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How to Find 49203-730-01 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "49203-730-01",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (49203-730-01)  > 30 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "49203-0730-01",
      "ProductNDC": "49203-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Skin Doctors Photo Age Reverse Night Serum",
      "NonProprietaryName": "Thermus Thermophilus Lysate And Glycerin",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100401",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cat Media Pty Ltd",
      "SubstanceName": "THERMUS THERMOPHILUS LYSATE; GLYCERIN",
      "StrengthNumber": "48.2; 2.54",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Scientifically shown to reverse years of visible premature ageing including wrinkles, sun spots and imperfections while you sleep. Problem - Everyday exposure to sunlight accounts for up to 80% of the signs of premature skin ageing. Many of these signs of 'photo-ageing' can begin to develop as early as in our 20's. Solution - Skin Doctors Photo Age Reverse Night Serum contains the revolutionary ingredient Venuceane. Rigorous tests under extreme UV exposure showed that it can reverse some of the worst signs of ageing caused by the sun. It was also seen to prevent the appearance of further photo-ageing of skin. Result - With regular use, Skin Doctors Photo Age Reverse Night Serum dramatically reduces the visible signs of premature ageing including existing wrinkles, spots and imperfections. It also helps prevent future visible skin ageing so you look younger for longer. In fact tests showed it could save up to 7 years of sun damage in just months."
    },
    {
      "NDCCode": "49203-730-02",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (49203-730-02)  > 30 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "49203-0730-02",
      "ProductNDC": "49203-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Skin Doctors Photo Age Reverse Night Serum",
      "NonProprietaryName": "Thermus Thermophilus Lysate And Glycerin",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100401",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cat Media Pty Ltd",
      "SubstanceName": "THERMUS THERMOPHILUS LYSATE; GLYCERIN",
      "StrengthNumber": "48.2; 2.54",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Scientifically shown to reverse years of visible premature ageing including wrinkles, sun spots and imperfections while you sleep. Problem - Everyday exposure to sunlight accounts for up to 80% of the signs of premature skin ageing. Many of these signs of 'photo-ageing' can begin to develop as early as in our 20's. Solution - Skin Doctors Photo Age Reverse Night Serum contains the revolutionary ingredient Venuceane. Rigorous tests under extreme UV exposure showed that it can reverse some of the worst signs of ageing caused by the sun. It was also seen to prevent the appearance of further photo-ageing of skin. Result - With regular use, Skin Doctors Photo Age Reverse Night Serum dramatically reduces the visible signs of premature ageing including existing wrinkles, spots and imperfections. It also helps prevent future visible skin ageing so you look younger for longer. In fact tests showed it could save up to 7 years of sun damage in just months."
    },
    {
      "NDCCode": "49203-710-01",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (49203-710-01)  > 50 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "49203-0710-01",
      "ProductNDC": "49203-710",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Skin Active",
      "ProprietaryNameSuffix": "Intensive Day",
      "NonProprietaryName": "Octocrylene, Avobenzone, Oxybenzone, And Ensulizole",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110701",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Cat Media Pty Ltd",
      "SubstanceName": "OCTOCRYLENE; AVOBENZONE; OXYBENZONE; ENSULIZOLE",
      "StrengthNumber": "49.7; 19.9; 9.9; 9.9",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
    },
    {
      "NDCCode": "49203-740-01",
      "PackageDescription": "1 JAR in 1 CARTON (49203-740-01)  > 50 mL in 1 JAR",
      "NDC11Code": "49203-0740-01",
      "ProductNDC": "49203-740",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Skin Doctors Photo Age Reverse",
      "NonProprietaryName": "Thermus Thermophilus Lysate And Glycerin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100401",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cat Media Pty Ltd",
      "SubstanceName": "THERMUS THERMOPHILUS LYSATE; GLYCERIN",
      "StrengthNumber": "46.1; 2.4",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Scientifically shown to reverse years of visible premature ageing including wrinkles, sun spots and imperfections. Problem - Everyday exposure to sunlight accounts for up to 80% of the signs of premature skin ageing. Many of these signs of 'photo-ageing' can begin to develop as early as in our 20's. Solution - Photo Age Reverse contains the revolutionary ingredient Venuceane. Rigorous tests under extreme UV exposure showed that it can reverse some of the worst signs of ageing caused by the sun. It was also seen to prevent the appearance of further photo-ageing of skin. Result - With regular use, Photo Age Reverse dramatically reduces the visible signs of premature ageing including existing wrinkles, spots and imperfections. It also helps prevent visible skin ageing so you look younger for longer. In fact tests showed it could save up to 5 years of visible skin ageing in just months."
    },
    {
      "NDCCode": "10135-730-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (10135-730-01) ",
      "NDC11Code": "10135-0730-01",
      "ProductNDC": "10135-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mexiletine Hydrochloride",
      "NonProprietaryName": "Mexiletine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213500",
      "LabelerName": "Marlex Pharmaceuticals, Inc.",
      "SubstanceName": "MEXILETINE HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20220201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mexiletine hydrochloride capsules, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life- threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
      "Description": "Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white to off-white crystalline powder with slightly bitter taste, freely soluble in water and in alcohol. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1- methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is. C 11H 17NO·HCl. Mol. Wt. 215.72. Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate and pregelatinized corn starch. The capsule shell contains: FD&C Yellow #6, gelatin and titanium dioxide. The 150 mg capsule also contains: yellow iron oxide, red iron oxide and black iron oxide. The 250 mg capsule also contains: FD&C Blue #1 and D&C Yellow #10. The imprinting ink contains: ammonium hydroxide, black iron oxide, propylene glycol and shellac."
