RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (185 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "51013-431-09",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (51013-431-09)  > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "51013-0431-09",
      "ProductNDC": "51013-431",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ultra Strength Gas Relief",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180327",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part332",
      "LabelerName": "PURACAP PHARMACEUTICAL LLC",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180327",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the relief of : 1 pressure and bloating commonly referred to as gas."
    },
    {
      "NDCCode": "51013-109-09",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (51013-109-09)  > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "51013-0109-09",
      "ProductNDC": "51013-109",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gas Relief",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160713",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part332",
      "LabelerName": "PuraCap Pharmaceutical LLC",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "IndicationAndUsage": "for the relief of: 1 pressure, bloating, and fullness commonly referred to as gas."
    },
    {
      "NDCCode": "51013-190-09",
      "PackageDescription": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-190-09) ",
      "NDC11Code": "51013-0190-09",
      "ProductNDC": "51013-190",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dutasteride",
      "NonProprietaryName": "Dutasteride",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180529",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209909",
      "LabelerName": "PuraCap Pharmaceutical LLC",
      "SubstanceName": "DUTASTERIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dutasteride capsules is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1): 1 improve symptoms,, 2 reduce the risk of acute urinary retention, and, 3 reduce the risk of the need for BPH-related surgery.",
      "Description": "Dutasteride capsules are a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula. Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water. Each dutasteride capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are gelatin (from certified BSE-free bovine sources), glycerin, titanium dioxide, ferric oxide (yellow), and medium chain triglyceride. The red edible ink contains ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, red iron oxide, shellac glaze and simethicone."
    },
    {
      "NDCCode": "51013-428-09",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (51013-428-09)  > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "51013-0428-09",
      "ProductNDC": "51013-428",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ultra Strength Gas Relief",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180208",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part332",
      "LabelerName": "PuraCap Pharmaceutical LLC",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180208",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the relief of : 1 pressure and bloating commonly referred to as gas."
    },
    {
      "NDCCode": "51013-430-09",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (51013-430-09)  > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "51013-0430-09",
      "ProductNDC": "51013-430",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gas Relief",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180327",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part332",
      "LabelerName": "PURACAP PHARMACEUTICAL LLC",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180327",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the relief of: 1 pressure, bloating, and fullness commonly referred to as gas."
    },
    {
      "NDCCode": "33342-431-09",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (33342-431-09) ",
      "NDC11Code": "33342-0431-09",
      "ProductNDC": "33342-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ticagrelor",
      "NonProprietaryName": "Ticagrelor",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251028",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212258",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "TICAGRELOR",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251028",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ticagrelor is a P2Y12 platelet inhibitor indicated.",
      "Description": "Ticagrelor tablets contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropyl]amino}-5(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is: Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 400, talc, titanium dioxide, and yellow iron oxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 400, talc, titanium dioxide, black iron oxide, and red iron oxide."
    },
    {
      "NDCCode": "43547-431-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (43547-431-09) ",
      "NDC11Code": "43547-0431-09",
      "ProductNDC": "43547-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211080",
      "LabelerName": "Solco Healthcare US, LLC",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "145",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fenofibrate tablets are indicated as adjunctive therapy to diet: 1 to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). , 2 to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. .",
      "Description": "Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains crospovidone, hypromellose 2910 (3 cps), lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, sodium lauryl sulfate, and sucrose. In addition, individual tablets contain. 48 mg tablets. iron oxide yellow, macrogol/PEG 3350, polyvinyl alcohol-part. hydrolyzed, talc, and titanium dioxide. 145 mg tablets. macrogol/PEG 3350, polyvinyl alcohol-part. hydrolyzed, talc, and titanium dioxide."
    },
    {
      "NDCCode": "69367-431-09",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (69367-431-09) ",
      "NDC11Code": "69367-0431-09",
      "ProductNDC": "69367-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251117",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212988",
      "LabelerName": "Westminster Pharmaceuticals, LLC",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251117",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
    },
    {
      "NDCCode": "69842-431-09",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (69842-431-09)  / 10 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "69842-0431-09",
      "ProductNDC": "69842-431",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cold, Flu, And Sore Throat",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200502",
      "EndMarketingDate": "20241206",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "CVS PHARMACY",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 10; 200; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200502",
      "EndMarketingDatePackage": "20241206",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these common cold and flu symptoms:nasal congestion sore throat headache coughminor aches and pains. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive . temporarily reduces fever."
