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RESTful Lookup — Test-Drive (2007 – 2026)

How to Find 78082-026-03 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "78082-026-03",
      "PackageDescription": "150 CLOTH in 1 BAG (78082-026-03) ",
      "NDC11Code": "78082-0026-03",
      "ProductNDC": "78082-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcohol Wipes 75% Alcohol",
      "NonProprietaryName": "Honour Hand Sanitizing Wipes 75% Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210518",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "PICO INC.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/1001",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20210518",
      "SamplePackage": "N",
      "IndicationAndUsage": "Open the lid and the sticker, pull out the wipes needed and then press the sticker back and close the lid to avoid alcohol evaporation."
    },
    {
      "NDCCode": "78082-026-01",
      "PackageDescription": "300 CLOTH in 1 BAG (78082-026-01) ",
      "NDC11Code": "78082-0026-01",
      "ProductNDC": "78082-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcohol Wipes 75% Alcohol",
      "NonProprietaryName": "Honour Hand Sanitizing Wipes 75% Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210518",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "PICO INC.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/1001",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20210518",
      "SamplePackage": "N",
      "IndicationAndUsage": "Open the lid and the sticker, pull out the wipes needed and then press the sticker back and close the lid to avoid alcohol evaporation."
    },
    {
      "NDCCode": "78082-026-02",
      "PackageDescription": "800 CLOTH in 1 BAG (78082-026-02) ",
      "NDC11Code": "78082-0026-02",
      "ProductNDC": "78082-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcohol Wipes 75% Alcohol",
      "NonProprietaryName": "Honour Hand Sanitizing Wipes 75% Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210518",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "PICO INC.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/1001",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20210518",
      "SamplePackage": "N",
      "IndicationAndUsage": "Open the lid and the sticker, pull out the wipes needed and then press the sticker back and close the lid to avoid alcohol evaporation."
    },
    {
      "NDCCode": "10702-026-03",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (10702-026-03) ",
      "NDC11Code": "10702-0026-03",
      "ProductNDC": "10702-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phentermine Hydrochloride",
      "NonProprietaryName": "Phentermine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120807",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040886",
      "LabelerName": "KVK-Tech, Inc.",
      "SubstanceName": "PHENTERMINE HYDROCHLORIDE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-04-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120807",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phentermine Hydrochloride, USP 15 mg and 30 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [ see CLINICAL PHARMACOLOGY (12.1,12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
      "Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine Hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&C Yellow #10, FD&C Blue #1, FD&C Red #3, FD&C Red #40, titanium dioxide and the 30 mg capsules contain D&C Yellow #10, FD&C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&C blue #1/Brilliant blue FCF Aluminum Lake, D&C red #28 and gelatin."
    },
    {
      "NDCCode": "13537-026-04",
      "PackageDescription": "1 TUBE in 1 BOX (13537-026-04)  > 10 mL in 1 TUBE (13537-026-03)",
      "NDC11Code": "13537-0026-04",
      "ProductNDC": "13537-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel",
      "ProprietaryNameSuffix": "Protege Expert",
      "NonProprietaryName": "Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110810",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation Ltd.",
      "SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE",
      "StrengthNumber": ".075; .05; .06; .0234",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn. Retains SPF after 40 minutes of activity in the water."
    },
    {
      "NDCCode": "14445-026-03",
      "PackageDescription": "5 kg in 1 DRUM (14445-026-03) ",
      "NDC11Code": "14445-0026-03",
      "ProductNDC": "14445-026",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Rivaroxaban",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240315",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Indoco Remedies Limited",
      "SubstanceName": "RIVAROXABAN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-05-22",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "15-MAR-24"
    },
    {
      "NDCCode": "24338-026-03",
      "PackageDescription": "30 TABLET in 1 BOTTLE (24338-026-03) ",
      "NDC11Code": "24338-0026-03",
      "ProductNDC": "24338-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Evekeo",
      "NonProprietaryName": "Amphetamine Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200166",
      "LabelerName": "Azurity Pharmaceuticals, Inc.",
      "SubstanceName": "AMPHETAMINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-10-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210312",
      "SamplePackage": "N",
      "IndicationAndUsage": "Evekeo® (amphetamine sulfate tablets, USP) is indicated for: : 1 Narcolepsy, 2 Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .",
      "Description": "Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1. Structural Formula. C18H28N2SO4                 MW 368.49."
    },
    {
      "NDCCode": "42385-026-03",
      "PackageDescription": ".2 kg in 1 DRUM (42385-026-03)",
      "NDC11Code": "42385-0026-03",
      "ProductNDC": "42385-026",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Oxaliplatin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20080301",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Aptuit Laurus Private Limited",
      "SubstanceName": "OXALIPLATIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "43116-026-03",
      "PackageDescription": "40 CLOTH in 1 BAG (43116-026-03) ",
      "NDC11Code": "43116-0026-03",
      "ProductNDC": "43116-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shierjie Disinfecting Soft Wipes Antibacterial",
      "NonProprietaryName": "Shierjie Disinfecting Soft Wipes Antibacterial",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200331",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Shenzhen Shierjie Biological Engineering Co., LTD",
      "SubstanceName": "BENZALKONIUM CHLORIDE; DIDECYLDIMONIUM CHLORIDE",
      "StrengthNumber": ".09; .04",
      "StrengthUnit": "g/1001; g/1001",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decreases bacteria on skin."
    },
    {
      "NDCCode": "49967-026-03",
      "PackageDescription": "4 mL in 1 BOTTLE (49967-026-03) ",
      "NDC11Code": "49967-0026-03",
      "ProductNDC": "49967-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "It Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "L'Oreal USA Products Inc",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220401",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the treatment of acne. helps prevent new acne blemishes from forming."
