RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "46287-037-01",
      "PackageDescription": "150 mL in 1 BOTTLE (46287-037-01) ",
      "NDC11Code": "46287-0037-01",
      "ProductNDC": "46287-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Norliqva",
      "NonProprietaryName": "Amlodipine",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260302",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA214439",
      "LabelerName": "CMP Pharma, Inc.",
      "SubstanceName": "AMLODIPINE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260302",
      "SamplePackage": "N",
      "IndicationAndUsage": "NORLIQVA is a calcium channel blocker for the treatment of: 1 Hypertension (1.1) NORLIQVA is indicated for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease (1.2) Chronic Stable AnginaVasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40%.",
      "Description": "NORLIQVA is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Each mL of NORLIQVA (amlodipine) oral solution contains 1 mg of amlodipine provided as 1.385 mg of amlodipine besylate and the following inactive ingredients: butylated hydroxyanisole, glycerin, propylene glycol and mixed berry flavor."
    },
    {
      "NDCCode": "46287-003-01",
      "PackageDescription": "25 g in 1 JAR (46287-003-01) ",
      "NDC11Code": "46287-0003-01",
      "ProductNDC": "46287-003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocortisone",
      "NonProprietaryName": "Hydrocortisone",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19850730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088138",
      "LabelerName": "CMP Pharma, Inc.",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19850906",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "46287-006-01",
      "PackageDescription": "473 mL in 1 BOTTLE (46287-006-01) ",
      "NDC11Code": "46287-0006-01",
      "ProductNDC": "46287-006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Polystyrene Sulfonate",
      "NonProprietaryName": "Sodium Polystyrene Sulfonate",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL; RECTAL",
      "StartMarketingDate": "19821208",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA087859",
      "LabelerName": "CMP Pharma, Inc.",
      "SubstanceName": "SODIUM POLYSTYRENE SULFONATE",
      "StrengthNumber": "15",
      "StrengthUnit": "g/60mL",
      "Status": "Active",
      "LastUpdate": "2021-08-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19821208",
      "SamplePackage": "N",
      "IndicationAndUsage": "SPS® Suspension is indicated for the treatment of hyperkalemia.",
      "Description": "Sodium Polystyrene Sulfonate Suspension USP (SPS® Suspension) can be administered orally or in an enema. It is a cherry-flavored suspension containing 15 grams of cation-exchange resin (Sodium Polystyrene Sulfonate USP); 21.5 mL of Sorbitol Solution USP (equivalent to approximately 20 grams of Sorbitol); 0.18 mL (0.3%) of Alcohol per 60 mL of suspension. Also contains Purified Water USP; Propylene Glycol USP; Magnesium Aluminum Silicate NF; Sodium Saccharin USP; Methylparaben NF; Propylparaben NF; and flavor. Sodium polystyrene sulfonate is a benzene, diethenyl-, polymer with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:. The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with an in‑vitro exchange capacity of approximately 3.1 mEq (in-vivo approximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema."
    },
    {
      "NDCCode": "46287-009-01",
      "PackageDescription": "473 mL in 1 BOTTLE (46287-009-01) ",
      "NDC11Code": "46287-0009-01",
      "ProductNDC": "46287-009",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isoniazid",
      "NonProprietaryName": "Isoniazid",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "19831111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088235",
      "LabelerName": "CMP Pharma, Inc.",
      "SubstanceName": "ISONIAZID",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Antimycobacterial [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19831111",
      "SamplePackage": "N",
      "IndicationAndUsage": "Isoniazid oral solution is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication is inadequate therapy. Isoniazid oral solution is recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy. , 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5 mm), therapy should be continued. , 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. , 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm). , 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin's disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. .",
      "Description": "Isoniazid is an antibacterial available as an orange-flavored solution for oral administration containing 50 mg of Isoniazid USP per 5 mL of oral solution. Sorbitol solution USP (containing 70% Sorbitol) is used as the vehicle. This product also contains citric acid USP and potassium sorbate NF. Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has a molecular formula of C6H7N3O and a molecular weight of 137.14. It has the following structural formula:. Isoniazid is odorless and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid is slowly affected by exposure to air and light."
    },
    {
      "NDCCode": "46287-014-01",
      "PackageDescription": "500 mL in 1 BOTTLE (46287-014-01) ",
      "NDC11Code": "46287-0014-01",
      "ProductNDC": "46287-014",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oracit",
      "NonProprietaryName": "Citric Acid And Sodium Citrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "19840515",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "CMP Pharma, Inc.",
      "SubstanceName": "CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": "640; 490",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2023-12-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19840515",
      "SamplePackage": "N",
      "IndicationAndUsage": "ORACIT® is indicated for the treatment of metabolic acidosis. This solution is also useful in conditions where long term maintenance of alkaline urine is needed (e.g. uric acid and cystine calculi of the urinary tract). ORACIT® is also effective in treatment for acidosis of certain renal tubular disorders.",
      "Description": "The product is a clear, colorless solution containing Citric Acid USP 640 mg/5 mL, and Hydrous Sodium Citrate USP 490 mg/5 mL. It also contains Methylparaben NF and Propylparaben NF as preservatives. These concentrations yield 1 mEq of sodium, equivalent to 1 mEq of bicarbonate per mL of solution."