    },
    {
      "NDCCode": "71919-431-09",
      "PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-431-09) ",
      "NDC11Code": "71919-0431-09",
      "ProductNDC": "71919-431",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Macrotinum",
      "NonProprietaryName": "Black Cohosh",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110517",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "BLACK COHOSH",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20110517",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10544-431-02",
      "PackageDescription": "120 TABLET in 1 BOTTLE (10544-431-02)",
      "NDC11Code": "10544-0431-02",
      "ProductNDC": "10544-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090796",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.Ibuprofen tablets are indicated for relief of mild to moderate pain.Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
      "Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77°C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone.The structural formula is represented below:Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), are available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide."
    },
    {
      "NDCCode": "10544-431-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (10544-431-90)",
      "NDC11Code": "10544-0431-90",
      "ProductNDC": "10544-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090796",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.Ibuprofen tablets are indicated for relief of mild to moderate pain.Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
      "Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77°C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone.The structural formula is represented below:Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), are available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide."
    },
    {
      "NDCCode": "10812-431-01",
      "PackageDescription": "88 mL in 1 TUBE (10812-431-01)",
      "NDC11Code": "10812-0431-01",
      "ProductNDC": "10812-431",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Pure And Free Baby",
      "ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf60 Plus",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "49; 47",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-05",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10812-431-02",
      "PackageDescription": "147 mL in 1 TUBE (10812-431-02)",
      "NDC11Code": "10812-0431-02",
      "ProductNDC": "10812-431",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Pure And Free Baby",
      "ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf60 Plus",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "49; 47",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-05",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10812-431-05",
      "PackageDescription": "14 mL in 1 TUBE (10812-431-05)",
      "NDC11Code": "10812-0431-05",
      "ProductNDC": "10812-431",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Pure And Free Baby",
      "ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf60 Plus",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "49; 47",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-05",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "13537-431-01",
      "PackageDescription": "50 mL in 1 BOTTLE, PLASTIC (13537-431-01)",
      "NDC11Code": "13537-0431-01",
      "ProductNDC": "13537-431",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cyzone",
      "ProprietaryNameSuffix": "Xpress Your Body Sensitive",
      "NonProprietaryName": "Aluminum Sesquichlorohydrate",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120608",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Ventura Corporation LTD.",
      "SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Reduce la transpiración de las axilas."
    },
    {
      "NDCCode": "16110-391-05",
      "PackageDescription": "5 PACKET in 1 CARTON (16110-391-05)  / .25 g in 1 PACKET",
      "NDC11Code": "16110-0391-05",
      "ProductNDC": "16110-391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Klisyri",
      "NonProprietaryName": "Tirbanibulin",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201214",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA213189",
      "LabelerName": "Almirall, LLC",
      "SubstanceName": "TIRBANIBULIN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20201214",
      "SamplePackage": "N",
      "IndicationAndUsage": "KLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp.",
      "Description": "KLISYRI (tirbanibulin) ointment is a microtubule inhibitor for topical use. The chemical name of tirbanibulin is N-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl) acetamide. The molecular weight is 431.4 and the molecular formula is C26H29N3O3. Tirbanibulin’s structural formula is. Tirbanibulin ointment 1% contains 10 mg tirbanibulin per gram of white to off-white ointment containing mono- and di-glycerides and propylene glycol."
    },
    {
      "NDCCode": "16110-391-55",
      "PackageDescription": "5 PACKET in 1 CARTON (16110-391-55)  / .35 g in 1 PACKET",
      "NDC11Code": "16110-0391-55",
      "ProductNDC": "16110-391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Klisyri",
      "NonProprietaryName": "Tirbanibulin",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201214",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA213189",
      "LabelerName": "Almirall, LLC",
      "SubstanceName": "TIRBANIBULIN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240607",
      "SamplePackage": "N",
      "IndicationAndUsage": "KLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp.",
      "Description": "KLISYRI (tirbanibulin) ointment is a microtubule inhibitor for topical use. The chemical name of tirbanibulin is N-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl) acetamide. The molecular weight is 431.4 and the molecular formula is C26H29N3O3. Tirbanibulin’s structural formula is. Tirbanibulin ointment 1% contains 10 mg tirbanibulin per gram of white to off-white ointment containing mono- and di-glycerides and propylene glycol."
