine sulfate monohydrate equivalent to 0.332 mg or 0.83 mg of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 5.0. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 H2SO4 H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d-and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug."
    },
    {
      "NDCCode": "31722-332-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (31722-332-01)",
      "NDC11Code": "31722-0332-01",
      "ProductNDC": "31722-332",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Warfarin Sodium",
      "NonProprietaryName": "Warfarin Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090935",
      "LabelerName": "Camber Pharmaceuticals",
      "SubstanceName": "WARFARIN SODIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": ". Warfarin sodium tablets, USP are indicated for: 1 ●Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 ●Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 ●Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
      "Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α- acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red #30 aluminum lake2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#22.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue#23 mg tablet contains:  FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake4 mg tablet contains: FD&C Blue#25 mg tablet contains: FD&C Yellow # 6 aluminum lake6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #27.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake 10 mg tablet is dye free."
    },
    {
      "NDCCode": "31722-332-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (31722-332-10)",
      "NDC11Code": "31722-0332-10",
      "ProductNDC": "31722-332",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Warfarin Sodium",
      "NonProprietaryName": "Warfarin Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090935",
      "LabelerName": "Camber Pharmaceuticals",
      "SubstanceName": "WARFARIN SODIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": ". Warfarin sodium tablets, USP are indicated for: 1 ●Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 ●Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 ●Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
      "Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α- acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red #30 aluminum lake2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#22.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue#23 mg tablet contains:  FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake4 mg tablet contains: FD&C Blue#25 mg tablet contains: FD&C Yellow # 6 aluminum lake6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #27.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake 10 mg tablet is dye free."
    },
    {
      "NDCCode": "49716-332-25",
      "PackageDescription": "25 kg in 1 DRUM (49716-332-25) ",
      "NDC11Code": "49716-0332-25",
      "ProductNDC": "49716-332",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20231015",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "IOL Chemicals and Pharmaceuticals Ltd.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-10-17",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "15-OCT-23"
    },
    {
      "NDCCode": "50742-332-30",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-332-30) ",
      "NDC11Code": "50742-0332-30",
      "ProductNDC": "50742-332",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pramipexole Dihydrochloride",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220310",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213444",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": ".75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220310",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pramipexole dihydrochloride extended- release tablet is a non-ergot dopamine agonist indicated for the treatment of Parkinson's disease (PD) (1).",
      "Description": "Pramipexole dihydrochloride extended-release tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7- tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride extended-release tablets 0.375 mg. Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 0.75 mg. Each extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 1.5 mg. Each extended-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 2.25 mg. Each extended-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 2.12 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 3 mg. Each extended-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.82 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 3.75 mg. Each extended-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 3.53 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 4.5 mg. Each extended-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 4.23 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of Pramipexole dihydrochloride extended-release tablets consist of hypromellose, corn starch, microcrystalline cellulose, sodium lauryl sulfate, sodium metabisulfite and magnesium stearate."
    },
    {
      "NDCCode": "61755-024-01",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (61755-024-01)  > 11.1 mL in 1 VIAL, GLASS (61755-024-00) ",
      "NDC11Code": "61755-0024-01",
      "ProductNDC": "61755-024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Casirivimab",
      "NonProprietaryName": "Casirivimab",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201121",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Regeneron Pharmaceuticals, Inc.",
      "SubstanceName": "CASIRIVIMAB",
      "StrengthNumber": "1332",
      "StrengthUnit": "mg/11.1mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20201121",
      "SamplePackage": "N",
      "IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
