RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "98132-204-30",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (98132-204-30)  / 30 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "98132-0204-30",
      "ProductNDC": "98132-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bareminerals Barepro Performance Wear Liquid Foundation Broad Spectrum Spf 20",
      "ProprietaryNameSuffix": "Aspen 04",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Orveon Global US LLC",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "33.2",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2023-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170801",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "98132-204-03",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (98132-204-03)  / 3 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "98132-0204-03",
      "ProductNDC": "98132-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bareminerals Barepro Performance Wear Liquid Foundation Broad Spectrum Spf 20",
      "ProprietaryNameSuffix": "Aspen 04",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Orveon Global US LLC",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "33.2",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2023-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170801",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "10544-204-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (10544-204-30)",
      "NDC11Code": "10544-0204-30",
      "ProductNDC": "10544-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acyclovir",
      "NonProprietaryName": "Acyclovir",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131210",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077309",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "ACYCLOVIR",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-03-20"
    },
    {
      "NDCCode": "13537-204-18",
      "PackageDescription": "1 BOTTLE in 1 BOX (13537-204-18)  > 30 mL in 1 BOTTLE (13537-204-17)",
      "NDC11Code": "13537-0204-18",
      "ProductNDC": "13537-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Filling Effect Foundation Spf 10",
      "ProprietaryNameSuffix": "(medium 5) - Brown",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131216",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE",
      "StrengthNumber": ".07",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "13668-204-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (13668-204-30) ",
      "NDC11Code": "13668-0204-30",
      "ProductNDC": "13668-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine And Valsartan",
      "NonProprietaryName": "Amlodipine And Valsartan",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150330",
      "EndMarketingDate": "20191031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202377",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
      "StrengthNumber": "10; 320",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150330",
      "EndMarketingDatePackage": "20191031",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "14783-204-18",
      "PackageDescription": "1 BOTTLE in 1 BOX (14783-204-18)  > 30 mL in 1 BOTTLE (14783-204-17)",
      "NDC11Code": "14783-0204-18",
      "ProductNDC": "14783-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Filling Effect Foundation Spf 10",
      "ProprietaryNameSuffix": "(medium 5) - Brown",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131216",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura International LTD",
      "SubstanceName": "OCTINOXATE",
      "StrengthNumber": ".07",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "27241-204-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (27241-204-30) ",
      "NDC11Code": "27241-0204-30",
      "ProductNDC": "27241-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Brexpiprazole",
      "NonProprietaryName": "Brexpiprazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213718",
      "LabelerName": "Ajanta Pharma USA Inc.",
      "SubstanceName": "BREXPIPRAZOLE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-02-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230203",
      "SamplePackage": "N",
      "IndicationAndUsage": "Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.",
      "Description": "Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg)."
    },
    {
      "NDCCode": "40104-204-02",
      "PackageDescription": "2 BOTTLE in 1 PACKAGE (40104-204-02)  > 30 mL in 1 BOTTLE (40104-204-01)",
      "NDC11Code": "40104-0204-02",
      "ProductNDC": "40104-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "My Little Pony Antibacterial Hand Sanitizer With Moisturizers",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150205",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Ningbo Pulisi Daily Chemical Products Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Uses  hand sanitizer to help reduce bacteria on the skin, when water, soap and towel are not available.  recommended for repeated use."
