RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (34 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "11673-315-10",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (11673-315-10)  > 5 TABLET in 1 BLISTER PACK",
      "NDC11Code": "11673-0315-10",
      "ProductNDC": "11673-315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief Medication",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075209",
      "LabelerName": "Target Brands, Inc.",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "11673-315-30",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (11673-315-30)  > 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "11673-0315-30",
      "ProductNDC": "11673-315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief Medication",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075209",
      "LabelerName": "Target Brands, Inc.",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "11673-315-40",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (11673-315-40)  > 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "11673-0315-40",
      "ProductNDC": "11673-315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief Medication",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075209",
      "LabelerName": "Target Brands, Inc.",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "11673-315-60",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (11673-315-60)  > 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "11673-0315-60",
      "ProductNDC": "11673-315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief Medication",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075209",
      "LabelerName": "Target Brands, Inc.",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "11673-315-15",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (11673-315-15)  > 5 TABLET in 1 BLISTER PACK",
      "NDC11Code": "11673-0315-15",
      "ProductNDC": "11673-315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief Medication",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075209",
      "LabelerName": "Target Brands, Inc.",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "11673-315-18",
      "PackageDescription": "1 BOTTLE in 1 CARTON (11673-315-18)  > 180 TABLET in 1 BOTTLE",
      "NDC11Code": "11673-0315-18",
      "ProductNDC": "11673-315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief Medication",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075209",
      "LabelerName": "Target Brands, Inc.",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "10695-315-10",
      "PackageDescription": "1 kg in 1 CONTAINER (10695-315-10) ",
      "NDC11Code": "10695-0315-10",
      "ProductNDC": "10695-315",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Melatonin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20250709",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Willow Birch Pharma, LLC",
      "SubstanceName": "MELATONIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-17",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "09-JUL-25"
    },
    {
      "NDCCode": "24208-315-10",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-315-10)  / 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "24208-0315-10",
      "ProductNDC": "24208-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Polymyxin B Sulfate And Trimethoprim",
      "NonProprietaryName": "Polymyxin B Sulfate And Trimethoprim Sulfate",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19970214",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA064120",
      "LabelerName": "Bausch & Lomb Incorporated",
      "SubstanceName": "POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE",
      "StrengthNumber": "10000; 1",
      "StrengthUnit": "[USP'U]/mL; mg/mL",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19970214",
      "SamplePackage": "N",
      "IndicationAndUsage": "Polymyxin B sulfate and trimethoprim ophthalmic solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzaeand Pseudomonas aeruginosa.1. 1Efficacy for this organism in this organ system was studied in fewer than 10 infections.",
      "Description": "Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is a sterile antimicrobial solution for topical ophthalmic use. It has pH of 4.0 to 5.5 and osmolality of 270 to 310 mOsm/kg. Chemical Names: Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine sulfate, is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula:. Polymyxin B sulfate is the sulfate salt of polymyxin B 1and B 2which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:. Each mL contains:Actives: polymyxin B sulfate equal to 10,000 polymyxin B units, trimethoprim sulfate (equivalent to trimethoprim 1 mg); Inactives: purified water, sodium chloride. Sulfuric acid and, if necessary, sodium hydroxide may be added to adjust pH (4.0 – 5.5). Preservative: benzalkonium chloride 0.004%."
    },
    {
      "NDCCode": "25021-315-98",
      "PackageDescription": "1 VIAL in 1 CARTON (25021-315-98)  > 10 mL in 1 VIAL",
      "NDC11Code": "25021-0315-98",
      "ProductNDC": "25021-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenylephrine Hydrochloride",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201015",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209967",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2020-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201015",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenylephrine Hydrochloride Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.",
      "Description": "Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine Hydrochloride Injection, USP 10 mg per mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α­[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C9H14ClNO2 with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine Hydrochloride Injection, USP 10 mg per mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5."
    },
    {
      "NDCCode": "25021-315-99",
      "PackageDescription": "10 VIAL in 1 CARTON (25021-315-99)  > 5 mL in 1 VIAL",
      "NDC11Code": "25021-0315-99",
      "ProductNDC": "25021-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenylephrine Hydrochloride",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201015",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209967",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2020-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201015",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenylephrine Hydrochloride Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.",
      "Description": "Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine Hydrochloride Injection, USP 10 mg per mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α­[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C9H14ClNO2 with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine Hydrochloride Injection, USP 10 mg per mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5."