    },
    {
      "NDCCode": "16714-730-01",
      "PackageDescription": "15 g in 1 TUBE (16714-730-01) ",
      "NDC11Code": "16714-0730-01",
      "ProductNDC": "16714-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobetasol Propionate",
      "NonProprietaryName": "Clobetasol Propionate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19960930",
      "EndMarketingDate": "20221231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074392",
      "LabelerName": "Northstar RxLLC",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20171106",
      "EndMarketingDatePackage": "20221231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "23155-730-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (23155-730-01) ",
      "NDC11Code": "23155-0730-01",
      "ProductNDC": "23155-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nadolol",
      "NonProprietaryName": "Nadolol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200710",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074229",
      "LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
      "SubstanceName": "NADOLOL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200710",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "24658-730-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (24658-730-01) ",
      "NDC11Code": "24658-0730-01",
      "ProductNDC": "24658-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Guanfacine",
      "NonProprietaryName": "Guanfacine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074673",
      "LabelerName": "PuraCap Laboratories LLC dba Blu Pharmaceuticals",
      "SubstanceName": "GUANFACINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Guanfacine hydrochloride tablets are indicated in the management of hypertension. Guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.",
      "Description": "Guanfacine hydrochloride is a centrally acting antihypertensive with α 2-adrenoceptor agonist properties in tablet form for oral administration. The chemical name of guanfacine hydrochloride is N-Amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride and its molecular weight is 282.55. Its structural formula is. Guanfacine hydrochloride is a white to off-white powder; sparingly soluble in water and alcohol and slightly soluble in acetone. Each tablet, for oral administration, contains guanfacine hydrochloride equivalent to 1 mg or 2 mg guanfacine. The tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, partially pregelatinized starch, magnesium stearate and talc. The 2 mg tablet also contains D&C Yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "46581-730-01",
      "PackageDescription": "1 PATCH in 1 POUCH (46581-730-01)  > 1.05 g in 1 PATCH",
      "NDC11Code": "46581-0730-01",
      "ProductNDC": "46581-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Salonpas",
      "ProprietaryNameSuffix": "Pain Relieving Hot",
      "NonProprietaryName": "Capsaicin",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Hisamitsu Pharmaceutical Co., Inc.",
      "SubstanceName": "CAPSICUM",
      "StrengthNumber": ".025",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2021-10-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20120101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "47781-730-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (47781-730-01) ",
      "NDC11Code": "47781-0730-01",
      "ProductNDC": "47781-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vancomycin Hydrochloride",
      "NonProprietaryName": "Vancomycin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120409",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065490",
      "LabelerName": "Alvogen Inc.",
      "SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Glycopeptide Antibacterial [EPC],Glycopeptides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20120409",
      "EndMarketingDatePackage": "20201231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49527-730-01",
      "PackageDescription": "1 JAR in 1 CARTON (49527-730-01)  > 50 mL in 1 JAR (49527-730-02)",
      "NDC11Code": "49527-0730-01",
      "ProductNDC": "49527-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Youth Surge",
      "ProprietaryNameSuffix": "Spf 15 Age Decelerating Moisturizer Dry Combination Skin",
      "NonProprietaryName": "Octinoxate Octisalate Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CLINIQUE LABORATORIES INC",
      "SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "7.5; 3.5; 1.2",
      "StrengthUnit": "mL/100mL; mL/100mL; mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "50580-730-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-730-01)  / 30 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "50580-0730-01",
      "ProductNDC": "50580-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Childrens Zyrtec",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022155",
      "LabelerName": "Kenvue Brands LLC",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170116",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "53208-730-02",
      "PackageDescription": "1 CONTAINER in 1 CARTON (53208-730-02)  / 18 g in 1 CONTAINER (53208-730-01) ",
      "NDC11Code": "53208-0730-02",
      "ProductNDC": "53208-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Belif Aqua Bomb - Glow Sunstick Spf50",
      "NonProprietaryName": "Homosalate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250414",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "LG H&H CO., LTD.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE",
      "StrengthNumber": "2.7; 9.5; 5; 4.5",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250414",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55111-730-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (55111-730-01) ",
      "NDC11Code": "55111-0730-01",
      "ProductNDC": "55111-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Allopurinol",
      "NonProprietaryName": "Allopurinol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071587",
      "LabelerName": "Dr. Reddy's Laboratories Limited",
      "SubstanceName": "ALLOPURINOL",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20091001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allopurinol Tablets is indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables).",
      "Description": "Allopurinol Tablets is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1,5-dihydro-4H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. It is available in 100 mg and 300 mg strengths. Inactive Ingredients: lactose, magnesium stearate, starch, povidone. Its solubility in water at 37°C is 800 mg/mL and is greater in an alkaline solution."
    },
    {
      "NDCCode": "55289-730-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-730-01) ",
      "NDC11Code": "55289-0730-01",
      "ProductNDC": "55289-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amitriptyline Hydrochloride",
      "NonProprietaryName": "Amitriptyline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970911",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040218",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20100413",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55513-730-01",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (55513-730-01)  / 1.7 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "55513-0730-01",
      "ProductNDC": "55513-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Xgeva",
      "NonProprietaryName": "Denosumab",
      "DosageFormName": "INJECTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20101118",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125320",
      "LabelerName": "Amgen, Inc",
      "SubstanceName": "DENOSUMAB",
      "StrengthNumber": "120",
      "StrengthUnit": "mg/1.7mL",
      "Pharm_Classes": "RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Xgeva is a RANK ligand (RANKL) inhibitor indicated for: 1 Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. (1.1), 2 Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. (1.2, 14.3), 3 Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. (1.3).",
      "Description": "Denosumab is a human IgG2 monoclonal antibody that binds to human RANKL. Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Xgeva (denosumab) injection is a sterile, preservative-free, clear, colorless to pale yellow solution. Each single-dose vial contains 1.7 mL solution of 120 mg denosumab, glacial acetic acid (1.8 mg), polysorbate 20 (0.17 mg), sorbitol (78.1 mg), Water for Injection (USP), and sodium hydroxide to adjust the pH to 5.2."
    },
    {
      "NDCCode": "55614-730-01",
      "PackageDescription": "1 POUCH in 1 BOX (55614-730-01)  / 5 PLASTER in 1 POUCH",
      "NDC11Code": "55614-0730-01",
      "ProductNDC": "55614-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "E Mei Shan Medicated",
      "NonProprietaryName": "Camphor And Menthol",
      "DosageFormName": "PLASTER",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20210216",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "MADISON ONE ACME INC",
      "SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL",
      "StrengthNumber": "31; 26",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Active",
      "LastUpdate": "2025-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210216",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses For the temporary relief of minor aches and pains of muscles and joints due to: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains."