    },
    {
      "NDCCode": "42002-204-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (42002-204-01)  > 30 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "42002-0204-01",
      "ProductNDC": "42002-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Visine",
      "ProprietaryNameSuffix": "L.r.",
      "NonProprietaryName": "Oxymetazoline Hydrochloride",
      "DosageFormName": "LIQUID",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20100405",
      "EndMarketingDate": "20160801",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019407",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "42211-204-23",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (42211-204-23) ",
      "NDC11Code": "42211-0204-23",
      "ProductNDC": "42211-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zorvolex",
      "NonProprietaryName": "Diclofenac",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131031",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204592",
      "LabelerName": "Iroko Pharmaceuticals LLC",
      "SubstanceName": "DICLOFENAC",
      "StrengthNumber": "35",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20131031",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZORVOLEX is indicated for: 1 Management of mild to moderate acute pain, 2 Management of osteoarthritis pain.",
      "Description": "ZORVOLEX (diclofenac) capsules are a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 18 mg and 35 mg for oral administration. The chemical name is 2-[(2, 6-dichlorophenyl) amino] benzeneacetic acid. The molecular weight is 296.15. Its molecular formula is C14H11Cl2NO2, and it has the following chemical structure. Diclofenac acid is a white to slight yellowish crystalline powder. Diclofenac acid has a pKa of 4.18 and a logP of 3.03. It is practically insoluble in water and sparingly soluble in ethanol. The inactive ingredients in ZORVOLEX include a combination of lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2, FDA/E172 Yellow Iron Oxide and FDA/E172 Black Iron Oxide. The imprinting on the gelatin capsules is white edible ink. The 18 mg capsules have a blue body imprinted with IP-203 and light green cap imprinted with 18 mg in white ink. The 35 mg capsules have a blue body imprinted with IP-204 and green cap imprinted with 35 mg in white ink."
    },
    {
      "NDCCode": "42254-204-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42254-204-30)",
      "NDC11Code": "42254-0204-30",
      "ProductNDC": "42254-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111024",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076000",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Olanzapine USP is an atypical antipsychotic indicated. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) , 3 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.",
      "Description": "Olanzapine USP is an atypical psychotropic agent that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine and has the following chemical structure:. C17H20N4S M.W. 312.44. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Each tablet, for oral administration, contains olanzapine equivalent to 2.5 mg (8 micromol), 5 mg (16 micromol), 7.5 mg (24 micromol), 10 mg (32 micromol) or 15 mg (48 micromol) and has the following inactive ingredients: anhydrous lactose, carrageenan, crospovidone, magnesium stearate, microcrystalline cellulose, and polyethylene glycol. In addition, the 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets contain titanium dioxide, and the 15 mg tablets contain FD&C blue #2 aluminum lake."
    },
    {
      "NDCCode": "42708-204-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (42708-204-30) ",
      "NDC11Code": "42708-0204-30",
      "ProductNDC": "42708-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate",
      "NonProprietaryName": "Amlodipine Besylate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078925",
      "LabelerName": "QPharma, Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "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": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260820",
      "SamplePackage": "Y",
      "IndicationAndUsage": "Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: * Hypertension ( 1.1) ○ Amlodipine besylate tablets is indicated 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. * Coronary Artery Disease ( 1.2) ○ Chronic Stable Angina ○ Vasospastic Angina (Prinzmetal's or Variant Angina) ○ Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
      "Description": "Amlodipine besylate 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 molecular formula is C 20H 25ClN 2O 5C 6H 6O 3S, 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. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate."