    },
    {
      "NDCCode": "46287-015-01",
      "PackageDescription": "473 mL in 1 BOTTLE (46287-015-01)",
      "NDC11Code": "46287-0015-01",
      "ProductNDC": "46287-015",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amantadine Hydrochloride",
      "NonProprietaryName": "Amantadine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020911",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075819",
      "LabelerName": "CMP Pharma, Inc.",
      "SubstanceName": "AMANTADINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-06",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "46287-020-01",
      "PackageDescription": "473 mL in 1 BOTTLE (46287-020-01) ",
      "NDC11Code": "46287-0020-01",
      "ProductNDC": "46287-020",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carospir",
      "NonProprietaryName": "Carospir",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170804",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209478",
      "LabelerName": "CMP Pharma, Inc.",
      "SubstanceName": "SPIRONOLACTONE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170804",
      "SamplePackage": "N",
      "IndicationAndUsage": "CAROSPIR is an antagonist of aldosterone indicated for: 1 the treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2), 3 the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions (1.3).",
      "Description": "CAROSPIR Oral Suspension contains 25 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21- carboxylic acid γ-lactone acetate per 5 mL, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include sorbic acid, potassium sorbate, citric acid anhydrous, sodium citrate dihydrate, simethicone emulsion, saccharin sodium, xanthan gum, Magnasweet 110, glycerin, banana flavor, and purified water."
    },
    {
      "NDCCode": "46287-030-01",
      "PackageDescription": "150 mL in 1 BOTTLE (46287-030-01) ",
      "NDC11Code": "46287-0030-01",
      "ProductNDC": "46287-030",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvaliq",
      "NonProprietaryName": "Atorvaliq",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA213260",
      "LabelerName": "CMP Pharma, Inc.",
      "SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-08-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "ATORVALIQ is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.oMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.oNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemia.oHypertriglyceridemia.",
      "Description": "ATORVALIQ (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium 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 is (C33H34 FN2O5)2Ca∙3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. ATORVALIQ oral suspension contains 20 mg/5 mL of atorvastatin and the following inactive ingredients: caroboxymethylcellulose sodium, magnesium aluminum silicate, methylparaben, ethylparaben, propylparaben, sucralose, acesulfame potassium, orange flavor, water."
    },
    {
      "NDCCode": "46287-055-01",
      "PackageDescription": "122 mL in 1 BOTTLE (46287-055-01) ",
      "NDC11Code": "46287-0055-01",
      "ProductNDC": "46287-055",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Liqrev",
      "NonProprietaryName": "Sildenafil",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230430",
      "EndMarketingDate": "20250430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA214952",
      "LabelerName": "CMP Pharma, Inc.",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230430",
      "EndMarketingDatePackage": "20250430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adults. LIQREV is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, because of Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
      "Description": "LIQREV, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. It has a chemical formula of C22H3N6O4S.C6H8O7 and a molecular weight of 666.7 g.mol-1. LIQREV (sildenafil) Oral Suspension 10 mg/mL is supplied as a white to off-white, opaque, strawberry-flavored suspension. LIQREV is provided in 122 mL in an amber glass bottle with a child resistant tamper-evident cap. Each bottle contains 1.22 g sildenafil (equivalent to 1.71g sildenafil citrate). The inactive ingredients include acesulfame potassium, citric acid monohydrate, glycerin, simethicone emulsion, sodium benzoate, sucralose, strawberry flavor, tri-sodium citrate dihydrate, xanthan gum, and water."
    },
    {
      "NDCCode": "46287-010-11",
      "PackageDescription": "110 g in 1 JAR (46287-010-11) ",
      "NDC11Code": "46287-0010-11",
      "ProductNDC": "46287-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Triamcinolone Acetonide",
      "NonProprietaryName": "Triamcinolone Acetonide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210823",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089595",
      "LabelerName": "CMP Pharma, Inc.",
      "SubstanceName": "TRIAMCINOLONE ACETONIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-01-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210823",
      "SamplePackage": "N",
      "IndicationAndUsage": "Triamcinolone Acetonide 0.05% in Absorbase® (Triamcinolone Acetonide Ointment, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
      "Description": "Topical corticosteroids, such as Triamcinolone Acetonide 0.05% in Absorbase® (Triamcinolone Acetonide Ointment, USP), constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Triamcinolone Acetonide 0.05% in Absorbase® (Triamcinolone Acetonide Ointment, USP) contains 0.5 mg of Triamcinolone Acetonide USP in a water-in-oil emulsion composed of Light Mineral Oil NF, Purified Water USP, White Petrolatum USP, Heavy Mineral Oil USP, Mineral Wax, and Lanolin Alcohols NF. The white ointment is for topical use only. Triamcinolone Acetonide has the molecular formula of C 24H 31FO 6 and is designated chemically as Pregna-1,4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-, (11β, 16α)-. It has a molecular weight of 434.50 and the following structural formula:."
    },
    {
      "NDCCode": "10129-037-01",
      "PackageDescription": "1 GEL in 1 BOTTLE, PLASTIC (10129-037-01) ",
      "NDC11Code": "10129-0037-01",
      "ProductNDC": "10129-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gingicaine Gel, Cotton Candy Flavor",
      "NonProprietaryName": "Gingicaine Gel, Cotton Candy Flavor",
      "DosageFormName": "GEL",
      "RouteName": "DENTAL; ORAL; PERIODONTAL",
      "StartMarketingDate": "19930326",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Gingi-Pak a Division of the Belport",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19930706",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of pain due to:  Minor irritation or injury of oral mucous membrane  Minor dental procedures  Minor irritation of mouth or gums caused by dentures or orthodontic appliances."
    },
    {
      "NDCCode": "10345-037-01",
      "PackageDescription": "40 mL in 1 TUBE (10345-037-01)",
      "NDC11Code": "10345-0037-01",
      "ProductNDC": "10345-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Loccitane - Immortelle Precious Bb Broad Spectrum Spf 30 01 Fair",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141118",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Laboratoires M&L",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "153.2",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "11086-037-01",
      "PackageDescription": "50 g in 1 TUBE (11086-037-01) ",
      "NDC11Code": "11086-0037-01",
      "ProductNDC": "11086-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dritho-creme",
      "ProprietaryNameSuffix": "Hp",
      "NonProprietaryName": "Anthralin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130101",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Summers Laboratories Inc",
      "SubstanceName": "ANTHRALIN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20130101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "11559-037-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (11559-037-01)  > 30 mL in 1 BOTTLE",
      "NDC11Code": "11559-0037-01",
      "ProductNDC": "11559-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cyberwhite Hd Uv Protector Broad Spectrum Spf 50",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131001",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "ESTEE LAUDER INC",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": ".0309; .0515; .0515; .0278; .0309",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "helps prevent sunburn."
