RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (27 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "72936-010-75",
      "PackageDescription": "1 TUBE in 1 CARTON (72936-010-75)  > 75 g in 1 TUBE",
      "NDC11Code": "72936-0010-75",
      "ProductNDC": "72936-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30",
      "NonProprietaryName": "Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190309",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Higher Education Skincare, LLC",
      "SubstanceName": "OCTINOXATE; OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "6.9; 3; 4",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190309",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "72936-010-88",
      "PackageDescription": "1 TUBE in 1 CARTON (72936-010-88)  / 88.7 g in 1 TUBE",
      "NDC11Code": "72936-0010-88",
      "ProductNDC": "72936-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30",
      "NonProprietaryName": "Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210621",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "M020",
      "LabelerName": "Higher Education Skincare, LLC",
      "SubstanceName": "OCTINOXATE; OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "6.9; 3; 4",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210621",
      "SamplePackage": "N",
      "IndicationAndUsage": " helps prevent sunburn.  if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "43353-010-75",
      "PackageDescription": "150 TABLET in 1 BOTTLE (43353-010-75) ",
      "NDC11Code": "43353-0010-75",
      "ProductNDC": "43353-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetaminophen And Codeine",
      "NonProprietaryName": "Acetaminophen And Codeine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080529",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040779",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
      "StrengthNumber": "300; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20150324",
      "SamplePackage": "N",
      "IndicationAndUsage": "Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain.",
      "Description": "Each tablet contains. Acetaminophen, USP……………………………………………………..300 mg. Codeine Phosphate, USP…………………………………………………...30 mg. (Warning:  May be habit forming). Inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanlllde, IS a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate: 7,8-didehydro-4,5α-epoxy-3-methoxy-l7-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula."
    },
    {
      "NDCCode": "48273-010-01",
      "PackageDescription": "424.75 L in 1 CYLINDER (48273-010-01) ",
      "NDC11Code": "48273-0010-01",
      "ProductNDC": "48273-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbon Dioxide",
      "NonProprietaryName": "Carbon Dioxide",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20190611",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205764",
      "LabelerName": "Keen Compressed Gas Co. Inc.",
      "SubstanceName": "CARBON DIOXIDE",
      "StrengthNumber": "990",
      "StrengthUnit": "mL/L",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190611",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50049-010-02",
      "PackageDescription": "60 BOTTLE in 1 CARTON (50049-010-02)  > 75 mL in 1 BOTTLE",
      "NDC11Code": "50049-0010-02",
      "ProductNDC": "50049-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200604",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200704",
      "SamplePackage": "N",
      "IndicationAndUsage": "For Hand Sanitizing."
    },
    {
      "NDCCode": "50594-010-75",
      "PackageDescription": "1 BOTTLE in 1 CARTON (50594-010-75)  / 90 TABLET in 1 BOTTLE",
      "NDC11Code": "50594-0010-75",
      "ProductNDC": "50594-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sound Body Allergy Relief",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150612",
      "EndMarketingDate": "20250731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076301",
      "LabelerName": "Big Lots Stores, Inc.",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190318",
      "EndMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "52755-010-05",
      "PackageDescription": "180 POUCH in 1 CARTON (52755-010-05)  > 75 g in 1 POUCH",
      "NDC11Code": "52755-0010-05",
      "ProductNDC": "52755-010",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Allantoin, Lidocaine, Petrolatum",
      "DosageFormName": "PATCH",
      "StartMarketingDate": "20150605",
      "EndMarketingDate": "20151118",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Shanghai Aquagel Bio-polymer Co., Ltd.",
      "SubstanceName": "ALLANTOIN; LIDOCAINE; PETROLATUM",
      "StrengthNumber": ".3; .6; 4.5",
      "StrengthUnit": "g/15g; g/15g; g/15g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20151118"
    },
    {
      "NDCCode": "53634-010-01",
      "PackageDescription": "14.75 mL in 1 BOTTLE (53634-010-01)",
      "NDC11Code": "53634-0010-01",
      "ProductNDC": "53634-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Malin And Goetz",
      "ProprietaryNameSuffix": "Acne Treatment",
      "NonProprietaryName": "Sulfur,salicylic Acid",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121105",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "Malin and Goetz Inc",
      "SubstanceName": "SULFUR",
      "StrengthNumber": "10",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-26",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "53634-010-02",
      "PackageDescription": "1 JAR in 1 CARTON (53634-010-02)  / 14.75 mL in 1 JAR (53634-010-01) ",
      "NDC11Code": "53634-0010-02",
      "ProductNDC": "53634-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Malin And Goetz",
      "ProprietaryNameSuffix": "Acne Treatment",
      "NonProprietaryName": "Sulfur",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121105",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "Malin and Goetz Inc",
      "SubstanceName": "SULFUR",
      "StrengthNumber": "10",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-10-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20121105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time."
    },
    {
      "NDCCode": "58518-010-01",
      "PackageDescription": "75 mL in 1 BOTTLE, PUMP (58518-010-01) ",
      "NDC11Code": "58518-0010-01",
      "ProductNDC": "58518-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Environmental Defense",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130718",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Avasol LLC",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "225",
      "StrengthUnit": "mg/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20130718",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "60934-010-00",
      "PackageDescription": "1 KIT in 1 KIT (60934-010-00)  *  1 TUBE in 1 CARTON (60934-011-00)  / 75 mL in 1 TUBE *  1 TUBE in 1 CARTON (60934-012-00)  / 15 mL in 1 TUBE",
      "NDC11Code": "60934-0010-00",
      "ProductNDC": "60934-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hydropeptide S.p.f. Sun Protection Friends",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20210101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "HydroPeptide LLC",
      "Status": "Active",
      "LastUpdate": "2025-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73043-010-01",
      "PackageDescription": "75 mL in 1 BOTTLE (73043-010-01) ",
      "NDC11Code": "73043-0010-01",
      "ProductNDC": "73043-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240705",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210374",
      "LabelerName": "Devatis, Inc.",
      "SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
      "StrengthNumber": "250; 62.5",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-03-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240815",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media – caused by beta-lactamase-producing isolates of H. influenzae and M.  catarrhalis., 3 Sinusitis - caused by beta-lactamase–producing isolates of H. influenzae and M.  catarrhalis., 4 Skin and Skin Structure Infections - caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections - caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.",
      "Description": "Amoxicillin and Clavulanate Potassium for Oral Suspension, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate  and  may  be  represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Each 5 mL of oral suspension contains 250 mg of amoxicillin as the trihydrate, and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 250 mg/62.5 mg per 5 mL contains 0.31 mEq of potassium and 0.12 mEq of sodium. Inactive Ingredients. Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Sucralose, Sodium Citrate, Anhydrous Citric Acid, Silicon Dioxide, Colloidal Silicon Dioxide, Mannitol, Xanthan Gum, Vanilla Flavor, Tutti Frutti Flavor."