      "Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
    },
    {
      "NDCCode": "61755-025-01",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (61755-025-01)  > 11.1 mL in 1 VIAL, GLASS (61755-025-00) ",
      "NDC11Code": "61755-0025-01",
      "ProductNDC": "61755-025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Imdevimab",
      "NonProprietaryName": "Imdevimab",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201121",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Regeneron Pharmaceuticals, Inc.",
      "SubstanceName": "IMDEVIMAB",
      "StrengthNumber": "1332",
      "StrengthUnit": "mg/11.1mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20201121",
      "SamplePackage": "N",
      "IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
      "Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
    },
    {
      "NDCCode": "61755-026-01",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (61755-026-01)  > 2.5 mL in 1 VIAL, GLASS (61755-026-00) ",
      "NDC11Code": "61755-0026-01",
      "ProductNDC": "61755-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Casirivimab",
      "NonProprietaryName": "Casirivimab",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201121",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Regeneron Pharmaceuticals, Inc.",
      "SubstanceName": "CASIRIVIMAB",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/2.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20201121",
      "SamplePackage": "N",
      "IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
      "Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
    },
    {
      "NDCCode": "61755-027-01",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (61755-027-01)  > 2.5 mL in 1 VIAL, GLASS (61755-027-00) ",
      "NDC11Code": "61755-0027-01",
      "ProductNDC": "61755-027",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Imdevimab",
      "NonProprietaryName": "Imdevimab",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201121",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Regeneron Pharmaceuticals, Inc.",
      "SubstanceName": "IMDEVIMAB",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/2.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20201121",
      "SamplePackage": "N",
      "IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
      "Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
    }
  ]
}
                    

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<NDCList>
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    <NDCCode>84167-332-23</NDCCode>
    <PackageDescription>5 BAG in 1 BOX (84167-332-23)  / 1 PATCH in 1 BAG</PackageDescription>
    <NDC11Code>84167-0332-23</NDC11Code>
    <ProductNDC>84167-332</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Apuree Pure Nailtific Extra-strength Fungal Nail Patches</ProprietaryName>
    <NonProprietaryName>Apuree Pure Nailtific Extra-strength Fungal Nail Patches</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251124</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>TOLNAFTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251124</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PUREE Pure Nailtific Extra-Strength Fungal Nail Patches.</IndicationAndUsage>
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  <NDC>
    <NDCCode>84167-662-23</NDCCode>
    <PackageDescription>5 BOTTLE, PLASTIC in 1 BOX (84167-662-23)  / 1 LIQUID in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>84167-0662-23</NDC11Code>
    <ProductNDC>84167-662</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Apuree Nailtific Extra-max Strength Antigungal</ProprietaryName>
    <NonProprietaryName>Apuree Nailtific Extra-max Strength Antigungal</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260209</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>UNDECYLENIC ACID; TOLNAFTATE</SubstanceName>
    <StrengthNumber>.25; .01</StrengthNumber>
    <StrengthUnit>g/1; g/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sterilization.</IndicationAndUsage>
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    <PackageDescription>700 mL in 1 BOTTLE, PLASTIC (37000-332-23)</PackageDescription>
    <NDC11Code>37000-0332-23</NDC11Code>
    <ProductNDC>37000-332</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Head And Shoulders 2in1</ProprietaryName>
    <ProprietaryNameSuffix>Itchy Scalp Care</ProprietaryNameSuffix>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>LOTION/SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110101</StartMarketingDate>
    <EndMarketingDate>20151026</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358H</ApplicationNumber>
    <LabelerName>Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42571-332-23</NDCCode>
    <PackageDescription>80 TABLET in 1 CARTON (42571-332-23) </PackageDescription>
    <NDC11Code>42571-0332-23</NDC11Code>
    <ProductNDC>42571-332</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methenamine Hippurate</ProprietaryName>
    <NonProprietaryName>Methenamine Hippurate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212172</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>METHENAMINE HIPPURATE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methenamine hippurate tablets USP are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate and other antibacterial drugs, methenamine hippurate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Each white to off-white capsule-shaped tablet contains 1 g Methenamine Hippurate USP which is the Hippuric Acid Salt of Methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients Colloidal silicon dioxide, magnesium stearate and povidone K90.</Description>
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  <NDC>
    <NDCCode>69230-332-23</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (69230-332-23)  / 237 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>69230-0332-23</NDC11Code>