    },
    {
      "NDCCode": "50017-026-04",
      "PackageDescription": "1 TUBE in 1 BOX (50017-026-04)  > 50 g in 1 TUBE (50017-026-03) ",
      "NDC11Code": "50017-0026-04",
      "ProductNDC": "50017-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neat 3b Baby B Diaper",
      "NonProprietaryName": "Skin Protectant",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130407",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "Neat Feat Products Limited",
      "SubstanceName": "ZINC ACETATE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/50g",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20130407",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52682-026-03",
      "PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (52682-026-03)",
      "NDC11Code": "52682-0026-03",
      "ProductNDC": "52682-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
      "NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110808",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040883",
      "LabelerName": "Mirror Pharmaceuticals LLC",
      "SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
      "StrengthNumber": "50; 500; 40",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-27",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "52862-026-03",
      "PackageDescription": "119 mL in 1 BOTTLE, PLASTIC (52862-026-03) ",
      "NDC11Code": "52862-0026-03",
      "ProductNDC": "52862-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Rubbing Alcohol 99% With Wintergreen",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200618",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Home Smart Products",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "99",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200618",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 to decrease germs in minor cuts and scrapes, 2 helps relieve minor muscular aches due to exertion."
    },
    {
      "NDCCode": "52959-026-03",
      "PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (52959-026-03)",
      "NDC11Code": "52959-0026-03",
      "ProductNDC": "52959-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carisoprodol",
      "NonProprietaryName": "Carisoprodol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040124",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "CARISOPRODOL",
      "StrengthNumber": "350",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see DOSAGE AND ADMINISTRATION (2)].",
      "Description": "Carisoprodol Tablets are available as 350 mg round, white tablets.  Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste.  It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH.  Carisoprodol is present as a racemic mixture.  Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33.   The structural formula is. Other Ingredients:  colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, methylcellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid."
    },
    {
      "NDCCode": "55319-026-03",
      "PackageDescription": "1 POUCH in 1 CARTON (55319-026-03)  > 3 PATCH in 1 POUCH",
      "NDC11Code": "55319-0026-03",
      "ProductNDC": "55319-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Family Wellness Cold And Hot Pain Relief",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121130",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "FAMILY DOLLAR",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Directions. adults and children over 12 years: 1 carefully remove backing from patch, 2 apply sticky side of patch to affected area."
    },
    {
      "NDCCode": "56136-026-03",
      "PackageDescription": "300 mL in 1 BOTTLE, PUMP (56136-026-03) ",
      "NDC11Code": "56136-0026-03",
      "ProductNDC": "56136-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizepx Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200508",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Ganzhou Olivee Cosmetic Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-05-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200508",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "60290-026-03",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (60290-026-03) ",
      "NDC11Code": "60290-0026-03",
      "ProductNDC": "60290-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208847",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure [see Dosage and Administration ( 2)] . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs. Limitations of Use Olmesartan medoxomil and hydrochlorothiazide tablets is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT 1subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 1H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2’-1H-Tetrazol-5yl)[1, 1’-Biphenyl]-4-yl]Methyl]-, (5-Methyl-2-Oxo-1, 3-Dioxol-4-yl) Methyl Ester. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil is a white to off white powder with a molecular weight of 558.59. It is slightly soluble in acetone and methanol, very slightly soluble in ethanol and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2and its structural formula is:. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. Hydrochlorothiazide is freely soluble in sodium hydroxide solution, in n-butyl amine and in dimethylformamide; very slightly soluble in water, sparingly soluble in methanol, insoluble in ether, in chloroform and in dilute mineral acids. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxy propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide."
    },
    {
      "NDCCode": "63545-026-03",
      "PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (63545-026-03) ",
      "NDC11Code": "63545-0026-03",
      "ProductNDC": "63545-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antimonium Metallicum",
      "NonProprietaryName": "Anitmonium Metallicum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210115",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, Inc.",
      "SubstanceName": "ANTIMONY",
      "StrengthNumber": "6",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "64232-026-03",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (64232-026-03)  > 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "64232-0026-03",
      "ProductNDC": "64232-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Candidasan",
      "NonProprietaryName": "Candida Parapsilosis",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180109",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "sanPharma GmbH",
      "SubstanceName": "CANDIDA PARAPSILOSIS",
      "StrengthNumber": "4",
      "StrengthUnit": "[hp_X]/10mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-12-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20180709",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65852-026-03",
      "PackageDescription": "74 mL in 1 BOTTLE, WITH APPLICATOR (65852-026-03) ",
      "NDC11Code": "65852-0026-03",
      "ProductNDC": "65852-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Icequake Lidocaine Analgesic",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Dextrum Laboratories, Inc",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": "4",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-11-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indication & usage section. Use Temporarily relieves minor pain.  adults and children over 12 years. apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period: 1 children 12 years or younger: ask a doctor."
    },
    {
      "NDCCode": "66854-026-03",
      "PackageDescription": "70 mL in 1 BOTTLE (66854-026-03)",
      "NDC11Code": "66854-0026-03",
      "ProductNDC": "66854-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermaprot",
      "ProprietaryNameSuffix": "Helioprot Ab Spf 30",
      "NonProprietaryName": "Octinoxate,titanium Dioxide,oxybenzone,avobenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120630",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OXYBENZONE",
      "StrengthNumber": "7.5; 3; 2.5; 1.5",
      "StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Provides moderate protection against sun. This product is for topical application."