    },
    {
      "NDCCode": "76446-010-75",
      "PackageDescription": "75 mL in 1 BOTTLE (76446-010-75)",
      "NDC11Code": "76446-0010-75",
      "ProductNDC": "76446-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Protective Day (uva/uvb) Spf 25",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate, Titanium Dioxide, Octocrylene, Benzophenone-3",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160519",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Anna Lotan Ltd.",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "70; 40; 40; 30",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-26",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "78936-010-02",
      "PackageDescription": "75 POUCH in 1 PAIL (78936-010-02)  > 1 g in 1 POUCH",
      "NDC11Code": "78936-0010-02",
      "ProductNDC": "78936-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bb1720d Antibacterial Hand Wipes Hawaiian Coconut Scented",
      "ProprietaryNameSuffix": "Bb1720d",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SWAB",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200904",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Hangzhou Caring Cleaning Commodity Co.,Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200904",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decreases bacteria on hands."
    },
    {
      "NDCCode": "79866-010-02",
      "PackageDescription": "75 CLOTH in 1 DRUM (79866-010-02) ",
      "NDC11Code": "79866-0010-02",
      "ProductNDC": "79866-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Wet Wipe",
      "NonProprietaryName": "Wet Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201207",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Osike Cosmetics Co., Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "1/1001",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20201207",
      "SamplePackage": "N",
      "IndicationAndUsage": "●Hand sanitizer to help reduce bacteria. ●For use when soap and water are not available."
    },
    {
      "NDCCode": "80948-010-75",
      "PackageDescription": "12 BOTTLE in 1 PACKAGE (80948-010-75)  / 250 mL in 1 BOTTLE",
      "NDC11Code": "80948-0010-75",
      "ProductNDC": "80948-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Puroma Hand Sanitizer Fragrance Free",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210312",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "ZENITH MICRO CONTROL",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20211019",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria on skin that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "10631-010-30",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-010-30) ",
      "NDC11Code": "10631-0010-30",
      "ProductNDC": "10631-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kapspargo",
      "NonProprietaryName": "Metoprolol Succinate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180315",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210428",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "METOPROLOL SUCCINATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-04-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180315",
      "SamplePackage": "N",
      "IndicationAndUsage": "KAPSPARGO Sprinkle is a beta1-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Angina Pectoris. (1.2) Heart Failure, to reduce the risk of cardiovascular mortality and heart-failure hospitalizations in patients with heart failure. (1.3).",
      "Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release capsules. Metoprolol succinate extended-release capsules have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The extended-release capsules comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The extended-release capsules contain 10.24 mg, 20.48 mg, 40.96 mg, and 81.92 mg of metoprolol free base, present as 23.75 mg, 47.5 mg, 95 mg, and 190 mg of metoprolol succinate and are equivalent to 25 mg, 50 mg, 100 mg, and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white to off-white powder with a molecular weight of 652.82. It is freely soluble in water, soluble in methanol, sparingly soluble in alcohol, slightly soluble in isopropyl alcohol. Inactive ingredients: ethyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 6000, sugar spheres (corn starch and sucrose), talc and triethyl citrate. The capsule shell and imprinting ink has the following composition: ferric oxide yellow (25 mg, 50 mg and 200 mg), ferrosoferric oxide, gelatin, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
    },
    {
      "NDCCode": "10812-010-01",
      "PackageDescription": "1 TUBE in 1 BLISTER PACK (10812-010-01)  > 4.2 g in 1 TUBE",
      "NDC11Code": "10812-0010-01",
      "ProductNDC": "10812-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Revitalizing Lip Balm",
      "ProprietaryNameSuffix": "Spf 20 - Soft Caramel 50",
      "NonProprietaryName": "Octinoxate And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101201",
      "EndMarketingDate": "20181201",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
      "StrengthNumber": "75; 50",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-04",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "11528-010-01",
      "PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (11528-010-01) ",
      "NDC11Code": "11528-0010-01",
      "ProductNDC": "11528-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Covaryx",
      "NonProprietaryName": "Estrogens, Esterified And Methyltestosterone",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070401",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "CENTRIX PHARMACEUTICAL, INC,",
      "SubstanceName": "ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE",
      "StrengthNumber": "1.25; 2.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20070401",
      "SamplePackage": "N",
      "IndicationAndUsage": "COVARYXT® and COVARYX® H.S. are indicated in the treatment of. Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). COVARYXT® and COVARYX® H.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (See BOXED WARNINGS).",
      "Description": "COVARYX®: Each light yellow, capsule-shaped, film coated tablet debossed \"C010\" on obverse and plain on the reverse contains 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. COVARYX® H.S. (Half-Strength): Each light pink, capsule-shaped, film coated tablet debossed \"C020\" on obverse and plain on the reverse contains 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Esterified Estrogens. Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Esterified Estrogens contain not less than 75.0 percent and not more than 85.0 percent of sodium estrone sulfate, and not less than 6.0 percent and not more than 15.0 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90.0 percent. Category: Estrogens. Methyltestosterone. Methyltestosterone, USP is an androgen. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone and methyltestosterone are synthetic derivatives of testosterone. Methyltestosterone is a white to light yellow crystalline substance that is virtually insoluble in water but soluble in organic solvents. It is stable in air but decomposes in light. Methyltestosterone structural formula. COVARYX® and COVARYX® H.S. Tablets contain the following inactive ingredients: Microcrystalline Cellulose, Colloidal Silicon Dioxide, Lactose, Sodium Bicarbonate, Sodium Citrate, Magnesium Stearate, Polyvinyl Alcohol, Polyethylene Glycol, Talc, Titanium Dioxide, FD&C Yellow #5 Tartrazine Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, and D&C Red #30 Helendon Pink Aluminum Lake."