    <ProductNDC>69230-332</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Adult Tussin</ProprietaryName>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250519</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Camber Consumer Care</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UsesHelps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.</IndicationAndUsage>
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  <NDC>
    <NDCCode>84167-001-01</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (84167-001-01) </PackageDescription>
    <NDC11Code>84167-0001-01</NDC11Code>
    <ProductNDC>84167-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName>
    <NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240313</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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>84167-001-02</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (84167-001-02) </PackageDescription>
    <NDC11Code>84167-0001-02</NDC11Code>
    <ProductNDC>84167-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName>
    <NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240313</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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>84167-001-03</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE (84167-001-03) </PackageDescription>
    <NDC11Code>84167-0001-03</NDC11Code>
    <ProductNDC>84167-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName>
    <NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240313</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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>84167-001-04</NDCCode>
    <PackageDescription>90 mL in 1 BOTTLE (84167-001-04) </PackageDescription>
    <NDC11Code>84167-0001-04</NDC11Code>
    <ProductNDC>84167-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName>
    <NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240313</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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>84167-001-05</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (84167-001-05) </PackageDescription>
    <NDC11Code>84167-0001-05</NDC11Code>
    <ProductNDC>84167-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName>
    <NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240313</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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>84167-001-06</NDCCode>
    <PackageDescription>120 mL in 1 BOTTLE (84167-001-06) </PackageDescription>
    <NDC11Code>84167-0001-06</NDC11Code>
    <ProductNDC>84167-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName>
    <NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240313</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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>84167-001-07</NDCCode>
    <PackageDescription>150 mL in 1 BOTTLE (84167-001-07) </PackageDescription>
    <NDC11Code>84167-0001-07</NDC11Code>
    <ProductNDC>84167-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName>
    <NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240313</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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>84167-001-08</NDCCode>
    <PackageDescription>200 mL in 1 BOTTLE (84167-001-08) </PackageDescription>
    <NDC11Code>84167-0001-08</NDC11Code>
    <ProductNDC>84167-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName>
    <NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240313</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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>84167-002-01</NDCCode>
    <PackageDescription>30 g in 1 BOTTLE (84167-002-01) </PackageDescription>
    <NDC11Code>84167-0002-01</NDC11Code>
    <ProductNDC>84167-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Doood Liquid Foundation Neutral With Broad Spectrum Spf50</ProprietaryName>
    <NonProprietaryName>Liquid Foundation Neutral With Broad Spectrum Spf50</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240710</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240710</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Provides broad-spectrum protection against UVA and UVB rays. Helps prevent sunburn and photodamage.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84167-003-01</NDCCode>
    <PackageDescription>35 g in 1 TUBE (84167-003-01) </PackageDescription>
    <NDC11Code>84167-0003-01</NDC11Code>
    <ProductNDC>84167-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Urose Full Coverage Cream</ProprietaryName>
    <NonProprietaryName>Full Coverage Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240912</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>7; 2; 6.65</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Product features: touch the skin as smooth as cream mousse, and facial integration to make the entire makeup naturally flawless, more texture, just the right amount of gloss, as if born with flawless skin, to create the exclusive elegant fog makeup feeling.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84167-004-01</NDCCode>
    <PackageDescription>25 mL in 1 BOTTLE, DROPPER (84167-004-01) </PackageDescription>
    <NDC11Code>84167-0004-01</NDC11Code>
    <ProductNDC>84167-004</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Urose Anti-acne Beauty Serum</ProprietaryName>
    <NonProprietaryName>Anti-acne Beauty Serum</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240912</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This product is specially designed for acne-prone skin and can effectively improve or slow down the acne skin condition, accelerate the reduction of acne, pimples, acne marks, and restore the delicate, smooth and beautiful skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84167-005-01</NDCCode>