    },
    {
      "NDCCode": "33342-315-10",
      "PackageDescription": "90 TABLET in 1 BOTTLE (33342-315-10) ",
      "NDC11Code": "33342-0315-10",
      "ProductNDC": "33342-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240603",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208480",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240603",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atorvastatin calcium tablets is indicated:  To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
      "Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
    },
    {
      "NDCCode": "33342-315-12",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-315-12)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "33342-0315-12",
      "ProductNDC": "33342-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240603",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208480",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240603",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atorvastatin calcium tablets is indicated:  To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
      "Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
    },
    {
      "NDCCode": "35573-315-10",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-315-10)",
      "NDC11Code": "35573-0315-10",
      "ProductNDC": "35573-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Indiomin Mb",
      "NonProprietaryName": "Hyoscyamine Sulfate, Methenamine, Methylene Blue, And Sodium Phosphate, Monobasic, Monohydrate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150928",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Burel Pharmaceuticals, Inc",
      "SubstanceName": "HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
      "StrengthNumber": ".12; 120; 10; 40.8",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-14",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "42023-315-10",
      "PackageDescription": "10 BAG in 1 CARTON (42023-315-10)  / 250 mL in 1 BAG (42023-315-01) ",
      "NDC11Code": "42023-0315-10",
      "ProductNDC": "42023-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adrenalin (epinephrine In Sodium Chloride)",
      "NonProprietaryName": "Epinephrine In Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20241004",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA215875",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "EPINEPHRINE",
      "StrengthNumber": "16",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241004",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adrenalin® is a non-selective alpha and beta adrenergic agonist indicated to: 1 Increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.1).",
      "Description": "Adrenalin (epinephrine in sodium chloride injection) is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2- Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2- (methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Adrenalin (epinephrine in sodium chloride injection) is a clear, colorless, sterile solution administered by intravenous infusion, supplied in a 250 mL infusion bag. It is provided in five (5) ready-to-use concentrations containing. It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. It has a pH range of 3.7 - 4.3. The headspace in the containers has been displaced with nitrogen gas."
    },
    {
      "NDCCode": "42291-315-10",
      "PackageDescription": "1000 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-315-10) ",
      "NDC11Code": "42291-0315-10",
      "ProductNDC": "42291-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrochlorothiazide",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160912",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078391",
      "LabelerName": "AvKARE",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20160912",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42571-315-11",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (42571-315-11)  / 10 TABLET in 1 BLISTER PACK (42571-315-32) ",
      "NDC11Code": "42571-0315-11",
      "ProductNDC": "42571-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobazam",
      "NonProprietaryName": "Clobazam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190402",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211711",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "CLOBAZAM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2026-05-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190402",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobazam tablet is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.",
      "Description": "Clobazam tablet is a benzodiazepine derivative. The chemical name of clobazam is 7-Chloro-1-methyl-5-phenyl-1H-1,5 benzodiazepine-2,4(3H,5H)-dione with the following structure.   Clobazam is a white or almost white, crystalline powder with a slightly bitter taste; is slightly soluble in water, sparingly soluble in ethanol, and freely soluble in methylenechloride. The melting range of clobazam is from 182ºC to 185ºC. The molecular formula is C 16H 13O 2N 2Cl and the molecular weight is 300.7. Each clobazam tablet contains 10 mg or 20 mg of clobazam. Tablets also contain as inactive ingredients: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate, maize starch 5%, pregelatinized starch, and talc."
    },
    {
      "NDCCode": "42571-315-91",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (42571-315-91)  / 10 TABLET in 1 BLISTER PACK (42571-315-20) ",
      "NDC11Code": "42571-0315-91",
      "ProductNDC": "42571-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobazam",
      "NonProprietaryName": "Clobazam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190402",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211711",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "CLOBAZAM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2026-05-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190402",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobazam tablet is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.",
      "Description": "Clobazam tablet is a benzodiazepine derivative. The chemical name of clobazam is 7-Chloro-1-methyl-5-phenyl-1H-1,5 benzodiazepine-2,4(3H,5H)-dione with the following structure.   Clobazam is a white or almost white, crystalline powder with a slightly bitter taste; is slightly soluble in water, sparingly soluble in ethanol, and freely soluble in methylenechloride. The melting range of clobazam is from 182ºC to 185ºC. The molecular formula is C 16H 13O 2N 2Cl and the molecular weight is 300.7. Each clobazam tablet contains 10 mg or 20 mg of clobazam. Tablets also contain as inactive ingredients: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate, maize starch 5%, pregelatinized starch, and talc."
    },
    {
      "NDCCode": "42806-315-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (42806-315-10) ",
      "NDC11Code": "42806-0315-10",
      "ProductNDC": "42806-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170313",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090564",
      "LabelerName": "Epic Pharma, LLC",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2019-11-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170313",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each metformin hydrochloride tablet, USP, contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients: povidone (K-30), povidone (K-90), pregelatinized starch, and magnesiium stearate. In addition, the coating for the tablet contains artificial blackberry flavor, hypromellose, macrogol and titanium dioxide."
    },
    {
      "NDCCode": "43975-315-10",
      "PackageDescription": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (43975-315-10) ",
      "NDC11Code": "43975-0315-10",
      "ProductNDC": "43975-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bexarotene",
      "NonProprietaryName": "Bexarotene",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180510",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209861",
      "LabelerName": "ANI Pharmaceuticals, Inc.",
      "SubstanceName": "BEXAROTENE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180510",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.",
      "Description": "Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follows. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C24H28O2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: gelatin, nitrogen, butylated hydroxyanisole, glycerin, hydrolyzed gelatin, medium chain triglyceride, Shellac glaze, FD&C red #40, FD&C blue #1, FD&C yellow #6, propylene glycol, simethicone, polyethylene glycol 400, polysorbate 20, povidone, sorbitol, 1,4-sorbitan, mannitol, soy lecithin and titanium dioxide."