    },
    {
      "NDCCode": "14141-010-01",
      "PackageDescription": "1 CASE in 1 BOX (14141-010-01)  > 9 g in 1 CASE",
      "NDC11Code": "14141-0010-01",
      "ProductNDC": "14141-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 260-n",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bel Star S.A.",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "75; 78.4",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "15310-010-01",
      "PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (15310-010-01) ",
      "NDC11Code": "15310-0010-01",
      "ProductNDC": "15310-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eemt",
      "NonProprietaryName": "Estrogens, Esterified And Methyltestosterone",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110901",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "CREEKWOOD PHARMACEUTICAL, INC,",
      "SubstanceName": "METHYLTESTOSTERONE; ESTROGENS, ESTERIFIED",
      "StrengthNumber": "2.5; 1.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20110901",
      "SamplePackage": "N",
      "IndicationAndUsage": "ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).",
      "Description": "ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH: Each light green, capsule-shaped, film-coated oral tablet contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH: Each light blue, capsule-shaped, film-coated oral tablet contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Esterified Estrogens. Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Esterified Estrogens contain not less than 75.0 percent and not more than 85.0 percent of sodium estrone sulfate, and not less than 6.0 percent and not more than 15.0 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90.0 percent. Category: Estrogens. Methyltestosterone. Methyltestosterone is an androgen. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone and methyltestosterone are synthetic derivatives of testosterone. Methyltestosterone is a white to light yellow crystalline substance that is virtually insoluble in water but soluble in organic solvents. It is stable in air but decomposes in light. Methyltestosterone structural formula. C 20H 30O 2. 302.46. Androst-4-en-3-one, 17-hydroxy-17-methyl-, (17B)-. Category: Androgen. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH TABLETS and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH TABLETS contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and other minor ingredients. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH TABLETS also contain: FD&C Blue No. 1 and D&C Yellow No. 10 and PEG. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH TABLETS also contain: D&C Yellow No. 10, FD&C Blue No. 1."
    },
    {
      "NDCCode": "42129-010-01",
      "PackageDescription": "50 CLOTH in 1 BAG (42129-010-01) ",
      "NDC11Code": "42129-0010-01",
      "ProductNDC": "42129-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "75% Alcohol Wipes",
      "NonProprietaryName": "75% Alcohol Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Fustin(Xiamen) Commodity Co., ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "1/1001",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decrease bacteria on the skin. Perfect for quick clean-ups."
    },
    {
      "NDCCode": "42509-010-01",
      "PackageDescription": "29 mL in 1 BOTTLE (42509-010-01) ",
      "NDC11Code": "42509-0010-01",
      "ProductNDC": "42509-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200529",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Wessco International",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: to help reduce germs on the skin."
    },
    {
      "NDCCode": "48433-010-03",
      "PackageDescription": "30 BLISTER PACK in 1 CARTON (48433-010-03)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-010-01) ",
      "NDC11Code": "48433-0010-03",
      "ProductNDC": "48433-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091226",
      "LabelerName": "Safecor Health, LLC",
      "SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260203",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atorvastatin calcium tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.",
      "Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is Calcium ( βR, δR)-2-( p-fluorophenyl)- β, δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl) pyrrole-1-heptanoate (1:2), trihydrate. The molecular formula of atorvastatin calcium is C 66H 68CaF 2N 4O 103H 2O and its molecular weight is 1209. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.84 mg, 21.69 mg, 43.38 mg, or 86.75 mg atorvastatin calcium trihydrate) and the following inactive ingredients: anhydrous lactose, anhydrous sodium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, L-Arginine, magnesium stearate and microcrystalline cellulose. The film coating of the tablets contains polyvinyl alcohol, talc and titanium dioxide, and may contain polyethylene glycol or lecithin and xanthan gum. Meets USP Dissolution Test 4."
    },
    {
      "NDCCode": "50049-010-01",
      "PackageDescription": "100 BOTTLE in 1 CARTON (50049-010-01)  > 45 mL in 1 BOTTLE",
      "NDC11Code": "50049-0010-01",
      "ProductNDC": "50049-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200604",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200704",
      "SamplePackage": "N",
      "IndicationAndUsage": "For Hand Sanitizing."
    },
    {
      "NDCCode": "50049-010-03",
      "PackageDescription": "24 BOTTLE in 1 CARTON (50049-010-03)  > 187.5 mL in 1 BOTTLE",
      "NDC11Code": "50049-0010-03",
      "ProductNDC": "50049-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200604",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200704",
      "SamplePackage": "N",
      "IndicationAndUsage": "For Hand Sanitizing."
    },
    {
      "NDCCode": "50049-010-04",
      "PackageDescription": "12 BOTTLE in 1 CARTON (50049-010-04)  > 375 mL in 1 BOTTLE",
      "NDC11Code": "50049-0010-04",
      "ProductNDC": "50049-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200604",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200704",
      "SamplePackage": "N",
      "IndicationAndUsage": "For Hand Sanitizing."