    <PackageDescription>30 g in 1 BOTTLE (84167-005-01) </PackageDescription>
    <NDC11Code>84167-0005-01</NDC11Code>
    <ProductNDC>84167-005</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aceast Clear Concealer Sunscreen Liquid Foundation Spf50 Pa</ProprietaryName>
    <NonProprietaryName>Clear Concealer Sunscreen Liquid Foundation Spf50 Pa</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241010</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>7.5; 2; 11; 1</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunbum. lf used as directed with other sun protectionmeasures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84167-170-02</NDCCode>
    <PackageDescription>5 BAG in 1 BOX (84167-170-02)  / 1 CREAM in 1 BAG</PackageDescription>
    <NDC11Code>84167-0170-02</NDC11Code>
    <ProductNDC>84167-170</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Apuree Maximum Strength Athletes Foot Antifungal</ProprietaryName>
    <NonProprietaryName>Apuree Maximum Strength Athletes Foot Antifungal</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260817</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>.02</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Net Wt. 4.23 oz (120 g).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84167-175-01</NDCCode>
    <PackageDescription>5 BAG in 1 BOX (84167-175-01)  / 1 CREAM in 1 BAG</PackageDescription>
    <NDC11Code>84167-0175-01</NDC11Code>
    <ProductNDC>84167-175</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Apuree Maximum Strength Ringworm Antifungal</ProprietaryName>
    <NonProprietaryName>Apuree Maximum Strength Ringworm Antifungal</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260817</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>.02</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Net Wt. 4.23 oz (120 g).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84167-177-01</NDCCode>
    <PackageDescription>5 BAG in 1 BOX (84167-177-01)  / 1 CREAM in 1 BAG</PackageDescription>
    <NDC11Code>84167-0177-01</NDC11Code>
    <ProductNDC>84167-177</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Apuree Maximum Strength Jock Itch Antifungal</ProprietaryName>
    <NonProprietaryName>Apuree Maximum Strength Jock Itch Antifungal</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260817</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Guangzhou Meixi Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>.02</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Net Wt. 4.23 oz (120 g).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0641-6274-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (0641-6274-25)  / 1 mL in 1 VIAL (0641-6274-01) </PackageDescription>
    <NDC11Code>00641-6274-25</NDC11Code>
    <ProductNDC>0641-6274</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropine Sulfate</ProprietaryName>
    <NonProprietaryName>Atropine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVASCULAR</RouteName>
    <StartMarketingDate>20251107</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217345</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>ATROPINE SULFATE</SubstanceName>
    <StrengthNumber>.4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atropine sulfate injection is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.</IndicationAndUsage>
    <Description>Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.4 mg or 1 mg of atropine sulfate monohydrate equivalent to 0.332 mg or 0.83 mg of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 5.0. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 H2SO4 H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d-and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug.</Description>
  </NDC>
  <NDC>
    <NDCCode>0641-6275-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (0641-6275-25)  / 1 mL in 1 VIAL (0641-6275-01) </PackageDescription>
    <NDC11Code>00641-6275-25</NDC11Code>
    <ProductNDC>0641-6275</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropine Sulfate</ProprietaryName>
    <NonProprietaryName>Atropine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20251107</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217345</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>ATROPINE SULFATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atropine sulfate injection is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.</IndicationAndUsage>
    <Description>Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.4 mg or 1 mg of atropine sulfate monohydrate equivalent to 0.332 mg or 0.83 mg of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 5.0. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 H2SO4 H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d-and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-332-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (31722-332-01)</PackageDescription>
    <NDC11Code>31722-0332-01</NDC11Code>
    <ProductNDC>31722-332</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Warfarin Sodium</ProprietaryName>
    <NonProprietaryName>Warfarin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090935</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals</LabelerName>
    <SubstanceName>WARFARIN SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>. Warfarin sodium tablets, USP are indicated for: 1 ●Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 ●Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 ●Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
