RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "65604-017-17",
      "PackageDescription": "2.5 kg in 1 BOX (65604-017-17)",
      "NDC11Code": "65604-0017-17",
      "ProductNDC": "65604-017",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "PLASTER",
      "StartMarketingDate": "20100101",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Akron Coating & Adhesives",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": ".4",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "10695-017-17",
      "PackageDescription": "500 g in 1 BOTTLE (10695-017-17)",
      "NDC11Code": "10695-0017-17",
      "ProductNDC": "10695-017",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sildenafil Citrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20160714",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Willow Birch Pharma, Inc.",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2017-12-20",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "11410-017-17",
      "PackageDescription": "1 TUBE in 1 BOX (11410-017-17)  > 50 mL in 1 TUBE",
      "NDC11Code": "11410-0017-17",
      "ProductNDC": "11410-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Proactiv Solution Oil Free Moisture Spf 15 Moisturizer",
      "NonProprietaryName": "Octinoxate And Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20070101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Guthy-Renker LLC",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "7.5; 3",
      "StrengthUnit": "mg/100mL; mg/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "41701-017-18",
      "PackageDescription": "1 BOTTLE in 1 BOTTLE (41701-017-18)  / 12 g in 1 BOTTLE (41701-017-17) ",
      "NDC11Code": "41701-0017-18",
      "ProductNDC": "41701-017",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Oxytocin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20110318",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Piramal Pharma Limited",
      "SubstanceName": "OXYTOCIN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-04-29",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "18-MAR-11"
    },
    {
      "NDCCode": "45861-017-05",
      "PackageDescription": "5 PACKET in 1 BOX (45861-017-05)  > 17 g in 1 PACKET",
      "NDC11Code": "45861-0017-05",
      "ProductNDC": "45861-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lenzapatch",
      "NonProprietaryName": "Lidocaine Hydrochloride, Menthol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130301",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Pharmaceutica North America, Inc.",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE; MENTHOL",
      "StrengthNumber": "4; 1",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-02-08",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "75749-017-17",
      "PackageDescription": "60 mL in 1 BOTTLE, SPRAY (75749-017-17) ",
      "NDC11Code": "75749-0017-17",
      "ProductNDC": "75749-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Ethanol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200628",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "NINGBO PRETTY TOURISM MANUFACTURE CO.,LTD.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200628",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "78880-017-02",
      "PackageDescription": "1 CASE in 1 BLISTER PACK (78880-017-02)  > 17 mL in 1 CASE",
      "NDC11Code": "78880-0017-02",
      "ProductNDC": "78880-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Handy Doctor Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210115",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Sauber Co.,Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "10.54",
      "StrengthUnit": "mL/17mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "85742-017-17",
      "PackageDescription": "1 KIT in 1 BOX (85742-017-17)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "85742-0017-17",
      "ProductNDC": "85742-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Varenicline Tartrate",
      "NonProprietaryName": "Varenicline Tartrate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20231001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217151",
      "LabelerName": "Kanchan Healthcare Inc",
      "Status": "Active",
      "LastUpdate": "2026-02-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Varenicline tablets  is indicated for use as an aid to smoking cessation treatment.",
      "Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3  C4H6O6. The chemical structure is:. Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg, white to off-white, capsule shaped, biconvex, film coated tablet, debossed with 'Ml' on one side and plain on other side and a 1 mg, light blue to blue, capsule shaped, biconvex, film coated tablet, debossed with 'M2' on one side and plain on other side. Each 0.5 mg Varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, maltodextrin, methyl alcohol, colloidal silicon dioxide, magnesium stearate, purified water, lnstacoat Universal White (for 0.5 mg), lnstacoat Universal blue (for 1 mg)."
    },
    {
      "NDCCode": "65604-014-14",
      "PackageDescription": "162 kg in 1 DRUM (65604-014-14)",
      "NDC11Code": "65604-0014-14",
      "ProductNDC": "65604-014",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20050601",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Akron Coating & Adhesives",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": ".17",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "17312-017-14",
      "PackageDescription": "1 BOTTLE in 1 PACKAGE (17312-017-14)  / 70 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE",
      "NDC11Code": "17312-0017-14",
      "ProductNDC": "17312-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Asthma Therapy",
      "NonProprietaryName": "Arsenic Trioxide - Histamine Dihydrochloride - Dermatophagoides Pteronyssinus - Magnesium Phosphate, Dibasic Trihydrate - Strychnos Nux-vomica Seed - Aspidosperma Quebracho-blanco Bark - Suplhur -",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111201",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "TRP Company",
      "SubstanceName": "STRYCHNOS NUX-VOMICA SEED; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; SULFUR; ARSENIC TRIOXIDE; HISTAMINE DIHYDROCHLORIDE; DERMATOPHAGOIDES PTERONYSSINUS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
      "StrengthNumber": "6; 6; 6; 6; 6; 6; 6",
      "StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Insect Proteins [CS], Magnesium Ion Exchange Activity [MoA], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20121030",
      "SamplePackage": "N",
      "IndicationAndUsage": "According to homeopathic indications, these ingredients provide temporary relief of Asthma and COPD like symptoms such as:  Difficulty Breathing  Inflammation in the airways  Coughing  Wheezing  Shortness of breath  Sensation of tightness of the chest  Congestion after a diagnosis of Asthma or COPD by a physician."