    },
    {
      "NDCCode": "51861-010-00",
      "PackageDescription": "38 mL in 1 BOTTLE (51861-010-00) ",
      "NDC11Code": "51861-0010-00",
      "ProductNDC": "51861-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sense Daytime Protective Broad Spectrum Spf 15",
      "NonProprietaryName": "Octinoxate, Oxybenzone, Avobenzone",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120328",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "USANA Health Sciences, Inc.",
      "SubstanceName": "OCTINOXATE; OXYBENZONE; AVOBENZONE",
      "StrengthNumber": "75; 30; 20",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20120328",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52244-010-02",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (52244-010-02)  / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE",
      "NDC11Code": "52244-0010-02",
      "ProductNDC": "52244-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Edex",
      "NonProprietaryName": "Alprostadil",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRACAVERNOUS",
      "StartMarketingDate": "20120415",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020649",
      "LabelerName": "Endo USA, Inc.",
      "SubstanceName": "ALPROSTADIL",
      "StrengthNumber": "10",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120415",
      "SamplePackage": "N",
      "IndicationAndUsage": "edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.",
      "Description": "edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). edex® is supplied in single-dose, dual-chamber cartridges. edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® cartridges are supplied in three strengths: 10-mcg cartridge (10.75 mcg alprostadil, 347.55 mcg α-cyclodextrin, 51.06 mg lactose); 20-mcg cartridge (21.5 mcg alprostadil, 695.2 mcg α-cyclodextrin, 51.06 mg lactose); 40-mcg cartridge (43 mcg alprostadil, 1,390.3 mcg α-cyclodextrin, 51.06 mg lactose). The edex® injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C20H34O5 and the molecular weight is 354.49. The chemical structure is:. The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of α-cyclodextrin is C36H60O30 and the molecular weight is 972.85. The chemical structure is. Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the α-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5, or 43 mcg of alprostadil is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 mcg, respectively."
    },
    {
      "NDCCode": "52244-010-06",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (52244-010-06)  / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE",
      "NDC11Code": "52244-0010-06",
      "ProductNDC": "52244-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Edex",
      "NonProprietaryName": "Alprostadil",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRACAVERNOUS",
      "StartMarketingDate": "20120415",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020649",
      "LabelerName": "Endo USA, Inc.",
      "SubstanceName": "ALPROSTADIL",
      "StrengthNumber": "10",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120415",
      "SamplePackage": "N",
      "IndicationAndUsage": "edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.",
      "Description": "edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). edex® is supplied in single-dose, dual-chamber cartridges. edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® cartridges are supplied in three strengths: 10-mcg cartridge (10.75 mcg alprostadil, 347.55 mcg α-cyclodextrin, 51.06 mg lactose); 20-mcg cartridge (21.5 mcg alprostadil, 695.2 mcg α-cyclodextrin, 51.06 mg lactose); 40-mcg cartridge (43 mcg alprostadil, 1,390.3 mcg α-cyclodextrin, 51.06 mg lactose). The edex® injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C20H34O5 and the molecular weight is 354.49. The chemical structure is:. The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of α-cyclodextrin is C36H60O30 and the molecular weight is 972.85. The chemical structure is. Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the α-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5, or 43 mcg of alprostadil is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 mcg, respectively."
    }
  ]
}
                    

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    <ProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</ProprietaryName>
    <NonProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
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    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Higher Education Skincare, LLC</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; ZINC OXIDE</SubstanceName>
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    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <NDCCode>72936-010-88</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (72936-010-88)  / 88.7 g in 1 TUBE</PackageDescription>
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    <ProductNDC>72936-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</ProprietaryName>
    <NonProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210621</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Higher Education Skincare, LLC</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>6.9; 3; 4</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
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    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210621</StartMarketingDatePackage>
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    <PackageDescription>150 TABLET in 1 BOTTLE (43353-010-75) </PackageDescription>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen And Codeine</ProprietaryName>
    <NonProprietaryName>Acetaminophen And Codeine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040779</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
    <StrengthNumber>300; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain.</IndicationAndUsage>
    <Description>Each tablet contains. Acetaminophen, USP……………………………………………………..300 mg. Codeine Phosphate, USP…………………………………………………...30 mg. (Warning:  May be habit forming). Inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanlllde, IS a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate: 7,8-didehydro-4,5α-epoxy-3-methoxy-l7-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula.</Description>
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    <NDCCode>48273-010-01</NDCCode>
    <PackageDescription>424.75 L in 1 CYLINDER (48273-010-01) </PackageDescription>
    <NDC11Code>48273-0010-01</NDC11Code>
    <ProductNDC>48273-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbon Dioxide</ProprietaryName>
    <NonProprietaryName>Carbon Dioxide</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20190611</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205764</ApplicationNumber>
    <LabelerName>Keen Compressed Gas Co. Inc.</LabelerName>
    <SubstanceName>CARBON DIOXIDE</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <NDCCode>50049-010-02</NDCCode>
    <PackageDescription>60 BOTTLE in 1 CARTON (50049-010-02)  &gt; 75 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>50049-0010-02</NDC11Code>
    <ProductNDC>50049-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200604</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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    <IndicationAndUsage>For Hand Sanitizing.</IndicationAndUsage>
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    <NDCCode>50594-010-75</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (50594-010-75)  / 90 TABLET in 1 BOTTLE</PackageDescription>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sound Body Allergy Relief</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
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    <EndMarketingDate>20250731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076301</ApplicationNumber>