    },
    {
      "NDCCode": "12120-037-01",
      "PackageDescription": "180 kg in 1 DRUM (12120-037-01)",
      "NDC11Code": "12120-0037-01",
      "ProductNDC": "12120-037",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20101001",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Crystal Claire Cosmetics Inc.",
      "SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
      "StrengthNumber": "100; 150",
      "StrengthUnit": "g/kg; g/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "12707-037-01",
      "PackageDescription": "10 g in 1 DRUM (12707-037-01) ",
      "NDC11Code": "12707-0037-01",
      "ProductNDC": "12707-037",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Naloxone Hydrochloride Dihydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20171211",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Macfarlan Smith Limited",
      "SubstanceName": "NALOXONE HYDROCHLORIDE DIHYDRATE",
      "StrengthNumber": "100",
      "StrengthUnit": "g/100g",
      "Status": "Unfinished",
      "LastUpdate": "2026-02-25",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "11-DEC-17"
    },
    {
      "NDCCode": "13537-037-02",
      "PackageDescription": "1 TUBE in 1 BOX (13537-037-02)  > 2 g in 1 TUBE (13537-037-01)",
      "NDC11Code": "13537-0037-02",
      "ProductNDC": "13537-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esika",
      "ProprietaryNameSuffix": "Perfect Skin Coverage Concealer Spf 17",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110923",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation (San Juan, P.R)",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": ".04",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "13668-037-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (13668-037-01) ",
      "NDC11Code": "13668-0037-01",
      "ProductNDC": "13668-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Risperidone",
      "NonProprietaryName": "Risperidone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079088",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "RISPERIDONE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).",
      "Description": "Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&C yellow # 6 Orange yellow S (E 110)."
    },
    {
      "NDCCode": "14141-037-01",
      "PackageDescription": "1 TUBE in 1 BOX (14141-037-01)  / 30 g in 1 TUBE",
      "NDC11Code": "14141-0037-01",
      "ProductNDC": "14141-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cyzone Studio Look Base De Alta Cobertura Y Larga Duracion Fps 20 Chocochip 330-c",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220413",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "BEL STAR S A",
      "SubstanceName": "ZINC OXIDE; OCTINOXATE",
      "StrengthNumber": "24; 40",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2025-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220413",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "14474-037-01",
      "PackageDescription": "5 kg in 1 BAG (14474-037-01) ",
      "NDC11Code": "14474-0037-01",
      "ProductNDC": "14474-037",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Caspofungin Acetate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20160615",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Sai Life Sciences Limited",
      "SubstanceName": "CASPOFUNGIN ACETATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "15-JUN-16"
    },
    {
      "NDCCode": "14783-037-02",
      "PackageDescription": "1 TUBE in 1 BOX (14783-037-02)  > 4 g in 1 TUBE (14783-037-01)",
      "NDC11Code": "14783-0037-02",
      "ProductNDC": "14783-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20",
      "ProprietaryNameSuffix": "(red Extassy) - Red",
      "NonProprietaryName": "Octinoxate And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161104",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura International LTD",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
      "StrengthNumber": ".071; .16",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "16714-037-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01) ",
      "NDC11Code": "16714-0037-10",
      "ProductNDC": "16714-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ephedrine Sulfate",
      "NonProprietaryName": "Ephedrine Sulfate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212932",
      "LabelerName": "NorthStar Rx LLC",
      "SubstanceName": "EPHEDRINE SULFATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.",
      "Description": "Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate, and the molecular weight is 428.5 g/mol. Its molecular formula is (C10H15NO)2.H2SO4 and structural formula is depicted below. Ephedrine sulfate, USP is a white to off-white powder; it is freely soluble in water and slightly soluble in alcohol. Each mL contains ephedrine sulfate, USP 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0."
    },
    {
      "NDCCode": "16714-037-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01) ",
      "NDC11Code": "16714-0037-25",
      "ProductNDC": "16714-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ephedrine Sulfate",
      "NonProprietaryName": "Ephedrine Sulfate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212932",
      "LabelerName": "NorthStar Rx LLC",
      "SubstanceName": "EPHEDRINE SULFATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-08-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20201202",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "21130-037-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (21130-037-01)  / 100 TABLET in 1 BOTTLE",
      "NDC11Code": "21130-0037-01",
      "ProductNDC": "21130-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Extra Strength Pain Relief",
      "NonProprietaryName": "Acetaminophen, Aspirin, Caffeine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230601",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "BETTER LIVING BRANDS, LLC",
      "SubstanceName": "ASPIRIN; ACETAMINOPHEN; CAFFEINE",
      "StrengthNumber": "250; 250; 65",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. Temporarily relieves minor aches and pains due to: 1 headache, 2 a cold, 3 arthritis, 4 muscular aches, 5 toothache, 6 premenstrual and menstrual cramps."
    },
    {
      "NDCCode": "23155-037-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (23155-037-01) ",
      "NDC11Code": "23155-0037-01",
      "ProductNDC": "23155-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Moexipril Hydrochloride And Hydrochlorothiazide",
      "NonProprietaryName": "Moexipril Hydrochloride And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140320",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202150",
      "LabelerName": "Heritage Pharmaceuticals Inc.",
      "SubstanceName": "MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "15; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-04-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20140320",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "24909-038-01",
      "PackageDescription": "1 KIT in 1 KIT (24909-038-01)  *  14 g in 1 TUBE (24909-106-15)  *  75 g in 1 BOX (24909-037-75) ",
      "NDC11Code": "24909-0038-01",
      "ProductNDC": "24909-038",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Terrasil The Fungal Solution Kit",
      "NonProprietaryName": "Clotrimazole",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20231002",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions",
      "Status": "Active",
      "LastUpdate": "2023-11-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231002",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ointment: Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions. Cleansing Bar: For relief of most fungal skin infection symptoms."
