RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (23 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "61924-092-16",
      "PackageDescription": "473 mL in 1 BOTTLE, PUMP (61924-092-16) ",
      "NDC11Code": "61924-0092-16",
      "ProductNDC": "61924-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermakleen",
      "NonProprietaryName": "Antimicrobial Drug Product",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120515",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Dermarite Industries LLC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".002",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200909",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "10631-092-16",
      "PackageDescription": "454 g in 1 BOTTLE (10631-092-16)",
      "NDC11Code": "10631-0092-16",
      "ProductNDC": "10631-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eurax",
      "NonProprietaryName": "Crotamiton",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20081113",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA009112",
      "LabelerName": "Ranbaxy Laboratories Inc.",
      "SubstanceName": "CROTAMITON",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "60432-092-16",
      "PackageDescription": "473 mL in 1 BOTTLE (60432-092-16) ",
      "NDC11Code": "60432-0092-16",
      "ProductNDC": "60432-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxybutynin Chloride",
      "NonProprietaryName": "Oxybutynin Chloride",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970212",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074868",
      "LabelerName": "Morton Grove Pharmaceuticals, Inc.",
      "SubstanceName": "OXYBUTYNIN CHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "19970212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxybutynin chloride syrup is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (ie, urgency, frequency, urinary leakage, urge incontinence, dysuria).",
      "Description": "Chemically, oxybutynin chloride is 4-(Diethylamino)-2-butynyl (±)-α-phenylcyclohexaneglycolate hydrochloride. The molecular formula of oxybutynin chloride is C22H31NO3HCl. The structural formula appears below. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.96. It is readily soluble in water and acids, but relatively insoluble in alkalis. Each 5 mL, for oral administration, contains 5 mg of oxybutynin chloride. In addition, the following inactive ingredients are present: Artificial raspberry flavor; citric acid, USP; D&C Yellow No. 10; FD&C Blue No. 1; glycerin, USP; liquid sugar; methylparaben, NF; propylene glycol, USP; sodium citrate, USP and sorbitol solution, USP. Therapeutic Category: Antispasmodic, anticholinergic."
    },
    {
      "NDCCode": "61924-092-01",
      "PackageDescription": "3800 mL in 1 JUG (61924-092-01) ",
      "NDC11Code": "61924-0092-01",
      "ProductNDC": "61924-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermakleen",
      "NonProprietaryName": "Antimicrobial Drug Product",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120515",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Dermarite Industries LLC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".002",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20120601",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "61924-092-08",
      "PackageDescription": "222 mL in 1 BOTTLE, PUMP (61924-092-08) ",
      "NDC11Code": "61924-0092-08",
      "ProductNDC": "61924-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermakleen",
      "NonProprietaryName": "Antimicrobial Drug Product",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120515",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Dermarite Industries LLC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".002",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20120515",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "61924-092-11",
      "PackageDescription": "1000 mL in 1 BOTTLE (61924-092-11) ",
      "NDC11Code": "61924-0092-11",
      "ProductNDC": "61924-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermakleen",
      "NonProprietaryName": "Antimicrobial Drug Product",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120515",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Dermarite Industries LLC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".002",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200327",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "61924-092-27",
      "PackageDescription": "800 mL in 1 BAG (61924-092-27) ",
      "NDC11Code": "61924-0092-27",
      "ProductNDC": "61924-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermakleen",
      "NonProprietaryName": "Antimicrobial Drug Product",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120515",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Dermarite Industries LLC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".002",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20120601",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "61924-092-34",
      "PackageDescription": "1000 mL in 1 BAG (61924-092-34) ",
      "NDC11Code": "61924-0092-34",
      "ProductNDC": "61924-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermakleen",
      "NonProprietaryName": "Antimicrobial Drug Product",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120515",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Dermarite Industries LLC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".002",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20120601",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "61924-106-16",
      "PackageDescription": "473 mL in 1 BOTTLE, PUMP (61924-106-16) ",
      "NDC11Code": "61924-0106-16",
      "ProductNDC": "61924-106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gelrite",
      "NonProprietaryName": "Hand Sanitizer",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20060425",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "DERMARITE INDUSTRIES, LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "65",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20060425",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on skin. Recommended for repeated use."
    },
    {
      "NDCCode": "61924-114-16",
      "PackageDescription": "500 mL in 1 BOTTLE, DISPENSING (61924-114-16) ",
      "NDC11Code": "61924-0114-16",
      "ProductNDC": "61924-114",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200618",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "DERMARITE INDUSTRIES, LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200618",
      "SamplePackage": "N",
      "IndicationAndUsage": "For cleansing/sanitizing of the hands when soap and water are not available. Recommended for repeated use."
    },
    {
      "NDCCode": "61924-174-16",
      "PackageDescription": "454 g in 1 JAR (61924-174-16) ",
      "NDC11Code": "61924-0174-16",
      "ProductNDC": "61924-174",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermacerin",
      "NonProprietaryName": "Skin Protectant",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161017",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "DermaRite Industries, LLC",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "33",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20161017",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily protects and helps relieve dry, chapped, or cracked skin. Helps protect skin from the drying effects of wind and cold weather."