    },
    {
      "NDCCode": "56136-730-01",
      "PackageDescription": "15 mL in 1 BOTTLE (56136-730-01) ",
      "NDC11Code": "56136-0730-01",
      "ProductNDC": "56136-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Brompton And Langley Moisturizing Hand Sanitizer Lavnder Vanilla",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20231016",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Ganzhou Olivee Cosmetic Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231016",
      "SamplePackage": "N",
      "IndicationAndUsage": "Antiseptic Cleanser, helps decrease bacteria on skin."
    },
    {
      "NDCCode": "58657-730-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (58657-730-01) ",
      "NDC11Code": "58657-0730-01",
      "ProductNDC": "58657-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Baclofen",
      "NonProprietaryName": "Baclofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240615",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212378",
      "LabelerName": "Method Pharmaceuticals LLC",
      "SubstanceName": "BACLOFEN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240615",
      "SamplePackage": "N",
      "IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
      "Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate."
    },
    {
      "NDCCode": "59898-730-01",
      "PackageDescription": "1728 PACKET in 1 CARTON (59898-730-01)  / .9 g in 1 PACKET",
      "NDC11Code": "59898-0730-01",
      "ProductNDC": "59898-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Water-jel Neomycin Antibiotic",
      "NonProprietaryName": "First Aid Ointment",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100331",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M004",
      "LabelerName": "Water-Jel Technologies",
      "SubstanceName": "NEOMYCIN SULFATE",
      "StrengthNumber": "3.5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100331",
      "SamplePackage": "N",
      "IndicationAndUsage": "first aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "60274-730-01",
      "PackageDescription": "58000 CAPSULE, EXTENDED RELEASE in 1 DRUM (60274-730-01) ",
      "NDC11Code": "60274-0730-01",
      "ProductNDC": "60274-730",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Dexmethylphenidate Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "StartMarketingDate": "20050531",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Societal CDMO Gainesville, LLC",
      "SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CII",
      "Status": "Unfinished",
      "LastUpdate": "2022-11-23",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "31-MAY-05"
    },
    {
      "NDCCode": "60687-730-01",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-730-01)  / 1 TABLET in 1 BLISTER PACK (60687-730-11) ",
      "NDC11Code": "60687-0730-01",
      "ProductNDC": "60687-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Meclizine Hydrochloride",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230420",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201451",
      "LabelerName": "American Health Packaging",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2025-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230420",
      "SamplePackage": "N",
      "IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
      "Description": "Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. Its molecular formula is C 25H 27ClN 22HClH 2O and its molecular weight is 481.88. It has the following structural formula:. Chemically, meclizine hydrochloride is 1-( p-chloro-α-phenylbenzyl)-4-( m-methylbenzyl) piperazine dihydrochloride monohydrate. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. Inactive ingredients for the tablets are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. The 12.5 mg tablets also contain FD&C Blue #1 Aluminum Lake. The 25 mg tablets also contain D&C Yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "61649-730-01",
      "PackageDescription": "120 g in 1 TUBE (61649-730-01) ",
      "NDC11Code": "61649-0730-01",
      "ProductNDC": "61649-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bio Spectra",
      "ProprietaryNameSuffix": "Attitude",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20240301",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "9055-7588 Quebec Inc. DBA Attitude",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".243",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2024-03-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prevents, fights and protects against cavities and tooth decay. Effective fluoride protection. Protects teeth from acid erosion. Penetrates tooth enamel to help rebuild weak spots."
    },
    {
      "NDCCode": "62157-730-01",
      "PackageDescription": "500 g in 1 JAR (62157-730-01)",
      "NDC11Code": "62157-0730-01",
      "ProductNDC": "62157-730",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Hydroxyprogesterone",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20181122",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "AX Pharmaceutical Corp",
      "SubstanceName": "HYDROXYPROGESTERONE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "62559-730-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (62559-730-01) ",
      "NDC11Code": "62559-0730-01",
      "ProductNDC": "62559-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Felbamate",
      "NonProprietaryName": "Felbamate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180904",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202284",
      "LabelerName": "ANI Pharmaceuticals, Inc.",
      "SubstanceName": "FELBAMATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-11-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180904",
      "SamplePackage": "N",
      "IndicationAndUsage": "Felbamate Tablets USP are not indicated as a first line antiepileptic treatment (see WARNINGS). Felbamate Tablets USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, Felbamate Tablets USP can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.",
      "Description": "Felbamate USP is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate USP is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate's molecular formula is C11H14N2O4; its structural formula is. The inactive ingredients for Felbamate Tablets USP, 400 mg and 600 mg are: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and iron oxide yellow."
    },
    {
      "NDCCode": "63545-699-01",
      "PackageDescription": "730 [hp_M] in 1 VIAL, GLASS (63545-699-01) ",
      "NDC11Code": "63545-0699-01",
      "ProductNDC": "63545-699",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Erbium Sulphuricum",
      "NonProprietaryName": "Erbium Sulphuricum",
      "DosageFormName": "PELLET",
      "RouteName": "BUCCAL; ORAL; SUBLINGUAL",
      "StartMarketingDate": "20180709",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, Inc.",
      "SubstanceName": "ERBIUM SULFATE OCTAHYDRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_M]/[hp_M]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180709",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63736-730-01",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (63736-730-01)  / 15 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "63736-0730-01",
      "ProductNDC": "63736-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nostrilla",
      "NonProprietaryName": "Oxymetazoline Hydrochloride",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20090608",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Insight Pharmaceuticals LLC",
      "SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
      "StrengthNumber": ".05",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090608",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves nasal congestion due to: ▪ a cold ▪ hay fever ▪ upper respiratory allergies ▪ helps clear nasal passages; shrinks swollen membranes ▪ temporarily restores freer breathing through the nose ."