    },
    {
      "NDCCode": "21922-017-04",
      "PackageDescription": "1 TUBE in 1 CARTON (21922-017-04)  / 15 g in 1 TUBE",
      "NDC11Code": "21922-0017-04",
      "ProductNDC": "21922-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobetasol Propionate",
      "NonProprietaryName": "Clobetasol Propionate Ointment Usp, 0.05%",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20191118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211295",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
      "Description": "Clobetasol propionate ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "21922-017-05",
      "PackageDescription": "1 TUBE in 1 CARTON (21922-017-05)  / 30 g in 1 TUBE",
      "NDC11Code": "21922-0017-05",
      "ProductNDC": "21922-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobetasol Propionate",
      "NonProprietaryName": "Clobetasol Propionate Ointment Usp, 0.05%",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20191118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211295",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
      "Description": "Clobetasol propionate ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "21922-017-06",
      "PackageDescription": "1 TUBE in 1 CARTON (21922-017-06)  / 45 g in 1 TUBE",
      "NDC11Code": "21922-0017-06",
      "ProductNDC": "21922-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobetasol Propionate",
      "NonProprietaryName": "Clobetasol Propionate Ointment Usp, 0.05%",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20191118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211295",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
      "Description": "Clobetasol propionate ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "21922-017-07",
      "PackageDescription": "1 TUBE in 1 CARTON (21922-017-07)  / 60 g in 1 TUBE",
      "NDC11Code": "21922-0017-07",
      "ProductNDC": "21922-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobetasol Propionate",
      "NonProprietaryName": "Clobetasol Propionate Ointment Usp, 0.05%",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20191118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211295",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
      "Description": "Clobetasol propionate ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "23155-017-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (23155-017-01) ",
      "NDC11Code": "23155-0017-01",
      "ProductNDC": "23155-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tetracycline Hydrochloride",
      "NonProprietaryName": "Tetracycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240915",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050278",
      "LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
      "SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-04-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240915",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible., 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae,Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus . (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcalinfections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis caused by Chlamydophila psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Klebsiella granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis ., 10 Chancroid caused by Hemophilus ducreyi ., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis ., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus ., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica ., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigellasp., Acinetobacter sp., Klebsiellasp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
      "Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is as follows. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. Inactive Ingredients: Lactose, light mineral oil, and magnesium stearate. The 250 mg and 500 mg capsule shells contain D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, gelatin, and titanium dioxide. The imprinting ink for the 250 mg and 500 mg capsules contains D&C yellow #10, FD&C blue no. 1, FD&C blue no. 2, FD&C red no. 40, iron oxide black, pharmaceutical shellac glaze, propylene glycol and n-butyl alcohol."
    },
    {
      "NDCCode": "42292-017-20",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (42292-017-20)  / 1 TABLET in 1 BLISTER PACK (42292-017-01) ",
      "NDC11Code": "42292-0017-20",
      "ProductNDC": "42292-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Spironolactone And Hydrochlorothiazide",
      "NonProprietaryName": "Spironolactone And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170512",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA086513",
      "LabelerName": "Mylan Institutional Inc.",
      "SubstanceName": "SPIRONOLACTONE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "25; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170512",
      "SamplePackage": "N",
      "IndicationAndUsage": "Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONSsection). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are indicated for. Edematous conditions for patients with:. Congestive heart failure: 1 For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures;, 2 The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate;, 3 The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate.",
      "Description": "Each tablet of spironolactone and hydrochlorothiazide contains 25 mg of spironolactone, USP and 25 mg of hydrochlorothiazide, USP. Spironolactone, an aldosterone antagonist, is 17-Hydroxy-7α-mercapto-3-oxo-17α -pregn-4-ene-21-carboxylic acid γ-lactone acetate and has the following structural formula, molecular formula and molecular weight:. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Hydrochlorothiazide, a diuretic and antihypertensive, is 6-Chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula, molecular formula and molecular weight:. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 25 mg of spironolactone and 25 mg of hydrochlorothiazide and the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, L-menthol, microcrystalline cellulose, peppermint oil, sodium lauryl sulfate and sodium starch glycolate (potato)."
    },
    {
      "NDCCode": "43419-017-16",
      "PackageDescription": "11 g in 1 CONTAINER (43419-017-16)",
      "NDC11Code": "43419-0017-16",
      "ProductNDC": "43419-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sulwhasoo Lumitouch Foundation",
      "ProprietaryNameSuffix": "Spf 25 No 25. Dark Beige",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111223",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "AMOREPACIFIC",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".352; .4697; .2156",
      "StrengthUnit": "g/11g; g/11g; g/11g",
      "Status": "Deprecated",
      "LastUpdate": "2018-08-17",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "49035-017-09",
      "PackageDescription": "9000 mg in 1 BOTTLE, WITH APPLICATOR (49035-017-09) ",
      "NDC11Code": "49035-0017-09",
      "ProductNDC": "49035-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Maximum Strength Wart Remover With Salicylic Acid",
      "NonProprietaryName": "Wart Remover With Salicylic Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M028",
      "LabelerName": "Wal-Mart Stores, Inc.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "17",
      "StrengthUnit": "mg/100mg",
      "Status": "Active",
      "LastUpdate": "2026-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20111231",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the removal of common warts and plantar warts on the bottom of the foot. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern."
    },
    {
      "NDCCode": "49430-017-15",
      "PackageDescription": "100 g in 1 PACKAGE (49430-017-15)",
      "NDC11Code": "49430-0017-15",
      "ProductNDC": "49430-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Elenza Patch",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131001",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Pharmaceutics Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE; MENTHOL",
      "StrengthNumber": "4; 1",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "49527-017-01",
      "PackageDescription": "1 JAR in 1 CARTON (49527-017-01)  / 50 mL in 1 JAR",
      "NDC11Code": "49527-0017-01",
      "ProductNDC": "49527-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Repairwear",
      "ProprietaryNameSuffix": "Uplifting Firming Broad Spectrum Spf 15 Dry",
      "NonProprietaryName": "Octinoxate, Octisalate, And Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120502",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "CLINIQUE LABORATORIES LLC",
      "SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "75; 35; 17",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201124",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn."