    },
    {
      "NDCCode": "68078-026-03",
      "PackageDescription": "10.2 g in 1 POUCH (68078-026-03) ",
      "NDC11Code": "68078-0026-03",
      "ProductNDC": "68078-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunforgettable Total Protection Body Shield",
      "NonProprietaryName": "Zinc Oxide, Sunscreen",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180612",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Colorescience",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180612",
      "SamplePackage": "Y"
    },
    {
      "NDCCode": "68981-026-03",
      "PackageDescription": "100 g in 1 JAR (68981-026-03) ",
      "NDC11Code": "68981-0026-03",
      "ProductNDC": "68981-026",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20210421",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Xenex Laboratories Inc",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "21-APR-21"
    },
    {
      "NDCCode": "69844-026-03",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (69844-026-03) ",
      "NDC11Code": "69844-0026-03",
      "ProductNDC": "69844-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amantadine Hydrochloride",
      "NonProprietaryName": "Amantadine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207570",
      "LabelerName": "Graviti Pharmaceuticals Private Limited",
      "SubstanceName": "AMANTADINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.",
      "Description": "Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H17N.HCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each capsules contains 100 mg of  amantadine hydrochloride and the following Inactive ingredients: microcrystalline cellulose, povidone,  FD&C yellow # 6 aluminum lake,  sodium starch glycolate and magnesium stearate.  The capsule shells and imprinting ink contain: gelatin, sodium lauryl sulfate, FD&C red #40, titanium dioxide, shellac, propylene glycol, strong ammonia solution and potassium hydroxide."
    },
    {
      "NDCCode": "70166-026-03",
      "PackageDescription": "15 mL in 1 SYRINGE, PLASTIC (70166-026-03) ",
      "NDC11Code": "70166-0026-03",
      "ProductNDC": "70166-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Chlorhexidine Gluconate",
      "NonProprietaryName": "Chlorhexidine Gluconate",
      "DosageFormName": "RINSE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077789",
      "LabelerName": "Lohxa",
      "SubstanceName": "CHLORHEXIDINE GLUCONATE",
      "StrengthNumber": "1.2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180403",
      "SamplePackage": "N",
      "IndicationAndUsage": "Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see  PRECAUTIONS.",
      "Description": "0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11 .6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:."
    },
    {
      "NDCCode": "70461-026-03",
      "PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (70461-026-03)  / .5 mL in 1 SYRINGE, GLASS (70461-026-04) ",
      "NDC11Code": "70461-0026-03",
      "ProductNDC": "70461-026",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluad",
      "NonProprietaryName": "Influenza A Virus A/missouri/11/2025 Ivr-279 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/michigan/105/2025 Ivr-285 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/tokyo/eis13-175/2025 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20260701",
      "EndMarketingDate": "20270731",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125510",
      "LabelerName": "Seqirus, Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/MISSOURI/11/2025 IVR-279 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/MICHIGAN/105/2025 IVR-285 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20260701",
      "EndMarketingDatePackage": "20270731",
      "SamplePackage": "N",
      "IndicationAndUsage": "FLUAD is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in adults 65 years of age and older. This indication is approved under accelerated approval based on the immune response elicited by FLUAD [see Clinical Studies (14)]. Clinical benefit of FLUAD based on efficacy has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
      "Description": "FLUAD (Influenza Vaccine, Adjuvanted), a sterile injectable emulsion for intramuscular use, is a trivalent inactivated influenza vaccine prepared from virus propagated in the allantoic cavity of embryonated hens' eggs inoculated with a specific type of influenza virus. FLUAD 0.5 mL dose is formulated to contain 15 mcg of hemagglutinin (HA) from each of the following influenza strains recommended by FDA for the 2026-2027 influenza season: A/Missouri/11/2025 IVR-279 (an A/Missouri/11/2025 (H1N1)pdm09-like virus), A/Michigan/105/2025 IVR-285 (an A/Darwin/1454/2025 (H3N2)-like virus), B/Tokyo/EIS13-175/2025 (B-Victoria lineage). FLUAD also contains MF59C.1 adjuvant (MF59®), a squalene based oil-in-water emulsion. Each of the strains is harvested and clarified separately by centrifugation and filtration prior to inactivation with formaldehyde. The inactivated virus is concentrated and purified by zonal centrifugation. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of cetyltrimethylammonium bromide (CTAB). The antigen preparation is further purified. FLUAD is prepared by combining the three virus antigens with the MF59C.1 adjuvant. After combining, FLUAD is a sterile, milky-white injectable emulsion supplied in single-dose pre-filled syringes containing 0.5 mL dose. Each 0.5 mL dose contains 15 mcg of hemagglutinin (HA) from each of the three recommended influenza strains and MF59C.1 adjuvant (9.75 mg squalene, 1.175 mg of polysorbate 80, 1.175 mg of sorbitan trioleate, 0.66 mg of sodium citrate dihydrate and 0.04 mg of citric acid monohydrate) at pH 6.9-7.7. FLUAD may contain trace amounts of neomycin (≤ 0.02 mcg by calculation), kanamycin (≤ 0.03 mcg by calculation) and hydrocortisone (≤ 0.005 ng by calculation) which are used during the initial stages of manufacture, as well as residual egg protein (ovalbumin) (≤ 0.4 mcg), formaldehyde (≤ 10 mcg) or CTAB (≤ 12 mcg). FLUAD does not contain a preservative. The syringe, syringe plunger stopper and tip caps are not made with natural rubber latex."