    },
    {
      "NDCCode": "48433-315-10",
      "PackageDescription": "100 POUCH in 1 BOX, UNIT-DOSE (48433-315-10)  > 1 TABLET in 1 POUCH (48433-315-01)",
      "NDC11Code": "48433-0315-10",
      "ProductNDC": "48433-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril",
      "NonProprietaryName": "Lisinopril",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075743",
      "LabelerName": "Safecor Health, LLC",
      "SubstanceName": "LISINOPRIL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-26",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "49643-315-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-315-10) ",
      "NDC11Code": "49643-0315-10",
      "ProductNDC": "49643-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Short Ragweed",
      "NonProprietaryName": "Ambrosia Artemisiifolia",
      "DosageFormName": "INJECTION",
      "RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19820322",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103113",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "AMBROSIA ARTEMISIIFOLIA POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/10mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19820322",
      "SamplePackage": "N",
      "IndicationAndUsage": "Studies have shown that properly performed an interpreted skin tests with ragweed pollen extract are useful in the diagnosis of allergy to ragweed pollen 7, 8, 20, 21. Immunotherapy with the appropriate dosage of short ragweed pollen extract is effective in reducing symptoms of hay fever and asthma resulting from exposure to short ragweed pollen (9, 10, 11), and it is believed to be effective with extract of giant ragweed, although carefully controlled studies are unavailable. However, clinical observations and known cross reactivity between short and giant ragweed pollens have led to the practice of using a mixture of the two species for skin testing and treatment 22, 23, 24, 25, 26, 27. This form of treatment is recommended for patients who cannot avoid exposure to pollen and who do not obtain satisfactory relief of symptoms from other medications, such as antihistamines. Immunologic changes resulting from treatment with short ragweed pollen extract are believed to include: : 1 The induction of specific anti-ragweed IgG antibodies commonly referred to as \"blocking antibodies\" 12, 13. , 2 A decrease in the elevation of ragweed specific IgE during and immediately following the ragweed pollen season 14. , 3 A reduction of circulating anti-ragweed IgE after long-term immunotherapy 15. , 4 A decrease in skin reactivity to the extract  16 and a decrease in leukocyte sensitivity to histamine release  17 after long-term immunotherapy. .",
      "Description": "INGREDIENTS - Allergenic extract of short ragweed pollen is a clear, amber-colored solution prepared from the dry, defatted pollen of Ambrosia elatior. The extract contains the water extractables of the pollen, 0.25% sodium chloride, 0.125% sodium bicarbonate, 0.5% phenol and 50% glycerol by volume. Extract of mixed short-giant ragweed has the same appearance as short ragweed pollen extract and contains the same chemical ingredients. It is prepared from equal gram weights of the pollens of Ambrosia elatior and Ambrosia trifida. STANDARDIZATION - The potency of ragweed pollen extract is based on antigen E, a protein component which is believed to be the most important allergen of short ragweed pollen. Extracts of short ragweed pollen sold in the U.S. must have a minimum antigen E content of 67.5 units per ml for a 1:20 w/v concentrate. Extracts of mixed short-giant ragweed must have a minimum antigen E content of 33.75 units/ml for a 1:20 w/v concentrate. The importance of antigen E in ragweed allergy is based on the following observations: : 1 In vitro studies with antigen E have shown that it is capable of causing histamine release from peripheral leukocytes of ragweed sensitive persons 1. , 2 The antigen E content of short ragweed pollen extract has been found to correlate with extract potency when measured by skin test response in persons allergic to short ragweed pollen 2. , 3 Immunotherapy with antigen E has been shown to be comparably effective to whole short ragweed pollen extract in reducing symptoms related to ragweed pollen exposure  3. ."
    },
    {
      "NDCCode": "52686-315-10",
      "PackageDescription": "1 BOTTLE in 1 CARTON (52686-315-10)  > 35.88 g in 1 BOTTLE",
      "NDC11Code": "52686-0315-10",
      "ProductNDC": "52686-315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shiseido Radiant Lifting Foundation",
      "ProprietaryNameSuffix": "B40",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120801",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SHISEIDO AMERICA INC.",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "682; 1471",
      "StrengthUnit": "mg/35.88g; mg/35.88g",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20120801",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "54575-315-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-315-10)",
      "NDC11Code": "54575-0315-10",
      "ProductNDC": "54575-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fire Ant",
      "NonProprietaryName": "Solenopsis Invicta",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "SOLENOPSIS INVICTA",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Ant Venoms [CS],Allergens [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": "55150-315-25",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (55150-315-25)  / 10 mL in 1 VIAL, MULTI-DOSE (55150-315-01) ",
      "NDC11Code": "55150-0315-25",
      "ProductNDC": "55150-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Succinylcholine Chloride",
      "NonProprietaryName": "Succinylcholine Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20231016",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217808",
      "LabelerName": "Eugia US LLC",
      "SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231016",
      "SamplePackage": "N",
      "IndicationAndUsage": "Succinylcholine chloride injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
      "Description": "Succinylcholine chloride injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride injection, USP contains succinylcholine chloride, USP as the active pharmaceutical ingredient. Succinylcholine chloride,  USP is chemically designated C14H30Cl2N2O4.2H2O   and its molecular weight is 397.34. The chemical name of succinylcholine chloride, USP  is 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-ethanaminium]dichloride. Succinylcholine chloride, USP is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:Succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine chloride, USP (equivalent to 22 mg of succinylcholine chloride dihydrate, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.6 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
    },
    {
      "NDCCode": "55289-315-10",
      "PackageDescription": "10 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-10) ",
      "NDC11Code": "55289-0315-10",
      "ProductNDC": "55289-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073192",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110923",
      "SamplePackage": "N",
      "IndicationAndUsage": "Loperamide hydrochloride is indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.",
      "Description": "Loperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water. Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Its structural formula is. C 29H 33ClN 2O 2HCl M.W. 513.51. Loperamide hydrochloride is available in 2 mg capsules. The inactive ingredients: dimethylpolysiloxane, gelatin, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, pregelatinized corn starch, magnesium stearate, shellac, and titanium dioxide."