    },
    {
      "NDCCode": "63868-730-01",
      "PackageDescription": "1 TUBE in 1 CARTON (63868-730-01)  / 100 g in 1 TUBE",
      "NDC11Code": "63868-0730-01",
      "ProductNDC": "63868-730",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium Topical Gel, 1%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200926",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210986",
      "LabelerName": "Chain Drug Marketing Association INC",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200926",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
    },
    {
      "NDCCode": "64380-730-02",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (64380-730-02)  / 10 CAPSULE in 1 BLISTER PACK (64380-730-01) ",
      "NDC11Code": "64380-0730-02",
      "ProductNDC": "64380-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vancomycin Hydrochloride",
      "NonProprietaryName": "Vancomycin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065490",
      "LabelerName": "Strides Pharma Science Limited",
      "SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20260101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use : 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections., 2 Orally administered vancomycin hydrochloride capsules are not effective for other types of infections.",
      "Description": "Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&C Blue No. 1, D & C Red No. 28, D & C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed. with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula."
    },
    {
      "NDCCode": "64679-730-01",
      "PackageDescription": "10 VIAL in 1 CARTON (64679-730-01)  > 10 mL in 1 VIAL (64679-730-02) ",
      "NDC11Code": "64679-0730-01",
      "ProductNDC": "64679-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fosphenytoin Sodium",
      "NonProprietaryName": "Fosphenytoin Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20070806",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078137",
      "LabelerName": "Wockhardt USA LLC.",
      "SubstanceName": "FOSPHENYTOIN SODIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-08-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20070806",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fosphenytoin sodium injection, USP is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection, USP can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection, USP should be used only when oral phenytoin administration is not possible [see  Dosage and Administration (2.4) and  Warnings and Precautions (5.2)] .",
      "Description": "Fosphenytoin sodium injection is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE . The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed in 2 mL vials containing a total of 100 mg PE and 10 mL vials containing a total of 500 mg PE, for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin sodium injection, USP is supplied in vials as a sterile solution in Water for Injection and Tromethamine (TRIS), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid or Sodium Hydroxide. Fosphenytoin sodium injection, USP is a clear, colorless sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"49203-730-01","ProprietaryName":"Skin Doctors Photo Age Reverse Night Serum","NonProprietaryName":"Thermus Thermophilus Lysate And Glycerin"},{"NDCCode":"49203-730-02","ProprietaryName":"Skin Doctors Photo Age Reverse Night Serum","NonProprietaryName":"Thermus Thermophilus Lysate And Glycerin"},{"NDCCode":"49203-710-01","ProprietaryName":"Skin Active","NonProprietaryName":"Octocrylene, Avobenzone, Oxybenzone, And Ensulizole"},{"NDCCode":"49203-740-01","ProprietaryName":"Skin Doctors Photo Age Reverse","NonProprietaryName":"Thermus Thermophilus Lysate And Glycerin"},{"NDCCode":"10135-730-01","ProprietaryName":"Mexiletine Hydrochloride","NonProprietaryName":"Mexiletine Hydrochloride"},{"NDCCode":"16714-730-01","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate"},{"NDCCode":"23155-730-01","ProprietaryName":"Nadolol","NonProprietaryName":"Nadolol"},{"NDCCode":"24658-730-01","ProprietaryName":"Guanfacine","NonProprietaryName":"Guanfacine"},{"NDCCode":"46581-730-01","ProprietaryName":"Salonpas","NonProprietaryName":"Capsaicin"},{"NDCCode":"47781-730-01","ProprietaryName":"Vancomycin Hydrochloride","NonProprietaryName":"Vancomycin Hydrochloride"},{"NDCCode":"49527-730-01","ProprietaryName":"Youth Surge","NonProprietaryName":"Octinoxate Octisalate Titanium Dioxide"},{"NDCCode":"50580-730-01","ProprietaryName":"Childrens Zyrtec","NonProprietaryName":"Cetirizine Hydrochloride"},{"NDCCode":"53208-730-02","ProprietaryName":"Belif Aqua Bomb - Glow Sunstick Spf50","NonProprietaryName":"Homosalate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane"},{"NDCCode":"55111-730-01","ProprietaryName":"Allopurinol","NonProprietaryName":"Allopurinol"},{"NDCCode":"55289-730-01","ProprietaryName":"Amitriptyline Hydrochloride","NonProprietaryName":"Amitriptyline Hydrochloride"},{"NDCCode":"55513-730-01","ProprietaryName":"Xgeva","NonProprietaryName":"Denosumab"},{"NDCCode":"55614-730-01","ProprietaryName":"E Mei Shan Medicated","NonProprietaryName":"Camphor And Menthol"},{"NDCCode":"56136-730-01","ProprietaryName":"Brompton And Langley Moisturizing Hand Sanitizer Lavnder Vanilla","NonProprietaryName":"Alcohol"},{"NDCCode":"58657-730-01","ProprietaryName":"Baclofen","NonProprietaryName":"Baclofen"},{"NDCCode":"59898-730-01","ProprietaryName":"Water-jel Neomycin Antibiotic","NonProprietaryName":"First Aid Ointment"},{"NDCCode":"60274-730-01","NonProprietaryName":"Dexmethylphenidate Hydrochloride"},{"NDCCode":"60687-730-01","ProprietaryName":"Meclizine Hydrochloride","NonProprietaryName":"Meclizine Hydrochloride"},{"NDCCode":"61649-730-01","ProprietaryName":"Bio Spectra","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"62157-730-01","NonProprietaryName":"Hydroxyprogesterone"},{"NDCCode":"62559-730-01","ProprietaryName":"Felbamate","NonProprietaryName":"Felbamate"},{"NDCCode":"63545-699-01","ProprietaryName":"Erbium Sulphuricum","NonProprietaryName":"Erbium Sulphuricum"},{"NDCCode":"63736-730-01","ProprietaryName":"Nostrilla","NonProprietaryName":"Oxymetazoline Hydrochloride"},{"NDCCode":"63868-730-01","ProprietaryName":"Diclofenac Sodium","NonProprietaryName":"Diclofenac Sodium Topical Gel, 1%"},{"NDCCode":"64380-730-02","ProprietaryName":"Vancomycin Hydrochloride","NonProprietaryName":"Vancomycin Hydrochloride"},{"NDCCode":"64679-730-01","ProprietaryName":"Fosphenytoin Sodium","NonProprietaryName":"Fosphenytoin Sodium"}]}
                    
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<NDCList>
  <NDC>
    <NDCCode>49203-730-01</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (49203-730-01)  &gt; 30 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>49203-0730-01</NDC11Code>
    <ProductNDC>49203-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Skin Doctors Photo Age Reverse Night Serum</ProprietaryName>
    <NonProprietaryName>Thermus Thermophilus Lysate And Glycerin</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100401</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Cat Media Pty Ltd</LabelerName>
    <SubstanceName>THERMUS THERMOPHILUS LYSATE; GLYCERIN</SubstanceName>