    },
    {
      "NDCCode": "24979-037-01",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-037-01) ",
      "NDC11Code": "24979-0037-01",
      "ProductNDC": "24979-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Succinate",
      "NonProprietaryName": "Metoprolol Succinate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207206",
      "LabelerName": "TWi Pharmaceuticals, Inc.",
      "SubstanceName": "METOPROLOL TARTRATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20191001",
      "SamplePackage": "N",
      "IndicationAndUsage": ". : 1 , 2 , 3 .",
      "Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1­(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
    },
    {
      "NDCCode": "26052-037-01",
      "PackageDescription": "85 g in 1 TUBE (26052-037-01) ",
      "NDC11Code": "26052-0037-01",
      "ProductNDC": "26052-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Baby Nourishing Mineral",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "BURT'S BEES",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "2.8; 13",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2021-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20161201",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "27808-037-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (27808-037-01) ",
      "NDC11Code": "27808-0037-01",
      "ProductNDC": "27808-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141006",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202214",
      "LabelerName": "Cranbury Pharmaceuticals, LLC",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "10; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20141006",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS],  reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .",
      "Description": "Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O6 2 ½ H2O     M.W. = 494.49. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2   M.W. = 151.16. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "31722-037-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (31722-037-01) ",
      "NDC11Code": "31722-0037-01",
      "ProductNDC": "31722-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mexiletine Hydrochloride",
      "NonProprietaryName": "Mexiletine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221109",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216463",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "MEXILETINE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-11-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221109",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mexiletine hydrochloride capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
      "Description": "Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white or almost white powder, freely soluble in dehydrated alcohol and water. Mexiletine hydrochloride, USP has a pKa of 8.30. The chemical name of mexiletine hydrochloride, USP is 2-Propanamine, 1-(2,6-dimethylphenoxy), hydrochloride,(±)- and its structural formula is. Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, corn starch, magnesium stearate. The capsule shell contains: D&C Red #28, FD&C Blue #1, gelatin and titanium dioxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"46287-037-01","ProprietaryName":"Norliqva","NonProprietaryName":"Amlodipine"},{"NDCCode":"46287-003-01","ProprietaryName":"Hydrocortisone","NonProprietaryName":"Hydrocortisone"},{"NDCCode":"46287-006-01","ProprietaryName":"Sodium Polystyrene Sulfonate","NonProprietaryName":"Sodium Polystyrene Sulfonate"},{"NDCCode":"46287-009-01","ProprietaryName":"Isoniazid","NonProprietaryName":"Isoniazid"},{"NDCCode":"46287-014-01","ProprietaryName":"Oracit","NonProprietaryName":"Citric Acid And Sodium Citrate"},{"NDCCode":"46287-015-01","ProprietaryName":"Amantadine Hydrochloride","NonProprietaryName":"Amantadine Hydrochloride"},{"NDCCode":"46287-020-01","ProprietaryName":"Carospir","NonProprietaryName":"Carospir"},{"NDCCode":"46287-030-01","ProprietaryName":"Atorvaliq","NonProprietaryName":"Atorvaliq"},{"NDCCode":"46287-055-01","ProprietaryName":"Liqrev","NonProprietaryName":"Sildenafil"},{"NDCCode":"46287-010-11","ProprietaryName":"Triamcinolone Acetonide","NonProprietaryName":"Triamcinolone Acetonide"},{"NDCCode":"10129-037-01","ProprietaryName":"Gingicaine Gel, Cotton Candy Flavor","NonProprietaryName":"Gingicaine Gel, Cotton Candy Flavor"},{"NDCCode":"10345-037-01","ProprietaryName":"Loccitane - Immortelle Precious Bb Broad Spectrum Spf 30 01 Fair","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"11086-037-01","ProprietaryName":"Dritho-creme","NonProprietaryName":"Anthralin"},{"NDCCode":"11559-037-01","ProprietaryName":"Cyberwhite Hd Uv Protector Broad Spectrum Spf 50","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone"},{"NDCCode":"12120-037-01","NonProprietaryName":"Zinc Oxide, Titanium Dioxide"},{"NDCCode":"12707-037-01","NonProprietaryName":"Naloxone Hydrochloride Dihydrate"},{"NDCCode":"13537-037-02","ProprietaryName":"Esika","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"13668-037-01","ProprietaryName":"Risperidone","NonProprietaryName":"Risperidone"},{"NDCCode":"14141-037-01","ProprietaryName":"Cyzone Studio Look Base De Alta Cobertura Y Larga Duracion Fps 20 Chocochip 330-c","NonProprietaryName":"Octinoxate, Zinc Oxide"},{"NDCCode":"14474-037-01","NonProprietaryName":"Caspofungin Acetate"},{"NDCCode":"14783-037-02","ProprietaryName":"Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20","NonProprietaryName":"Octinoxate And Oxybenzone"},{"NDCCode":"16714-037-10","ProprietaryName":"Ephedrine Sulfate","NonProprietaryName":"Ephedrine Sulfate"},{"NDCCode":"16714-037-25","ProprietaryName":"Ephedrine Sulfate","NonProprietaryName":"Ephedrine Sulfate"},{"NDCCode":"21130-037-01","ProprietaryName":"Extra Strength Pain Relief","NonProprietaryName":"Acetaminophen, Aspirin, Caffeine"},{"NDCCode":"23155-037-01","ProprietaryName":"Moexipril Hydrochloride And Hydrochlorothiazide","NonProprietaryName":"Moexipril Hydrochloride And Hydrochlorothiazide"},{"NDCCode":"24909-038-01","ProprietaryName":"Terrasil The Fungal Solution Kit","NonProprietaryName":"Clotrimazole"},{"NDCCode":"24979-037-01","ProprietaryName":"Metoprolol Succinate","NonProprietaryName":"Metoprolol Succinate"},{"NDCCode":"26052-037-01","ProprietaryName":"Baby Nourishing Mineral","NonProprietaryName":"Titanium Dioxide, Zinc Oxide"},{"NDCCode":"27808-037-01","ProprietaryName":"Hydrocodone Bitartrate And Acetaminophen","NonProprietaryName":"Hydrocodone Bitartrate And Acetaminophen"},{"NDCCode":"31722-037-01","ProprietaryName":"Mexiletine Hydrochloride","NonProprietaryName":"Mexiletine Hydrochloride"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>46287-037-01</NDCCode>
    <PackageDescription>150 mL in 1 BOTTLE (46287-037-01) </PackageDescription>
    <NDC11Code>46287-0037-01</NDC11Code>
    <ProductNDC>46287-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norliqva</ProprietaryName>
    <NonProprietaryName>Amlodipine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260302</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214439</ApplicationNumber>