    },
    {
      "NDCCode": "55316-315-10",
      "PackageDescription": "295 mL in 1 BOTTLE, PUMP (55316-315-10)",
      "NDC11Code": "55316-0315-10",
      "ProductNDC": "55316-315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Healthy Accents",
      "ProprietaryNameSuffix": "Moisture Healing",
      "NonProprietaryName": "Dimethicone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100625",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "DZA Brands LLC",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "1",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "55390-315-10",
      "PackageDescription": "10 VIAL in 1 BOX (55390-315-10)  > .5 mL in 1 VIAL",
      "NDC11Code": "55390-0315-10",
      "ProductNDC": "55390-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sumatriptan Succinate",
      "NonProprietaryName": "Sumatriptan Succinate",
      "DosageFormName": "INJECTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20100206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079123",
      "LabelerName": "Bedford Laboratories",
      "SubstanceName": "SUMATRIPTAN",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/.5mL",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2014-04-22"
    },
    {
      "NDCCode": "55648-315-04",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-315-04)  > 10 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "55648-0315-04",
      "ProductNDC": "55648-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clopidogrel",
      "NonProprietaryName": "Clopidogrel",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121113",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202266",
      "LabelerName": "Wockhardt Limited",
      "SubstanceName": "CLOPIDOGREL BISULFATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Clopidogrel is a P2Y12 platelet inhibitor indicated for:. ●     Acute coronary syndrome : 1 For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)] including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel tablets has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1) , 2 For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary PCI is unknown. (1.1) .",
      "Description": "Clopidogrel  bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H) acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is white to off white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablet, USP for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink, modified capsule shaped, debossed film-coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains glyceryl behenate, hydrogenated castor oil, hydroxypropylcellulose, mannitol, microcrystalline cellulose and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains iron oxide red, hypromellose 2910, lactose monohydrate, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "57687-315-30",
      "PackageDescription": "1 KIT in 1 CARTON (57687-315-30)  *  1 BOTTLE, DROPPER in 1 CARTON (57687-212-10)  / 10 mL in 1 BOTTLE, DROPPER *  1 BOTTLE, DROPPER in 1 CARTON (57687-229-10)  / 10 mL in 1 BOTTLE, DROPPER *  1 BOTTLE, DROPPER in 1 CARTON (57687-228-10)  / 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "57687-0315-30",
      "ProductNDC": "57687-315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bach Hope And Joy Comfort Kit",
      "NonProprietaryName": "Star Of Bethlehem, Gorse, Sweet Chestnut",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20231101",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Nelson Bach USA Limited",
      "Status": "Active",
      "LastUpdate": "2023-11-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231101",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of naturally occurring simple nervous tension."
    },
    {
      "NDCCode": "58633-315-10",
      "PackageDescription": "1 TUBE in 1 CARTON (58633-315-10)  / 50 mL in 1 TUBE",
      "NDC11Code": "58633-0315-10",
      "ProductNDC": "58633-315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dark Spot Sun Defense",
      "ProprietaryNameSuffix": "Broad Spectrum Spf 50",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150424",
      "EndMarketingDate": "20240601",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Dr. Dennis Gross Skincare�, LLC",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "49; 44.2",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150424",
      "EndMarketingDatePackage": "20240601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    }
  ]
}
                    

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    <NDCCode>11673-315-10</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (11673-315-10)  &gt; 5 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>11673-0315-10</NDC11Code>
    <ProductNDC>11673-315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief Medication</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075209</ApplicationNumber>
    <LabelerName>Target Brands, Inc.</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
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    <PackageDescription>3 BLISTER PACK in 1 CARTON (11673-315-30)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>11673-0315-30</NDC11Code>
    <ProductNDC>11673-315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief Medication</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
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    <LabelerName>Target Brands, Inc.</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>11673-315-40</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (11673-315-40)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>11673-0315-40</NDC11Code>
    <ProductNDC>11673-315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief Medication</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075209</ApplicationNumber>
    <LabelerName>Target Brands, Inc.</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>11673-315-60</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (11673-315-60)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>11673-0315-60</NDC11Code>
    <ProductNDC>11673-315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief Medication</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075209</ApplicationNumber>
    <LabelerName>Target Brands, Inc.</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11673-315-15</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (11673-315-15)  &gt; 5 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>11673-0315-15</NDC11Code>
    <ProductNDC>11673-315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief Medication</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075209</ApplicationNumber>
    <LabelerName>Target Brands, Inc.</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11673-315-18</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (11673-315-18)  &gt; 180 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>11673-0315-18</NDC11Code>
    <ProductNDC>11673-315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief Medication</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075209</ApplicationNumber>