    },
    {
      "NDCCode": "70594-026-04",
      "PackageDescription": "10 VIAL, GLASS in 1 CARTON (70594-026-04)  > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (70594-026-03) ",
      "NDC11Code": "70594-0026-04",
      "ProductNDC": "70594-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bacitracin",
      "NonProprietaryName": "Bacitracin",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20181001",
      "EndMarketingDate": "20230331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203177",
      "LabelerName": "Xellia Pharmaceuticals USA LLC",
      "SubstanceName": "BACITRACIN",
      "StrengthNumber": "50000",
      "StrengthUnit": "[USP'U]/1",
      "Pharm_Classes": "Decreased Cell Wall Synthesis & Repair [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190614",
      "EndMarketingDatePackage": "20211130",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71205-026-03",
      "PackageDescription": "3 TABLET, FILM COATED in 1 BOTTLE (71205-026-03) ",
      "NDC11Code": "71205-0026-03",
      "ProductNDC": "71205-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quetiapine",
      "NonProprietaryName": "Quetiapine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077745",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
      "Description": "Quetiapine Tablets USP are a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. The structural formula is. C42H50N6O4S2C4H4O4 M.W. 883.11 (fumarate salt). Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Tablets USP are supplied for oral administration as 25 mg (round, light orange), 50 mg (round, white to off-white), 100 mg (round, light orange), 200 mg (round, white to off-white), 300 mg (capsule-shaped, pale yellow), and 400 mg (capsule-shaped, white to off-white) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide and triacetin. Additionally, the 25 mg, 100 mg, and 300 mg tablets contain iron oxide yellow; the 25 mg and 100 mg tablets contain FD&C yellow #6/sunset yellow FCF/aluminum lake; and the 50 mg, 200 mg, and 400 mg tablets contain polydextrose and polyethylene glycol."
    },
    {
      "NDCCode": "71490-026-03",
      "PackageDescription": "50 mL in 1 BOTTLE (71490-026-03) ",
      "NDC11Code": "71490-0026-03",
      "ProductNDC": "71490-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Higeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Fragrance Free With Silicon Holder",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170918",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO)",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170918",
      "SamplePackage": "N",
      "IndicationAndUsage": " for handwashing to decrease bacteria on the skin.  recommended for repeated use."
    },
    {
      "NDCCode": "71530-026-03",
      "PackageDescription": "1249190 mL in 1 TANK (71530-026-03) ",
      "NDC11Code": "71530-0026-03",
      "ProductNDC": "71530-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nano Pure",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200612",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Nano Global",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200729",
      "SamplePackage": "N",
      "IndicationAndUsage": " Helps reduce bacteria on skin that potentially cause disease."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"78082-026-03","ProprietaryName":"Alcohol Wipes 75% Alcohol","NonProprietaryName":"Honour Hand Sanitizing Wipes 75% Alcohol"},{"NDCCode":"78082-026-01","ProprietaryName":"Alcohol Wipes 75% Alcohol","NonProprietaryName":"Honour Hand Sanitizing Wipes 75% Alcohol"},{"NDCCode":"78082-026-02","ProprietaryName":"Alcohol Wipes 75% Alcohol","NonProprietaryName":"Honour Hand Sanitizing Wipes 75% Alcohol"},{"NDCCode":"10702-026-03","ProprietaryName":"Phentermine Hydrochloride","NonProprietaryName":"Phentermine Hydrochloride"},{"NDCCode":"13537-026-04","ProprietaryName":"Lbel","NonProprietaryName":"Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide"},{"NDCCode":"14445-026-03","NonProprietaryName":"Rivaroxaban"},{"NDCCode":"24338-026-03","ProprietaryName":"Evekeo","NonProprietaryName":"Amphetamine Sulfate"},{"NDCCode":"42385-026-03","NonProprietaryName":"Oxaliplatin"},{"NDCCode":"43116-026-03","ProprietaryName":"Shierjie Disinfecting Soft Wipes Antibacterial","NonProprietaryName":"Shierjie Disinfecting Soft Wipes Antibacterial"},{"NDCCode":"49967-026-03","ProprietaryName":"It Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"50017-026-04","ProprietaryName":"Neat 3b Baby B Diaper","NonProprietaryName":"Skin Protectant"},{"NDCCode":"52682-026-03","ProprietaryName":"Butalbital, Acetaminophen, And Caffeine","NonProprietaryName":"Butalbital, Acetaminophen, And Caffeine"},{"NDCCode":"52862-026-03","ProprietaryName":"Isopropyl Rubbing Alcohol 99% With Wintergreen","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"52959-026-03","ProprietaryName":"Carisoprodol","NonProprietaryName":"Carisoprodol"},{"NDCCode":"55319-026-03","ProprietaryName":"Family Wellness Cold And Hot Pain Relief","NonProprietaryName":"Menthol"},{"NDCCode":"56136-026-03","ProprietaryName":"Sanitizepx Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"60290-026-03","ProprietaryName":"Olmesartan Medoxomil And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil And Hydrochlorothiazide"},{"NDCCode":"63545-026-03","ProprietaryName":"Antimonium Metallicum","NonProprietaryName":"Anitmonium Metallicum"},{"NDCCode":"64232-026-03","ProprietaryName":"Candidasan","NonProprietaryName":"Candida Parapsilosis"},{"NDCCode":"65852-026-03","ProprietaryName":"Icequake Lidocaine Analgesic","NonProprietaryName":"Lidocaine Hydrochloride"},{"NDCCode":"66854-026-03","ProprietaryName":"Dermaprot","NonProprietaryName":"Octinoxate,titanium Dioxide,oxybenzone,avobenzone"},{"NDCCode":"68078-026-03","ProprietaryName":"Sunforgettable Total Protection Body Shield","NonProprietaryName":"Zinc Oxide, Sunscreen"},{"NDCCode":"68981-026-03","NonProprietaryName":"Clindamycin Phosphate"},{"NDCCode":"69844-026-03","ProprietaryName":"Amantadine Hydrochloride","NonProprietaryName":"Amantadine Hydrochloride"},{"NDCCode":"70166-026-03","ProprietaryName":"Chlorhexidine Gluconate","NonProprietaryName":"Chlorhexidine Gluconate"},{"NDCCode":"70461-026-03","ProprietaryName":"Fluad","NonProprietaryName":"Influenza A Virus A/missouri/11/2025 Ivr-279 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/michigan/105/2025 Ivr-285 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/tokyo/eis13-175/2025 Antigen (formaldehyde Inactivated)"},{"NDCCode":"70594-026-04","ProprietaryName":"Bacitracin","NonProprietaryName":"Bacitracin"},{"NDCCode":"71205-026-03","ProprietaryName":"Quetiapine","NonProprietaryName":"Quetiapine"},{"NDCCode":"71490-026-03","ProprietaryName":"Higeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Fragrance Free With Silicon Holder","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"71530-026-03","ProprietaryName":"Nano Pure","NonProprietaryName":"Benzalkonium Chloride"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>78082-026-03</NDCCode>
    <PackageDescription>150 CLOTH in 1 BAG (78082-026-03) </PackageDescription>
    <NDC11Code>78082-0026-03</NDC11Code>
    <ProductNDC>78082-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcohol Wipes 75% Alcohol</ProprietaryName>