    <LabelerName>CMP Pharma, Inc.</LabelerName>
    <SubstanceName>AMLODIPINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260302</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NORLIQVA is a calcium channel blocker for the treatment of: 1 Hypertension (1.1) NORLIQVA is indicated for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease (1.2) Chronic Stable AnginaVasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt;40%.</IndicationAndUsage>
    <Description>NORLIQVA is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Each mL of NORLIQVA (amlodipine) oral solution contains 1 mg of amlodipine provided as 1.385 mg of amlodipine besylate and the following inactive ingredients: butylated hydroxyanisole, glycerin, propylene glycol and mixed berry flavor.</Description>
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  <NDC>
    <NDCCode>46287-003-01</NDCCode>
    <PackageDescription>25 g in 1 JAR (46287-003-01) </PackageDescription>
    <NDC11Code>46287-0003-01</NDC11Code>
    <ProductNDC>46287-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19850730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088138</ApplicationNumber>
    <LabelerName>CMP Pharma, Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>46287-006-01</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (46287-006-01) </PackageDescription>
    <NDC11Code>46287-0006-01</NDC11Code>
    <ProductNDC>46287-006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName>
    <NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL; RECTAL</RouteName>
    <StartMarketingDate>19821208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087859</ApplicationNumber>
    <LabelerName>CMP Pharma, Inc.</LabelerName>
    <SubstanceName>SODIUM POLYSTYRENE SULFONATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>g/60mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-08-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19821208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SPS® Suspension is indicated for the treatment of hyperkalemia.</IndicationAndUsage>
    <Description>Sodium Polystyrene Sulfonate Suspension USP (SPS® Suspension) can be administered orally or in an enema. It is a cherry-flavored suspension containing 15 grams of cation-exchange resin (Sodium Polystyrene Sulfonate USP); 21.5 mL of Sorbitol Solution USP (equivalent to approximately 20 grams of Sorbitol); 0.18 mL (0.3%) of Alcohol per 60 mL of suspension. Also contains Purified Water USP; Propylene Glycol USP; Magnesium Aluminum Silicate NF; Sodium Saccharin USP; Methylparaben NF; Propylparaben NF; and flavor. Sodium polystyrene sulfonate is a benzene, diethenyl-, polymer with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:. The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with an in‑vitro exchange capacity of approximately 3.1 mEq (in-vivo approximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema.</Description>
  </NDC>
  <NDC>
    <NDCCode>46287-009-01</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (46287-009-01) </PackageDescription>
    <NDC11Code>46287-0009-01</NDC11Code>
    <ProductNDC>46287-009</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isoniazid</ProprietaryName>
    <NonProprietaryName>Isoniazid</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19831111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088235</ApplicationNumber>
    <LabelerName>CMP Pharma, Inc.</LabelerName>
    <SubstanceName>ISONIAZID</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19831111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isoniazid oral solution is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication is inadequate therapy. Isoniazid oral solution is recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy. , 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5 mm), therapy should be continued. , 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. , 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm). , 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin's disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. .</IndicationAndUsage>
    <Description>Isoniazid is an antibacterial available as an orange-flavored solution for oral administration containing 50 mg of Isoniazid USP per 5 mL of oral solution. Sorbitol solution USP (containing 70% Sorbitol) is used as the vehicle. This product also contains citric acid USP and potassium sorbate NF. Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has a molecular formula of C6H7N3O and a molecular weight of 137.14. It has the following structural formula:. Isoniazid is odorless and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid is slowly affected by exposure to air and light.</Description>
  </NDC>
  <NDC>
    <NDCCode>46287-014-01</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE (46287-014-01) </PackageDescription>
    <NDC11Code>46287-0014-01</NDC11Code>
    <ProductNDC>46287-014</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oracit</ProprietaryName>
    <NonProprietaryName>Citric Acid And Sodium Citrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840515</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>CMP Pharma, Inc.</LabelerName>
    <SubstanceName>CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>640; 490</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19840515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ORACIT® is indicated for the treatment of metabolic acidosis. This solution is also useful in conditions where long term maintenance of alkaline urine is needed (e.g. uric acid and cystine calculi of the urinary tract). ORACIT® is also effective in treatment for acidosis of certain renal tubular disorders.</IndicationAndUsage>
    <Description>The product is a clear, colorless solution containing Citric Acid USP 640 mg/5 mL, and Hydrous Sodium Citrate USP 490 mg/5 mL. It also contains Methylparaben NF and Propylparaben NF as preservatives. These concentrations yield 1 mEq of sodium, equivalent to 1 mEq of bicarbonate per mL of solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>46287-015-01</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (46287-015-01)</PackageDescription>
    <NDC11Code>46287-0015-01</NDC11Code>
    <ProductNDC>46287-015</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020911</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075819</ApplicationNumber>
    <LabelerName>CMP Pharma, Inc.</LabelerName>
    <SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-11-06</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>46287-020-01</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (46287-020-01) </PackageDescription>
    <NDC11Code>46287-0020-01</NDC11Code>
    <ProductNDC>46287-020</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carospir</ProprietaryName>
    <NonProprietaryName>Carospir</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170804</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209478</ApplicationNumber>