    },
    {
      "NDCCode": "16571-431-11",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (16571-431-11)",
      "NDC11Code": "16571-0431-11",
      "ProductNDC": "16571-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atenolol",
      "NonProprietaryName": "Atenolol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100610",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077443",
      "LabelerName": "Pack Pharmaceuticals LLC",
      "SubstanceName": "ATENOLOL",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Atenolol tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets USP may be administered with other antihypertensive agents.",
      "Description": "Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP is available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, hydroxypropyl methylcellulose, titanium dioxide and glycerine."
    },
    {
      "NDCCode": "33358-431-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33358-431-30)",
      "NDC11Code": "33358-0431-30",
      "ProductNDC": "33358-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080226",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078155",
      "LabelerName": "RxChange Co.",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.",
      "Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of  HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole , ascorbic acid, citric acid monohydrate, and triethyl citrate."
    },
    {
      "NDCCode": "43063-431-08",
      "PackageDescription": "8 CAPSULE in 1 BOTTLE, PLASTIC (43063-431-08) ",
      "NDC11Code": "43063-0431-08",
      "ProductNDC": "43063-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19910918",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072741",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20060712",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43063-431-12",
      "PackageDescription": "12 CAPSULE in 1 BOTTLE, PLASTIC (43063-431-12) ",
      "NDC11Code": "43063-0431-12",
      "ProductNDC": "43063-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19910918",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072741",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20060712",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43063-431-15",
      "PackageDescription": "15 CAPSULE in 1 BOTTLE, PLASTIC (43063-431-15) ",
      "NDC11Code": "43063-0431-15",
      "ProductNDC": "43063-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19910918",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072741",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20060712",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43063-431-20",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (43063-431-20) ",
      "NDC11Code": "43063-0431-20",
      "ProductNDC": "43063-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19910918",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072741",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20060712",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "46122-431-40",
      "PackageDescription": "355 mL in 1 BOTTLE (46122-431-40) ",
      "NDC11Code": "46122-0431-40",
      "ProductNDC": "46122-431",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antacid Antigas",
      "ProprietaryNameSuffix": "Nta",
      "NonProprietaryName": "Aluminum Hydroxide, Magnesium Hydroxide, Simethicone",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M001",
      "LabelerName": "AMERISOURCEBERGEN DRUG CORPORATION",
      "SubstanceName": "ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE",
      "StrengthNumber": "800; 800; 80",
      "StrengthUnit": "mg/10mL; mg/10mL; mg/10mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2023-11-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180131",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves. : 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 symptoms of gas."
    },
    {
      "NDCCode": "51285-431-82",
      "PackageDescription": "1 POUCH in 1 CARTON (51285-431-82)  > 1 KIT in 1 POUCH",
      "NDC11Code": "51285-0431-82",
      "ProductNDC": "51285-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quartette",
      "NonProprietaryName": "Levonorgestrel/ethinyl Estradiol Tablets And Ethinyl Estradiol Tablets",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20130329",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204061",
      "LabelerName": "Teva Women's Health, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2015-01-09"
    },
    {
      "NDCCode": "52427-431-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (52427-431-90) ",
      "NDC11Code": "52427-0431-90",
      "ProductNDC": "52427-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tenormin",
      "NonProprietaryName": "Atenolol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150415",
      "EndMarketingDate": "20260901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018240",
      "LabelerName": "Almatica Pharma LLC",
      "SubstanceName": "ATENOLOL",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150415",
      "EndMarketingDatePackage": "20260901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypertension. TENORMIN is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. TENORMIN may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis. TENORMIN is indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction. TENORMIN is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient’s clinical condition allows. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.",
      "Description": "TENORMIN® (atenolol), a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). TENORMIN is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate."