    <LabelerName>Target Brands, Inc.</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10695-315-10</NDCCode>
    <PackageDescription>1 kg in 1 CONTAINER (10695-315-10) </PackageDescription>
    <NDC11Code>10695-0315-10</NDC11Code>
    <ProductNDC>10695-315</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Melatonin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20250709</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Willow Birch Pharma, LLC</LabelerName>
    <SubstanceName>MELATONIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>09-JUL-25</StartMarketingDatePackage>
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  <NDC>
    <NDCCode>24208-315-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-315-10)  / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>24208-0315-10</NDC11Code>
    <ProductNDC>24208-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Polymyxin B Sulfate And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Polymyxin B Sulfate And Trimethoprim Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19970214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064120</ApplicationNumber>
    <LabelerName>Bausch &amp; Lomb Incorporated</LabelerName>
    <SubstanceName>POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE</SubstanceName>
    <StrengthNumber>10000; 1</StrengthNumber>
    <StrengthUnit>[USP'U]/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19970214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Polymyxin B sulfate and trimethoprim ophthalmic solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzaeand Pseudomonas aeruginosa.1. 1Efficacy for this organism in this organ system was studied in fewer than 10 infections.</IndicationAndUsage>
    <Description>Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is a sterile antimicrobial solution for topical ophthalmic use. It has pH of 4.0 to 5.5 and osmolality of 270 to 310 mOsm/kg. Chemical Names: Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine sulfate, is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula:. Polymyxin B sulfate is the sulfate salt of polymyxin B 1and B 2which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:. Each mL contains:Actives: polymyxin B sulfate equal to 10,000 polymyxin B units, trimethoprim sulfate (equivalent to trimethoprim 1 mg); Inactives: purified water, sodium chloride. Sulfuric acid and, if necessary, sodium hydroxide may be added to adjust pH (4.0 – 5.5). Preservative: benzalkonium chloride 0.004%.</Description>
  </NDC>
  <NDC>
    <NDCCode>25021-315-98</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (25021-315-98)  &gt; 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>25021-0315-98</NDC11Code>
    <ProductNDC>25021-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209967</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phenylephrine Hydrochloride Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.</IndicationAndUsage>
    <Description>Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine Hydrochloride Injection, USP 10 mg per mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α­[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C9H14ClNO2 with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine Hydrochloride Injection, USP 10 mg per mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>25021-315-99</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (25021-315-99)  &gt; 5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>25021-0315-99</NDC11Code>
    <ProductNDC>25021-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209967</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phenylephrine Hydrochloride Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.</IndicationAndUsage>
    <Description>Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine Hydrochloride Injection, USP 10 mg per mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α­[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C9H14ClNO2 with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine Hydrochloride Injection, USP 10 mg per mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-315-10</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (33342-315-10) </PackageDescription>
    <NDC11Code>33342-0315-10</NDC11Code>
    <ProductNDC>33342-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208480</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets is indicated:  To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-315-12</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-315-12)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0315-12</NDC11Code>
    <ProductNDC>33342-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208480</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets is indicated:  To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>35573-315-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (35573-315-10)</PackageDescription>
    <NDC11Code>35573-0315-10</NDC11Code>
    <ProductNDC>35573-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Indiomin Mb</ProprietaryName>
    <NonProprietaryName>Hyoscyamine Sulfate, Methenamine, Methylene Blue, And Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150928</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE</SubstanceName>
    <StrengthNumber>.12; 120; 10; 40.8</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-14</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>42023-315-10</NDCCode>
    <PackageDescription>10 BAG in 1 CARTON (42023-315-10)  / 250 mL in 1 BAG (42023-315-01) </PackageDescription>
    <NDC11Code>42023-0315-10</NDC11Code>
    <ProductNDC>42023-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adrenalin (epinephrine In Sodium Chloride)</ProprietaryName>
    <NonProprietaryName>Epinephrine In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20241004</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215875</ApplicationNumber>
    <LabelerName>Par Health USA, LLC</LabelerName>
    <SubstanceName>EPINEPHRINE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241004</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adrenalin® is a non-selective alpha and beta adrenergic agonist indicated to: 1 Increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.1).</IndicationAndUsage>
    <Description>Adrenalin (epinephrine in sodium chloride injection) is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2- Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2- (methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Adrenalin (epinephrine in sodium chloride injection) is a clear, colorless, sterile solution administered by intravenous infusion, supplied in a 250 mL infusion bag. It is provided in five (5) ready-to-use concentrations containing. It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. It has a pH range of 3.7 - 4.3. The headspace in the containers has been displaced with nitrogen gas.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-315-10</NDCCode>
    <PackageDescription>1000 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-315-10) </PackageDescription>
    <NDC11Code>42291-0315-10</NDC11Code>