    <Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α- acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&amp;C Red #30 aluminum lake2 mg tablet contains: FD&amp;C Red #40 aluminum lake and FD&amp;C Blue#22.5 mg tablet contains: D&amp;C Yellow # 10 aluminum lake and FD&amp;C Blue#23 mg tablet contains:  FD&amp;C Yellow # 6 aluminum lake, FD&amp;C Blue#2 and FD&amp;C Red # 40 aluminum lake4 mg tablet contains: FD&amp;C Blue#25 mg tablet contains: FD&amp;C Yellow # 6 aluminum lake6 mg tablet contains: FD&amp;C Yellow # 6 aluminum lake and FD&amp;C Blue #27.5 mg tablet contains: D&amp;C Yellow # 10 aluminum lake and FD&amp;C Yellow # 6 aluminum lake 10 mg tablet is dye free.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-332-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (31722-332-10)</PackageDescription>
    <NDC11Code>31722-0332-10</NDC11Code>
    <ProductNDC>31722-332</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Warfarin Sodium</ProprietaryName>
    <NonProprietaryName>Warfarin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090935</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals</LabelerName>
    <SubstanceName>WARFARIN SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>. Warfarin sodium tablets, USP are indicated for: 1 ●Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 ●Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 ●Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
    <Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α- acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&amp;C Red #30 aluminum lake2 mg tablet contains: FD&amp;C Red #40 aluminum lake and FD&amp;C Blue#22.5 mg tablet contains: D&amp;C Yellow # 10 aluminum lake and FD&amp;C Blue#23 mg tablet contains:  FD&amp;C Yellow # 6 aluminum lake, FD&amp;C Blue#2 and FD&amp;C Red # 40 aluminum lake4 mg tablet contains: FD&amp;C Blue#25 mg tablet contains: FD&amp;C Yellow # 6 aluminum lake6 mg tablet contains: FD&amp;C Yellow # 6 aluminum lake and FD&amp;C Blue #27.5 mg tablet contains: D&amp;C Yellow # 10 aluminum lake and FD&amp;C Yellow # 6 aluminum lake 10 mg tablet is dye free.</Description>
  </NDC>
  <NDC>
    <NDCCode>49716-332-25</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (49716-332-25) </PackageDescription>
    <NDC11Code>49716-0332-25</NDC11Code>
    <ProductNDC>49716-332</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20231015</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>IOL Chemicals and Pharmaceuticals Ltd.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-10-17</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>15-OCT-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>50742-332-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-332-30) </PackageDescription>
    <NDC11Code>50742-0332-30</NDC11Code>
    <ProductNDC>50742-332</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220310</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213444</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220310</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride extended- release tablet is a non-ergot dopamine agonist indicated for the treatment of Parkinson's disease (PD) (1).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride extended-release tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7- tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride extended-release tablets 0.375 mg. Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 0.75 mg. Each extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 1.5 mg. Each extended-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 2.25 mg. Each extended-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 2.12 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 3 mg. Each extended-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.82 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 3.75 mg. Each extended-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 3.53 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 4.5 mg. Each extended-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 4.23 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of Pramipexole dihydrochloride extended-release tablets consist of hypromellose, corn starch, microcrystalline cellulose, sodium lauryl sulfate, sodium metabisulfite and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>61755-024-01</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (61755-024-01)  &gt; 11.1 mL in 1 VIAL, GLASS (61755-024-00) </PackageDescription>
    <NDC11Code>61755-0024-01</NDC11Code>
    <ProductNDC>61755-024</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Casirivimab</ProprietaryName>
    <NonProprietaryName>Casirivimab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201121</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CASIRIVIMAB</SubstanceName>
    <StrengthNumber>1332</StrengthNumber>
    <StrengthUnit>mg/11.1mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
    <Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>61755-025-01</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (61755-025-01)  &gt; 11.1 mL in 1 VIAL, GLASS (61755-025-00) </PackageDescription>
    <NDC11Code>61755-0025-01</NDC11Code>
    <ProductNDC>61755-025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Imdevimab</ProprietaryName>
    <NonProprietaryName>Imdevimab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201121</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>IMDEVIMAB</SubstanceName>
    <StrengthNumber>1332</StrengthNumber>
    <StrengthUnit>mg/11.1mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
    <Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>61755-026-01</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (61755-026-01)  &gt; 2.5 mL in 1 VIAL, GLASS (61755-026-00) </PackageDescription>
    <NDC11Code>61755-0026-01</NDC11Code>
    <ProductNDC>61755-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Casirivimab</ProprietaryName>
    <NonProprietaryName>Casirivimab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201121</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CASIRIVIMAB</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/2.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