    <NonProprietaryName>Honour Hand Sanitizing Wipes 75% Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210518</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>PICO INC.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Open the lid and the sticker, pull out the wipes needed and then press the sticker back and close the lid to avoid alcohol evaporation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78082-026-01</NDCCode>
    <PackageDescription>300 CLOTH in 1 BAG (78082-026-01) </PackageDescription>
    <NDC11Code>78082-0026-01</NDC11Code>
    <ProductNDC>78082-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcohol Wipes 75% Alcohol</ProprietaryName>
    <NonProprietaryName>Honour Hand Sanitizing Wipes 75% Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210518</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>PICO INC.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Open the lid and the sticker, pull out the wipes needed and then press the sticker back and close the lid to avoid alcohol evaporation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78082-026-02</NDCCode>
    <PackageDescription>800 CLOTH in 1 BAG (78082-026-02) </PackageDescription>
    <NDC11Code>78082-0026-02</NDC11Code>
    <ProductNDC>78082-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcohol Wipes 75% Alcohol</ProprietaryName>
    <NonProprietaryName>Honour Hand Sanitizing Wipes 75% Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210518</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>PICO INC.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Open the lid and the sticker, pull out the wipes needed and then press the sticker back and close the lid to avoid alcohol evaporation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10702-026-03</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (10702-026-03) </PackageDescription>
    <NDC11Code>10702-0026-03</NDC11Code>
    <ProductNDC>10702-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040886</ApplicationNumber>
    <LabelerName>KVK-Tech, Inc.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-04-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120807</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine Hydrochloride, USP 15 mg and 30 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [ see CLINICAL PHARMACOLOGY (12.1,12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine Hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF Aluminum Lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>13537-026-04</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13537-026-04)  &gt; 10 mL in 1 TUBE (13537-026-03)</PackageDescription>
    <NDC11Code>13537-0026-04</NDC11Code>
    <ProductNDC>13537-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel</ProprietaryName>
    <ProprietaryNameSuffix>Protege Expert</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110810</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation Ltd.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>.075; .05; .06; .0234</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL; g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn. Retains SPF after 40 minutes of activity in the water.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>14445-026-03</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (14445-026-03) </PackageDescription>
    <NDC11Code>14445-0026-03</NDC11Code>
    <ProductNDC>14445-026</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Rivaroxaban</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20240315</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Indoco Remedies Limited</LabelerName>
    <SubstanceName>RIVAROXABAN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-05-22</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>15-MAR-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>24338-026-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (24338-026-03) </PackageDescription>
    <NDC11Code>24338-0026-03</NDC11Code>
    <ProductNDC>24338-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Evekeo</ProprietaryName>
    <NonProprietaryName>Amphetamine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200166</ApplicationNumber>
    <LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Evekeo® (amphetamine sulfate tablets, USP) is indicated for: : 1 Narcolepsy, 2 Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .</IndicationAndUsage>
    <Description>Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&amp;C Blue #1. Structural Formula. C18H28N2SO4                 MW 368.49.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-026-03</NDCCode>
    <PackageDescription>.2 kg in 1 DRUM (42385-026-03)</PackageDescription>
    <NDC11Code>42385-0026-03</NDC11Code>
    <ProductNDC>42385-026</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Oxaliplatin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20080301</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Aptuit Laurus Private Limited</LabelerName>
    <SubstanceName>OXALIPLATIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43116-026-03</NDCCode>
    <PackageDescription>40 CLOTH in 1 BAG (43116-026-03) </PackageDescription>
    <NDC11Code>43116-0026-03</NDC11Code>
    <ProductNDC>43116-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shierjie Disinfecting Soft Wipes Antibacterial</ProprietaryName>
    <NonProprietaryName>Shierjie Disinfecting Soft Wipes Antibacterial</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Shenzhen Shierjie Biological Engineering Co., LTD</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE; DIDECYLDIMONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.09; .04</StrengthNumber>
    <StrengthUnit>g/1001; g/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Decreases bacteria on skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49967-026-03</NDCCode>
    <PackageDescription>4 mL in 1 BOTTLE (49967-026-03) </PackageDescription>
    <NDC11Code>49967-0026-03</NDC11Code>
    <ProductNDC>49967-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>It Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>L'Oreal USA Products Inc</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the treatment of acne. helps prevent new acne blemishes from forming.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50017-026-04</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (50017-026-04)  &gt; 50 g in 1 TUBE (50017-026-03) </PackageDescription>
    <NDC11Code>50017-0026-04</NDC11Code>
    <ProductNDC>50017-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neat 3b Baby B Diaper</ProprietaryName>
    <NonProprietaryName>Skin Protectant</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130407</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>Neat Feat Products Limited</LabelerName>
    <SubstanceName>ZINC ACETATE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/50g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52682-026-03</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (52682-026-03)</PackageDescription>
    <NDC11Code>52682-0026-03</NDC11Code>
    <ProductNDC>52682-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Butalbital, Acetaminophen, And Caffeine</ProprietaryName>