    },
    {
      "NDCCode": "52565-017-15",
      "PackageDescription": "1 TUBE in 1 CARTON (52565-017-15)  > 15 g in 1 TUBE",
      "NDC11Code": "52565-0017-15",
      "ProductNDC": "52565-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Flurandrenolide",
      "NonProprietaryName": "Flurandrenolide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207851",
      "LabelerName": "Teligent Pharma, Inc.",
      "SubstanceName": "FLURANDRENOLIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20161230",
      "SamplePackage": "N",
      "IndicationAndUsage": "Flurandrenolide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "Flurandrenolide, USP is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of flurandrenolide ointment USP, 0.05% contains 0.5 mg (1.145 μmol; 0.05%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "52565-017-30",
      "PackageDescription": "1 TUBE in 1 CARTON (52565-017-30)  > 30 g in 1 TUBE",
      "NDC11Code": "52565-0017-30",
      "ProductNDC": "52565-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Flurandrenolide",
      "NonProprietaryName": "Flurandrenolide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207851",
      "LabelerName": "Teligent Pharma, Inc.",
      "SubstanceName": "FLURANDRENOLIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20161230",
      "SamplePackage": "N",
      "IndicationAndUsage": "Flurandrenolide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "Flurandrenolide, USP is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of flurandrenolide ointment USP, 0.05% contains 0.5 mg (1.145 μmol; 0.05%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "52565-017-60",
      "PackageDescription": "1 TUBE in 1 CARTON (52565-017-60)  > 60 g in 1 TUBE",
      "NDC11Code": "52565-0017-60",
      "ProductNDC": "52565-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Flurandrenolide",
      "NonProprietaryName": "Flurandrenolide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207851",
      "LabelerName": "Teligent Pharma, Inc.",
      "SubstanceName": "FLURANDRENOLIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20161230",
      "SamplePackage": "N",
      "IndicationAndUsage": "Flurandrenolide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "Flurandrenolide, USP is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of flurandrenolide ointment USP, 0.05% contains 0.5 mg (1.145 μmol; 0.05%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "54304-017-01",
      "PackageDescription": "53 mL in 1 BOTTLE, PLASTIC (54304-017-01) ",
      "NDC11Code": "54304-0017-01",
      "ProductNDC": "54304-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Wish Peony Scented Hand Sanitizer",
      "ProprietaryNameSuffix": "01",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200403",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Zhejiang Meizhiyuan Cosmetics Co., Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "64",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200403",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "54436-017-01",
      "PackageDescription": "1 SYRINGE in 1 CARTON (54436-017-01)  / .4 mL in 1 SYRINGE",
      "NDC11Code": "54436-0017-01",
      "ProductNDC": "54436-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Otrexup",
      "NonProprietaryName": "Methotrexate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20131011",
      "EndMarketingDate": "20270430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204824",
      "LabelerName": "Antares Pharma, Inc.",
      "SubstanceName": "METHOTREXATE",
      "StrengthNumber": "17.5",
      "StrengthUnit": "mg/.4mL",
      "Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160324",
      "EndMarketingDatePackage": "20270430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Otrexup is a folate analog metabolic inhibitor indicated for the.  Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy ( 1.1).  Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy ( 1.2). Limitation of Use. Otrexup is not indicated for the treatment of neoplastic diseases ( 1.3).",
      "Description": "Otrexup contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is. C 20H 22N 8O 5M.W.= 454.45. Otrexup contains methotrexate in a sterile, preservative-free, unbuffered solution with a 27 gauge ½ inch needle for a single subcutaneous injection. Otrexup solution is yellow in color. Inactive ingredients include sodium chloride and water for injection, USP. The amounts of sodium chloride vary with the amount of methotrexate. Hydrochloric acid and additional sodium hydroxide may have been added, if necessary, to adjust the pH to 8.0."
    },
    {
      "NDCCode": "54436-017-03",
      "PackageDescription": "1 SYRINGE in 1 CARTON (54436-017-03)  / .4 mL in 1 SYRINGE",
      "NDC11Code": "54436-0017-03",
      "ProductNDC": "54436-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Otrexup",
      "NonProprietaryName": "Methotrexate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20131011",
      "EndMarketingDate": "20270430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204824",
      "LabelerName": "Antares Pharma, Inc.",
      "SubstanceName": "METHOTREXATE",
      "StrengthNumber": "17.5",
      "StrengthUnit": "mg/.4mL",
      "Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160324",
      "EndMarketingDatePackage": "20270430",
      "SamplePackage": "Y",
      "IndicationAndUsage": "Otrexup is a folate analog metabolic inhibitor indicated for the.  Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy ( 1.1).  Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy ( 1.2). Limitation of Use. Otrexup is not indicated for the treatment of neoplastic diseases ( 1.3).",
      "Description": "Otrexup contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is. C 20H 22N 8O 5M.W.= 454.45. Otrexup contains methotrexate in a sterile, preservative-free, unbuffered solution with a 27 gauge ½ inch needle for a single subcutaneous injection. Otrexup solution is yellow in color. Inactive ingredients include sodium chloride and water for injection, USP. The amounts of sodium chloride vary with the amount of methotrexate. Hydrochloric acid and additional sodium hydroxide may have been added, if necessary, to adjust the pH to 8.0."
    },
    {
      "NDCCode": "54436-017-04",
      "PackageDescription": "4 SYRINGE in 1 CARTON (54436-017-04)  / .4 mL in 1 SYRINGE (54436-017-02) ",
      "NDC11Code": "54436-0017-04",
      "ProductNDC": "54436-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Otrexup",
      "NonProprietaryName": "Methotrexate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20131011",
      "EndMarketingDate": "20270430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204824",
      "LabelerName": "Antares Pharma, Inc.",
      "SubstanceName": "METHOTREXATE",
      "StrengthNumber": "17.5",
      "StrengthUnit": "mg/.4mL",
      "Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160324",
      "EndMarketingDatePackage": "20270430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Otrexup is a folate analog metabolic inhibitor indicated for the.  Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy ( 1.1).  Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy ( 1.2). Limitation of Use. Otrexup is not indicated for the treatment of neoplastic diseases ( 1.3).",
      "Description": "Otrexup contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is. C 20H 22N 8O 5M.W.= 454.45. Otrexup contains methotrexate in a sterile, preservative-free, unbuffered solution with a 27 gauge ½ inch needle for a single subcutaneous injection. Otrexup solution is yellow in color. Inactive ingredients include sodium chloride and water for injection, USP. The amounts of sodium chloride vary with the amount of methotrexate. Hydrochloric acid and additional sodium hydroxide may have been added, if necessary, to adjust the pH to 8.0."