    <LabelerName>Big Lots Stores, Inc.</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190318</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
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  <NDC>
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    <PackageDescription>180 POUCH in 1 CARTON (52755-010-05)  &gt; 75 g in 1 POUCH</PackageDescription>
    <NDC11Code>52755-0010-05</NDC11Code>
    <ProductNDC>52755-010</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Allantoin, Lidocaine, Petrolatum</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <StartMarketingDate>20150605</StartMarketingDate>
    <EndMarketingDate>20151118</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Shanghai Aquagel Bio-polymer Co., Ltd.</LabelerName>
    <SubstanceName>ALLANTOIN; LIDOCAINE; PETROLATUM</SubstanceName>
    <StrengthNumber>.3; .6; 4.5</StrengthNumber>
    <StrengthUnit>g/15g; g/15g; g/15g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20151118</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>53634-010-01</NDCCode>
    <PackageDescription>14.75 mL in 1 BOTTLE (53634-010-01)</PackageDescription>
    <NDC11Code>53634-0010-01</NDC11Code>
    <ProductNDC>53634-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Malin And Goetz</ProprietaryName>
    <ProprietaryNameSuffix>Acne Treatment</ProprietaryNameSuffix>
    <NonProprietaryName>Sulfur,salicylic Acid</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20121105</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>Malin and Goetz Inc</LabelerName>
    <SubstanceName>SULFUR</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-26</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>53634-010-02</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (53634-010-02)  / 14.75 mL in 1 JAR (53634-010-01) </PackageDescription>
    <NDC11Code>53634-0010-02</NDC11Code>
    <ProductNDC>53634-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Malin And Goetz</ProprietaryName>
    <ProprietaryNameSuffix>Acne Treatment</ProprietaryNameSuffix>
    <NonProprietaryName>Sulfur</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20121105</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>Malin and Goetz Inc</LabelerName>
    <SubstanceName>SULFUR</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.</IndicationAndUsage>
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  <NDC>
    <NDCCode>58518-010-01</NDCCode>
    <PackageDescription>75 mL in 1 BOTTLE, PUMP (58518-010-01) </PackageDescription>
    <NDC11Code>58518-0010-01</NDC11Code>
    <ProductNDC>58518-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Environmental Defense</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130718</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Avasol LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>225</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130718</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>60934-010-00</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (60934-010-00)  *  1 TUBE in 1 CARTON (60934-011-00)  / 75 mL in 1 TUBE *  1 TUBE in 1 CARTON (60934-012-00)  / 15 mL in 1 TUBE</PackageDescription>
    <NDC11Code>60934-0010-00</NDC11Code>
    <ProductNDC>60934-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hydropeptide S.p.f. Sun Protection Friends</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20210101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>HydroPeptide LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>73043-010-01</NDCCode>
    <PackageDescription>75 mL in 1 BOTTLE (73043-010-01) </PackageDescription>
    <NDC11Code>73043-0010-01</NDC11Code>
    <ProductNDC>73043-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
    <NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210374</ApplicationNumber>
    <LabelerName>Devatis, Inc.</LabelerName>
    <SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
    <StrengthNumber>250; 62.5</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media – caused by beta-lactamase-producing isolates of H. influenzae and M.  catarrhalis., 3 Sinusitis - caused by beta-lactamase–producing isolates of H. influenzae and M.  catarrhalis., 4 Skin and Skin Structure Infections - caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections - caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.</IndicationAndUsage>
    <Description>Amoxicillin and Clavulanate Potassium for Oral Suspension, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate  and  may  be  represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Each 5 mL of oral suspension contains 250 mg of amoxicillin as the trihydrate, and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 250 mg/62.5 mg per 5 mL contains 0.31 mEq of potassium and 0.12 mEq of sodium. Inactive Ingredients. Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Sucralose, Sodium Citrate, Anhydrous Citric Acid, Silicon Dioxide, Colloidal Silicon Dioxide, Mannitol, Xanthan Gum, Vanilla Flavor, Tutti Frutti Flavor.</Description>
  </NDC>
  <NDC>
    <NDCCode>76446-010-75</NDCCode>
    <PackageDescription>75 mL in 1 BOTTLE (76446-010-75)</PackageDescription>
    <NDC11Code>76446-0010-75</NDC11Code>
    <ProductNDC>76446-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Protective Day (uva/uvb) Spf 25</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate, Titanium Dioxide, Octocrylene, Benzophenone-3</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160519</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Anna Lotan Ltd.</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>70; 40; 40; 30</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-26</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>78936-010-02</NDCCode>
    <PackageDescription>75 POUCH in 1 PAIL (78936-010-02)  &gt; 1 g in 1 POUCH</PackageDescription>
    <NDC11Code>78936-0010-02</NDC11Code>
    <ProductNDC>78936-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bb1720d Antibacterial Hand Wipes Hawaiian Coconut Scented</ProprietaryName>
    <ProprietaryNameSuffix>Bb1720d</ProprietaryNameSuffix>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SWAB</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200904</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Hangzhou Caring Cleaning Commodity Co.,Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200904</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Decreases bacteria on hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>79866-010-02</NDCCode>
    <PackageDescription>75 CLOTH in 1 DRUM (79866-010-02) </PackageDescription>
    <NDC11Code>79866-0010-02</NDC11Code>
    <ProductNDC>79866-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Wet Wipe</ProprietaryName>
    <NonProprietaryName>Wet Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201207</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Osike Cosmetics Co., Ltd.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>1/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>●Hand sanitizer to help reduce bacteria. ●For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>80948-010-75</NDCCode>
    <PackageDescription>12 BOTTLE in 1 PACKAGE (80948-010-75)  / 250 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>80948-0010-75</NDC11Code>
    <ProductNDC>80948-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Puroma Hand Sanitizer Fragrance Free</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210312</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>ZENITH MICRO CONTROL</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211019</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria on skin that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10631-010-30</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-010-30) </PackageDescription>
    <NDC11Code>10631-0010-30</NDC11Code>