    <NonProprietaryName>Butalbital, Acetaminophen, And Caffeine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110808</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040883</ApplicationNumber>
    <LabelerName>Mirror Pharmaceuticals LLC</LabelerName>
    <SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
    <StrengthNumber>50; 500; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-27</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52862-026-03</NDCCode>
    <PackageDescription>119 mL in 1 BOTTLE, PLASTIC (52862-026-03) </PackageDescription>
    <NDC11Code>52862-0026-03</NDC11Code>
    <ProductNDC>52862-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Isopropyl Rubbing Alcohol 99% With Wintergreen</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200618</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Home Smart Products</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200618</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 to decrease germs in minor cuts and scrapes, 2 helps relieve minor muscular aches due to exertion.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52959-026-03</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (52959-026-03)</PackageDescription>
    <NDC11Code>52959-0026-03</NDC11Code>
    <ProductNDC>52959-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carisoprodol</ProprietaryName>
    <NonProprietaryName>Carisoprodol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960124</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040124</ApplicationNumber>
    <LabelerName>H.J. Harkins Company, Inc.</LabelerName>
    <SubstanceName>CARISOPRODOL</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see DOSAGE AND ADMINISTRATION (2)].</IndicationAndUsage>
    <Description>Carisoprodol Tablets are available as 350 mg round, white tablets.  Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste.  It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH.  Carisoprodol is present as a racemic mixture.  Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33.   The structural formula is. Other Ingredients:  colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, methylcellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>55319-026-03</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (55319-026-03)  &gt; 3 PATCH in 1 POUCH</PackageDescription>
    <NDC11Code>55319-0026-03</NDC11Code>
    <ProductNDC>55319-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Family Wellness Cold And Hot Pain Relief</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20121130</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>FAMILY DOLLAR</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Directions. adults and children over 12 years: 1 carefully remove backing from patch, 2 apply sticky side of patch to affected area.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>56136-026-03</NDCCode>
    <PackageDescription>300 mL in 1 BOTTLE, PUMP (56136-026-03) </PackageDescription>
    <NDC11Code>56136-0026-03</NDC11Code>
    <ProductNDC>56136-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizepx Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200508</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Ganzhou Olivee Cosmetic Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-05-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200508</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>60290-026-03</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (60290-026-03) </PackageDescription>
    <NDC11Code>60290-0026-03</NDC11Code>
    <ProductNDC>60290-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208847</ApplicationNumber>
    <LabelerName>Umedica Laboratories USA Inc.</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>40; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure [see Dosage and Administration ( 2)] . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs. Limitations of Use Olmesartan medoxomil and hydrochlorothiazide tablets is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
    <Description>Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT 1subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 1H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2’-1H-Tetrazol-5yl)[1, 1’-Biphenyl]-4-yl]Methyl]-, (5-Methyl-2-Oxo-1, 3-Dioxol-4-yl) Methyl Ester. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil is a white to off white powder with a molecular weight of 558.59. It is slightly soluble in acetone and methanol, very slightly soluble in ethanol and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2and its structural formula is:. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. Hydrochlorothiazide is freely soluble in sodium hydroxide solution, in n-butyl amine and in dimethylformamide; very slightly soluble in water, sparingly soluble in methanol, insoluble in ether, in chloroform and in dilute mineral acids. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxy propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63545-026-03</NDCCode>
    <PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (63545-026-03) </PackageDescription>
    <NDC11Code>63545-0026-03</NDC11Code>
    <ProductNDC>63545-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antimonium Metallicum</ProprietaryName>
    <NonProprietaryName>Anitmonium Metallicum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210115</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
    <SubstanceName>ANTIMONY</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>64232-026-03</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (64232-026-03)  &gt; 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>64232-0026-03</NDC11Code>
    <ProductNDC>64232-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Candidasan</ProprietaryName>
    <NonProprietaryName>Candida Parapsilosis</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180109</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>sanPharma GmbH</LabelerName>
    <SubstanceName>CANDIDA PARAPSILOSIS</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>[hp_X]/10mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65852-026-03</NDCCode>
    <PackageDescription>74 mL in 1 BOTTLE, WITH APPLICATOR (65852-026-03) </PackageDescription>
    <NDC11Code>65852-0026-03</NDC11Code>
    <ProductNDC>65852-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Icequake Lidocaine Analgesic</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Dextrum Laboratories, Inc</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Indication &amp; usage section. Use Temporarily relieves minor pain.  adults and children over 12 years. apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period: 1 children 12 years or younger: ask a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>66854-026-03</NDCCode>
    <PackageDescription>70 mL in 1 BOTTLE (66854-026-03)</PackageDescription>
    <NDC11Code>66854-0026-03</NDC11Code>
    <ProductNDC>66854-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermaprot</ProprietaryName>
    <ProprietaryNameSuffix>Helioprot Ab Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate,titanium Dioxide,oxybenzone,avobenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OXYBENZONE</SubstanceName>
    <StrengthNumber>7.5; 3; 2.5; 1.5</StrengthNumber>