    },
    {
      "NDCCode": "43744-204-30",
      "PackageDescription": "50 g in 1 DRUM (43744-204-30)",
      "NDC11Code": "43744-0204-30",
      "ProductNDC": "43744-204",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Clemastine Fumarate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20110606",
      "EndMarketingDate": "20110607",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CBSCHEM LIMITED",
      "SubstanceName": "CLEMASTINE FUMARATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20110607"
    },
    {
      "NDCCode": "46122-204-30",
      "PackageDescription": "177 mL in 1 BOTTLE (46122-204-30)",
      "NDC11Code": "46122-0204-30",
      "ProductNDC": "46122-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Good Neighbor Pharmacy Sleep Time",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part338",
      "LabelerName": "Amerisource Bergen",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-26",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "46708-204-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (46708-204-30) ",
      "NDC11Code": "46708-0204-30",
      "ProductNDC": "46708-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Itraconazole",
      "NonProprietaryName": "Itraconazole",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206741",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "ITRACONAZOLE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-01-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161216",
      "SamplePackage": "N",
      "IndicationAndUsage": "Itraconazole capsules   are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients:.             1. Blastomycosis, pulmonary and extrapulmonary.             2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non- meningeal histoplasmosis, and.             3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules   are also indicated for the treatment of the following fungal infections in non-immunocompromised patients:.             1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and.             2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Post-marketing Experience for more information.). Description of Clinical Studies:. Blastomycosis:. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=73 combined) in patients with normal or abnormal immune status. The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. Histoplasmosis:. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=34 combined) in patients with normal or abnormal immune status (not including HIV-infected patients). The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. Histoplasmosis in HIV-infected patients:. Data from a small number of HIV-infected patients suggested that the response rate of histoplasmosis in HIV-infected patients is similar to that of non-HIV-infected patients. The clinical course of histoplasmosis in HIV-infected patients is more severe and usually requires maintenance therapy to prevent relapse. Aspergillosis:. Analyses were conducted on data from an open-label, “single-patient-use” protocol designed to make itraconazole available in the U.S. for patients who either failed or were intolerant of amphotericin B therapy (N=190). The findings were corroborated by two smaller open-label studies (N=31 combined) in the same patient population. Most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. Results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin B therapy. Onychomycosis of the toenail:. Analyses were conducted on data from three double-blind, placebo-controlled studies (N=214 total; 110 given itraconazole capsules   in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules   once daily for 12 consecutive weeks. Results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 54% of patients. Thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). The mean time to overall success was approximately 10 months. Twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of KOH or culture from negative to positive). Onychomycosis of the fingernail:. Analyses were conducted on data from a double-blind, placebo-controlled study (N=73 total; 37 given itraconazole capsules   in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules   b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules   b.i.d. Results demonstrated mycologic cure in 61% of patients. Fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. The mean time to overall success was approximately 5 months. None of the patients who achieved overall success relapsed.",
      "Description": "Itraconazole Capsule   is the generic name for itraconazole, an azole  antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. ±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one mixture with (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2S*,4R*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one. or. (±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one. Itraconazole has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64. It is a white or almost white powder. It is freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran, very slightly soluble in alcohol and practically insoluble in water. It has a pKa of 3.7 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres (composed of  sucrose, starch and purified water). Inactive ingredients are hydroxypropyl methylcellulose, polyethylene glycol, hypromellose, gelatin, titanium dioxide, D&C Red No. 22, FD&C Blue No. 1, and D&C Red No. 28. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide."
    },
    {
      "NDCCode": "47219-204-20",
      "PackageDescription": "1 BOTTLE, DISPENSING in 1 BOX (47219-204-20)  > 30 mL in 1 BOTTLE, DISPENSING",
      "NDC11Code": "47219-0204-20",
      "ProductNDC": "47219-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nyloxin",
      "ProprietaryNameSuffix": "Stage 2 Pain Relief",
      "NonProprietaryName": "Naja Naja Venom",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090825",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "RECEPTOPHARM INC",
      "SubstanceName": "NAJA NAJA VENOM",
      "StrengthNumber": ".02",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Uses: Temporarily relieves joint pain associated with overuse and pain associated with arthritis."
    },
    {
      "NDCCode": "49349-204-02",
      "PackageDescription": "30 CAPSULE in 1 BLISTER PACK (49349-204-02)",
      "NDC11Code": "49349-0204-02",
      "ProductNDC": "49349-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prazosin Hydrochloride",
      "NonProprietaryName": "Prazosin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110421",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071745",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "PRAZOSIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-03-14"
    },
    {
      "NDCCode": "49702-204-13",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49702-204-13) ",
      "NDC11Code": "49702-0204-13",
      "ProductNDC": "49702-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Epivir",
      "NonProprietaryName": "Lamivudine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101004",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020564",
      "LabelerName": "ViiV Healthcare Company",
      "SubstanceName": "LAMIVUDINE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101004",
      "SamplePackage": "N",
      "IndicationAndUsage": "EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use: 1 The dosage of this product is for HIV‑1 and not for HBV.",
      "Description": "EPIVIR (also known as 3TC) is a brand name for lamivudine, a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. EPIVIR tablets are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Each 300-mg film-coated tablet contains 300 mg of lamivudine and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. EPIVIR oral solution is for oral administration. One milliliter (1 mL) of EPIVIR oral solution contains 10 mg of lamivudine (10 mg per mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg)."