    <ProductNDC>42291-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160912</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078391</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42571-315-11</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (42571-315-11)  / 10 TABLET in 1 BLISTER PACK (42571-315-32) </PackageDescription>
    <NDC11Code>42571-0315-11</NDC11Code>
    <ProductNDC>42571-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobazam</ProprietaryName>
    <NonProprietaryName>Clobazam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190402</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211711</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>CLOBAZAM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190402</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobazam tablet is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.</IndicationAndUsage>
    <Description>Clobazam tablet is a benzodiazepine derivative. The chemical name of clobazam is 7-Chloro-1-methyl-5-phenyl-1H-1,5 benzodiazepine-2,4(3H,5H)-dione with the following structure.   Clobazam is a white or almost white, crystalline powder with a slightly bitter taste; is slightly soluble in water, sparingly soluble in ethanol, and freely soluble in methylenechloride. The melting range of clobazam is from 182ºC to 185ºC. The molecular formula is C 16H 13O 2N 2Cl and the molecular weight is 300.7. Each clobazam tablet contains 10 mg or 20 mg of clobazam. Tablets also contain as inactive ingredients: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate, maize starch 5%, pregelatinized starch, and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-315-91</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (42571-315-91)  / 10 TABLET in 1 BLISTER PACK (42571-315-20) </PackageDescription>
    <NDC11Code>42571-0315-91</NDC11Code>
    <ProductNDC>42571-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobazam</ProprietaryName>
    <NonProprietaryName>Clobazam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190402</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211711</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>CLOBAZAM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190402</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobazam tablet is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.</IndicationAndUsage>
    <Description>Clobazam tablet is a benzodiazepine derivative. The chemical name of clobazam is 7-Chloro-1-methyl-5-phenyl-1H-1,5 benzodiazepine-2,4(3H,5H)-dione with the following structure.   Clobazam is a white or almost white, crystalline powder with a slightly bitter taste; is slightly soluble in water, sparingly soluble in ethanol, and freely soluble in methylenechloride. The melting range of clobazam is from 182ºC to 185ºC. The molecular formula is C 16H 13O 2N 2Cl and the molecular weight is 300.7. Each clobazam tablet contains 10 mg or 20 mg of clobazam. Tablets also contain as inactive ingredients: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate, maize starch 5%, pregelatinized starch, and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-315-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42806-315-10) </PackageDescription>
    <NDC11Code>42806-0315-10</NDC11Code>
    <ProductNDC>42806-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170313</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090564</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each metformin hydrochloride tablet, USP, contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients: povidone (K-30), povidone (K-90), pregelatinized starch, and magnesiium stearate. In addition, the coating for the tablet contains artificial blackberry flavor, hypromellose, macrogol and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>43975-315-10</NDCCode>
    <PackageDescription>100 CAPSULE, LIQUID FILLED in 1 BOTTLE (43975-315-10) </PackageDescription>
    <NDC11Code>43975-0315-10</NDC11Code>
    <ProductNDC>43975-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bexarotene</ProprietaryName>
    <NonProprietaryName>Bexarotene</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180510</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209861</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>BEXAROTENE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.</IndicationAndUsage>
    <Description>Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follows. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C24H28O2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: gelatin, nitrogen, butylated hydroxyanisole, glycerin, hydrolyzed gelatin, medium chain triglyceride, Shellac glaze, FD&amp;C red #40, FD&amp;C blue #1, FD&amp;C yellow #6, propylene glycol, simethicone, polyethylene glycol 400, polysorbate 20, povidone, sorbitol, 1,4-sorbitan, mannitol, soy lecithin and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>48433-315-10</NDCCode>
    <PackageDescription>100 POUCH in 1 BOX, UNIT-DOSE (48433-315-10)  &gt; 1 TABLET in 1 POUCH (48433-315-01)</PackageDescription>
    <NDC11Code>48433-0315-10</NDC11Code>
    <ProductNDC>48433-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisinopril</ProprietaryName>
    <NonProprietaryName>Lisinopril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075743</ApplicationNumber>
    <LabelerName>Safecor Health, LLC</LabelerName>
    <SubstanceName>LISINOPRIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-26</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49643-315-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49643-315-10) </PackageDescription>
    <NDC11Code>49643-0315-10</NDC11Code>
    <ProductNDC>49643-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Short Ragweed</ProprietaryName>
    <NonProprietaryName>Ambrosia Artemisiifolia</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19820322</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103113</ApplicationNumber>
    <LabelerName>Allermed Laboratories, Inc.</LabelerName>
    <SubstanceName>AMBROSIA ARTEMISIIFOLIA POLLEN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/10mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19820322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Studies have shown that properly performed an interpreted skin tests with ragweed pollen extract are useful in the diagnosis of allergy to ragweed pollen 7, 8, 20, 21. Immunotherapy with the appropriate dosage of short ragweed pollen extract is effective in reducing symptoms of hay fever and asthma resulting from exposure to short ragweed pollen (9, 10, 11), and it is believed to be effective with extract of giant ragweed, although carefully controlled studies are unavailable. However, clinical observations and known cross reactivity between short and giant ragweed pollens have led to the practice of using a mixture of the two species for skin testing and treatment 22, 23, 24, 25, 26, 27. This form of treatment is recommended for patients who cannot avoid exposure to pollen and who do not obtain satisfactory relief of symptoms from other medications, such as antihistamines. Immunologic changes resulting from treatment with short ragweed pollen extract are believed to include: : 1 The induction of specific anti-ragweed IgG antibodies commonly referred to as "blocking antibodies" 12, 13. , 2 A decrease in the elevation of ragweed specific IgE during and immediately following the ragweed pollen season 14. , 3 A reduction of circulating anti-ragweed IgE after long-term immunotherapy 15. , 4 A decrease in skin reactivity to the extract  16 and a decrease in leukocyte sensitivity to histamine release  17 after long-term immunotherapy. .</IndicationAndUsage>