    <StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Provides moderate protection against sun. This product is for topical application.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68078-026-03</NDCCode>
    <PackageDescription>10.2 g in 1 POUCH (68078-026-03) </PackageDescription>
    <NDC11Code>68078-0026-03</NDC11Code>
    <ProductNDC>68078-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunforgettable Total Protection Body Shield</ProprietaryName>
    <NonProprietaryName>Zinc Oxide, Sunscreen</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180612</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Colorescience</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180612</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68981-026-03</NDCCode>
    <PackageDescription>100 g in 1 JAR (68981-026-03) </PackageDescription>
    <NDC11Code>68981-0026-03</NDC11Code>
    <ProductNDC>68981-026</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20210421</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Xenex Laboratories Inc</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-APR-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>69844-026-03</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (69844-026-03) </PackageDescription>
    <NDC11Code>69844-0026-03</NDC11Code>
    <ProductNDC>69844-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207570</ApplicationNumber>
    <LabelerName>Graviti Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.</IndicationAndUsage>
    <Description>Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H17N.HCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each capsules contains 100 mg of  amantadine hydrochloride and the following Inactive ingredients: microcrystalline cellulose, povidone,  FD&amp;C yellow # 6 aluminum lake,  sodium starch glycolate and magnesium stearate.  The capsule shells and imprinting ink contain: gelatin, sodium lauryl sulfate, FD&amp;C red #40, titanium dioxide, shellac, propylene glycol, strong ammonia solution and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70166-026-03</NDCCode>
    <PackageDescription>15 mL in 1 SYRINGE, PLASTIC (70166-026-03) </PackageDescription>
    <NDC11Code>70166-0026-03</NDC11Code>
    <ProductNDC>70166-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chlorhexidine Gluconate</ProprietaryName>
    <NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
    <DosageFormName>RINSE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077789</ApplicationNumber>
    <LabelerName>Lohxa</LabelerName>
    <SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
    <StrengthNumber>1.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see  PRECAUTIONS.</IndicationAndUsage>
    <Description>0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11 .6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&amp;C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>70461-026-03</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (70461-026-03)  / .5 mL in 1 SYRINGE, GLASS (70461-026-04) </PackageDescription>
    <NDC11Code>70461-0026-03</NDC11Code>
    <ProductNDC>70461-026</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluad</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/missouri/11/2025 Ivr-279 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/michigan/105/2025 Ivr-285 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/tokyo/eis13-175/2025 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20260701</StartMarketingDate>
    <EndMarketingDate>20270731</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125510</ApplicationNumber>
    <LabelerName>Seqirus, Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/MISSOURI/11/2025 IVR-279 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/MICHIGAN/105/2025 IVR-285 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20260701</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FLUAD is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in adults 65 years of age and older. This indication is approved under accelerated approval based on the immune response elicited by FLUAD [see Clinical Studies (14)]. Clinical benefit of FLUAD based on efficacy has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.</IndicationAndUsage>
    <Description>FLUAD (Influenza Vaccine, Adjuvanted), a sterile injectable emulsion for intramuscular use, is a trivalent inactivated influenza vaccine prepared from virus propagated in the allantoic cavity of embryonated hens' eggs inoculated with a specific type of influenza virus. FLUAD 0.5 mL dose is formulated to contain 15 mcg of hemagglutinin (HA) from each of the following influenza strains recommended by FDA for the 2026-2027 influenza season: A/Missouri/11/2025 IVR-279 (an A/Missouri/11/2025 (H1N1)pdm09-like virus), A/Michigan/105/2025 IVR-285 (an A/Darwin/1454/2025 (H3N2)-like virus), B/Tokyo/EIS13-175/2025 (B-Victoria lineage). FLUAD also contains MF59C.1 adjuvant (MF59®), a squalene based oil-in-water emulsion. Each of the strains is harvested and clarified separately by centrifugation and filtration prior to inactivation with formaldehyde. The inactivated virus is concentrated and purified by zonal centrifugation. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of cetyltrimethylammonium bromide (CTAB). The antigen preparation is further purified. FLUAD is prepared by combining the three virus antigens with the MF59C.1 adjuvant. After combining, FLUAD is a sterile, milky-white injectable emulsion supplied in single-dose pre-filled syringes containing 0.5 mL dose. Each 0.5 mL dose contains 15 mcg of hemagglutinin (HA) from each of the three recommended influenza strains and MF59C.1 adjuvant (9.75 mg squalene, 1.175 mg of polysorbate 80, 1.175 mg of sorbitan trioleate, 0.66 mg of sodium citrate dihydrate and 0.04 mg of citric acid monohydrate) at pH 6.9-7.7. FLUAD may contain trace amounts of neomycin (≤ 0.02 mcg by calculation), kanamycin (≤ 0.03 mcg by calculation) and hydrocortisone (≤ 0.005 ng by calculation) which are used during the initial stages of manufacture, as well as residual egg protein (ovalbumin) (≤ 0.4 mcg), formaldehyde (≤ 10 mcg) or CTAB (≤ 12 mcg). FLUAD does not contain a preservative. The syringe, syringe plunger stopper and tip caps are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>70594-026-04</NDCCode>
    <PackageDescription>10 VIAL, GLASS in 1 CARTON (70594-026-04)  &gt; 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (70594-026-03) </PackageDescription>
    <NDC11Code>70594-0026-04</NDC11Code>
    <ProductNDC>70594-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bacitracin</ProprietaryName>
    <NonProprietaryName>Bacitracin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20181001</StartMarketingDate>
    <EndMarketingDate>20230331</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203177</ApplicationNumber>
    <LabelerName>Xellia Pharmaceuticals USA LLC</LabelerName>
    <SubstanceName>BACITRACIN</SubstanceName>
    <StrengthNumber>50000</StrengthNumber>
    <StrengthUnit>[USP'U]/1</StrengthUnit>
    <Pharm_Classes>Decreased Cell Wall Synthesis &amp; Repair [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190614</StartMarketingDatePackage>