    },
    {
      "NDCCode": "59088-017-54",
      "PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-017-54) ",
      "NDC11Code": "59088-0017-54",
      "ProductNDC": "59088-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Flotrex",
      "NonProprietaryName": "Multivitamins, Sodium Fluoride 0.25 Mg",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250319",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
      "StrengthNumber": ".25; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5",
      "StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250319",
      "SamplePackage": "N",
      "IndicationAndUsage": "This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.",
      "Description": "Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid) ...................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ................................................................... 0.25 mg. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet."
    },
    {
      "NDCCode": "59883-017-03",
      "PackageDescription": "1 g in 1 TUBE (59883-017-03) ",
      "NDC11Code": "59883-0017-03",
      "ProductNDC": "59883-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Perio Daily Defense",
      "NonProprietaryName": "Hydrogen Peroxide",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220831",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Den-Mat Holdings, LLC",
      "SubstanceName": "HYDROGEN PEROXIDE",
      "StrengthNumber": "17",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20220831",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary use in cleansing minor wounds and retreatment of inflammation resulting from dental procedures, or other irritations of the mouth and gums. Perio Daily Defense may be used for lessening the presence of plaque, a known factor in development of gingivitis."
    },
    {
      "NDCCode": "59883-017-85",
      "PackageDescription": "1 TUBE in 1 BOX (59883-017-85)  / 85 g in 1 TUBE",
      "NDC11Code": "59883-0017-85",
      "ProductNDC": "59883-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Perio Daily Defense",
      "NonProprietaryName": "Hydrogen Peroxide",
      "DosageFormName": "GEL",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20190116",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "DEN-MAT HOLDINGS, LLC.",
      "SubstanceName": "HYDROGEN PEROXIDE",
      "StrengthNumber": "17",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190116",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary use in cleansing minor wounds and retreatment of inflammation resulting from dental procedures, or other irritations of the mouth and gums. Perio Daily Defense may be used for lessening the presence of plaque, a known factor in development of gingivitis."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"65604-017-17","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"10695-017-17","NonProprietaryName":"Sildenafil Citrate"},{"NDCCode":"11410-017-17","ProprietaryName":"Proactiv Solution Oil Free Moisture Spf 15 Moisturizer","NonProprietaryName":"Octinoxate And Zinc Oxide"},{"NDCCode":"41701-017-18","NonProprietaryName":"Oxytocin"},{"NDCCode":"45861-017-05","ProprietaryName":"Lenzapatch","NonProprietaryName":"Lidocaine Hydrochloride, Menthol"},{"NDCCode":"75749-017-17","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Ethanol"},{"NDCCode":"78880-017-02","ProprietaryName":"Handy Doctor Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"85742-017-17","ProprietaryName":"Varenicline Tartrate","NonProprietaryName":"Varenicline Tartrate"},{"NDCCode":"65604-014-14","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"17312-017-14","ProprietaryName":"Asthma Therapy","NonProprietaryName":"Arsenic Trioxide - Histamine Dihydrochloride - Dermatophagoides Pteronyssinus - Magnesium Phosphate, Dibasic Trihydrate - Strychnos Nux-vomica Seed - Aspidosperma Quebracho-blanco Bark - Suplhur -"},{"NDCCode":"21922-017-04","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate Ointment Usp, 0.05%"},{"NDCCode":"21922-017-05","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate Ointment Usp, 0.05%"},{"NDCCode":"21922-017-06","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate Ointment Usp, 0.05%"},{"NDCCode":"21922-017-07","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate Ointment Usp, 0.05%"},{"NDCCode":"23155-017-01","ProprietaryName":"Tetracycline Hydrochloride","NonProprietaryName":"Tetracycline Hydrochloride"},{"NDCCode":"42292-017-20","ProprietaryName":"Spironolactone And Hydrochlorothiazide","NonProprietaryName":"Spironolactone And Hydrochlorothiazide"},{"NDCCode":"43419-017-16","ProprietaryName":"Sulwhasoo Lumitouch Foundation","NonProprietaryName":"Octinoxate, Titanium Dioxide, And Zinc Oxide"},{"NDCCode":"49035-017-09","ProprietaryName":"Maximum Strength Wart Remover With Salicylic Acid","NonProprietaryName":"Wart Remover With Salicylic Acid"},{"NDCCode":"49430-017-15","ProprietaryName":"Elenza Patch","NonProprietaryName":"Lidocaine Hydrochloride"},{"NDCCode":"49527-017-01","ProprietaryName":"Repairwear","NonProprietaryName":"Octinoxate, Octisalate, And Titanium Dioxide"},{"NDCCode":"52565-017-15","ProprietaryName":"Flurandrenolide","NonProprietaryName":"Flurandrenolide"},{"NDCCode":"52565-017-30","ProprietaryName":"Flurandrenolide","NonProprietaryName":"Flurandrenolide"},{"NDCCode":"52565-017-60","ProprietaryName":"Flurandrenolide","NonProprietaryName":"Flurandrenolide"},{"NDCCode":"54304-017-01","ProprietaryName":"Wish Peony Scented Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"54436-017-01","ProprietaryName":"Otrexup","NonProprietaryName":"Methotrexate"},{"NDCCode":"54436-017-03","ProprietaryName":"Otrexup","NonProprietaryName":"Methotrexate"},{"NDCCode":"54436-017-04","ProprietaryName":"Otrexup","NonProprietaryName":"Methotrexate"},{"NDCCode":"59088-017-54","ProprietaryName":"Flotrex","NonProprietaryName":"Multivitamins, Sodium Fluoride 0.25 Mg"},{"NDCCode":"59883-017-03","ProprietaryName":"Perio Daily Defense","NonProprietaryName":"Hydrogen Peroxide"},{"NDCCode":"59883-017-85","ProprietaryName":"Perio Daily Defense","NonProprietaryName":"Hydrogen Peroxide"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>65604-017-17</NDCCode>
    <PackageDescription>2.5 kg in 1 BOX (65604-017-17)</PackageDescription>
    <NDC11Code>65604-0017-17</NDC11Code>
    <ProductNDC>65604-017</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>PLASTER</DosageFormName>
    <StartMarketingDate>20100101</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Akron Coating &amp; Adhesives</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>.4</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10695-017-17</NDCCode>
    <PackageDescription>500 g in 1 BOTTLE (10695-017-17)</PackageDescription>
    <NDC11Code>10695-0017-17</NDC11Code>
    <ProductNDC>10695-017</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20160714</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Willow Birch Pharma, Inc.</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11410-017-17</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (11410-017-17)  &gt; 50 mL in 1 TUBE</PackageDescription>
    <NDC11Code>11410-0017-17</NDC11Code>
    <ProductNDC>11410-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Proactiv Solution Oil Free Moisture Spf 15 Moisturizer</ProprietaryName>