    <Description>INGREDIENTS - Allergenic extract of short ragweed pollen is a clear, amber-colored solution prepared from the dry, defatted pollen of Ambrosia elatior. The extract contains the water extractables of the pollen, 0.25% sodium chloride, 0.125% sodium bicarbonate, 0.5% phenol and 50% glycerol by volume. Extract of mixed short-giant ragweed has the same appearance as short ragweed pollen extract and contains the same chemical ingredients. It is prepared from equal gram weights of the pollens of Ambrosia elatior and Ambrosia trifida. STANDARDIZATION - The potency of ragweed pollen extract is based on antigen E, a protein component which is believed to be the most important allergen of short ragweed pollen. Extracts of short ragweed pollen sold in the U.S. must have a minimum antigen E content of 67.5 units per ml for a 1:20 w/v concentrate. Extracts of mixed short-giant ragweed must have a minimum antigen E content of 33.75 units/ml for a 1:20 w/v concentrate. The importance of antigen E in ragweed allergy is based on the following observations: : 1 In vitro studies with antigen E have shown that it is capable of causing histamine release from peripheral leukocytes of ragweed sensitive persons 1. , 2 The antigen E content of short ragweed pollen extract has been found to correlate with extract potency when measured by skin test response in persons allergic to short ragweed pollen 2. , 3 Immunotherapy with antigen E has been shown to be comparably effective to whole short ragweed pollen extract in reducing symptoms related to ragweed pollen exposure  3. .</Description>
  </NDC>
  <NDC>
    <NDCCode>52686-315-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (52686-315-10)  &gt; 35.88 g in 1 BOTTLE</PackageDescription>
    <NDC11Code>52686-0315-10</NDC11Code>
    <ProductNDC>52686-315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shiseido Radiant Lifting Foundation</ProprietaryName>
    <ProprietaryNameSuffix>B40</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SHISEIDO AMERICA INC.</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>682; 1471</StrengthNumber>
    <StrengthUnit>mg/35.88g; mg/35.88g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>54575-315-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-315-10)</PackageDescription>
    <NDC11Code>54575-0315-10</NDC11Code>
    <ProductNDC>54575-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fire Ant</ProprietaryName>
    <NonProprietaryName>Solenopsis Invicta</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19671207</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101376</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>SOLENOPSIS INVICTA</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Ant Venoms [CS],Allergens [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>55150-315-25</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (55150-315-25)  / 10 mL in 1 VIAL, MULTI-DOSE (55150-315-01) </PackageDescription>
    <NDC11Code>55150-0315-25</NDC11Code>
    <ProductNDC>55150-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Succinylcholine Chloride</ProprietaryName>
    <NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20231016</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217808</ApplicationNumber>
    <LabelerName>Eugia US LLC</LabelerName>
    <SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-10-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Succinylcholine chloride injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
    <Description>Succinylcholine chloride injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride injection, USP contains succinylcholine chloride, USP as the active pharmaceutical ingredient. Succinylcholine chloride,  USP is chemically designated C14H30Cl2N2O4.2H2O   and its molecular weight is 397.34. The chemical name of succinylcholine chloride, USP  is 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-ethanaminium]dichloride. Succinylcholine chloride, USP is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:Succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine chloride, USP (equivalent to 22 mg of succinylcholine chloride dihydrate, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.6 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-315-10</NDCCode>
    <PackageDescription>10 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-10) </PackageDescription>
    <NDC11Code>55289-0315-10</NDC11Code>
    <ProductNDC>55289-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073192</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110923</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Loperamide hydrochloride is indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.</IndicationAndUsage>
    <Description>Loperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water. Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Its structural formula is. C 29H 33ClN 2O 2HCl M.W. 513.51. Loperamide hydrochloride is available in 2 mg capsules. The inactive ingredients: dimethylpolysiloxane, gelatin, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, pregelatinized corn starch, magnesium stearate, shellac, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55316-315-10</NDCCode>
    <PackageDescription>295 mL in 1 BOTTLE, PUMP (55316-315-10)</PackageDescription>
    <NDC11Code>55316-0315-10</NDC11Code>
    <ProductNDC>55316-315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Healthy Accents</ProprietaryName>
    <ProprietaryNameSuffix>Moisture Healing</ProprietaryNameSuffix>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100625</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>DZA Brands LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55390-315-10</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (55390-315-10)  &gt; .5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>55390-0315-10</NDC11Code>
    <ProductNDC>55390-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan Succinate</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20100206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079123</ApplicationNumber>
    <LabelerName>Bedford Laboratories</LabelerName>
    <SubstanceName>SUMATRIPTAN</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2014-04-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55648-315-04</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (55648-315-04)  &gt; 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55648-0315-04</NDC11Code>
    <ProductNDC>55648-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clopidogrel</ProprietaryName>