    <EndMarketingDatePackage>20211130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71205-026-03</NDCCode>
    <PackageDescription>3 TABLET, FILM COATED in 1 BOTTLE (71205-026-03) </PackageDescription>
    <NDC11Code>71205-0026-03</NDC11Code>
    <ProductNDC>71205-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077745</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine Tablets USP are a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. The structural formula is. C42H50N6O4S2C4H4O4 M.W. 883.11 (fumarate salt). Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Tablets USP are supplied for oral administration as 25 mg (round, light orange), 50 mg (round, white to off-white), 100 mg (round, light orange), 200 mg (round, white to off-white), 300 mg (capsule-shaped, pale yellow), and 400 mg (capsule-shaped, white to off-white) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide and triacetin. Additionally, the 25 mg, 100 mg, and 300 mg tablets contain iron oxide yellow; the 25 mg and 100 mg tablets contain FD&amp;C yellow #6/sunset yellow FCF/aluminum lake; and the 50 mg, 200 mg, and 400 mg tablets contain polydextrose and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>71490-026-03</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (71490-026-03) </PackageDescription>
    <NDC11Code>71490-0026-03</NDC11Code>
    <ProductNDC>71490-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Higeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Fragrance Free With Silicon Holder</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170918</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>SUKHTIAN-HTM ( HOUSEHOLDS &amp; TOILETRIES MFG.CO)</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170918</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> for handwashing to decrease bacteria on the skin.  recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71530-026-03</NDCCode>
    <PackageDescription>1249190 mL in 1 TANK (71530-026-03) </PackageDescription>
    <NDC11Code>71530-0026-03</NDC11Code>
    <ProductNDC>71530-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nano Pure</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200612</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Nano Global</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200729</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> Helps reduce bacteria on skin that potentially cause disease.</IndicationAndUsage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>78082-026-03</NDCCode><ProprietaryName>Alcohol Wipes 75% Alcohol</ProprietaryName><NonProprietaryName>Honour Hand Sanitizing Wipes 75% Alcohol</NonProprietaryName></NDC><NDC><NDCCode>78082-026-01</NDCCode><ProprietaryName>Alcohol Wipes 75% Alcohol</ProprietaryName><NonProprietaryName>Honour Hand Sanitizing Wipes 75% Alcohol</NonProprietaryName></NDC><NDC><NDCCode>78082-026-02</NDCCode><ProprietaryName>Alcohol Wipes 75% Alcohol</ProprietaryName><NonProprietaryName>Honour Hand Sanitizing Wipes 75% Alcohol</NonProprietaryName></NDC><NDC><NDCCode>10702-026-03</NDCCode><ProprietaryName>Phentermine Hydrochloride</ProprietaryName><NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>13537-026-04</NDCCode><ProprietaryName>Lbel</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>14445-026-03</NDCCode><NonProprietaryName>Rivaroxaban</NonProprietaryName></NDC><NDC><NDCCode>24338-026-03</NDCCode><ProprietaryName>Evekeo</ProprietaryName><NonProprietaryName>Amphetamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>42385-026-03</NDCCode><NonProprietaryName>Oxaliplatin</NonProprietaryName></NDC><NDC><NDCCode>43116-026-03</NDCCode><ProprietaryName>Shierjie Disinfecting Soft Wipes Antibacterial</ProprietaryName><NonProprietaryName>Shierjie Disinfecting Soft Wipes Antibacterial</NonProprietaryName></NDC><NDC><NDCCode>49967-026-03</NDCCode><ProprietaryName>It Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>50017-026-04</NDCCode><ProprietaryName>Neat 3b Baby B Diaper</ProprietaryName><NonProprietaryName>Skin Protectant</NonProprietaryName></NDC><NDC><NDCCode>52682-026-03</NDCCode><ProprietaryName>Butalbital, Acetaminophen, And Caffeine</ProprietaryName><NonProprietaryName>Butalbital, Acetaminophen, And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>52862-026-03</NDCCode><ProprietaryName>Isopropyl Rubbing Alcohol 99% With Wintergreen</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>52959-026-03</NDCCode><ProprietaryName>Carisoprodol</ProprietaryName><NonProprietaryName>Carisoprodol</NonProprietaryName></NDC><NDC><NDCCode>55319-026-03</NDCCode><ProprietaryName>Family Wellness Cold And Hot Pain Relief</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>56136-026-03</NDCCode><ProprietaryName>Sanitizepx Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>60290-026-03</NDCCode><ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>63545-026-03</NDCCode><ProprietaryName>Antimonium Metallicum</ProprietaryName><NonProprietaryName>Anitmonium Metallicum</NonProprietaryName></NDC><NDC><NDCCode>64232-026-03</NDCCode><ProprietaryName>Candidasan</ProprietaryName><NonProprietaryName>Candida Parapsilosis</NonProprietaryName></NDC><NDC><NDCCode>65852-026-03</NDCCode><ProprietaryName>Icequake Lidocaine Analgesic</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>66854-026-03</NDCCode><ProprietaryName>Dermaprot</ProprietaryName><NonProprietaryName>Octinoxate,titanium Dioxide,oxybenzone,avobenzone</NonProprietaryName></NDC><NDC><NDCCode>68078-026-03</NDCCode><ProprietaryName>Sunforgettable Total Protection Body Shield</ProprietaryName><NonProprietaryName>Zinc Oxide, Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>68981-026-03</NDCCode><NonProprietaryName>Clindamycin Phosphate</NonProprietaryName></NDC><NDC><NDCCode>69844-026-03</NDCCode><ProprietaryName>Amantadine Hydrochloride</ProprietaryName><NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70166-026-03</NDCCode><ProprietaryName>Chlorhexidine Gluconate</ProprietaryName><NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName></NDC><NDC><NDCCode>70461-026-03</NDCCode><ProprietaryName>Fluad</ProprietaryName><NonProprietaryName>Influenza A Virus A/missouri/11/2025 Ivr-279 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/michigan/105/2025 Ivr-285 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/tokyo/eis13-175/2025 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>70594-026-04</NDCCode><ProprietaryName>Bacitracin</ProprietaryName><NonProprietaryName>Bacitracin</NonProprietaryName></NDC><NDC><NDCCode>71205-026-03</NDCCode><ProprietaryName>Quetiapine</ProprietaryName><NonProprietaryName>Quetiapine</NonProprietaryName></NDC><NDC><NDCCode>71490-026-03</NDCCode><ProprietaryName>Higeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Fragrance Free With Silicon Holder</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>71530-026-03</NDCCode><ProprietaryName>Nano Pure</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</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",
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      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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"
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}
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