    <NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20070101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Guthy-Renker LLC</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>7.5; 3</StrengthNumber>
    <StrengthUnit>mg/100mL; mg/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>41701-017-18</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOTTLE (41701-017-18)  / 12 g in 1 BOTTLE (41701-017-17) </PackageDescription>
    <NDC11Code>41701-0017-18</NDC11Code>
    <ProductNDC>41701-017</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Oxytocin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20110318</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Piramal Pharma Limited</LabelerName>
    <SubstanceName>OXYTOCIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-04-29</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>18-MAR-11</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>45861-017-05</NDCCode>
    <PackageDescription>5 PACKET in 1 BOX (45861-017-05)  &gt; 17 g in 1 PACKET</PackageDescription>
    <NDC11Code>45861-0017-05</NDC11Code>
    <ProductNDC>45861-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lenzapatch</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride, Menthol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Pharmaceutica North America, Inc.</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; MENTHOL</SubstanceName>
    <StrengthNumber>4; 1</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-02-08</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>75749-017-17</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, SPRAY (75749-017-17) </PackageDescription>
    <NDC11Code>75749-0017-17</NDC11Code>
    <ProductNDC>75749-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethanol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200628</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>NINGBO PRETTY TOURISM MANUFACTURE CO.,LTD.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78880-017-02</NDCCode>
    <PackageDescription>1 CASE in 1 BLISTER PACK (78880-017-02)  &gt; 17 mL in 1 CASE</PackageDescription>
    <NDC11Code>78880-0017-02</NDC11Code>
    <ProductNDC>78880-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Handy Doctor Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Sauber Co.,Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>10.54</StrengthNumber>
    <StrengthUnit>mL/17mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>85742-017-17</NDCCode>
    <PackageDescription>1 KIT in 1 BOX (85742-017-17)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>85742-0017-17</NDC11Code>
    <ProductNDC>85742-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varenicline Tartrate</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217151</ApplicationNumber>
    <LabelerName>Kanchan Healthcare Inc</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Varenicline tablets  is indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
    <Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3  C4H6O6. The chemical structure is:. Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg, white to off-white, capsule shaped, biconvex, film coated tablet, debossed with 'Ml' on one side and plain on other side and a 1 mg, light blue to blue, capsule shaped, biconvex, film coated tablet, debossed with 'M2' on one side and plain on other side. Each 0.5 mg Varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, maltodextrin, methyl alcohol, colloidal silicon dioxide, magnesium stearate, purified water, lnstacoat Universal White (for 0.5 mg), lnstacoat Universal blue (for 1 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>65604-014-14</NDCCode>
    <PackageDescription>162 kg in 1 DRUM (65604-014-14)</PackageDescription>
    <NDC11Code>65604-0014-14</NDC11Code>
    <ProductNDC>65604-014</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20050601</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Akron Coating &amp; Adhesives</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>.17</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>17312-017-14</NDCCode>
    <PackageDescription>1 BOTTLE in 1 PACKAGE (17312-017-14)  / 70 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE</PackageDescription>
    <NDC11Code>17312-0017-14</NDC11Code>
    <ProductNDC>17312-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Asthma Therapy</ProprietaryName>
    <NonProprietaryName>Arsenic Trioxide - Histamine Dihydrochloride - Dermatophagoides Pteronyssinus - Magnesium Phosphate, Dibasic Trihydrate - Strychnos Nux-vomica Seed - Aspidosperma Quebracho-blanco Bark - Suplhur -</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111201</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>TRP Company</LabelerName>
    <SubstanceName>STRYCHNOS NUX-VOMICA SEED; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; SULFUR; ARSENIC TRIOXIDE; HISTAMINE DIHYDROCHLORIDE; DERMATOPHAGOIDES PTERONYSSINUS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE</SubstanceName>
    <StrengthNumber>6; 6; 6; 6; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Insect Proteins [CS], Magnesium Ion Exchange Activity [MoA], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>According to homeopathic indications, these ingredients provide temporary relief of Asthma and COPD like symptoms such as:  Difficulty Breathing  Inflammation in the airways  Coughing  Wheezing  Shortness of breath  Sensation of tightness of the chest  Congestion after a diagnosis of Asthma or COPD by a physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21922-017-04</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-017-04)  / 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0017-04</NDC11Code>
    <ProductNDC>21922-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate Ointment Usp, 0.05%</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211295</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
    <Description>Clobetasol propionate ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-017-05</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-017-05)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0017-05</NDC11Code>
    <ProductNDC>21922-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate Ointment Usp, 0.05%</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211295</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
    <Description>Clobetasol propionate ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-017-06</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-017-06)  / 45 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0017-06</NDC11Code>
    <ProductNDC>21922-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate Ointment Usp, 0.05%</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211295</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
    <Description>Clobetasol propionate ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-017-07</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-017-07)  / 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0017-07</NDC11Code>
    <ProductNDC>21922-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate Ointment Usp, 0.05%</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211295</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
    <Description>Clobetasol propionate ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>23155-017-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (23155-017-01) </PackageDescription>
    <NDC11Code>23155-0017-01</NDC11Code>