    },
    {
      "NDCCode": "61924-184-16",
      "PackageDescription": "454 g in 1 JAR (61924-184-16) ",
      "NDC11Code": "61924-0184-16",
      "ProductNDC": "61924-184",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermaphor",
      "NonProprietaryName": "Skin Protectant",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161117",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "DermaRite Industries, LLC",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "44",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20161117",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply liberally to affected area as needed."
    },
    {
      "NDCCode": "61924-208-16",
      "PackageDescription": "452 g in 1 BOTTLE, PLASTIC (61924-208-16) ",
      "NDC11Code": "61924-0208-16",
      "ProductNDC": "61924-208",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "4-n-1 Wash",
      "NonProprietaryName": "Otc Skin Protectant Drug Product",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100102",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "DermaRite Industries, LLC",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": ".01",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20100102",
      "SamplePackage": "N",
      "IndicationAndUsage": "A gentle alternative to soap and water.  Cleans, restores, nourishes, and protects even most delicate skin.  Ideal for frequent cleansing and incontinence care."
    },
    {
      "NDCCode": "13537-092-12",
      "PackageDescription": "1 TUBE in 1 BOX (13537-092-12)  > 4 g in 1 TUBE (13537-092-01)",
      "NDC11Code": "13537-0092-12",
      "ProductNDC": "13537-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20",
      "ProprietaryNameSuffix": "(amour) - Red",
      "NonProprietaryName": "Octinoxate And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161104",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
      "StrengthNumber": ".071; .16",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "42851-092-34",
      "PackageDescription": "1 TUBE in 1 CARTON (42851-092-34)  / 96 g in 1 TUBE",
      "NDC11Code": "42851-0092-34",
      "ProductNDC": "42851-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zo Skin Health Gel Sunscreen Broad-spectrum Spf 50",
      "NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251030",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "ZO Skin Health, Inc.",
      "SubstanceName": "OCTOCRYLENE; AVOBENZONE; OCTISALATE",
      "StrengthNumber": "4.5; 1.35; 2.25",
      "StrengthUnit": "g/45g; g/45g; g/45g",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251030",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "48433-092-20",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (48433-092-20)  / 1 CAPSULE in 1 BLISTER PACK (48433-092-01) ",
      "NDC11Code": "48433-0092-20",
      "ProductNDC": "48433-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tacrolimus",
      "NonProprietaryName": "Tacrolimus",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260313",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090596",
      "LabelerName": "Safecor Health LLC",
      "SubstanceName": "TACROLIMUS",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260313",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, or heart transplants, in combination with other immunosuppressants. ( 1.1).",
      "Description": "Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5."
    },
    {
      "NDCCode": "63304-092-27",
      "PackageDescription": "28 CAPSULE in 1 BOTTLE (63304-092-27) ",
      "NDC11Code": "63304-0092-27",
      "ProductNDC": "63304-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sunitinib Malate",
      "NonProprietaryName": "Sunitinib Malate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213914",
      "LabelerName": "Sun Pharmaceutical Industries Inc.",
      "SubstanceName": "SUNITINIB MALATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191225",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
      "Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide, compound with (S)-2-hydroxybutanedioic acid. The molecular formula is C 22H 27FN 4O 2.C 4H 6O 5and the molecular weight is 532.57 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is light yellow to brownish orange colored powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in the range of 12 to 70 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively) together with croscarmellose sodium, magnesium stearate, mannitol and povidone (K-30) as inactive ingredients. The reddish brown gelatin capsule shells contain ferric oxide red and titanium dioxide. The caramel gelatin capsule shells contain ferric oxide red, ferric oxide yellow, ferrosoferric oxide and titanium dioxide. The yellow gelatin capsule shells contain ferric oxide yellow and titanium dioxide. The white printing ink contains potassium hydroxide, shellac and titanium dioxide. The black printing ink contains ferrosoferric oxide, potassium hydroxide and shellac."
    },
    {
      "NDCCode": "63304-092-86",
      "PackageDescription": "4 BLISTER PACK in 1 BOX (63304-092-86)  / 7 CAPSULE in 1 BLISTER PACK (63304-092-11) ",
      "NDC11Code": "63304-0092-86",
      "ProductNDC": "63304-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sunitinib Malate",
      "NonProprietaryName": "Sunitinib Malate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213914",
      "LabelerName": "Sun Pharmaceutical Industries Inc.",
      "SubstanceName": "SUNITINIB MALATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191225",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
      "Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide, compound with (S)-2-hydroxybutanedioic acid. The molecular formula is C 22H 27FN 4O 2.C 4H 6O 5and the molecular weight is 532.57 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is light yellow to brownish orange colored powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in the range of 12 to 70 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively) together with croscarmellose sodium, magnesium stearate, mannitol and povidone (K-30) as inactive ingredients. The reddish brown gelatin capsule shells contain ferric oxide red and titanium dioxide. The caramel gelatin capsule shells contain ferric oxide red, ferric oxide yellow, ferrosoferric oxide and titanium dioxide. The yellow gelatin capsule shells contain ferric oxide yellow and titanium dioxide. The white printing ink contains potassium hydroxide, shellac and titanium dioxide. The black printing ink contains ferrosoferric oxide, potassium hydroxide and shellac."