    },
    {
      "NDCCode": "50390-204-30",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50390-204-30)  / 30 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "50390-0204-30",
      "ProductNDC": "50390-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Artistry Exact Fit Longwearing Foundation Shade Cream",
      "ProprietaryNameSuffix": "L1w2",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Amway Corp",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "40.25",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2023-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "51060-204-01",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (51060-204-01)  / 30 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "51060-0204-01",
      "ProductNDC": "51060-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Foundcealer Multi-tasking Foundation Broad Spectrum Spf 20 Sunscreen",
      "ProprietaryNameSuffix": "22n Light Neutral",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190321",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Tarte, Inc.",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "74.7; 47.5",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190321",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "51206-204-01",
      "PackageDescription": "30 mL in 1 BOTTLE (51206-204-01) ",
      "NDC11Code": "51206-0204-01",
      "ProductNDC": "51206-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ultracare Oral Anesthetic Pina Colada",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "GEL",
      "RouteName": "DENTAL",
      "StartMarketingDate": "19860601",
      "EndMarketingDate": "20190830",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Ultradent Products, Inc.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-08-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19860601",
      "EndMarketingDatePackage": "20190830",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51316-204-01",
      "PackageDescription": "1 KIT in 1 KIT (51316-204-01)  *  30 g in 1 TUBE (51316-206-01) ",
      "NDC11Code": "51316-0204-01",
      "ProductNDC": "51316-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Hemorrhoidal Lidocaine 5 Rapid Pain Relief With 10 Finger Cots",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20251130",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M015",
      "LabelerName": "CVS PHARMACY, INC",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251130",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders."
    },
    {
      "NDCCode": "51706-204-02",
      "PackageDescription": "1 BOTTLE in 1 BOX (51706-204-02)  > 30 mL in 1 BOTTLE (51706-204-01)",
      "NDC11Code": "51706-0204-02",
      "ProductNDC": "51706-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bodycology",
      "ProprietaryNameSuffix": "Sweet Petals Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100625",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333",
      "LabelerName": "Landy International",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "65",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Uses: to decrease bacteria on the skin that could cause disease. Directions: wet hands, apply palmful to hands, scrub thoroughly for 30 seconds, rinse."
    },
    {
      "NDCCode": "52125-204-02",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (52125-204-02)",
      "NDC11Code": "52125-0204-02",
      "ProductNDC": "52125-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quetiapine Fumarate",
      "NonProprietaryName": "Quetiapine Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120823",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202152",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-10",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "52810-204-11",
      "PackageDescription": "30 mL in 1 JAR (52810-204-11) ",
      "NDC11Code": "52810-0204-11",
      "ProductNDC": "52810-204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Intensive Skin Repair",
      "NonProprietaryName": "Sambucus Nigra Flower Calendula Officinalis Flower Pinus Lambertiana Resin Abies Balsamea Leaf Oil",
      "DosageFormName": "SALVE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121018",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PUREMEDY",
      "SubstanceName": "ABIES BALSAMEA LEAF OIL; CALENDULA OFFICINALIS FLOWER; PINUS LAMBERTIANA RESIN; SAMBUCUS NIGRA FLOWER",
      "StrengthNumber": "1; 1; 1; 1",
      "StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20121018",
      "SamplePackage": "N",
      "IndicationAndUsage": "USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH EXTREMELY DRY, DAMAGED, OR AGING SKIN."
    },
    {
      "NDCCode": "52959-204-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (52959-204-30)",
      "NDC11Code": "52959-0204-30",
      "ProductNDC": "52959-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carvedilol",
      "NonProprietaryName": "Carvedilol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078251",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "CARVEDILOL",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2) , 2 Hypertension (1.3) .",
      "Description": "Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film coated circular shaped tablets. The 12.5 mg tablets are white film coated capsule shaped tablets. Inactive ingredients: consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2."