    },
    {
      "NDCCode": "52685-431-21",
      "PackageDescription": "1 CONTAINER in 1 CARTON (52685-431-21)  > 10 g in 1 CONTAINER",
      "NDC11Code": "52685-0431-21",
      "ProductNDC": "52685-431",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shiseido The Makeup Foundation",
      "ProprietaryNameSuffix": "O60",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20010101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SHISEIDO CO., LTD.",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "410",
      "StrengthUnit": "mg/10g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "54575-431-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-431-02)",
      "NDC11Code": "54575-0431-02",
      "ProductNDC": "54575-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Green Pea",
      "NonProprietaryName": "Pea",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "PEA",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-431-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-431-10)",
      "NDC11Code": "54575-0431-10",
      "ProductNDC": "54575-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Green Pea",
      "NonProprietaryName": "Pea",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "PEA",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    }
  ]
}
                    

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    <NonProprietaryName>Simethicone</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
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    <ApplicationNumber>part332</ApplicationNumber>
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    <SubstanceName>DIMETHICONE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
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    <LastUpdate>2025-01-01</LastUpdate>
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    <IndicationAndUsage>for the relief of : 1 pressure and bloating commonly referred to as gas.</IndicationAndUsage>
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    <NDCCode>51013-109-09</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (51013-109-09)  &gt; 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51013-0109-09</NDC11Code>
    <ProductNDC>51013-109</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gas Relief</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
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    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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    <LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
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    <NDCCode>51013-190-09</NDCCode>
    <PackageDescription>90 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-190-09) </PackageDescription>
    <NDC11Code>51013-0190-09</NDC11Code>
    <ProductNDC>51013-190</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dutasteride</ProprietaryName>
    <NonProprietaryName>Dutasteride</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209909</ApplicationNumber>
    <LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
    <SubstanceName>DUTASTERIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dutasteride capsules is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1): 1 improve symptoms,, 2 reduce the risk of acute urinary retention, and, 3 reduce the risk of the need for BPH-related surgery.</IndicationAndUsage>
    <Description>Dutasteride capsules are a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula. Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water. Each dutasteride capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are gelatin (from certified BSE-free bovine sources), glycerin, titanium dioxide, ferric oxide (yellow), and medium chain triglyceride. The red edible ink contains ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, red iron oxide, shellac glaze and simethicone.</Description>
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  <NDC>
    <NDCCode>51013-428-09</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (51013-428-09)  &gt; 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51013-0428-09</NDC11Code>
    <ProductNDC>51013-428</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ultra Strength Gas Relief</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180208</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part332</ApplicationNumber>
    <LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the relief of : 1 pressure and bloating commonly referred to as gas.</IndicationAndUsage>
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  <NDC>
    <NDCCode>51013-430-09</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (51013-430-09)  &gt; 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51013-0430-09</NDC11Code>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gas Relief</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
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    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part332</ApplicationNumber>
    <LabelerName>PURACAP PHARMACEUTICAL LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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  <NDC>
    <NDCCode>33342-431-09</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (33342-431-09) </PackageDescription>
    <NDC11Code>33342-0431-09</NDC11Code>
    <ProductNDC>33342-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ticagrelor</ProprietaryName>
    <NonProprietaryName>Ticagrelor</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251028</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212258</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TICAGRELOR</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ticagrelor is a P2Y12 platelet inhibitor indicated.</IndicationAndUsage>
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    <NDCCode>43547-431-09</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (43547-431-09) </PackageDescription>
    <NDC11Code>43547-0431-09</NDC11Code>
    <ProductNDC>43547-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211080</ApplicationNumber>