    },
    {
      "NDCCode": "66343-092-60",
      "PackageDescription": "60 mL in 1 BOTTLE (66343-092-60) ",
      "NDC11Code": "66343-0092-60",
      "ProductNDC": "66343-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Emvita 5",
      "NonProprietaryName": "Bufo Rana, Cuprum Metallicum, Glandula Suprarenalis, Phosphorus, Pulsatilla, Zincum Metallicum",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221221",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "RUBIMED AG",
      "SubstanceName": "BUFO BUFO CUTANEOUS GLAND; COPPER; SUS SCROFA ADRENAL GLAND; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; ZINC",
      "StrengthNumber": "800; 18; 21; 21; 16; 21",
      "StrengthUnit": "[hp_C]/60mL; [hp_M]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_M]/60mL; [hp_X]/60mL",
      "Pharm_Classes": "Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]",
      "Status": "Active",
      "LastUpdate": "2024-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221221",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: (†) Homeopathic remedy for general well being: nervousness."
    },
    {
      "NDCCode": "69067-092-04",
      "PackageDescription": "118 mL in 1 BOTTLE (69067-092-04) ",
      "NDC11Code": "69067-0092-04",
      "ProductNDC": "69067-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diphen",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190911",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA087513",
      "LabelerName": "Foxland Pharmaceuticals, Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20190911",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70377-092-11",
      "PackageDescription": "28 TABLET, FOR SUSPENSION in 1 BOTTLE (70377-092-11) ",
      "NDC11Code": "70377-0092-11",
      "ProductNDC": "70377-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Everolimus",
      "NonProprietaryName": "Everolimus",
      "DosageFormName": "TABLET, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217216",
      "LabelerName": "Biocon Pharma Inc.",
      "SubstanceName": "EVEROLIMUS",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).",
      "Description": "Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose."
    },
    {
      "NDCCode": "70377-092-23",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-092-23)  / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK",
      "NDC11Code": "70377-0092-23",
      "ProductNDC": "70377-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Everolimus",
      "NonProprietaryName": "Everolimus",
      "DosageFormName": "TABLET, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217216",
      "LabelerName": "Biocon Pharma Inc.",
      "SubstanceName": "EVEROLIMUS",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).",
      "Description": "Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose."
    },
    {
      "NDCCode": "71205-092-15",
      "PackageDescription": "1 TUBE in 1 CARTON (71205-092-15)  > 15 g in 1 TUBE",
      "NDC11Code": "71205-0092-15",
      "ProductNDC": "71205-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluocinonide",
      "NonProprietaryName": "Fluocinonide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073085",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "FLUOCINONIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20180801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluocinonide Cream, USP 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "Fluocinonide Cream, USP 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6∝,11ß,16∝). Its molecular formula is C26H32F2O7, and has the molecular weight of 494.53. It has the following chemical structure:Fluocinonide Cream, USP 0.05% contains fluocinonide 0.5 mg/g in a cream base consisting of citric acid, 1,2,6-hexanetriol, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties. In the Fluocinonide Cream, USP 0.05% formulation, the active ingredient is totally in solution."
    },
    {
      "NDCCode": "72578-092-01",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (72578-092-01)  / 150 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "72578-0092-01",
      "ProductNDC": "72578-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200720",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206411",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "16.05",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200720",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diclofenac sodium topical solution, 1.5% w/w is a nonsteroidal anti-inflammatory drug  indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). (1).",
      "Description": "Diclofenac sodium topical solution, USP 1.5% w/w is a nonsteroidal anti-inflammatory drug, available as a clear, colorless to faintly pink-orange solution for topical application. Diclofenac sodium topical solution, USP contains 1.5% w/w diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula. Each 1 mL of solution contains 16.05 mg of diclofenac sodium USP. In addition, diclofenac sodium topical solution, 1.5% w/w contains the following inactive ingredients: alcohol, dimethyl sulfoxide (DMSO, 45.5% w/w), glycerin, propylene glycol and purified water."
    },
    {
      "NDCCode": "72789-092-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-092-30) ",
      "NDC11Code": "72789-0092-30",
      "ProductNDC": "72789-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077206",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-01-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200814",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.",
      "Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
    },
    {
      "NDCCode": "72789-092-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-092-60) ",
      "NDC11Code": "72789-0092-60",
      "ProductNDC": "72789-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077206",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-01-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200930",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.",
      "Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
    },
    {
      "NDCCode": "72789-092-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-092-90) ",
      "NDC11Code": "72789-0092-90",
      "ProductNDC": "72789-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077206",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-01-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200622",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.",
      "Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
    },
    {
      "NDCCode": "85248-092-01",
      "PackageDescription": "30 mL in 1 BOTTLE (85248-092-01) ",
      "NDC11Code": "85248-0092-01",
      "ProductNDC": "85248-092",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Puvida Liquid Wart Corn Remover",
      "NonProprietaryName": "Salicylic Acid 17% Liquid Wart Corn Remover",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260208",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M028",
      "LabelerName": "Jiangxi Yudexi Pharmaceutical Co., LTD",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "17",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-06-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260208",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the removal of common warts and plantar warts.Common warts have a rough\"cauliflower-like\" surface and are easily recognizable.Plantar warts are located only on the soles of the feet, tender to touch, with an interrupted footprint pattern."