    <ProductNDC>10631-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kapspargo</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180315</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210428</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KAPSPARGO Sprinkle is a beta1-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Angina Pectoris. (1.2) Heart Failure, to reduce the risk of cardiovascular mortality and heart-failure hospitalizations in patients with heart failure. (1.3).</IndicationAndUsage>
    <Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release capsules. Metoprolol succinate extended-release capsules have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The extended-release capsules comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The extended-release capsules contain 10.24 mg, 20.48 mg, 40.96 mg, and 81.92 mg of metoprolol free base, present as 23.75 mg, 47.5 mg, 95 mg, and 190 mg of metoprolol succinate and are equivalent to 25 mg, 50 mg, 100 mg, and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white to off-white powder with a molecular weight of 652.82. It is freely soluble in water, soluble in methanol, sparingly soluble in alcohol, slightly soluble in isopropyl alcohol. Inactive ingredients: ethyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 6000, sugar spheres (corn starch and sucrose), talc and triethyl citrate. The capsule shell and imprinting ink has the following composition: ferric oxide yellow (25 mg, 50 mg and 200 mg), ferrosoferric oxide, gelatin, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10812-010-01</NDCCode>
    <PackageDescription>1 TUBE in 1 BLISTER PACK (10812-010-01)  &gt; 4.2 g in 1 TUBE</PackageDescription>
    <NDC11Code>10812-0010-01</NDC11Code>
    <ProductNDC>10812-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Revitalizing Lip Balm</ProprietaryName>
    <ProprietaryNameSuffix>Spf 20 - Soft Caramel 50</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101201</StartMarketingDate>
    <EndMarketingDate>20181201</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>75; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
  <NDC>
    <NDCCode>11528-010-01</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (11528-010-01) </PackageDescription>
    <NDC11Code>11528-0010-01</NDC11Code>
    <ProductNDC>11528-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Covaryx</ProprietaryName>
    <NonProprietaryName>Estrogens, Esterified And Methyltestosterone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070401</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>CENTRIX PHARMACEUTICAL, INC,</LabelerName>
    <SubstanceName>ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE</SubstanceName>
    <StrengthNumber>1.25; 2.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COVARYXT® and COVARYX® H.S. are indicated in the treatment of. Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). COVARYXT® and COVARYX® H.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (See BOXED WARNINGS).</IndicationAndUsage>
    <Description>COVARYX®: Each light yellow, capsule-shaped, film coated tablet debossed "C010" on obverse and plain on the reverse contains 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. COVARYX® H.S. (Half-Strength): Each light pink, capsule-shaped, film coated tablet debossed "C020" on obverse and plain on the reverse contains 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Esterified Estrogens. Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Esterified Estrogens contain not less than 75.0 percent and not more than 85.0 percent of sodium estrone sulfate, and not less than 6.0 percent and not more than 15.0 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90.0 percent. Category: Estrogens. Methyltestosterone. Methyltestosterone, USP is an androgen. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone and methyltestosterone are synthetic derivatives of testosterone. Methyltestosterone is a white to light yellow crystalline substance that is virtually insoluble in water but soluble in organic solvents. It is stable in air but decomposes in light. Methyltestosterone structural formula. COVARYX® and COVARYX® H.S. Tablets contain the following inactive ingredients: Microcrystalline Cellulose, Colloidal Silicon Dioxide, Lactose, Sodium Bicarbonate, Sodium Citrate, Magnesium Stearate, Polyvinyl Alcohol, Polyethylene Glycol, Talc, Titanium Dioxide, FD&amp;C Yellow #5 Tartrazine Aluminum Lake, FD&amp;C Yellow #6 Sunset Yellow FCF Aluminum Lake, and D&amp;C Red #30 Helendon Pink Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>14141-010-01</NDCCode>
    <PackageDescription>1 CASE in 1 BOX (14141-010-01)  &gt; 9 g in 1 CASE</PackageDescription>
    <NDC11Code>14141-0010-01</NDC11Code>
    <ProductNDC>14141-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 260-n</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bel Star S.A.</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>75; 78.4</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>15310-010-01</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (15310-010-01) </PackageDescription>
    <NDC11Code>15310-0010-01</NDC11Code>
    <ProductNDC>15310-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eemt</ProprietaryName>
    <NonProprietaryName>Estrogens, Esterified And Methyltestosterone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>CREEKWOOD PHARMACEUTICAL, INC,</LabelerName>
    <SubstanceName>METHYLTESTOSTERONE; ESTROGENS, ESTERIFIED</SubstanceName>
    <StrengthNumber>2.5; 1.25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).</IndicationAndUsage>
    <Description>ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH: Each light green, capsule-shaped, film-coated oral tablet contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH: Each light blue, capsule-shaped, film-coated oral tablet contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Esterified Estrogens. Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Esterified Estrogens contain not less than 75.0 percent and not more than 85.0 percent of sodium estrone sulfate, and not less than 6.0 percent and not more than 15.0 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90.0 percent. Category: Estrogens. Methyltestosterone. Methyltestosterone is an androgen. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone and methyltestosterone are synthetic derivatives of testosterone. Methyltestosterone is a white to light yellow crystalline substance that is virtually insoluble in water but soluble in organic solvents. It is stable in air but decomposes in light. Methyltestosterone structural formula. C 20H 30O 2. 302.46. Androst-4-en-3-one, 17-hydroxy-17-methyl-, (17B)-. Category: Androgen. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH TABLETS and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH TABLETS contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and other minor ingredients. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH TABLETS also contain: FD&amp;C Blue No. 1 and D&amp;C Yellow No. 10 and PEG. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH TABLETS also contain: D&amp;C Yellow No. 10, FD&amp;C Blue No. 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>42129-010-01</NDCCode>
    <PackageDescription>50 CLOTH in 1 BAG (42129-010-01) </PackageDescription>
    <NDC11Code>42129-0010-01</NDC11Code>
    <ProductNDC>42129-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>75% Alcohol Wipes</ProprietaryName>
    <NonProprietaryName>75% Alcohol Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Fustin(Xiamen) Commodity Co., ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>1/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Decrease bacteria on the skin. Perfect for quick clean-ups.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42509-010-01</NDCCode>
    <PackageDescription>29 mL in 1 BOTTLE (42509-010-01) </PackageDescription>
    <NDC11Code>42509-0010-01</NDC11Code>