    <ProductNDC>23155-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240915</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050278</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible., 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae,Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus . (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcalinfections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis caused by Chlamydophila psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Klebsiella granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis ., 10 Chancroid caused by Hemophilus ducreyi ., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis ., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus ., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica ., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigellasp., Acinetobacter sp., Klebsiellasp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
    <Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is as follows. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. Inactive Ingredients: Lactose, light mineral oil, and magnesium stearate. The 250 mg and 500 mg capsule shells contain D&amp;C yellow no. 10, FD&amp;C blue no. 1, FD&amp;C yellow no. 6, gelatin, and titanium dioxide. The imprinting ink for the 250 mg and 500 mg capsules contains D&amp;C yellow #10, FD&amp;C blue no. 1, FD&amp;C blue no. 2, FD&amp;C red no. 40, iron oxide black, pharmaceutical shellac glaze, propylene glycol and n-butyl alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>42292-017-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (42292-017-20)  / 1 TABLET in 1 BLISTER PACK (42292-017-01) </PackageDescription>
    <NDC11Code>42292-0017-20</NDC11Code>
    <ProductNDC>42292-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Spironolactone And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170512</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA086513</ApplicationNumber>
    <LabelerName>Mylan Institutional Inc.</LabelerName>
    <SubstanceName>SPIRONOLACTONE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>25; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONSsection). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are indicated for. Edematous conditions for patients with:. Congestive heart failure: 1 For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures;, 2 The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate;, 3 The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate.</IndicationAndUsage>
    <Description>Each tablet of spironolactone and hydrochlorothiazide contains 25 mg of spironolactone, USP and 25 mg of hydrochlorothiazide, USP. Spironolactone, an aldosterone antagonist, is 17-Hydroxy-7α-mercapto-3-oxo-17α -pregn-4-ene-21-carboxylic acid γ-lactone acetate and has the following structural formula, molecular formula and molecular weight:. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Hydrochlorothiazide, a diuretic and antihypertensive, is 6-Chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula, molecular formula and molecular weight:. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 25 mg of spironolactone and 25 mg of hydrochlorothiazide and the following inactive ingredients: colloidal silicon dioxide, corn starch, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, L-menthol, microcrystalline cellulose, peppermint oil, sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
  </NDC>
  <NDC>
    <NDCCode>43419-017-16</NDCCode>
    <PackageDescription>11 g in 1 CONTAINER (43419-017-16)</PackageDescription>
    <NDC11Code>43419-0017-16</NDC11Code>
    <ProductNDC>43419-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sulwhasoo Lumitouch Foundation</ProprietaryName>
    <ProprietaryNameSuffix>Spf 25 No 25. Dark Beige</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111223</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>AMOREPACIFIC</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.352; .4697; .2156</StrengthNumber>
    <StrengthUnit>g/11g; g/11g; g/11g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-08-17</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49035-017-09</NDCCode>
    <PackageDescription>9000 mg in 1 BOTTLE, WITH APPLICATOR (49035-017-09) </PackageDescription>
    <NDC11Code>49035-0017-09</NDC11Code>
    <ProductNDC>49035-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Maximum Strength Wart Remover With Salicylic Acid</ProprietaryName>
    <NonProprietaryName>Wart Remover With Salicylic Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111231</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M028</ApplicationNumber>
    <LabelerName>Wal-Mart Stores, Inc.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>mg/100mg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the removal of common warts and plantar warts on the bottom of the foot. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49430-017-15</NDCCode>
    <PackageDescription>100 g in 1 PACKAGE (49430-017-15)</PackageDescription>
    <NDC11Code>49430-0017-15</NDC11Code>
    <ProductNDC>49430-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Elenza Patch</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Pharmaceutics Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; MENTHOL</SubstanceName>
    <StrengthNumber>4; 1</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49527-017-01</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (49527-017-01)  / 50 mL in 1 JAR</PackageDescription>
    <NDC11Code>49527-0017-01</NDC11Code>
    <ProductNDC>49527-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Repairwear</ProprietaryName>
    <ProprietaryNameSuffix>Uplifting Firming Broad Spectrum Spf 15 Dry</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Octisalate, And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120502</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>CLINIQUE LABORATORIES LLC</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>75; 35; 17</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201124</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52565-017-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (52565-017-15)  &gt; 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>52565-0017-15</NDC11Code>
    <ProductNDC>52565-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Flurandrenolide</ProprietaryName>
    <NonProprietaryName>Flurandrenolide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161230</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207851</ApplicationNumber>
    <LabelerName>Teligent Pharma, Inc.</LabelerName>
    <SubstanceName>FLURANDRENOLIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161230</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Flurandrenolide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Flurandrenolide, USP is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of flurandrenolide ointment USP, 0.05% contains 0.5 mg (1.145 μmol; 0.05%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>52565-017-30</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (52565-017-30)  &gt; 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>52565-0017-30</NDC11Code>
    <ProductNDC>52565-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Flurandrenolide</ProprietaryName>
    <NonProprietaryName>Flurandrenolide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161230</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207851</ApplicationNumber>