    },
    {
      "NDCCode": "61924-093-34",
      "PackageDescription": "1000 mL in 1 CARTRIDGE (61924-093-34) ",
      "NDC11Code": "61924-0093-34",
      "ProductNDC": "61924-093",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kleenfoam",
      "NonProprietaryName": "Otc Antimicrobial Drug Product",
      "DosageFormName": "AEROSOL, FOAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111212",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Dermarite Industries LLC",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".005",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20111212",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin. after changing diapers;. after assisting ill persons;. before contact with a person under medical care or treatmentRecommended for repeated use."
    },
    {
      "NDCCode": "61924-102-08",
      "PackageDescription": "237 mL in 1 BOTTLE, PUMP (61924-102-08) ",
      "NDC11Code": "61924-0102-08",
      "ProductNDC": "61924-102",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand-e-foam",
      "NonProprietaryName": "Otc Antimicrobial Drug Products",
      "DosageFormName": "AEROSOL, FOAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20020808",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "DermaRite Industries, LLC",
      "SubstanceName": "BENZETHONIUM CHLORIDE",
      "StrengthNumber": ".002",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20020808",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer: Helps reduce bacteria on skin that could cause disease. Recommended for repeated use. . First aid to help protect against skin infection in minor cuts, scrapes, burns. ."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"61924-092-16","ProprietaryName":"Dermakleen","NonProprietaryName":"Antimicrobial Drug Product"},{"NDCCode":"10631-092-16","ProprietaryName":"Eurax","NonProprietaryName":"Crotamiton"},{"NDCCode":"60432-092-16","ProprietaryName":"Oxybutynin Chloride","NonProprietaryName":"Oxybutynin Chloride"},{"NDCCode":"61924-092-01","ProprietaryName":"Dermakleen","NonProprietaryName":"Antimicrobial Drug Product"},{"NDCCode":"61924-092-08","ProprietaryName":"Dermakleen","NonProprietaryName":"Antimicrobial Drug Product"},{"NDCCode":"61924-092-11","ProprietaryName":"Dermakleen","NonProprietaryName":"Antimicrobial Drug Product"},{"NDCCode":"61924-092-27","ProprietaryName":"Dermakleen","NonProprietaryName":"Antimicrobial Drug Product"},{"NDCCode":"61924-092-34","ProprietaryName":"Dermakleen","NonProprietaryName":"Antimicrobial Drug Product"},{"NDCCode":"61924-106-16","ProprietaryName":"Gelrite","NonProprietaryName":"Hand Sanitizer"},{"NDCCode":"61924-114-16","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"61924-174-16","ProprietaryName":"Dermacerin","NonProprietaryName":"Skin Protectant"},{"NDCCode":"61924-184-16","ProprietaryName":"Dermaphor","NonProprietaryName":"Skin Protectant"},{"NDCCode":"61924-208-16","ProprietaryName":"4-n-1 Wash","NonProprietaryName":"Otc Skin Protectant Drug Product"},{"NDCCode":"13537-092-12","ProprietaryName":"Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20","NonProprietaryName":"Octinoxate And Oxybenzone"},{"NDCCode":"42851-092-34","ProprietaryName":"Zo Skin Health Gel Sunscreen Broad-spectrum Spf 50","NonProprietaryName":"Avobenzone, Octisalate, Octocrylene"},{"NDCCode":"48433-092-20","ProprietaryName":"Tacrolimus","NonProprietaryName":"Tacrolimus"},{"NDCCode":"63304-092-27","ProprietaryName":"Sunitinib Malate","NonProprietaryName":"Sunitinib Malate"},{"NDCCode":"63304-092-86","ProprietaryName":"Sunitinib Malate","NonProprietaryName":"Sunitinib Malate"},{"NDCCode":"66343-092-60","ProprietaryName":"Emvita 5","NonProprietaryName":"Bufo Rana, Cuprum Metallicum, Glandula Suprarenalis, Phosphorus, Pulsatilla, Zincum Metallicum"},{"NDCCode":"69067-092-04","ProprietaryName":"Diphen","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"70377-092-11","ProprietaryName":"Everolimus","NonProprietaryName":"Everolimus"},{"NDCCode":"70377-092-23","ProprietaryName":"Everolimus","NonProprietaryName":"Everolimus"},{"NDCCode":"71205-092-15","ProprietaryName":"Fluocinonide","NonProprietaryName":"Fluocinonide"},{"NDCCode":"72578-092-01","ProprietaryName":"Diclofenac Sodium","NonProprietaryName":"Diclofenac Sodium"},{"NDCCode":"72789-092-30","ProprietaryName":"Sertraline Hydrochloride","NonProprietaryName":"Sertraline Hydrochloride"},{"NDCCode":"72789-092-60","ProprietaryName":"Sertraline Hydrochloride","NonProprietaryName":"Sertraline Hydrochloride"},{"NDCCode":"72789-092-90","ProprietaryName":"Sertraline Hydrochloride","NonProprietaryName":"Sertraline Hydrochloride"},{"NDCCode":"85248-092-01","ProprietaryName":"Puvida Liquid Wart Corn Remover","NonProprietaryName":"Salicylic Acid 17% Liquid Wart Corn Remover"},{"NDCCode":"61924-093-34","ProprietaryName":"Kleenfoam","NonProprietaryName":"Otc Antimicrobial Drug Product"},{"NDCCode":"61924-102-08","ProprietaryName":"Hand-e-foam","NonProprietaryName":"Otc Antimicrobial Drug Products"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>61924-092-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE, PUMP (61924-092-16) </PackageDescription>
    <NDC11Code>61924-0092-16</NDC11Code>
    <ProductNDC>61924-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermakleen</ProprietaryName>
    <NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Dermarite Industries LLC</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>.002</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200909</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10631-092-16</NDCCode>
    <PackageDescription>454 g in 1 BOTTLE (10631-092-16)</PackageDescription>
    <NDC11Code>10631-0092-16</NDC11Code>
    <ProductNDC>10631-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eurax</ProprietaryName>
    <NonProprietaryName>Crotamiton</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20081113</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA009112</ApplicationNumber>
    <LabelerName>Ranbaxy Laboratories Inc.</LabelerName>
    <SubstanceName>CROTAMITON</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>60432-092-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (60432-092-16) </PackageDescription>
    <NDC11Code>60432-0092-16</NDC11Code>
    <ProductNDC>60432-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxybutynin Chloride</ProprietaryName>