    <LabelerName>CMP Pharma, Inc.</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170804</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CAROSPIR is an antagonist of aldosterone indicated for: 1 the treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2), 3 the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions (1.3).</IndicationAndUsage>
    <Description>CAROSPIR Oral Suspension contains 25 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21- carboxylic acid γ-lactone acetate per 5 mL, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include sorbic acid, potassium sorbate, citric acid anhydrous, sodium citrate dihydrate, simethicone emulsion, saccharin sodium, xanthan gum, Magnasweet 110, glycerin, banana flavor, and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>46287-030-01</NDCCode>
    <PackageDescription>150 mL in 1 BOTTLE (46287-030-01) </PackageDescription>
    <NDC11Code>46287-0030-01</NDC11Code>
    <ProductNDC>46287-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvaliq</ProprietaryName>
    <NonProprietaryName>Atorvaliq</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230301</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213260</ApplicationNumber>
    <LabelerName>CMP Pharma, Inc.</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ATORVALIQ is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.oMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.oNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemia.oHypertriglyceridemia.</IndicationAndUsage>
    <Description>ATORVALIQ (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium 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 is (C33H34 FN2O5)2Ca∙3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. ATORVALIQ oral suspension contains 20 mg/5 mL of atorvastatin and the following inactive ingredients: caroboxymethylcellulose sodium, magnesium aluminum silicate, methylparaben, ethylparaben, propylparaben, sucralose, acesulfame potassium, orange flavor, water.</Description>
  </NDC>
  <NDC>
    <NDCCode>46287-055-01</NDCCode>
    <PackageDescription>122 mL in 1 BOTTLE (46287-055-01) </PackageDescription>
    <NDC11Code>46287-0055-01</NDC11Code>
    <ProductNDC>46287-055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Liqrev</ProprietaryName>
    <NonProprietaryName>Sildenafil</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230430</StartMarketingDate>
    <EndMarketingDate>20250430</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214952</ApplicationNumber>
    <LabelerName>CMP Pharma, Inc.</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230430</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adults. LIQREV is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, because of Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>LIQREV, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. It has a chemical formula of C22H3N6O4S.C6H8O7 and a molecular weight of 666.7 g.mol-1. LIQREV (sildenafil) Oral Suspension 10 mg/mL is supplied as a white to off-white, opaque, strawberry-flavored suspension. LIQREV is provided in 122 mL in an amber glass bottle with a child resistant tamper-evident cap. Each bottle contains 1.22 g sildenafil (equivalent to 1.71g sildenafil citrate). The inactive ingredients include acesulfame potassium, citric acid monohydrate, glycerin, simethicone emulsion, sodium benzoate, sucralose, strawberry flavor, tri-sodium citrate dihydrate, xanthan gum, and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>46287-010-11</NDCCode>
    <PackageDescription>110 g in 1 JAR (46287-010-11) </PackageDescription>
    <NDC11Code>46287-0010-11</NDC11Code>
    <ProductNDC>46287-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089595</ApplicationNumber>
    <LabelerName>CMP Pharma, Inc.</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triamcinolone Acetonide 0.05% in Absorbase® (Triamcinolone Acetonide Ointment, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
    <Description>Topical corticosteroids, such as Triamcinolone Acetonide 0.05% in Absorbase® (Triamcinolone Acetonide Ointment, USP), constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Triamcinolone Acetonide 0.05% in Absorbase® (Triamcinolone Acetonide Ointment, USP) contains 0.5 mg of Triamcinolone Acetonide USP in a water-in-oil emulsion composed of Light Mineral Oil NF, Purified Water USP, White Petrolatum USP, Heavy Mineral Oil USP, Mineral Wax, and Lanolin Alcohols NF. The white ointment is for topical use only. Triamcinolone Acetonide has the molecular formula of C 24H 31FO 6 and is designated chemically as Pregna-1,4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-, (11β, 16α)-. It has a molecular weight of 434.50 and the following structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>10129-037-01</NDCCode>
    <PackageDescription>1 GEL in 1 BOTTLE, PLASTIC (10129-037-01) </PackageDescription>
    <NDC11Code>10129-0037-01</NDC11Code>
    <ProductNDC>10129-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gingicaine Gel, Cotton Candy Flavor</ProprietaryName>
    <NonProprietaryName>Gingicaine Gel, Cotton Candy Flavor</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>DENTAL; ORAL; PERIODONTAL</RouteName>
    <StartMarketingDate>19930326</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Gingi-Pak a Division of the Belport</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19930706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain due to:  Minor irritation or injury of oral mucous membrane  Minor dental procedures  Minor irritation of mouth or gums caused by dentures or orthodontic appliances.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10345-037-01</NDCCode>
    <PackageDescription>40 mL in 1 TUBE (10345-037-01)</PackageDescription>
    <NDC11Code>10345-0037-01</NDC11Code>
    <ProductNDC>10345-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Loccitane - Immortelle Precious Bb Broad Spectrum Spf 30 01 Fair</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Laboratoires M&amp;L</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>153.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>11086-037-01</NDCCode>
    <PackageDescription>50 g in 1 TUBE (11086-037-01) </PackageDescription>
    <NDC11Code>11086-0037-01</NDC11Code>
    <ProductNDC>11086-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dritho-creme</ProprietaryName>
    <ProprietaryNameSuffix>Hp</ProprietaryNameSuffix>
    <NonProprietaryName>Anthralin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Summers Laboratories Inc</LabelerName>
    <SubstanceName>ANTHRALIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11559-037-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (11559-037-01)  &gt; 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>11559-0037-01</NDC11Code>
    <ProductNDC>11559-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cyberwhite Hd Uv Protector Broad Spectrum Spf 50</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>ESTEE LAUDER INC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.0309; .0515; .0515; .0278; .0309</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>12120-037-01</NDCCode>
    <PackageDescription>180 kg in 1 DRUM (12120-037-01)</PackageDescription>
    <NDC11Code>12120-0037-01</NDC11Code>