    },
    {
      "NDCCode": "53217-204-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (53217-204-30)",
      "NDC11Code": "53217-0204-30",
      "ProductNDC": "53217-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130902",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078155",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.",
      "Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of  HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole , ascorbic acid, citric acid monohydrate, and triethyl citrate."
    },
    {
      "NDCCode": "54766-204-01",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54766-204-01) ",
      "NDC11Code": "54766-0204-01",
      "ProductNDC": "54766-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pexeva",
      "NonProprietaryName": "Paroxetine Mesylate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170602",
      "EndMarketingDate": "20240531",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021299",
      "LabelerName": "Sebela Pharmaceuticals Inc.",
      "SubstanceName": "PAROXETINE MESYLATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170602",
      "EndMarketingDatePackage": "20240531",
      "SamplePackage": "N",
      "IndicationAndUsage": "PEXEVA is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Generalized anxiety disorder (GAD).",
      "Description": "PEXEVA contains paroxetine mesylate, an SSRI. It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C 19H 20FNO 3CH 3SO 3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:. Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water. PEXEVA tablets are intended for oral administration. Each oval, film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg paroxetine equivalent to 12.9 mg, 25.8 mg, 38.8 mg, or 51.7 mg paroxetine mesylate, respectively. Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only)."
    },
    {
      "NDCCode": "55700-204-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (55700-204-30)",
      "NDC11Code": "55700-0204-30",
      "ProductNDC": "55700-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zonisamide",
      "NonProprietaryName": "Zonisamide",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121022",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077637",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "ZONISAMIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-07-12",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
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      "NDCCode": "55910-204-30",
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      "StartMarketingDate": "20230918",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M008",
      "LabelerName": "DOLGENCORP, INC.",
      "SubstanceName": "BISMUTH SUBSALICYLATE",
      "StrengthNumber": "262",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230918",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: o heartburn o indigestion o nausea o gas o belching o fullness."
    }
  ]
}
                    

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    <NDC11Code>98132-0204-30</NDC11Code>
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    <ProprietaryNameSuffix>Aspen 04</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
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    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Orveon Global US LLC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
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    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  </NDC>
  <NDC>
    <NDCCode>98132-204-03</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (98132-204-03)  / 3 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>98132-0204-03</NDC11Code>
    <ProductNDC>98132-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bareminerals Barepro Performance Wear Liquid Foundation Broad Spectrum Spf 20</ProprietaryName>
    <ProprietaryNameSuffix>Aspen 04</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Orveon Global US LLC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>33.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>10544-204-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (10544-204-30)</PackageDescription>
    <NDC11Code>10544-0204-30</NDC11Code>
    <ProductNDC>10544-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077309</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-03-20</LastUpdate>
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  <NDC>
    <NDCCode>13537-204-18</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (13537-204-18)  &gt; 30 mL in 1 BOTTLE (13537-204-17)</PackageDescription>
    <NDC11Code>13537-0204-18</NDC11Code>
    <ProductNDC>13537-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Filling Effect Foundation Spf 10</ProprietaryName>
    <ProprietaryNameSuffix>(medium 5) - Brown</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131216</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE</SubstanceName>
    <StrengthNumber>.07</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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  <NDC>
    <NDCCode>13668-204-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (13668-204-30) </PackageDescription>
    <NDC11Code>13668-0204-30</NDC11Code>
    <ProductNDC>13668-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
    <NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150330</StartMarketingDate>
    <EndMarketingDate>20191031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202377</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
    <StrengthNumber>10; 320</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150330</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>14783-204-18</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (14783-204-18)  &gt; 30 mL in 1 BOTTLE (14783-204-17)</PackageDescription>
    <NDC11Code>14783-0204-18</NDC11Code>