    <NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074868</ApplicationNumber>
    <LabelerName>Morton Grove Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19970212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxybutynin chloride syrup is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (ie, urgency, frequency, urinary leakage, urge incontinence, dysuria).</IndicationAndUsage>
    <Description>Chemically, oxybutynin chloride is 4-(Diethylamino)-2-butynyl (±)-α-phenylcyclohexaneglycolate hydrochloride. The molecular formula of oxybutynin chloride is C22H31NO3HCl. The structural formula appears below. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.96. It is readily soluble in water and acids, but relatively insoluble in alkalis. Each 5 mL, for oral administration, contains 5 mg of oxybutynin chloride. In addition, the following inactive ingredients are present: Artificial raspberry flavor; citric acid, USP; D&amp;C Yellow No. 10; FD&amp;C Blue No. 1; glycerin, USP; liquid sugar; methylparaben, NF; propylene glycol, USP; sodium citrate, USP and sorbitol solution, USP. Therapeutic Category: Antispasmodic, anticholinergic.</Description>
  </NDC>
  <NDC>
    <NDCCode>61924-092-01</NDCCode>
    <PackageDescription>3800 mL in 1 JUG (61924-092-01) </PackageDescription>
    <NDC11Code>61924-0092-01</NDC11Code>
    <ProductNDC>61924-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermakleen</ProprietaryName>
    <NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Dermarite Industries LLC</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>.002</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61924-092-08</NDCCode>
    <PackageDescription>222 mL in 1 BOTTLE, PUMP (61924-092-08) </PackageDescription>
    <NDC11Code>61924-0092-08</NDC11Code>
    <ProductNDC>61924-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermakleen</ProprietaryName>
    <NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Dermarite Industries LLC</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>.002</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61924-092-11</NDCCode>
    <PackageDescription>1000 mL in 1 BOTTLE (61924-092-11) </PackageDescription>
    <NDC11Code>61924-0092-11</NDC11Code>
    <ProductNDC>61924-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermakleen</ProprietaryName>
    <NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Dermarite Industries LLC</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>.002</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61924-092-27</NDCCode>
    <PackageDescription>800 mL in 1 BAG (61924-092-27) </PackageDescription>
    <NDC11Code>61924-0092-27</NDC11Code>
    <ProductNDC>61924-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermakleen</ProprietaryName>
    <NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Dermarite Industries LLC</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>.002</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61924-092-34</NDCCode>
    <PackageDescription>1000 mL in 1 BAG (61924-092-34) </PackageDescription>
    <NDC11Code>61924-0092-34</NDC11Code>
    <ProductNDC>61924-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermakleen</ProprietaryName>
    <NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Dermarite Industries LLC</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>.002</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61924-106-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE, PUMP (61924-106-16) </PackageDescription>
    <NDC11Code>61924-0106-16</NDC11Code>
    <ProductNDC>61924-106</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gelrite</ProprietaryName>
    <NonProprietaryName>Hand Sanitizer</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20060425</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>DERMARITE INDUSTRIES, LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060425</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61924-114-16</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE, DISPENSING (61924-114-16) </PackageDescription>
    <NDC11Code>61924-0114-16</NDC11Code>
    <ProductNDC>61924-114</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200618</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>DERMARITE INDUSTRIES, LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200618</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For cleansing/sanitizing of the hands when soap and water are not available. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61924-174-16</NDCCode>
    <PackageDescription>454 g in 1 JAR (61924-174-16) </PackageDescription>
    <NDC11Code>61924-0174-16</NDC11Code>
    <ProductNDC>61924-174</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermacerin</ProprietaryName>
    <NonProprietaryName>Skin Protectant</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161017</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>DermaRite Industries, LLC</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>33</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161017</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily protects and helps relieve dry, chapped, or cracked skin. Helps protect skin from the drying effects of wind and cold weather.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61924-184-16</NDCCode>
    <PackageDescription>454 g in 1 JAR (61924-184-16) </PackageDescription>
    <NDC11Code>61924-0184-16</NDC11Code>
    <ProductNDC>61924-184</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermaphor</ProprietaryName>
    <NonProprietaryName>Skin Protectant</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161117</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>DermaRite Industries, LLC</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>44</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply liberally to affected area as needed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61924-208-16</NDCCode>
    <PackageDescription>452 g in 1 BOTTLE, PLASTIC (61924-208-16) </PackageDescription>
    <NDC11Code>61924-0208-16</NDC11Code>
    <ProductNDC>61924-208</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>4-n-1 Wash</ProprietaryName>