    <Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>61755-027-01</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (61755-027-01)  &gt; 2.5 mL in 1 VIAL, GLASS (61755-027-00) </PackageDescription>
    <NDC11Code>61755-0027-01</NDC11Code>
    <ProductNDC>61755-027</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Imdevimab</ProprietaryName>
    <NonProprietaryName>Imdevimab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201121</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>IMDEVIMAB</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/2.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
    <Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>84167-332-23</NDCCode><ProprietaryName>Apuree Pure Nailtific Extra-strength Fungal Nail Patches</ProprietaryName><NonProprietaryName>Apuree Pure Nailtific Extra-strength Fungal Nail Patches</NonProprietaryName></NDC><NDC><NDCCode>84167-662-23</NDCCode><ProprietaryName>Apuree Nailtific Extra-max Strength Antigungal</ProprietaryName><NonProprietaryName>Apuree Nailtific Extra-max Strength Antigungal</NonProprietaryName></NDC><NDC><NDCCode>37000-332-23</NDCCode><ProprietaryName>Head And Shoulders 2in1</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>42571-332-23</NDCCode><ProprietaryName>Methenamine Hippurate</ProprietaryName><NonProprietaryName>Methenamine Hippurate</NonProprietaryName></NDC><NDC><NDCCode>69230-332-23</NDCCode><ProprietaryName>Adult Tussin</ProprietaryName><NonProprietaryName>Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>84167-001-01</NDCCode><ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName><NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>84167-001-02</NDCCode><ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName><NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>84167-001-03</NDCCode><ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName><NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>84167-001-04</NDCCode><ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName><NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>84167-001-05</NDCCode><ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName><NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>84167-001-06</NDCCode><ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName><NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>84167-001-07</NDCCode><ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName><NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>84167-001-08</NDCCode><ProprietaryName>Quarxery Quarxery Physical Sunscreen</ProprietaryName><NonProprietaryName>Quarxery Physical Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>84167-002-01</NDCCode><ProprietaryName>Doood Liquid Foundation Neutral With Broad Spectrum Spf50</ProprietaryName><NonProprietaryName>Liquid Foundation Neutral With Broad Spectrum Spf50</NonProprietaryName></NDC><NDC><NDCCode>84167-003-01</NDCCode><ProprietaryName>Urose Full Coverage Cream</ProprietaryName><NonProprietaryName>Full Coverage Cream</NonProprietaryName></NDC><NDC><NDCCode>84167-004-01</NDCCode><ProprietaryName>Urose Anti-acne Beauty Serum</ProprietaryName><NonProprietaryName>Anti-acne Beauty Serum</NonProprietaryName></NDC><NDC><NDCCode>84167-005-01</NDCCode><ProprietaryName>Aceast Clear Concealer Sunscreen Liquid Foundation Spf50 Pa</ProprietaryName><NonProprietaryName>Clear Concealer Sunscreen Liquid Foundation Spf50 Pa</NonProprietaryName></NDC><NDC><NDCCode>84167-170-02</NDCCode><ProprietaryName>Apuree Maximum Strength Athletes Foot Antifungal</ProprietaryName><NonProprietaryName>Apuree Maximum Strength Athletes Foot Antifungal</NonProprietaryName></NDC><NDC><NDCCode>84167-175-01</NDCCode><ProprietaryName>Apuree Maximum Strength Ringworm Antifungal</ProprietaryName><NonProprietaryName>Apuree Maximum Strength Ringworm Antifungal</NonProprietaryName></NDC><NDC><NDCCode>84167-177-01</NDCCode><ProprietaryName>Apuree Maximum Strength Jock Itch Antifungal</ProprietaryName><NonProprietaryName>Apuree Maximum Strength Jock Itch Antifungal</NonProprietaryName></NDC><NDC><NDCCode>0641-6274-25</NDCCode><ProprietaryName>Atropine Sulfate</ProprietaryName><NonProprietaryName>Atropine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0641-6275-25</NDCCode><ProprietaryName>Atropine Sulfate</ProprietaryName><NonProprietaryName>Atropine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>31722-332-01</NDCCode><ProprietaryName>Warfarin Sodium</ProprietaryName><NonProprietaryName>Warfarin Sodium</NonProprietaryName></NDC><NDC><NDCCode>31722-332-10</NDCCode><ProprietaryName>Warfarin Sodium</ProprietaryName><NonProprietaryName>Warfarin Sodium</NonProprietaryName></NDC><NDC><NDCCode>49716-332-25</NDCCode><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>50742-332-30</NDCCode><ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName><NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>61755-024-01</NDCCode><ProprietaryName>Casirivimab</ProprietaryName><NonProprietaryName>Casirivimab</NonProprietaryName></NDC><NDC><NDCCode>61755-025-01</NDCCode><ProprietaryName>Imdevimab</ProprietaryName><NonProprietaryName>Imdevimab</NonProprietaryName></NDC><NDC><NDCCode>61755-026-01</NDCCode><ProprietaryName>Casirivimab</ProprietaryName><NonProprietaryName>Casirivimab</NonProprietaryName></NDC><NDC><NDCCode>61755-027-01</NDCCode><ProprietaryName>Imdevimab</ProprietaryName><NonProprietaryName>Imdevimab</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
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      "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",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
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}
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