    <LabelerName>Teligent Pharma, Inc.</LabelerName>
    <SubstanceName>FLURANDRENOLIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161230</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Flurandrenolide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Flurandrenolide, USP is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of flurandrenolide ointment USP, 0.05% contains 0.5 mg (1.145 μmol; 0.05%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>52565-017-60</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (52565-017-60)  &gt; 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>52565-0017-60</NDC11Code>
    <ProductNDC>52565-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Flurandrenolide</ProprietaryName>
    <NonProprietaryName>Flurandrenolide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161230</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207851</ApplicationNumber>
    <LabelerName>Teligent Pharma, Inc.</LabelerName>
    <SubstanceName>FLURANDRENOLIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161230</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Flurandrenolide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Flurandrenolide, USP is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of flurandrenolide ointment USP, 0.05% contains 0.5 mg (1.145 μmol; 0.05%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>54304-017-01</NDCCode>
    <PackageDescription>53 mL in 1 BOTTLE, PLASTIC (54304-017-01) </PackageDescription>
    <NDC11Code>54304-0017-01</NDC11Code>
    <ProductNDC>54304-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Wish Peony Scented Hand Sanitizer</ProprietaryName>
    <ProprietaryNameSuffix>01</ProprietaryNameSuffix>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200403</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Zhejiang Meizhiyuan Cosmetics Co., Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>64</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>54436-017-01</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (54436-017-01)  / .4 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>54436-0017-01</NDC11Code>
    <ProductNDC>54436-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Otrexup</ProprietaryName>
    <NonProprietaryName>Methotrexate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20131011</StartMarketingDate>
    <EndMarketingDate>20270430</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204824</ApplicationNumber>
    <LabelerName>Antares Pharma, Inc.</LabelerName>
    <SubstanceName>METHOTREXATE</SubstanceName>
    <StrengthNumber>17.5</StrengthNumber>
    <StrengthUnit>mg/.4mL</StrengthUnit>
    <Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160324</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Otrexup is a folate analog metabolic inhibitor indicated for the.  Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy ( 1.1).  Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy ( 1.2). Limitation of Use. Otrexup is not indicated for the treatment of neoplastic diseases ( 1.3).</IndicationAndUsage>
    <Description>Otrexup contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is. C 20H 22N 8O 5M.W.= 454.45. Otrexup contains methotrexate in a sterile, preservative-free, unbuffered solution with a 27 gauge ½ inch needle for a single subcutaneous injection. Otrexup solution is yellow in color. Inactive ingredients include sodium chloride and water for injection, USP. The amounts of sodium chloride vary with the amount of methotrexate. Hydrochloric acid and additional sodium hydroxide may have been added, if necessary, to adjust the pH to 8.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>54436-017-03</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (54436-017-03)  / .4 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>54436-0017-03</NDC11Code>
    <ProductNDC>54436-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Otrexup</ProprietaryName>
    <NonProprietaryName>Methotrexate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20131011</StartMarketingDate>
    <EndMarketingDate>20270430</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204824</ApplicationNumber>
    <LabelerName>Antares Pharma, Inc.</LabelerName>
    <SubstanceName>METHOTREXATE</SubstanceName>
    <StrengthNumber>17.5</StrengthNumber>
    <StrengthUnit>mg/.4mL</StrengthUnit>
    <Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160324</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270430</EndMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Otrexup is a folate analog metabolic inhibitor indicated for the.  Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy ( 1.1).  Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy ( 1.2). Limitation of Use. Otrexup is not indicated for the treatment of neoplastic diseases ( 1.3).</IndicationAndUsage>
    <Description>Otrexup contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is. C 20H 22N 8O 5M.W.= 454.45. Otrexup contains methotrexate in a sterile, preservative-free, unbuffered solution with a 27 gauge ½ inch needle for a single subcutaneous injection. Otrexup solution is yellow in color. Inactive ingredients include sodium chloride and water for injection, USP. The amounts of sodium chloride vary with the amount of methotrexate. Hydrochloric acid and additional sodium hydroxide may have been added, if necessary, to adjust the pH to 8.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>54436-017-04</NDCCode>
    <PackageDescription>4 SYRINGE in 1 CARTON (54436-017-04)  / .4 mL in 1 SYRINGE (54436-017-02) </PackageDescription>
    <NDC11Code>54436-0017-04</NDC11Code>
    <ProductNDC>54436-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Otrexup</ProprietaryName>
    <NonProprietaryName>Methotrexate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20131011</StartMarketingDate>
    <EndMarketingDate>20270430</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204824</ApplicationNumber>
    <LabelerName>Antares Pharma, Inc.</LabelerName>
    <SubstanceName>METHOTREXATE</SubstanceName>
    <StrengthNumber>17.5</StrengthNumber>
    <StrengthUnit>mg/.4mL</StrengthUnit>
    <Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160324</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Otrexup is a folate analog metabolic inhibitor indicated for the.  Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy ( 1.1).  Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy ( 1.2). Limitation of Use. Otrexup is not indicated for the treatment of neoplastic diseases ( 1.3).</IndicationAndUsage>
    <Description>Otrexup contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is. C 20H 22N 8O 5M.W.= 454.45. Otrexup contains methotrexate in a sterile, preservative-free, unbuffered solution with a 27 gauge ½ inch needle for a single subcutaneous injection. Otrexup solution is yellow in color. Inactive ingredients include sodium chloride and water for injection, USP. The amounts of sodium chloride vary with the amount of methotrexate. Hydrochloric acid and additional sodium hydroxide may have been added, if necessary, to adjust the pH to 8.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-017-54</NDCCode>
    <PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-017-54) </PackageDescription>
    <NDC11Code>59088-0017-54</NDC11Code>
    <ProductNDC>59088-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Flotrex</ProprietaryName>