    <NonProprietaryName>Otc Skin Protectant Drug Product</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100102</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>DermaRite Industries, LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>.01</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A gentle alternative to soap and water.  Cleans, restores, nourishes, and protects even most delicate skin.  Ideal for frequent cleansing and incontinence care.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13537-092-12</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13537-092-12)  &gt; 4 g in 1 TUBE (13537-092-01)</PackageDescription>
    <NDC11Code>13537-0092-12</NDC11Code>
    <ProductNDC>13537-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20</ProprietaryName>
    <ProprietaryNameSuffix>(amour) - Red</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161104</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.071; .16</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42851-092-34</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (42851-092-34)  / 96 g in 1 TUBE</PackageDescription>
    <NDC11Code>42851-0092-34</NDC11Code>
    <ProductNDC>42851-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zo Skin Health Gel Sunscreen Broad-spectrum Spf 50</ProprietaryName>
    <NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251030</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>ZO Skin Health, Inc.</LabelerName>
    <SubstanceName>OCTOCRYLENE; AVOBENZONE; OCTISALATE</SubstanceName>
    <StrengthNumber>4.5; 1.35; 2.25</StrengthNumber>
    <StrengthUnit>g/45g; g/45g; g/45g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>48433-092-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (48433-092-20)  / 1 CAPSULE in 1 BLISTER PACK (48433-092-01) </PackageDescription>
    <NDC11Code>48433-0092-20</NDC11Code>
    <ProductNDC>48433-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tacrolimus</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260313</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090596</ApplicationNumber>
    <LabelerName>Safecor Health LLC</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, or heart transplants, in combination with other immunosuppressants. ( 1.1).</IndicationAndUsage>
    <Description>Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&amp;C Red No. 28, D&amp;C Yellow No. 10 and FD&amp;C Red No. 40, the 1 mg capsules also contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3 and the 5 mg capsules also contain D&amp;C Red No. 33, D&amp;C Red No. 28 and D&amp;C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-092-27</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BOTTLE (63304-092-27) </PackageDescription>
    <NDC11Code>63304-0092-27</NDC11Code>
    <ProductNDC>63304-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sunitinib Malate</ProprietaryName>
    <NonProprietaryName>Sunitinib Malate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191225</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213914</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries Inc.</LabelerName>
    <SubstanceName>SUNITINIB MALATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191225</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
    <Description>Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide, compound with (S)-2-hydroxybutanedioic acid. The molecular formula is C 22H 27FN 4O 2.C 4H 6O 5and the molecular weight is 532.57 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is light yellow to brownish orange colored powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in the range of 12 to 70 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively) together with croscarmellose sodium, magnesium stearate, mannitol and povidone (K-30) as inactive ingredients. The reddish brown gelatin capsule shells contain ferric oxide red and titanium dioxide. The caramel gelatin capsule shells contain ferric oxide red, ferric oxide yellow, ferrosoferric oxide and titanium dioxide. The yellow gelatin capsule shells contain ferric oxide yellow and titanium dioxide. The white printing ink contains potassium hydroxide, shellac and titanium dioxide. The black printing ink contains ferrosoferric oxide, potassium hydroxide and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-092-86</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 BOX (63304-092-86)  / 7 CAPSULE in 1 BLISTER PACK (63304-092-11) </PackageDescription>
    <NDC11Code>63304-0092-86</NDC11Code>
    <ProductNDC>63304-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sunitinib Malate</ProprietaryName>
    <NonProprietaryName>Sunitinib Malate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191225</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213914</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries Inc.</LabelerName>
    <SubstanceName>SUNITINIB MALATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191225</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
    <Description>Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide, compound with (S)-2-hydroxybutanedioic acid. The molecular formula is C 22H 27FN 4O 2.C 4H 6O 5and the molecular weight is 532.57 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is light yellow to brownish orange colored powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in the range of 12 to 70 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively) together with croscarmellose sodium, magnesium stearate, mannitol and povidone (K-30) as inactive ingredients. The reddish brown gelatin capsule shells contain ferric oxide red and titanium dioxide. The caramel gelatin capsule shells contain ferric oxide red, ferric oxide yellow, ferrosoferric oxide and titanium dioxide. The yellow gelatin capsule shells contain ferric oxide yellow and titanium dioxide. The white printing ink contains potassium hydroxide, shellac and titanium dioxide. The black printing ink contains ferrosoferric oxide, potassium hydroxide and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>66343-092-60</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE (66343-092-60) </PackageDescription>
    <NDC11Code>66343-0092-60</NDC11Code>
    <ProductNDC>66343-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Emvita 5</ProprietaryName>
    <NonProprietaryName>Bufo Rana, Cuprum Metallicum, Glandula Suprarenalis, Phosphorus, Pulsatilla, Zincum Metallicum</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221221</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>RUBIMED AG</LabelerName>