    <ProductNDC>14783-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Filling Effect Foundation Spf 10</ProprietaryName>
    <ProprietaryNameSuffix>(medium 5) - Brown</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131216</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura International LTD</LabelerName>
    <SubstanceName>OCTINOXATE</SubstanceName>
    <StrengthNumber>.07</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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  <NDC>
    <NDCCode>27241-204-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (27241-204-30) </PackageDescription>
    <NDC11Code>27241-0204-30</NDC11Code>
    <ProductNDC>27241-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brexpiprazole</ProprietaryName>
    <NonProprietaryName>Brexpiprazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213718</ApplicationNumber>
    <LabelerName>Ajanta Pharma USA Inc.</LabelerName>
    <SubstanceName>BREXPIPRAZOLE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-02-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.</IndicationAndUsage>
    <Description>Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&amp;C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&amp;C Blue #2 (2 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>40104-204-02</NDCCode>
    <PackageDescription>2 BOTTLE in 1 PACKAGE (40104-204-02)  &gt; 30 mL in 1 BOTTLE (40104-204-01)</PackageDescription>
    <NDC11Code>40104-0204-02</NDC11Code>
    <ProductNDC>40104-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>My Little Pony Antibacterial Hand Sanitizer With Moisturizers</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150205</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Ningbo Pulisi Daily Chemical Products Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses  hand sanitizer to help reduce bacteria on the skin, when water, soap and towel are not available.  recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42002-204-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (42002-204-01)  &gt; 30 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>42002-0204-01</NDC11Code>
    <ProductNDC>42002-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Visine</ProprietaryName>
    <ProprietaryNameSuffix>L.r.</ProprietaryNameSuffix>
    <NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20100405</StartMarketingDate>
    <EndMarketingDate>20160801</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019407</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42211-204-23</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (42211-204-23) </PackageDescription>
    <NDC11Code>42211-0204-23</NDC11Code>
    <ProductNDC>42211-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zorvolex</ProprietaryName>
    <NonProprietaryName>Diclofenac</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131031</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204592</ApplicationNumber>
    <LabelerName>Iroko Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DICLOFENAC</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZORVOLEX is indicated for: 1 Management of mild to moderate acute pain, 2 Management of osteoarthritis pain.</IndicationAndUsage>
    <Description>ZORVOLEX (diclofenac) capsules are a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 18 mg and 35 mg for oral administration. The chemical name is 2-[(2, 6-dichlorophenyl) amino] benzeneacetic acid. The molecular weight is 296.15. Its molecular formula is C14H11Cl2NO2, and it has the following chemical structure. Diclofenac acid is a white to slight yellowish crystalline powder. Diclofenac acid has a pKa of 4.18 and a logP of 3.03. It is practically insoluble in water and sparingly soluble in ethanol. The inactive ingredients in ZORVOLEX include a combination of lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&amp;C blue #1, FD&amp;C blue #2, FDA/E172 Yellow Iron Oxide and FDA/E172 Black Iron Oxide. The imprinting on the gelatin capsules is white edible ink. The 18 mg capsules have a blue body imprinted with IP-203 and light green cap imprinted with 18 mg in white ink. The 35 mg capsules have a blue body imprinted with IP-204 and green cap imprinted with 35 mg in white ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>42254-204-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42254-204-30)</PackageDescription>
    <NDC11Code>42254-0204-30</NDC11Code>
    <ProductNDC>42254-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076000</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Olanzapine USP is an atypical antipsychotic indicated. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) , 3 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
    <Description>Olanzapine USP is an atypical psychotropic agent that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine and has the following chemical structure:. C17H20N4S M.W. 312.44. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Each tablet, for oral administration, contains olanzapine equivalent to 2.5 mg (8 micromol), 5 mg (16 micromol), 7.5 mg (24 micromol), 10 mg (32 micromol) or 15 mg (48 micromol) and has the following inactive ingredients: anhydrous lactose, carrageenan, crospovidone, magnesium stearate, microcrystalline cellulose, and polyethylene glycol. In addition, the 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets contain titanium dioxide, and the 15 mg tablets contain FD&amp;C blue #2 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>42708-204-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (42708-204-30) </PackageDescription>
    <NDC11Code>42708-0204-30</NDC11Code>
    <ProductNDC>42708-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078925</ApplicationNumber>