    <LabelerName>Solco Healthcare US, LLC</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets are indicated as adjunctive therapy to diet: 1 to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). , 2 to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. .</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains crospovidone, hypromellose 2910 (3 cps), lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, sodium lauryl sulfate, and sucrose. In addition, individual tablets contain. 48 mg tablets. iron oxide yellow, macrogol/PEG 3350, polyvinyl alcohol-part. hydrolyzed, talc, and titanium dioxide. 145 mg tablets. macrogol/PEG 3350, polyvinyl alcohol-part. hydrolyzed, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>69367-431-09</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (69367-431-09) </PackageDescription>
    <NDC11Code>69367-0431-09</NDC11Code>
    <ProductNDC>69367-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251117</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212988</ApplicationNumber>
    <LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>69842-431-09</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (69842-431-09)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>69842-0431-09</NDC11Code>
    <ProductNDC>69842-431</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cold, Flu, And Sore Throat</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200502</StartMarketingDate>
    <EndMarketingDate>20241206</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>CVS PHARMACY</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 10; 200; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200502</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241206</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these common cold and flu symptoms:nasal congestion sore throat headache coughminor aches and pains. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive . temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71919-431-09</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-431-09) </PackageDescription>
    <NDC11Code>71919-0431-09</NDC11Code>
    <ProductNDC>71919-431</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Macrotinum</ProprietaryName>
    <NonProprietaryName>Black Cohosh</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110517</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>BLACK COHOSH</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10544-431-02</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE (10544-431-02)</PackageDescription>
    <NDC11Code>10544-0431-02</NDC11Code>
    <ProductNDC>10544-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090796</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.Ibuprofen tablets are indicated for relief of mild to moderate pain.Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77°C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone.The structural formula is represented below:Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), are available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-431-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (10544-431-90)</PackageDescription>
    <NDC11Code>10544-0431-90</NDC11Code>
    <ProductNDC>10544-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090796</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.Ibuprofen tablets are indicated for relief of mild to moderate pain.Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77°C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone.The structural formula is represented below:Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), are available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10812-431-01</NDCCode>
    <PackageDescription>88 mL in 1 TUBE (10812-431-01)</PackageDescription>
    <NDC11Code>10812-0431-01</NDC11Code>
    <ProductNDC>10812-431</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Pure And Free Baby</ProprietaryName>
    <ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf60 Plus</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>49; 47</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-09-05</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10812-431-02</NDCCode>
    <PackageDescription>147 mL in 1 TUBE (10812-431-02)</PackageDescription>
    <NDC11Code>10812-0431-02</NDC11Code>
    <ProductNDC>10812-431</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Pure And Free Baby</ProprietaryName>
    <ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf60 Plus</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>49; 47</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-09-05</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10812-431-05</NDCCode>
    <PackageDescription>14 mL in 1 TUBE (10812-431-05)</PackageDescription>
    <NDC11Code>10812-0431-05</NDC11Code>
    <ProductNDC>10812-431</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Pure And Free Baby</ProprietaryName>
    <ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf60 Plus</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>49; 47</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-09-05</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>13537-431-01</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE, PLASTIC (13537-431-01)</PackageDescription>
    <NDC11Code>13537-0431-01</NDC11Code>
    <ProductNDC>13537-431</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cyzone</ProprietaryName>
    <ProprietaryNameSuffix>Xpress Your Body Sensitive</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120608</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD.</LabelerName>
    <SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Reduce la transpiración de las axilas.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16110-391-05</NDCCode>
    <PackageDescription>5 PACKET in 1 CARTON (16110-391-05)  / .25 g in 1 PACKET</PackageDescription>
    <NDC11Code>16110-0391-05</NDC11Code>
    <ProductNDC>16110-391</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Klisyri</ProprietaryName>
    <NonProprietaryName>Tirbanibulin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201214</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213189</ApplicationNumber>
    <LabelerName>Almirall, LLC</LabelerName>
    <SubstanceName>TIRBANIBULIN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp.</IndicationAndUsage>