    <SubstanceName>BUFO BUFO CUTANEOUS GLAND; COPPER; SUS SCROFA ADRENAL GLAND; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; ZINC</SubstanceName>
    <StrengthNumber>800; 18; 21; 21; 16; 21</StrengthNumber>
    <StrengthUnit>[hp_C]/60mL; [hp_M]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_M]/60mL; [hp_X]/60mL</StrengthUnit>
    <Pharm_Classes>Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: (†) Homeopathic remedy for general well being: nervousness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69067-092-04</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE (69067-092-04) </PackageDescription>
    <NDC11Code>69067-0092-04</NDC11Code>
    <ProductNDC>69067-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diphen</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190911</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087513</ApplicationNumber>
    <LabelerName>Foxland Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70377-092-11</NDCCode>
    <PackageDescription>28 TABLET, FOR SUSPENSION in 1 BOTTLE (70377-092-11) </PackageDescription>
    <NDC11Code>70377-0092-11</NDC11Code>
    <ProductNDC>70377-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Everolimus</ProprietaryName>
    <NonProprietaryName>Everolimus</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217216</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>EVEROLIMUS</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
    <Description>Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-092-23</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (70377-092-23)  / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>70377-0092-23</NDC11Code>
    <ProductNDC>70377-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Everolimus</ProprietaryName>
    <NonProprietaryName>Everolimus</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217216</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>EVEROLIMUS</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
    <Description>Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-092-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (71205-092-15)  &gt; 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>71205-0092-15</NDC11Code>
    <ProductNDC>71205-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluocinonide</ProprietaryName>
    <NonProprietaryName>Fluocinonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073085</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>FLUOCINONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluocinonide Cream, USP 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Fluocinonide Cream, USP 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6∝,11ß,16∝). Its molecular formula is C26H32F2O7, and has the molecular weight of 494.53. It has the following chemical structure:Fluocinonide Cream, USP 0.05% contains fluocinonide 0.5 mg/g in a cream base consisting of citric acid, 1,2,6-hexanetriol, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties. In the Fluocinonide Cream, USP 0.05% formulation, the active ingredient is totally in solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>72578-092-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (72578-092-01)  / 150 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>72578-0092-01</NDC11Code>
    <ProductNDC>72578-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200720</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206411</ApplicationNumber>
    <LabelerName>Viona Pharmaceuticals Inc</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>16.05</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diclofenac sodium topical solution, 1.5% w/w is a nonsteroidal anti-inflammatory drug  indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). (1).</IndicationAndUsage>
    <Description>Diclofenac sodium topical solution, USP 1.5% w/w is a nonsteroidal anti-inflammatory drug, available as a clear, colorless to faintly pink-orange solution for topical application. Diclofenac sodium topical solution, USP contains 1.5% w/w diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula. Each 1 mL of solution contains 16.05 mg of diclofenac sodium USP. In addition, diclofenac sodium topical solution, 1.5% w/w contains the following inactive ingredients: alcohol, dimethyl sulfoxide (DMSO, 45.5% w/w), glycerin, propylene glycol and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>72789-092-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-092-30) </PackageDescription>
    <NDC11Code>72789-0092-30</NDC11Code>
    <ProductNDC>72789-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077206</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.</IndicationAndUsage>
    <Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&amp;C yellow #10 aluminum lake, FD&amp;C blue #1 aluminum lake, FD&amp;C red #40 aluminum lake; 50 mg contains FD&amp;C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>72789-092-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-092-60) </PackageDescription>
    <NDC11Code>72789-0092-60</NDC11Code>
    <ProductNDC>72789-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077206</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.</IndicationAndUsage>
    <Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&amp;C yellow #10 aluminum lake, FD&amp;C blue #1 aluminum lake, FD&amp;C red #40 aluminum lake; 50 mg contains FD&amp;C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>72789-092-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-092-90) </PackageDescription>
    <NDC11Code>72789-0092-90</NDC11Code>
    <ProductNDC>72789-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077206</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.</IndicationAndUsage>
    <Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&amp;C yellow #10 aluminum lake, FD&amp;C blue #1 aluminum lake, FD&amp;C red #40 aluminum lake; 50 mg contains FD&amp;C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>85248-092-01</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (85248-092-01) </PackageDescription>
    <NDC11Code>85248-0092-01</NDC11Code>
    <ProductNDC>85248-092</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Puvida Liquid Wart Corn Remover</ProprietaryName>
    <NonProprietaryName>Salicylic Acid 17% Liquid Wart Corn Remover</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260208</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M028</ApplicationNumber>