    <StrengthNumber>48.2; 2.54</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Scientifically shown to reverse years of visible premature ageing including wrinkles, sun spots and imperfections while you sleep. Problem - Everyday exposure to sunlight accounts for up to 80% of the signs of premature skin ageing. Many of these signs of 'photo-ageing' can begin to develop as early as in our 20's. Solution - Skin Doctors Photo Age Reverse Night Serum contains the revolutionary ingredient Venuceane. Rigorous tests under extreme UV exposure showed that it can reverse some of the worst signs of ageing caused by the sun. It was also seen to prevent the appearance of further photo-ageing of skin. Result - With regular use, Skin Doctors Photo Age Reverse Night Serum dramatically reduces the visible signs of premature ageing including existing wrinkles, spots and imperfections. It also helps prevent future visible skin ageing so you look younger for longer. In fact tests showed it could save up to 7 years of sun damage in just months.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49203-730-02</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (49203-730-02)  &gt; 30 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>49203-0730-02</NDC11Code>
    <ProductNDC>49203-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Skin Doctors Photo Age Reverse Night Serum</ProprietaryName>
    <NonProprietaryName>Thermus Thermophilus Lysate And Glycerin</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100401</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Cat Media Pty Ltd</LabelerName>
    <SubstanceName>THERMUS THERMOPHILUS LYSATE; GLYCERIN</SubstanceName>
    <StrengthNumber>48.2; 2.54</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Scientifically shown to reverse years of visible premature ageing including wrinkles, sun spots and imperfections while you sleep. Problem - Everyday exposure to sunlight accounts for up to 80% of the signs of premature skin ageing. Many of these signs of 'photo-ageing' can begin to develop as early as in our 20's. Solution - Skin Doctors Photo Age Reverse Night Serum contains the revolutionary ingredient Venuceane. Rigorous tests under extreme UV exposure showed that it can reverse some of the worst signs of ageing caused by the sun. It was also seen to prevent the appearance of further photo-ageing of skin. Result - With regular use, Skin Doctors Photo Age Reverse Night Serum dramatically reduces the visible signs of premature ageing including existing wrinkles, spots and imperfections. It also helps prevent future visible skin ageing so you look younger for longer. In fact tests showed it could save up to 7 years of sun damage in just months.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49203-710-01</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (49203-710-01)  &gt; 50 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>49203-0710-01</NDC11Code>
    <ProductNDC>49203-710</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Skin Active</ProprietaryName>
    <ProprietaryNameSuffix>Intensive Day</ProprietaryNameSuffix>
    <NonProprietaryName>Octocrylene, Avobenzone, Oxybenzone, And Ensulizole</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Cat Media Pty Ltd</LabelerName>
    <SubstanceName>OCTOCRYLENE; AVOBENZONE; OXYBENZONE; ENSULIZOLE</SubstanceName>
    <StrengthNumber>49.7; 19.9; 9.9; 9.9</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49203-740-01</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (49203-740-01)  &gt; 50 mL in 1 JAR</PackageDescription>
    <NDC11Code>49203-0740-01</NDC11Code>
    <ProductNDC>49203-740</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Skin Doctors Photo Age Reverse</ProprietaryName>
    <NonProprietaryName>Thermus Thermophilus Lysate And Glycerin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100401</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Cat Media Pty Ltd</LabelerName>
    <SubstanceName>THERMUS THERMOPHILUS LYSATE; GLYCERIN</SubstanceName>
    <StrengthNumber>46.1; 2.4</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Scientifically shown to reverse years of visible premature ageing including wrinkles, sun spots and imperfections. Problem - Everyday exposure to sunlight accounts for up to 80% of the signs of premature skin ageing. Many of these signs of 'photo-ageing' can begin to develop as early as in our 20's. Solution - Photo Age Reverse contains the revolutionary ingredient Venuceane. Rigorous tests under extreme UV exposure showed that it can reverse some of the worst signs of ageing caused by the sun. It was also seen to prevent the appearance of further photo-ageing of skin. Result - With regular use, Photo Age Reverse dramatically reduces the visible signs of premature ageing including existing wrinkles, spots and imperfections. It also helps prevent visible skin ageing so you look younger for longer. In fact tests showed it could save up to 5 years of visible skin ageing in just months.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10135-730-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (10135-730-01) </PackageDescription>
    <NDC11Code>10135-0730-01</NDC11Code>
    <ProductNDC>10135-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mexiletine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Mexiletine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213500</ApplicationNumber>
    <LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MEXILETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mexiletine hydrochloride capsules, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life- threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
    <Description>Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white to off-white crystalline powder with slightly bitter taste, freely soluble in water and in alcohol. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1- methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is. C 11H 17NO·HCl. Mol. Wt. 215.72. Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate and pregelatinized corn starch. The capsule shell contains: FD&amp;C Yellow #6, gelatin and titanium dioxide. The 150 mg capsule also contains: yellow iron oxide, red iron oxide and black iron oxide. The 250 mg capsule also contains: FD&amp;C Blue #1 and D&amp;C Yellow #10. The imprinting ink contains: ammonium hydroxide, black iron oxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-730-01</NDCCode>
    <PackageDescription>15 g in 1 TUBE (16714-730-01) </PackageDescription>
    <NDC11Code>16714-0730-01</NDC11Code>
    <ProductNDC>16714-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19960930</StartMarketingDate>
    <EndMarketingDate>20221231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074392</ApplicationNumber>
    <LabelerName>Northstar RxLLC</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20171106</StartMarketingDatePackage>
    <EndMarketingDatePackage>20221231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>23155-730-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (23155-730-01) </PackageDescription>
    <NDC11Code>23155-0730-01</NDC11Code>
    <ProductNDC>23155-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nadolol</ProprietaryName>
    <NonProprietaryName>Nadolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200710</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074229</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>NADOLOL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-10-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200710</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>24658-730-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (24658-730-01) </PackageDescription>
    <NDC11Code>24658-0730-01</NDC11Code>