    <ProductNDC>42509-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200529</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Wessco International</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: to help reduce germs on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48433-010-03</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (48433-010-03)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-010-01) </PackageDescription>
    <NDC11Code>48433-0010-03</NDC11Code>
    <ProductNDC>48433-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091226</ApplicationNumber>
    <LabelerName>Safecor Health, LLC</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is Calcium ( βR, δR)-2-( p-fluorophenyl)- β, δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl) pyrrole-1-heptanoate (1:2), trihydrate. The molecular formula of atorvastatin calcium is C 66H 68CaF 2N 4O 103H 2O and its molecular weight is 1209. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.84 mg, 21.69 mg, 43.38 mg, or 86.75 mg atorvastatin calcium trihydrate) and the following inactive ingredients: anhydrous lactose, anhydrous sodium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, L-Arginine, magnesium stearate and microcrystalline cellulose. The film coating of the tablets contains polyvinyl alcohol, talc and titanium dioxide, and may contain polyethylene glycol or lecithin and xanthan gum. Meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>50049-010-01</NDCCode>
    <PackageDescription>100 BOTTLE in 1 CARTON (50049-010-01)  &gt; 45 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>50049-0010-01</NDC11Code>
    <ProductNDC>50049-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200604</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200704</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For Hand Sanitizing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50049-010-03</NDCCode>
    <PackageDescription>24 BOTTLE in 1 CARTON (50049-010-03)  &gt; 187.5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>50049-0010-03</NDC11Code>
    <ProductNDC>50049-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200604</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200704</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For Hand Sanitizing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50049-010-04</NDCCode>
    <PackageDescription>12 BOTTLE in 1 CARTON (50049-010-04)  &gt; 375 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>50049-0010-04</NDC11Code>
    <ProductNDC>50049-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200604</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200704</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For Hand Sanitizing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51861-010-00</NDCCode>
    <PackageDescription>38 mL in 1 BOTTLE (51861-010-00) </PackageDescription>
    <NDC11Code>51861-0010-00</NDC11Code>
    <ProductNDC>51861-010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sense Daytime Protective Broad Spectrum Spf 15</ProprietaryName>
    <NonProprietaryName>Octinoxate, Oxybenzone, Avobenzone</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120328</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>USANA Health Sciences, Inc.</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE; AVOBENZONE</SubstanceName>
    <StrengthNumber>75; 30; 20</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52244-010-02</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (52244-010-02)  / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>52244-0010-02</NDC11Code>
    <ProductNDC>52244-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Edex</ProprietaryName>
    <NonProprietaryName>Alprostadil</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRACAVERNOUS</RouteName>
    <StartMarketingDate>20120415</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020649</ApplicationNumber>
    <LabelerName>Endo USA, Inc.</LabelerName>
    <SubstanceName>ALPROSTADIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.</IndicationAndUsage>
    <Description>edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). edex® is supplied in single-dose, dual-chamber cartridges. edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® cartridges are supplied in three strengths: 10-mcg cartridge (10.75 mcg alprostadil, 347.55 mcg α-cyclodextrin, 51.06 mg lactose); 20-mcg cartridge (21.5 mcg alprostadil, 695.2 mcg α-cyclodextrin, 51.06 mg lactose); 40-mcg cartridge (43 mcg alprostadil, 1,390.3 mcg α-cyclodextrin, 51.06 mg lactose). The edex® injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C20H34O5 and the molecular weight is 354.49. The chemical structure is:. The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of α-cyclodextrin is C36H60O30 and the molecular weight is 972.85. The chemical structure is. Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the α-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5, or 43 mcg of alprostadil is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 mcg, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>52244-010-06</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (52244-010-06)  / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>52244-0010-06</NDC11Code>
    <ProductNDC>52244-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Edex</ProprietaryName>
    <NonProprietaryName>Alprostadil</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRACAVERNOUS</RouteName>
    <StartMarketingDate>20120415</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020649</ApplicationNumber>
    <LabelerName>Endo USA, Inc.</LabelerName>
    <SubstanceName>ALPROSTADIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.</IndicationAndUsage>
    <Description>edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). edex® is supplied in single-dose, dual-chamber cartridges. edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® cartridges are supplied in three strengths: 10-mcg cartridge (10.75 mcg alprostadil, 347.55 mcg α-cyclodextrin, 51.06 mg lactose); 20-mcg cartridge (21.5 mcg alprostadil, 695.2 mcg α-cyclodextrin, 51.06 mg lactose); 40-mcg cartridge (43 mcg alprostadil, 1,390.3 mcg α-cyclodextrin, 51.06 mg lactose). The edex® injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C20H34O5 and the molecular weight is 354.49. The chemical structure is:. The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of α-cyclodextrin is C36H60O30 and the molecular weight is 972.85. The chemical structure is. Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the α-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5, or 43 mcg of alprostadil is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 mcg, respectively.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>72936-010-75</NDCCode><ProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</ProprietaryName><NonProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</NonProprietaryName></NDC><NDC><NDCCode>72936-010-88</NDCCode><ProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</ProprietaryName><NonProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</NonProprietaryName></NDC><NDC><NDCCode>43353-010-75</NDCCode><ProprietaryName>Acetaminophen And Codeine</ProprietaryName><NonProprietaryName>Acetaminophen And Codeine</NonProprietaryName></NDC><NDC><NDCCode>48273-010-01</NDCCode><ProprietaryName>Carbon Dioxide</ProprietaryName><NonProprietaryName>Carbon Dioxide</NonProprietaryName></NDC><NDC><NDCCode>50049-010-02</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>50594-010-75</NDCCode><ProprietaryName>Sound Body Allergy Relief</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>52755-010-05</NDCCode><NonProprietaryName>Allantoin, Lidocaine, Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>53634-010-01</NDCCode><ProprietaryName>Malin And Goetz</ProprietaryName><NonProprietaryName>Sulfur,salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>53634-010-02</NDCCode><ProprietaryName>Malin And