    <Description>KLISYRI (tirbanibulin) ointment is a microtubule inhibitor for topical use. The chemical name of tirbanibulin is N-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl) acetamide. The molecular weight is 431.4 and the molecular formula is C26H29N3O3. Tirbanibulin’s structural formula is. Tirbanibulin ointment 1% contains 10 mg tirbanibulin per gram of white to off-white ointment containing mono- and di-glycerides and propylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>16110-391-55</NDCCode>
    <PackageDescription>5 PACKET in 1 CARTON (16110-391-55)  / .35 g in 1 PACKET</PackageDescription>
    <NDC11Code>16110-0391-55</NDC11Code>
    <ProductNDC>16110-391</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Klisyri</ProprietaryName>
    <NonProprietaryName>Tirbanibulin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201214</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213189</ApplicationNumber>
    <LabelerName>Almirall, LLC</LabelerName>
    <SubstanceName>TIRBANIBULIN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp.</IndicationAndUsage>
    <Description>KLISYRI (tirbanibulin) ointment is a microtubule inhibitor for topical use. The chemical name of tirbanibulin is N-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl) acetamide. The molecular weight is 431.4 and the molecular formula is C26H29N3O3. Tirbanibulin’s structural formula is. Tirbanibulin ointment 1% contains 10 mg tirbanibulin per gram of white to off-white ointment containing mono- and di-glycerides and propylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-431-11</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (16571-431-11)</PackageDescription>
    <NDC11Code>16571-0431-11</NDC11Code>
    <ProductNDC>16571-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atenolol</ProprietaryName>
    <NonProprietaryName>Atenolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077443</ApplicationNumber>
    <LabelerName>Pack Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ATENOLOL</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Atenolol tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets USP may be administered with other antihypertensive agents.</IndicationAndUsage>
    <Description>Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP is available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, hydroxypropyl methylcellulose, titanium dioxide and glycerine.</Description>
  </NDC>
  <NDC>
    <NDCCode>33358-431-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33358-431-30)</PackageDescription>
    <NDC11Code>33358-0431-30</NDC11Code>
    <ProductNDC>33358-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078155</ApplicationNumber>
    <LabelerName>RxChange Co.</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.</IndicationAndUsage>
    <Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of  HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole , ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-431-08</NDCCode>
    <PackageDescription>8 CAPSULE in 1 BOTTLE, PLASTIC (43063-431-08) </PackageDescription>
    <NDC11Code>43063-0431-08</NDC11Code>
    <ProductNDC>43063-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19910918</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072741</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060712</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43063-431-12</NDCCode>
    <PackageDescription>12 CAPSULE in 1 BOTTLE, PLASTIC (43063-431-12) </PackageDescription>
    <NDC11Code>43063-0431-12</NDC11Code>
    <ProductNDC>43063-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19910918</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072741</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060712</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43063-431-15</NDCCode>
    <PackageDescription>15 CAPSULE in 1 BOTTLE, PLASTIC (43063-431-15) </PackageDescription>
    <NDC11Code>43063-0431-15</NDC11Code>
    <ProductNDC>43063-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19910918</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072741</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060712</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43063-431-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (43063-431-20) </PackageDescription>
    <NDC11Code>43063-0431-20</NDC11Code>
    <ProductNDC>43063-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19910918</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072741</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060712</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>46122-431-40</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (46122-431-40) </PackageDescription>
    <NDC11Code>46122-0431-40</NDC11Code>
    <ProductNDC>46122-431</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antacid Antigas</ProprietaryName>
    <ProprietaryNameSuffix>Nta</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Hydroxide, Magnesium Hydroxide, Simethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M001</ApplicationNumber>
    <LabelerName>AMERISOURCEBERGEN DRUG CORPORATION</LabelerName>
    <SubstanceName>ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE</SubstanceName>
    <StrengthNumber>800; 800; 80</StrengthNumber>
    <StrengthUnit>mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves. : 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 symptoms of gas.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51285-431-82</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (51285-431-82)  &gt; 1 KIT in 1 POUCH</PackageDescription>
    <NDC11Code>51285-0431-82</NDC11Code>
    <ProductNDC>51285-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quartette</ProprietaryName>
    <NonProprietaryName>Levonorgestrel/ethinyl Estradiol Tablets And Ethinyl Estradiol Tablets</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20130329</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204061</ApplicationNumber>
    <LabelerName>Teva Women's Health, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2015-01-09</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>52427-431-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (52427-431-90) </PackageDescription>