    <ProductNDC>24658-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Guanfacine</ProprietaryName>
    <NonProprietaryName>Guanfacine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074673</ApplicationNumber>
    <LabelerName>PuraCap Laboratories LLC dba Blu Pharmaceuticals</LabelerName>
    <SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Guanfacine hydrochloride tablets are indicated in the management of hypertension. Guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
    <Description>Guanfacine hydrochloride is a centrally acting antihypertensive with α 2-adrenoceptor agonist properties in tablet form for oral administration. The chemical name of guanfacine hydrochloride is N-Amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride and its molecular weight is 282.55. Its structural formula is. Guanfacine hydrochloride is a white to off-white powder; sparingly soluble in water and alcohol and slightly soluble in acetone. Each tablet, for oral administration, contains guanfacine hydrochloride equivalent to 1 mg or 2 mg guanfacine. The tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, partially pregelatinized starch, magnesium stearate and talc. The 2 mg tablet also contains D&amp;C Yellow #10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>46581-730-01</NDCCode>
    <PackageDescription>1 PATCH in 1 POUCH (46581-730-01)  &gt; 1.05 g in 1 PATCH</PackageDescription>
    <NDC11Code>46581-0730-01</NDC11Code>
    <ProductNDC>46581-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Salonpas</ProprietaryName>
    <ProprietaryNameSuffix>Pain Relieving Hot</ProprietaryNameSuffix>
    <NonProprietaryName>Capsaicin</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Hisamitsu Pharmaceutical Co., Inc.</LabelerName>
    <SubstanceName>CAPSICUM</SubstanceName>
    <StrengthNumber>.025</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>47781-730-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (47781-730-01) </PackageDescription>
    <NDC11Code>47781-0730-01</NDC11Code>
    <ProductNDC>47781-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120409</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065490</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC],Glycopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120409</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49527-730-01</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (49527-730-01)  &gt; 50 mL in 1 JAR (49527-730-02)</PackageDescription>
    <NDC11Code>49527-0730-01</NDC11Code>
    <ProductNDC>49527-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Youth Surge</ProprietaryName>
    <ProprietaryNameSuffix>Spf 15 Age Decelerating Moisturizer Dry Combination Skin</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate Octisalate Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CLINIQUE LABORATORIES INC</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>7.5; 3.5; 1.2</StrengthNumber>
    <StrengthUnit>mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>50580-730-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-730-01)  / 30 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>50580-0730-01</NDC11Code>
    <ProductNDC>50580-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Childrens Zyrtec</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022155</ApplicationNumber>
    <LabelerName>Kenvue Brands LLC</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>53208-730-02</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (53208-730-02)  / 18 g in 1 CONTAINER (53208-730-01) </PackageDescription>
    <NDC11Code>53208-0730-02</NDC11Code>
    <ProductNDC>53208-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Belif Aqua Bomb - Glow Sunstick Spf50</ProprietaryName>
    <NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250414</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>LG H&amp;H CO., LTD.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE</SubstanceName>
    <StrengthNumber>2.7; 9.5; 5; 4.5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55111-730-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (55111-730-01) </PackageDescription>
    <NDC11Code>55111-0730-01</NDC11Code>
    <ProductNDC>55111-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Allopurinol</ProprietaryName>
    <NonProprietaryName>Allopurinol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071587</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>ALLOPURINOL</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allopurinol Tablets is indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables).</IndicationAndUsage>
    <Description>Allopurinol Tablets is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1,5-dihydro-4H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. It is available in 100 mg and 300 mg strengths. Inactive Ingredients: lactose, magnesium stearate, starch, povidone. Its solubility in water at 37°C is 800 mg/mL and is greater in an alkaline solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-730-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-730-01) </PackageDescription>
    <NDC11Code>55289-0730-01</NDC11Code>
    <ProductNDC>55289-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970911</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040218</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55513-730-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (55513-730-01)  / 1.7 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>55513-0730-01</NDC11Code>
    <ProductNDC>55513-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xgeva</ProprietaryName>
    <NonProprietaryName>Denosumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20101118</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125320</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>DENOSUMAB</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1.7mL</StrengthUnit>
    <Pharm_Classes>RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xgeva is a RANK ligand (RANKL) inhibitor indicated for: 1 Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. (1.1), 2 Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. (1.2, 14.3), 3 Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. (1.3).</IndicationAndUsage>
    <Description>Denosumab is a human IgG2 monoclonal antibody that binds to human RANKL. Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Xgeva (denosumab) injection is a sterile, preservative-free, clear, colorless to pale yellow solution. Each single-dose vial contains 1.7 mL solution of 120 mg denosumab, glacial acetic acid (1.8 mg), polysorbate 20 (0.17 mg), sorbitol (78.1 mg), Water for Injection (USP), and sodium hydroxide to adjust the pH to 5.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>55614-730-01</NDCCode>
    <PackageDescription>1 POUCH in 1 BOX (55614-730-01)  / 5 PLASTER in 1 POUCH</PackageDescription>
    <NDC11Code>55614-0730-01</NDC11Code>
    <ProductNDC>55614-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>E Mei Shan Medicated</ProprietaryName>
    <NonProprietaryName>Camphor And Menthol</NonProprietaryName>
    <DosageFormName>PLASTER</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20210216</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>MADISON ONE ACME INC</LabelerName>
    <SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL</SubstanceName>
    <StrengthNumber>31; 26</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses For the temporary relief of minor aches and pains of muscles and joints due to: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>56136-730-01</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE (56136-730-01) </PackageDescription>