    <LabelerName>Jiangxi Yudexi Pharmaceutical Co., LTD</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the removal of common warts and plantar warts.Common warts have a rough"cauliflower-like" surface and are easily recognizable.Plantar warts are located only on the soles of the feet, tender to touch, with an interrupted footprint pattern.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61924-093-34</NDCCode>
    <PackageDescription>1000 mL in 1 CARTRIDGE (61924-093-34) </PackageDescription>
    <NDC11Code>61924-0093-34</NDC11Code>
    <ProductNDC>61924-093</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kleenfoam</ProprietaryName>
    <NonProprietaryName>Otc Antimicrobial Drug Product</NonProprietaryName>
    <DosageFormName>AEROSOL, FOAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111212</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Dermarite Industries LLC</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>.005</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on the skin. after changing diapers;. after assisting ill persons;. before contact with a person under medical care or treatmentRecommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61924-102-08</NDCCode>
    <PackageDescription>237 mL in 1 BOTTLE, PUMP (61924-102-08) </PackageDescription>
    <NDC11Code>61924-0102-08</NDC11Code>
    <ProductNDC>61924-102</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand-e-foam</ProprietaryName>
    <NonProprietaryName>Otc Antimicrobial Drug Products</NonProprietaryName>
    <DosageFormName>AEROSOL, FOAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20020808</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>DermaRite Industries, LLC</LabelerName>
    <SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.002</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020808</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer: Helps reduce bacteria on skin that could cause disease. Recommended for repeated use. . First aid to help protect against skin infection in minor cuts, scrapes, burns. .</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>61924-092-16</NDCCode><ProprietaryName>Dermakleen</ProprietaryName><NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName></NDC><NDC><NDCCode>10631-092-16</NDCCode><ProprietaryName>Eurax</ProprietaryName><NonProprietaryName>Crotamiton</NonProprietaryName></NDC><NDC><NDCCode>60432-092-16</NDCCode><ProprietaryName>Oxybutynin Chloride</ProprietaryName><NonProprietaryName>Oxybutynin Chloride</NonProprietaryName></NDC><NDC><NDCCode>61924-092-01</NDCCode><ProprietaryName>Dermakleen</ProprietaryName><NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName></NDC><NDC><NDCCode>61924-092-08</NDCCode><ProprietaryName>Dermakleen</ProprietaryName><NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName></NDC><NDC><NDCCode>61924-092-11</NDCCode><ProprietaryName>Dermakleen</ProprietaryName><NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName></NDC><NDC><NDCCode>61924-092-27</NDCCode><ProprietaryName>Dermakleen</ProprietaryName><NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName></NDC><NDC><NDCCode>61924-092-34</NDCCode><ProprietaryName>Dermakleen</ProprietaryName><NonProprietaryName>Antimicrobial Drug Product</NonProprietaryName></NDC><NDC><NDCCode>61924-106-16</NDCCode><ProprietaryName>Gelrite</ProprietaryName><NonProprietaryName>Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>61924-114-16</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>61924-174-16</NDCCode><ProprietaryName>Dermacerin</ProprietaryName><NonProprietaryName>Skin Protectant</NonProprietaryName></NDC><NDC><NDCCode>61924-184-16</NDCCode><ProprietaryName>Dermaphor</ProprietaryName><NonProprietaryName>Skin Protectant</NonProprietaryName></NDC><NDC><NDCCode>61924-208-16</NDCCode><ProprietaryName>4-n-1 Wash</ProprietaryName><NonProprietaryName>Otc Skin Protectant Drug Product</NonProprietaryName></NDC><NDC><NDCCode>13537-092-12</NDCCode><ProprietaryName>Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>42851-092-34</NDCCode><ProprietaryName>Zo Skin Health Gel Sunscreen Broad-spectrum Spf 50</ProprietaryName><NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>48433-092-20</NDCCode><ProprietaryName>Tacrolimus</ProprietaryName><NonProprietaryName>Tacrolimus</NonProprietaryName></NDC><NDC><NDCCode>63304-092-27</NDCCode><ProprietaryName>Sunitinib Malate</ProprietaryName><NonProprietaryName>Sunitinib Malate</NonProprietaryName></NDC><NDC><NDCCode>63304-092-86</NDCCode><ProprietaryName>Sunitinib Malate</ProprietaryName><NonProprietaryName>Sunitinib Malate</NonProprietaryName></NDC><NDC><NDCCode>66343-092-60</NDCCode><ProprietaryName>Emvita 5</ProprietaryName><NonProprietaryName>Bufo Rana, Cuprum Metallicum, Glandula Suprarenalis, Phosphorus, Pulsatilla, Zincum Metallicum</NonProprietaryName></NDC><NDC><NDCCode>69067-092-04</NDCCode><ProprietaryName>Diphen</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70377-092-11</NDCCode><ProprietaryName>Everolimus</ProprietaryName><NonProprietaryName>Everolimus</NonProprietaryName></NDC><NDC><NDCCode>70377-092-23</NDCCode><ProprietaryName>Everolimus</ProprietaryName><NonProprietaryName>Everolimus</NonProprietaryName></NDC><NDC><NDCCode>71205-092-15</NDCCode><ProprietaryName>Fluocinonide</ProprietaryName><NonProprietaryName>Fluocinonide</NonProprietaryName></NDC><NDC><NDCCode>72578-092-01</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>72789-092-30</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>72789-092-60</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>72789-092-90</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>85248-092-01</NDCCode><ProprietaryName>Puvida Liquid Wart Corn Remover</ProprietaryName><NonProprietaryName>Salicylic Acid 17% Liquid Wart Corn Remover</NonProprietaryName></NDC><NDC><NDCCode>61924-093-34</NDCCode><ProprietaryName>Kleenfoam</ProprietaryName><NonProprietaryName>Otc Antimicrobial Drug Product</NonProprietaryName></NDC><NDC><NDCCode>61924-102-08</NDCCode><ProprietaryName>Hand-e-foam</ProprietaryName><NonProprietaryName>Otc Antimicrobial Drug Products</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",
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      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
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}
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