    <NDC11Code>52427-0431-90</NDC11Code>
    <ProductNDC>52427-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tenormin</ProprietaryName>
    <NonProprietaryName>Atenolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150415</StartMarketingDate>
    <EndMarketingDate>20260901</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018240</ApplicationNumber>
    <LabelerName>Almatica Pharma LLC</LabelerName>
    <SubstanceName>ATENOLOL</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150415</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260901</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypertension. TENORMIN is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. TENORMIN may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis. TENORMIN is indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction. TENORMIN is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient’s clinical condition allows. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.</IndicationAndUsage>
    <Description>TENORMIN® (atenolol), a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). TENORMIN is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>52685-431-21</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (52685-431-21)  &gt; 10 g in 1 CONTAINER</PackageDescription>
    <NDC11Code>52685-0431-21</NDC11Code>
    <ProductNDC>52685-431</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shiseido The Makeup Foundation</ProprietaryName>
    <ProprietaryNameSuffix>O60</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20010101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SHISEIDO CO., LTD.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>410</StrengthNumber>
    <StrengthUnit>mg/10g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>54575-431-02</NDCCode>
    <PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (54575-431-02)</PackageDescription>
    <NDC11Code>54575-0431-02</NDC11Code>
    <ProductNDC>54575-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Green Pea</ProprietaryName>
    <NonProprietaryName>Pea</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>PEA</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>54575-431-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-431-10)</PackageDescription>
    <NDC11Code>54575-0431-10</NDC11Code>
    <ProductNDC>54575-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Green Pea</ProprietaryName>
    <NonProprietaryName>Pea</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>PEA</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>51013-431-09</NDCCode><ProprietaryName>Ultra Strength Gas Relief</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC><NDC><NDCCode>51013-109-09</NDCCode><ProprietaryName>Gas Relief</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC><NDC><NDCCode>51013-190-09</NDCCode><ProprietaryName>Dutasteride</ProprietaryName><NonProprietaryName>Dutasteride</NonProprietaryName></NDC><NDC><NDCCode>51013-428-09</NDCCode><ProprietaryName>Ultra Strength Gas Relief</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC><NDC><NDCCode>51013-430-09</NDCCode><ProprietaryName>Gas Relief</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC><NDC><NDCCode>33342-431-09</NDCCode><ProprietaryName>Ticagrelor</ProprietaryName><NonProprietaryName>Ticagrelor</NonProprietaryName></NDC><NDC><NDCCode>43547-431-09</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>69367-431-09</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>69842-431-09</NDCCode><ProprietaryName>Cold, Flu, And Sore Throat</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>71919-431-09</NDCCode><ProprietaryName>Macrotinum</ProprietaryName><NonProprietaryName>Black Cohosh</NonProprietaryName></NDC><NDC><NDCCode>10544-431-02</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>10544-431-90</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>10812-431-01</NDCCode><ProprietaryName>Neutrogena Pure And Free Baby</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10812-431-02</NDCCode><ProprietaryName>Neutrogena Pure And Free Baby</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10812-431-05</NDCCode><ProprietaryName>Neutrogena Pure And Free Baby</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>13537-431-01</NDCCode><ProprietaryName>Cyzone</ProprietaryName><NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>16110-391-05</NDCCode><ProprietaryName>Klisyri</ProprietaryName><NonProprietaryName>Tirbanibulin</NonProprietaryName></NDC><NDC><NDCCode>16110-391-55</NDCCode><ProprietaryName>Klisyri</ProprietaryName><NonProprietaryName>Tirbanibulin</NonProprietaryName></NDC><NDC><NDCCode>16571-431-11</NDCCode><ProprietaryName>Atenolol</ProprietaryName><NonProprietaryName>Atenolol</NonProprietaryName></NDC><NDC><NDCCode>33358-431-30</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>43063-431-08</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43063-431-12</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43063-431-15</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43063-431-20</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>46122-431-40</NDCCode><ProprietaryName>Antacid Antigas</ProprietaryName><NonProprietaryName>Aluminum Hydroxide, Magnesium Hydroxide, Simethicone</NonProprietaryName></NDC><NDC><NDCCode>51285-431-82</NDCCode><ProprietaryName>Quartette</ProprietaryName><NonProprietaryName>Levonorgestrel/ethinyl Estradiol Tablets And Ethinyl Estradiol Tablets</NonProprietaryName></NDC><NDC><NDCCode>52427-431-90</NDCCode><ProprietaryName>Tenormin</ProprietaryName><NonProprietaryName>Atenolol</NonProprietaryName></NDC><NDC><NDCCode>52685-431-21</NDCCode><ProprietaryName>Shiseido The Makeup Foundation</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>54575-431-02</NDCCode><ProprietaryName>Green Pea</ProprietaryName><NonProprietaryName>Pea</NonProprietaryName></NDC><NDC><NDCCode>54575-431-10</NDCCode><ProprietaryName>Green Pea</ProprietaryName><NonProprietaryName>Pea</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",
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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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