    <ProductNDC>12120-037</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20101001</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Crystal Claire Cosmetics Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>100; 150</StrengthNumber>
    <StrengthUnit>g/kg; g/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>12707-037-01</NDCCode>
    <PackageDescription>10 g in 1 DRUM (12707-037-01) </PackageDescription>
    <NDC11Code>12707-0037-01</NDC11Code>
    <ProductNDC>12707-037</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Naloxone Hydrochloride Dihydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20171211</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Macfarlan Smith Limited</LabelerName>
    <SubstanceName>NALOXONE HYDROCHLORIDE DIHYDRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-02-25</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-DEC-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>13537-037-02</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13537-037-02)  &gt; 2 g in 1 TUBE (13537-037-01)</PackageDescription>
    <NDC11Code>13537-0037-02</NDC11Code>
    <ProductNDC>13537-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Esika</ProprietaryName>
    <ProprietaryNameSuffix>Perfect Skin Coverage Concealer Spf 17</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110923</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation (San Juan, P.R)</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>.04</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13668-037-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (13668-037-01) </PackageDescription>
    <NDC11Code>13668-0037-01</NDC11Code>
    <ProductNDC>13668-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>14141-037-01</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (14141-037-01)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>14141-0037-01</NDC11Code>
    <ProductNDC>14141-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cyzone Studio Look Base De Alta Cobertura Y Larga Duracion Fps 20 Chocochip 330-c</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220413</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>BEL STAR S A</LabelerName>
    <SubstanceName>ZINC OXIDE; OCTINOXATE</SubstanceName>
    <StrengthNumber>24; 40</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>14474-037-01</NDCCode>
    <PackageDescription>5 kg in 1 BAG (14474-037-01) </PackageDescription>
    <NDC11Code>14474-0037-01</NDC11Code>
    <ProductNDC>14474-037</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Caspofungin Acetate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20160615</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Sai Life Sciences Limited</LabelerName>
    <SubstanceName>CASPOFUNGIN ACETATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>15-JUN-16</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14783-037-02</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (14783-037-02)  &gt; 4 g in 1 TUBE (14783-037-01)</PackageDescription>
    <NDC11Code>14783-0037-02</NDC11Code>
    <ProductNDC>14783-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20</ProprietaryName>
    <ProprietaryNameSuffix>(red Extassy) - Red</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161104</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura International LTD</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.071; .16</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-037-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01) </PackageDescription>
    <NDC11Code>16714-0037-10</NDC11Code>
    <ProductNDC>16714-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ephedrine Sulfate</ProprietaryName>
    <NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212932</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>EPHEDRINE SULFATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.</IndicationAndUsage>
    <Description>Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate, and the molecular weight is 428.5 g/mol. Its molecular formula is (C10H15NO)2.H2SO4 and structural formula is depicted below. Ephedrine sulfate, USP is a white to off-white powder; it is freely soluble in water and slightly soluble in alcohol. Each mL contains ephedrine sulfate, USP 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-037-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01) </PackageDescription>
    <NDC11Code>16714-0037-25</NDC11Code>
    <ProductNDC>16714-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ephedrine Sulfate</ProprietaryName>
    <NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212932</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>EPHEDRINE SULFATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-08-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>21130-037-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21130-037-01)  / 100 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>21130-0037-01</NDC11Code>
    <ProductNDC>21130-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Extra Strength Pain Relief</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Aspirin, Caffeine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>BETTER LIVING BRANDS, LLC</LabelerName>
    <SubstanceName>ASPIRIN; ACETAMINOPHEN; CAFFEINE</SubstanceName>
    <StrengthNumber>250; 250; 65</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. Temporarily relieves minor aches and pains due to: 1 headache, 2 a cold, 3 arthritis, 4 muscular aches, 5 toothache, 6 premenstrual and menstrual cramps.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>23155-037-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (23155-037-01) </PackageDescription>
    <NDC11Code>23155-0037-01</NDC11Code>
    <ProductNDC>23155-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Moexipril Hydrochloride And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Moexipril Hydrochloride And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202150</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>15; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>24909-038-01</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (24909-038-01)  *  14 g in 1 TUBE (24909-106-15)  *  75 g in 1 BOX (24909-037-75) </PackageDescription>
    <NDC11Code>24909-0038-01</NDC11Code>
    <ProductNDC>24909-038</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Terrasil The Fungal Solution Kit</ProprietaryName>
    <NonProprietaryName>Clotrimazole</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231002</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Aidance Scientific, Inc, DBA Aidance Skincare &amp; Topical Solutions</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-11-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231002</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ointment: Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions. Cleansing Bar: For relief of most fungal skin infection symptoms.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>24979-037-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-037-01) </PackageDescription>
    <NDC11Code>24979-0037-01</NDC11Code>