    <NonProprietaryName>Clopidogrel</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202266</ApplicationNumber>
    <LabelerName>Wockhardt Limited</LabelerName>
    <SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Clopidogrel is a P2Y12 platelet inhibitor indicated for:. ●     Acute coronary syndrome : 1 For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)] including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel tablets has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1) , 2 For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary PCI is unknown. (1.1) .</IndicationAndUsage>
    <Description>Clopidogrel  bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H) acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is white to off white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablet, USP for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink, modified capsule shaped, debossed film-coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains glyceryl behenate, hydrogenated castor oil, hydroxypropylcellulose, mannitol, microcrystalline cellulose and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains iron oxide red, hypromellose 2910, lactose monohydrate, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>57687-315-30</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (57687-315-30)  *  1 BOTTLE, DROPPER in 1 CARTON (57687-212-10)  / 10 mL in 1 BOTTLE, DROPPER *  1 BOTTLE, DROPPER in 1 CARTON (57687-229-10)  / 10 mL in 1 BOTTLE, DROPPER *  1 BOTTLE, DROPPER in 1 CARTON (57687-228-10)  / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>57687-0315-30</NDC11Code>
    <ProductNDC>57687-315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bach Hope And Joy Comfort Kit</ProprietaryName>
    <NonProprietaryName>Star Of Bethlehem, Gorse, Sweet Chestnut</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Nelson Bach USA Limited</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-11-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of naturally occurring simple nervous tension.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58633-315-10</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (58633-315-10)  / 50 mL in 1 TUBE</PackageDescription>
    <NDC11Code>58633-0315-10</NDC11Code>
    <ProductNDC>58633-315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dark Spot Sun Defense</ProprietaryName>
    <ProprietaryNameSuffix>Broad Spectrum Spf 50</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150424</StartMarketingDate>
    <EndMarketingDate>20240601</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Dr. Dennis Gross Skincare�, LLC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>49; 44.2</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150424</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240601</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>11673-315-10</NDCCode><ProprietaryName>Allergy Relief Medication</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>11673-315-30</NDCCode><ProprietaryName>Allergy Relief Medication</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>11673-315-40</NDCCode><ProprietaryName>Allergy Relief Medication</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>11673-315-60</NDCCode><ProprietaryName>Allergy Relief Medication</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>11673-315-15</NDCCode><ProprietaryName>Allergy Relief Medication</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>11673-315-18</NDCCode><ProprietaryName>Allergy Relief Medication</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>10695-315-10</NDCCode><NonProprietaryName>Melatonin</NonProprietaryName></NDC><NDC><NDCCode>24208-315-10</NDCCode><ProprietaryName>Polymyxin B Sulfate And Trimethoprim</ProprietaryName><NonProprietaryName>Polymyxin B Sulfate And Trimethoprim Sulfate</NonProprietaryName></NDC><NDC><NDCCode>25021-315-98</NDCCode><ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>25021-315-99</NDCCode><ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33342-315-10</NDCCode><ProprietaryName>Atorvastatin Calcium</ProprietaryName><NonProprietaryName>Atorvastatin Calcium</NonProprietaryName></NDC><NDC><NDCCode>33342-315-12</NDCCode><ProprietaryName>Atorvastatin Calcium</ProprietaryName><NonProprietaryName>Atorvastatin Calcium</NonProprietaryName></NDC><NDC><NDCCode>35573-315-10</NDCCode><ProprietaryName>Indiomin Mb</ProprietaryName><NonProprietaryName>Hyoscyamine Sulfate, Methenamine, Methylene Blue, And Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>42023-315-10</NDCCode><ProprietaryName>Adrenalin (epinephrine In Sodium Chloride)</ProprietaryName><NonProprietaryName>Epinephrine In Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>42291-315-10</NDCCode><ProprietaryName>Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>42571-315-11</NDCCode><ProprietaryName>Clobazam</ProprietaryName><NonProprietaryName>Clobazam</NonProprietaryName></NDC><NDC><NDCCode>42571-315-91</NDCCode><ProprietaryName>Clobazam</ProprietaryName><NonProprietaryName>Clobazam</NonProprietaryName></NDC><NDC><NDCCode>42806-315-10</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43975-315-10</NDCCode><ProprietaryName>Bexarotene</ProprietaryName><NonProprietaryName>Bexarotene</NonProprietaryName></NDC><NDC><NDCCode>48433-315-10</NDCCode><ProprietaryName>Lisinopril</ProprietaryName><NonProprietaryName>Lisinopril</NonProprietaryName></NDC><NDC><NDCCode>49643-315-10</NDCCode><ProprietaryName>Short Ragweed</ProprietaryName><NonProprietaryName>Ambrosia Artemisiifolia</NonProprietaryName></NDC><NDC><NDCCode>52686-315-10</NDCCode><ProprietaryName>Shiseido Radiant Lifting Foundation</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>54575-315-10</NDCCode><ProprietaryName>Fire Ant</ProprietaryName><NonProprietaryName>Solenopsis Invicta</NonProprietaryName></NDC><NDC><NDCCode>55150-315-25</NDCCode><ProprietaryName>Succinylcholine Chloride</ProprietaryName><NonProprietaryName>Succinylcholine Chloride</NonProprietaryName></NDC><NDC><NDCCode>55289-315-10</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55316-315-10</NDCCode><ProprietaryName>Healthy Accents</ProprietaryName><NonProprietaryName>Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>55390-315-10</NDCCode><ProprietaryName>Sumatriptan Succinate</ProprietaryName><NonProprietaryName>Sumatriptan Succinate</NonProprietaryName></NDC><NDC><NDCCode>55648-315-04</NDCCode><ProprietaryName>Clopidogrel</ProprietaryName><NonProprietaryName>Clopidogrel</NonProprietaryName></NDC><NDC><NDCCode>57687-315-30</NDCCode><ProprietaryName>Bach Hope And Joy Comfort Kit</ProprietaryName><NonProprietaryName>Star Of Bethlehem, Gorse, Sweet Chestnut</NonProprietaryName></NDC><NDC><NDCCode>58633-315-10</NDCCode><ProprietaryName>Dark Spot Sun Defense</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</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",
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      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "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",
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}
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