    <NonProprietaryName>Multivitamins, Sodium Fluoride 0.25 Mg</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250319</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
    <StrengthNumber>.25; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5</StrengthNumber>
    <StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.</IndicationAndUsage>
    <Description>Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid) ...................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ................................................................... 0.25 mg. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&amp;C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
  </NDC>
  <NDC>
    <NDCCode>59883-017-03</NDCCode>
    <PackageDescription>1 g in 1 TUBE (59883-017-03) </PackageDescription>
    <NDC11Code>59883-0017-03</NDC11Code>
    <ProductNDC>59883-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Perio Daily Defense</ProprietaryName>
    <NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220831</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Den-Mat Holdings, LLC</LabelerName>
    <SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220831</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary use in cleansing minor wounds and retreatment of inflammation resulting from dental procedures, or other irritations of the mouth and gums. Perio Daily Defense may be used for lessening the presence of plaque, a known factor in development of gingivitis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59883-017-85</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (59883-017-85)  / 85 g in 1 TUBE</PackageDescription>
    <NDC11Code>59883-0017-85</NDC11Code>
    <ProductNDC>59883-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Perio Daily Defense</ProprietaryName>
    <NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20190116</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>DEN-MAT HOLDINGS, LLC.</LabelerName>
    <SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary use in cleansing minor wounds and retreatment of inflammation resulting from dental procedures, or other irritations of the mouth and gums. Perio Daily Defense may be used for lessening the presence of plaque, a known factor in development of gingivitis.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>65604-017-17</NDCCode><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>10695-017-17</NDCCode><NonProprietaryName>Sildenafil Citrate</NonProprietaryName></NDC><NDC><NDCCode>11410-017-17</NDCCode><ProprietaryName>Proactiv Solution Oil Free Moisture Spf 15 Moisturizer</ProprietaryName><NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>41701-017-18</NDCCode><NonProprietaryName>Oxytocin</NonProprietaryName></NDC><NDC><NDCCode>45861-017-05</NDCCode><ProprietaryName>Lenzapatch</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride, Menthol</NonProprietaryName></NDC><NDC><NDCCode>75749-017-17</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethanol</NonProprietaryName></NDC><NDC><NDCCode>78880-017-02</NDCCode><ProprietaryName>Handy Doctor Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>85742-017-17</NDCCode><ProprietaryName>Varenicline Tartrate</ProprietaryName><NonProprietaryName>Varenicline Tartrate</NonProprietaryName></NDC><NDC><NDCCode>65604-014-14</NDCCode><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>17312-017-14</NDCCode><ProprietaryName>Asthma Therapy</ProprietaryName><NonProprietaryName>Arsenic Trioxide - Histamine Dihydrochloride - Dermatophagoides Pteronyssinus - Magnesium Phosphate, Dibasic Trihydrate - Strychnos Nux-vomica Seed - Aspidosperma Quebracho-blanco Bark - Suplhur -</NonProprietaryName></NDC><NDC><NDCCode>21922-017-04</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate Ointment Usp, 0.05%</NonProprietaryName></NDC><NDC><NDCCode>21922-017-05</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate Ointment Usp, 0.05%</NonProprietaryName></NDC><NDC><NDCCode>21922-017-06</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate Ointment Usp, 0.05%</NonProprietaryName></NDC><NDC><NDCCode>21922-017-07</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate Ointment Usp, 0.05%</NonProprietaryName></NDC><NDC><NDCCode>23155-017-01</NDCCode><ProprietaryName>Tetracycline Hydrochloride</ProprietaryName><NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42292-017-20</NDCCode><ProprietaryName>Spironolactone And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Spironolactone And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>43419-017-16</NDCCode><ProprietaryName>Sulwhasoo Lumitouch Foundation</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>49035-017-09</NDCCode><ProprietaryName>Maximum Strength Wart Remover With Salicylic Acid</ProprietaryName><NonProprietaryName>Wart Remover With Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>49430-017-15</NDCCode><ProprietaryName>Elenza Patch</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49527-017-01</NDCCode><ProprietaryName>Repairwear</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate, And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>52565-017-15</NDCCode><ProprietaryName>Flurandrenolide</ProprietaryName><NonProprietaryName>Flurandrenolide</NonProprietaryName></NDC><NDC><NDCCode>52565-017-30</NDCCode><ProprietaryName>Flurandrenolide</ProprietaryName><NonProprietaryName>Flurandrenolide</NonProprietaryName></NDC><NDC><NDCCode>52565-017-60</NDCCode><ProprietaryName>Flurandrenolide</ProprietaryName><NonProprietaryName>Flurandrenolide</NonProprietaryName></NDC><NDC><NDCCode>54304-017-01</NDCCode><ProprietaryName>Wish Peony Scented Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>54436-017-01</NDCCode><ProprietaryName>Otrexup</ProprietaryName><NonProprietaryName>Methotrexate</NonProprietaryName></NDC><NDC><NDCCode>54436-017-03</NDCCode><ProprietaryName>Otrexup</ProprietaryName><NonProprietaryName>Methotrexate</NonProprietaryName></NDC><NDC><NDCCode>54436-017-04</NDCCode><ProprietaryName>Otrexup</ProprietaryName><NonProprietaryName>Methotrexate</NonProprietaryName></NDC><NDC><NDCCode>59088-017-54</NDCCode><ProprietaryName>Flotrex</ProprietaryName><NonProprietaryName>Multivitamins, Sodium Fluoride 0.25 Mg</NonProprietaryName></NDC><NDC><NDCCode>59883-017-03</NDCCode><ProprietaryName>Perio Daily Defense</ProprietaryName><NonProprietaryName>Hydrogen Peroxide</NonProprietaryName></NDC><NDC><NDCCode>59883-017-85</NDCCode><ProprietaryName>Perio Daily Defense</ProprietaryName><NonProprietaryName>Hydrogen Peroxide</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "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": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "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.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
      "FirstLineMailingAddress": "15230 NE 24TH ST STE Q",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-5540",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-562-2015",
      "MailingAddressFaxNumber": "425-562-2010",
      "FirstLinePracticeLocationAddress": "15230 NE 24TH ST STE Q",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-5540",
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      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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",
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}
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