    <ProductNDC>24979-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207206</ApplicationNumber>
    <LabelerName>TWi Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>METOPROLOL TARTRATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
    <Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1­(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>26052-037-01</NDCCode>
    <PackageDescription>85 g in 1 TUBE (26052-037-01) </PackageDescription>
    <NDC11Code>26052-0037-01</NDC11Code>
    <ProductNDC>26052-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Baby Nourishing Mineral</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>BURT'S BEES</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>2.8; 13</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>27808-037-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (27808-037-01) </PackageDescription>
    <NDC11Code>27808-0037-01</NDC11Code>
    <ProductNDC>27808-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141006</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202214</ApplicationNumber>
    <LabelerName>Cranbury Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS],  reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .</IndicationAndUsage>
    <Description>Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O6 2 ½ H2O     M.W. = 494.49. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2   M.W. = 151.16. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-037-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (31722-037-01) </PackageDescription>
    <NDC11Code>31722-0037-01</NDC11Code>
    <ProductNDC>31722-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mexiletine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Mexiletine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216463</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MEXILETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-11-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mexiletine hydrochloride capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
    <Description>Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white or almost white powder, freely soluble in dehydrated alcohol and water. Mexiletine hydrochloride, USP has a pKa of 8.30. The chemical name of mexiletine hydrochloride, USP is 2-Propanamine, 1-(2,6-dimethylphenoxy), hydrochloride,(±)- and its structural formula is. Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, corn starch, magnesium stearate. The capsule shell contains: D&amp;C Red #28, FD&amp;C Blue #1, gelatin and titanium dioxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>46287-037-01</NDCCode><ProprietaryName>Norliqva</ProprietaryName><NonProprietaryName>Amlodipine</NonProprietaryName></NDC><NDC><NDCCode>46287-003-01</NDCCode><ProprietaryName>Hydrocortisone</ProprietaryName><NonProprietaryName>Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>46287-006-01</NDCCode><ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName><NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName></NDC><NDC><NDCCode>46287-009-01</NDCCode><ProprietaryName>Isoniazid</ProprietaryName><NonProprietaryName>Isoniazid</NonProprietaryName></NDC><NDC><NDCCode>46287-014-01</NDCCode><ProprietaryName>Oracit</ProprietaryName><NonProprietaryName>Citric Acid And Sodium Citrate</NonProprietaryName></NDC><NDC><NDCCode>46287-015-01</NDCCode><ProprietaryName>Amantadine Hydrochloride</ProprietaryName><NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>46287-020-01</NDCCode><ProprietaryName>Carospir</ProprietaryName><NonProprietaryName>Carospir</NonProprietaryName></NDC><NDC><NDCCode>46287-030-01</NDCCode><ProprietaryName>Atorvaliq</ProprietaryName><NonProprietaryName>Atorvaliq</NonProprietaryName></NDC><NDC><NDCCode>46287-055-01</NDCCode><ProprietaryName>Liqrev</ProprietaryName><NonProprietaryName>Sildenafil</NonProprietaryName></NDC><NDC><NDCCode>46287-010-11</NDCCode><ProprietaryName>Triamcinolone Acetonide</ProprietaryName><NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName></NDC><NDC><NDCCode>10129-037-01</NDCCode><ProprietaryName>Gingicaine Gel, Cotton Candy Flavor</ProprietaryName><NonProprietaryName>Gingicaine Gel, Cotton Candy Flavor</NonProprietaryName></NDC><NDC><NDCCode>10345-037-01</NDCCode><ProprietaryName>Loccitane - Immortelle Precious Bb Broad Spectrum Spf 30 01 Fair</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>11086-037-01</NDCCode><ProprietaryName>Dritho-creme</ProprietaryName><NonProprietaryName>Anthralin</NonProprietaryName></NDC><NDC><NDCCode>11559-037-01</NDCCode><ProprietaryName>Cyberwhite Hd Uv Protector Broad Spectrum Spf 50</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>12120-037-01</NDCCode><NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>12707-037-01</NDCCode><NonProprietaryName>Naloxone Hydrochloride Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>13537-037-02</NDCCode><ProprietaryName>Esika</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>13668-037-01</NDCCode><ProprietaryName>Risperidone</ProprietaryName><NonProprietaryName>Risperidone</NonProprietaryName></NDC><NDC><NDCCode>14141-037-01</NDCCode><ProprietaryName>Cyzone Studio Look Base De Alta Cobertura Y Larga Duracion Fps 20 Chocochip 330-c</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>14474-037-01</NDCCode><NonProprietaryName>Caspofungin Acetate</NonProprietaryName></NDC><NDC><NDCCode>14783-037-02</NDCCode><ProprietaryName>Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>16714-037-10</NDCCode><ProprietaryName>Ephedrine Sulfate</ProprietaryName><NonProprietaryName>Ephedrine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>16714-037-25</NDCCode><ProprietaryName>Ephedrine Sulfate</ProprietaryName><NonProprietaryName>Ephedrine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>21130-037-01</NDCCode><ProprietaryName>Extra Strength Pain Relief</ProprietaryName><NonProprietaryName>Acetaminophen, Aspirin, Caffeine</NonProprietaryName></NDC><NDC><NDCCode>23155-037-01</NDCCode><ProprietaryName>Moexipril Hydrochloride And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Moexipril Hydrochloride And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>24909-038-01</NDCCode><ProprietaryName>Terrasil The Fungal Solution Kit</ProprietaryName><NonProprietaryName>Clotrimazole</NonProprietaryName></NDC><NDC><NDCCode>24979-037-01</NDCCode><ProprietaryName>Metoprolol Succinate</ProprietaryName><NonProprietaryName>Metoprolol Succinate</NonProprietaryName></NDC><NDC><NDCCode>26052-037-01</NDCCode><ProprietaryName>Baby Nourishing Mineral</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>27808-037-01</NDCCode><ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName><NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>31722-037-01</NDCCode><ProprietaryName>Mexiletine Hydrochloride</ProprietaryName><NonProprietaryName>Mexiletine Hydrochloride</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",
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      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
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}
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