    <NDC11Code>56136-0730-01</NDC11Code>
    <ProductNDC>56136-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Brompton And Langley Moisturizing Hand Sanitizer Lavnder Vanilla</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231016</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Ganzhou Olivee Cosmetic Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-10-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Antiseptic Cleanser, helps decrease bacteria on skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58657-730-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (58657-730-01) </PackageDescription>
    <NDC11Code>58657-0730-01</NDC11Code>
    <ProductNDC>58657-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Baclofen</ProprietaryName>
    <NonProprietaryName>Baclofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240615</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212378</ApplicationNumber>
    <LabelerName>Method Pharmaceuticals LLC</LabelerName>
    <SubstanceName>BACLOFEN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
    <Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>59898-730-01</NDCCode>
    <PackageDescription>1728 PACKET in 1 CARTON (59898-730-01)  / .9 g in 1 PACKET</PackageDescription>
    <NDC11Code>59898-0730-01</NDC11Code>
    <ProductNDC>59898-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Water-jel Neomycin Antibiotic</ProprietaryName>
    <NonProprietaryName>First Aid Ointment</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M004</ApplicationNumber>
    <LabelerName>Water-Jel Technologies</LabelerName>
    <SubstanceName>NEOMYCIN SULFATE</SubstanceName>
    <StrengthNumber>3.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>first aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60274-730-01</NDCCode>
    <PackageDescription>58000 CAPSULE, EXTENDED RELEASE in 1 DRUM (60274-730-01) </PackageDescription>
    <NDC11Code>60274-0730-01</NDC11Code>
    <ProductNDC>60274-730</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <StartMarketingDate>20050531</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Societal CDMO Gainesville, LLC</LabelerName>
    <SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2022-11-23</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-MAY-05</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>60687-730-01</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (60687-730-01)  / 1 TABLET in 1 BLISTER PACK (60687-730-11) </PackageDescription>
    <NDC11Code>60687-0730-01</NDC11Code>
    <ProductNDC>60687-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230420</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201451</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
    <Description>Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. Its molecular formula is C 25H 27ClN 22HClH 2O and its molecular weight is 481.88. It has the following structural formula:. Chemically, meclizine hydrochloride is 1-( p-chloro-α-phenylbenzyl)-4-( m-methylbenzyl) piperazine dihydrochloride monohydrate. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. Inactive ingredients for the tablets are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. The 12.5 mg tablets also contain FD&amp;C Blue #1 Aluminum Lake. The 25 mg tablets also contain D&amp;C Yellow #10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>61649-730-01</NDCCode>
    <PackageDescription>120 g in 1 TUBE (61649-730-01) </PackageDescription>
    <NDC11Code>61649-0730-01</NDC11Code>
    <ProductNDC>61649-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bio Spectra</ProprietaryName>
    <ProprietaryNameSuffix>Attitude</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>GEL, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20240301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>9055-7588 Quebec Inc. DBA Attitude</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.243</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-03-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prevents, fights and protects against cavities and tooth decay. Effective fluoride protection. Protects teeth from acid erosion. Penetrates tooth enamel to help rebuild weak spots.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62157-730-01</NDCCode>
    <PackageDescription>500 g in 1 JAR (62157-730-01)</PackageDescription>
    <NDC11Code>62157-0730-01</NDC11Code>
    <ProductNDC>62157-730</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Hydroxyprogesterone</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20181122</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AX Pharmaceutical Corp</LabelerName>
    <SubstanceName>HYDROXYPROGESTERONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62559-730-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (62559-730-01) </PackageDescription>
    <NDC11Code>62559-0730-01</NDC11Code>
    <ProductNDC>62559-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felbamate</ProprietaryName>
    <NonProprietaryName>Felbamate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180904</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202284</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FELBAMATE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180904</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Felbamate Tablets USP are not indicated as a first line antiepileptic treatment (see WARNINGS). Felbamate Tablets USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, Felbamate Tablets USP can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.</IndicationAndUsage>
    <Description>Felbamate USP is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate USP is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate's molecular formula is C11H14N2O4; its structural formula is. The inactive ingredients for Felbamate Tablets USP, 400 mg and 600 mg are: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>63545-699-01</NDCCode>
    <PackageDescription>730 [hp_M] in 1 VIAL, GLASS (63545-699-01) </PackageDescription>
    <NDC11Code>63545-0699-01</NDC11Code>
    <ProductNDC>63545-699</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Erbium Sulphuricum</ProprietaryName>
    <NonProprietaryName>Erbium Sulphuricum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>BUCCAL; ORAL; SUBLINGUAL</RouteName>
    <StartMarketingDate>20180709</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
    <SubstanceName>ERBIUM SULFATE OCTAHYDRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_M]/[hp_M]</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63736-730-01</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (63736-730-01)  / 15 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>63736-0730-01</NDC11Code>
    <ProductNDC>63736-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nostrilla</ProprietaryName>
    <NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20090608</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Insight Pharmaceuticals LLC</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090608</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves nasal congestion due to: ▪ a cold ▪ hay fever ▪ upper respiratory allergies ▪ helps clear nasal passages; shrinks swollen membranes ▪ temporarily restores freer breathing through the nose .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63868-730-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (63868-730-01)  / 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>63868-0730-01</NDC11Code>