Goetz</ProprietaryName><NonProprietaryName>Sulfur</NonProprietaryName></NDC><NDC><NDCCode>58518-010-01</NDCCode><ProprietaryName>Environmental Defense</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>60934-010-00</NDCCode><ProprietaryName>Hydropeptide S.p.f. Sun Protection Friends</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>73043-010-01</NDCCode><ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName><NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName></NDC><NDC><NDCCode>76446-010-75</NDCCode><ProprietaryName>Protective Day (uva/uvb) Spf 25</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate, Titanium Dioxide, Octocrylene, Benzophenone-3</NonProprietaryName></NDC><NDC><NDCCode>78936-010-02</NDCCode><ProprietaryName>Bb1720d Antibacterial Hand Wipes Hawaiian Coconut Scented</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>79866-010-02</NDCCode><ProprietaryName>Wet Wipe</ProprietaryName><NonProprietaryName>Wet Wipes</NonProprietaryName></NDC><NDC><NDCCode>80948-010-75</NDCCode><ProprietaryName>Puroma Hand Sanitizer Fragrance Free</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>10631-010-30</NDCCode><ProprietaryName>Kapspargo</ProprietaryName><NonProprietaryName>Metoprolol Succinate</NonProprietaryName></NDC><NDC><NDCCode>10812-010-01</NDCCode><ProprietaryName>Neutrogena Revitalizing Lip Balm</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>11528-010-01</NDCCode><ProprietaryName>Covaryx</ProprietaryName><NonProprietaryName>Estrogens, Esterified And Methyltestosterone</NonProprietaryName></NDC><NDC><NDCCode>14141-010-01</NDCCode><ProprietaryName>Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 260-n</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>15310-010-01</NDCCode><ProprietaryName>Eemt</ProprietaryName><NonProprietaryName>Estrogens, Esterified And Methyltestosterone</NonProprietaryName></NDC><NDC><NDCCode>42129-010-01</NDCCode><ProprietaryName>75% Alcohol Wipes</ProprietaryName><NonProprietaryName>75% Alcohol Wipes</NonProprietaryName></NDC><NDC><NDCCode>42509-010-01</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>48433-010-03</NDCCode><ProprietaryName>Atorvastatin Calcium</ProprietaryName><NonProprietaryName>Atorvastatin Calcium</NonProprietaryName></NDC><NDC><NDCCode>50049-010-01</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>50049-010-03</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>50049-010-04</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>51861-010-00</NDCCode><ProprietaryName>Sense Daytime Protective Broad Spectrum Spf 15</ProprietaryName><NonProprietaryName>Octinoxate, Oxybenzone, Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>52244-010-02</NDCCode><ProprietaryName>Edex</ProprietaryName><NonProprietaryName>Alprostadil</NonProprietaryName></NDC><NDC><NDCCode>52244-010-06</NDCCode><ProprietaryName>Edex</ProprietaryName><NonProprietaryName>Alprostadil</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
      "FirstLineMailingAddress": "15230 NE 24TH ST STE Q",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-5540",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-562-2015",
      "MailingAddressFaxNumber": "425-562-2010",
      "FirstLinePracticeLocationAddress": "15230 NE 24TH ST STE Q",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-5540",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-562-2015",
      "PracticeLocationAddressFaxNumber": "425-562-2010",
      "EnumerationDate": "10/26/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "WONG",
      "AuthorizedOfficialFirstName": "TONY",
      "AuthorizedOfficialTitle": "OPTOMETRIST",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-562-2015",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "WA 3422 TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1760539969",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "DR TIFFANY J HOLLENBECK PLLC",
      "OtherOrgName": "REDMOND RIDGE EYE CARE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "22310 NE MARKETPLACE DR",
      "SecondLineMailingAddress": "SUITE 106",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98053-2038",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-898-9222",
      "MailingAddressFaxNumber": "425-898-9225",
      "FirstLinePracticeLocationAddress": "22310 NE MARKETPLACE DR",
      "SecondLinePracticeLocationAddress": "SUITE 106",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98053-2038",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-898-9222",
      "PracticeLocationAddressFaxNumber": "425-898-9225",
      "EnumerationDate": "01/03/2007",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "HOLLENBECK",
      "AuthorizedOfficialFirstName": "TIFFANY",
      "AuthorizedOfficialMiddleName": "J",
      "AuthorizedOfficialTitle": "CO OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-898-9222",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3825",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1629124649",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "TRI-COUNTY EYE CARE AND OPTOMETRY PC",
      "FirstLineMailingAddress": "3685 BURGOYNE AVE",
      "MailingAddressCityName": "HUDSON FALLS",
      "MailingAddressStateName": "NY",
      "MailingAddressPostalCode": "12839-2168",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "518-747-4100",
      "MailingAddressFaxNumber": "518-747-6151",
      "FirstLinePracticeLocationAddress": "3685 BURGOYNE AVE",
      "PracticeLocationAddressCityName": "HUDSON FALLS",
      "PracticeLocationAddressStateName": "NY",
      "PracticeLocationAddressPostalCode": "12839-2168",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "518-747-4100",
      "PracticeLocationAddressFaxNumber": "518-747-6151",
      "EnumerationDate": "01/25/2007",
      "LastUpdateDate": "08/29/2011",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "MONICA",
      "AuthorizedOfficialTitle": "OPTOMETRIST",
      "AuthorizedOfficialCredential": "OD",
      "AuthorizedOfficialTelephoneNumber": "518-747-4100",
      "TaxonomyCode1": "152WC0802X",
      "Taxonomy1": "Corneal and Contact Management",
      "LicenseNumber1": "TUV006839-1",
      "LicenseNumberStateCode1": "NY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "152WP0200X",
      "Taxonomy2": "Pediatrics",
      "LicenseNumber2": "TUV006839-1",
      "LicenseNumberStateCode2": "NY",
      "PrimaryTaxonomySwitch2": "Y",
      "TaxonomyCode3": "152WS0006X",
      "Taxonomy3": "Sports Vision",
      "LicenseNumber3": "TUV006839-1",
      "LicenseNumberStateCode3": "NY",
      "PrimaryTaxonomySwitch3": "N",
      "OtherIdentifier1": "10089360",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "NY",
      "OtherIdentifierIssuer1": "CDPHP",
      "OtherIdentifier2": "C369F1",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "NY",
      "OtherIdentifierIssuer2": "EMPIRE",
      "OtherIdentifier3": "782077",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "NY",
      "OtherIdentifierIssuer3": "MVP",
      "OtherIdentifier4": "000408532001",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierState4": "NY",
      "OtherIdentifierIssuer4": "BSNENY",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1063635506",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "04/11/2007",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "261QA1903X",
      "Taxonomy1": "Ambulatory Surgical",
      "LicenseNumber1": "071581",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "165450",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OR",
      "OtherIdentifier2": "138874101",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "BLUE CROSS PARTICIPATING",
      "OtherIdentifier3": "490003253",
      "OtherIdentifierType3": "OTHER",
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      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "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",
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}
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