    <ProductNDC>63868-730</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200926</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210986</ApplicationNumber>
    <LabelerName>Chain Drug Marketing Association INC</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64380-730-02</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (64380-730-02)  / 10 CAPSULE in 1 BLISTER PACK (64380-730-01) </PackageDescription>
    <NDC11Code>64380-0730-02</NDC11Code>
    <ProductNDC>64380-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065490</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use : 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections., 2 Orally administered vancomycin hydrochloride capsules are not effective for other types of infections.</IndicationAndUsage>
    <Description>Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&amp;C Blue No. 1, D &amp; C Red No. 28, D &amp; C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed. with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-730-01</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (64679-730-01)  &gt; 10 mL in 1 VIAL (64679-730-02) </PackageDescription>
    <NDC11Code>64679-0730-01</NDC11Code>
    <ProductNDC>64679-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fosphenytoin Sodium</ProprietaryName>
    <NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20070806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078137</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fosphenytoin sodium injection, USP is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection, USP can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection, USP should be used only when oral phenytoin administration is not possible [see  Dosage and Administration (2.4) and  Warnings and Precautions (5.2)] .</IndicationAndUsage>
    <Description>Fosphenytoin sodium injection is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE . The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed in 2 mL vials containing a total of 100 mg PE and 10 mL vials containing a total of 500 mg PE, for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin sodium injection, USP is supplied in vials as a sterile solution in Water for Injection and Tromethamine (TRIS), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid or Sodium Hydroxide. Fosphenytoin sodium injection, USP is a clear, colorless sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>49203-730-01</NDCCode><ProprietaryName>Skin Doctors Photo Age Reverse Night Serum</ProprietaryName><NonProprietaryName>Thermus Thermophilus Lysate And Glycerin</NonProprietaryName></NDC><NDC><NDCCode>49203-730-02</NDCCode><ProprietaryName>Skin Doctors Photo Age Reverse Night Serum</ProprietaryName><NonProprietaryName>Thermus Thermophilus Lysate And Glycerin</NonProprietaryName></NDC><NDC><NDCCode>49203-710-01</NDCCode><ProprietaryName>Skin Active</ProprietaryName><NonProprietaryName>Octocrylene, Avobenzone, Oxybenzone, And Ensulizole</NonProprietaryName></NDC><NDC><NDCCode>49203-740-01</NDCCode><ProprietaryName>Skin Doctors Photo Age Reverse</ProprietaryName><NonProprietaryName>Thermus Thermophilus Lysate And Glycerin</NonProprietaryName></NDC><NDC><NDCCode>10135-730-01</NDCCode><ProprietaryName>Mexiletine Hydrochloride</ProprietaryName><NonProprietaryName>Mexiletine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16714-730-01</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>23155-730-01</NDCCode><ProprietaryName>Nadolol</ProprietaryName><NonProprietaryName>Nadolol</NonProprietaryName></NDC><NDC><NDCCode>24658-730-01</NDCCode><ProprietaryName>Guanfacine</ProprietaryName><NonProprietaryName>Guanfacine</NonProprietaryName></NDC><NDC><NDCCode>46581-730-01</NDCCode><ProprietaryName>Salonpas</ProprietaryName><NonProprietaryName>Capsaicin</NonProprietaryName></NDC><NDC><NDCCode>47781-730-01</NDCCode><ProprietaryName>Vancomycin Hydrochloride</ProprietaryName><NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49527-730-01</NDCCode><ProprietaryName>Youth Surge</ProprietaryName><NonProprietaryName>Octinoxate Octisalate Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>50580-730-01</NDCCode><ProprietaryName>Childrens Zyrtec</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>53208-730-02</NDCCode><ProprietaryName>Belif Aqua Bomb - Glow Sunstick Spf50</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane</NonProprietaryName></NDC><NDC><NDCCode>55111-730-01</NDCCode><ProprietaryName>Allopurinol</ProprietaryName><NonProprietaryName>Allopurinol</NonProprietaryName></NDC><NDC><NDCCode>55289-730-01</NDCCode><ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName><NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55513-730-01</NDCCode><ProprietaryName>Xgeva</ProprietaryName><NonProprietaryName>Denosumab</NonProprietaryName></NDC><NDC><NDCCode>55614-730-01</NDCCode><ProprietaryName>E Mei Shan Medicated</ProprietaryName><NonProprietaryName>Camphor And Menthol</NonProprietaryName></NDC><NDC><NDCCode>56136-730-01</NDCCode><ProprietaryName>Brompton And Langley Moisturizing Hand Sanitizer Lavnder Vanilla</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>58657-730-01</NDCCode><ProprietaryName>Baclofen</ProprietaryName><NonProprietaryName>Baclofen</NonProprietaryName></NDC><NDC><NDCCode>59898-730-01</NDCCode><ProprietaryName>Water-jel Neomycin Antibiotic</ProprietaryName><NonProprietaryName>First Aid Ointment</NonProprietaryName></NDC><NDC><NDCCode>60274-730-01</NDCCode><NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>60687-730-01</NDCCode><ProprietaryName>Meclizine Hydrochloride</ProprietaryName><NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>61649-730-01</NDCCode><ProprietaryName>Bio Spectra</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>62157-730-01</NDCCode><NonProprietaryName>Hydroxyprogesterone</NonProprietaryName></NDC><NDC><NDCCode>62559-730-01</NDCCode><ProprietaryName>Felbamate</ProprietaryName><NonProprietaryName>Felbamate</NonProprietaryName></NDC><NDC><NDCCode>63545-699-01</NDCCode><ProprietaryName>Erbium Sulphuricum</ProprietaryName><NonProprietaryName>Erbium Sulphuricum</NonProprietaryName></NDC><NDC><NDCCode>63736-730-01</NDCCode><ProprietaryName>Nostrilla</ProprietaryName><NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63868-730-01</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName></NDC><NDC><NDCCode>64380-730-02</NDCCode><ProprietaryName>Vancomycin Hydrochloride</ProprietaryName><NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>64679-730-01</NDCCode><ProprietaryName>Fosphenytoin Sodium</ProprietaryName><NonProprietaryName>Fosphenytoin Sodium</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.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) 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.
    • 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.
  • 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.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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();
    }
}
            
        

Output

            
{
  "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",
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      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
{
  "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",
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}
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