    <LabelerName>QPharma, Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</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>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260820</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: * Hypertension ( 1.1) ○ Amlodipine besylate tablets is indicated 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. * Coronary Artery Disease ( 1.2) ○ Chronic Stable Angina ○ Vasospastic Angina (Prinzmetal's or Variant Angina) ○ Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt; 40%.</IndicationAndUsage>
    <Description>Amlodipine besylate 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 molecular formula is C 20H 25ClN 2O 5C 6H 6O 3S, 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. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43744-204-30</NDCCode>
    <PackageDescription>50 g in 1 DRUM (43744-204-30)</PackageDescription>
    <NDC11Code>43744-0204-30</NDC11Code>
    <ProductNDC>43744-204</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Clemastine Fumarate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20110606</StartMarketingDate>
    <EndMarketingDate>20110607</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>CLEMASTINE FUMARATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20110607</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>46122-204-30</NDCCode>
    <PackageDescription>177 mL in 1 BOTTLE (46122-204-30)</PackageDescription>
    <NDC11Code>46122-0204-30</NDC11Code>
    <ProductNDC>46122-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Good Neighbor Pharmacy Sleep Time</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part338</ApplicationNumber>
    <LabelerName>Amerisource Bergen</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-26</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>46708-204-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (46708-204-30) </PackageDescription>
    <NDC11Code>46708-0204-30</NDC11Code>
    <ProductNDC>46708-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Itraconazole</ProprietaryName>
    <NonProprietaryName>Itraconazole</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206741</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ITRACONAZOLE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-01-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Itraconazole capsules   are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients:.             1. Blastomycosis, pulmonary and extrapulmonary.             2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non- meningeal histoplasmosis, and.             3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules   are also indicated for the treatment of the following fungal infections in non-immunocompromised patients:.             1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and.             2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Post-marketing Experience for more information.). Description of Clinical Studies:. Blastomycosis:. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=73 combined) in patients with normal or abnormal immune status. The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. Histoplasmosis:. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=34 combined) in patients with normal or abnormal immune status (not including HIV-infected patients). The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. Histoplasmosis in HIV-infected patients:. Data from a small number of HIV-infected patients suggested that the response rate of histoplasmosis in HIV-infected patients is similar to that of non-HIV-infected patients. The clinical course of histoplasmosis in HIV-infected patients is more severe and usually requires maintenance therapy to prevent relapse. Aspergillosis:. Analyses were conducted on data from an open-label, “single-patient-use” protocol designed to make itraconazole available in the U.S. for patients who either failed or were intolerant of amphotericin B therapy (N=190). The findings were corroborated by two smaller open-label studies (N=31 combined) in the same patient population. Most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. Results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin B therapy. Onychomycosis of the toenail:. Analyses were conducted on data from three double-blind, placebo-controlled studies (N=214 total; 110 given itraconazole capsules   in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules   once daily for 12 consecutive weeks. Results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 54% of patients. Thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). The mean time to overall success was approximately 10 months. Twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of KOH or culture from negative to positive). Onychomycosis of the fingernail:. Analyses were conducted on data from a double-blind, placebo-controlled study (N=73 total; 37 given itraconazole capsules   in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules   b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules   b.i.d. Results demonstrated mycologic cure in 61% of patients. Fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. The mean time to overall success was approximately 5 months. None of the patients who achieved overall success relapsed.</IndicationAndUsage>
    <Description>Itraconazole Capsule   is the generic name for itraconazole, an azole  antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. ±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one mixture with (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2S*,4R*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one. or. (±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one. Itraconazole has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64. It is a white or almost white powder. It is freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran, very slightly soluble in alcohol and practically insoluble in water. It has a pKa of 3.7 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres (composed of  sucrose, starch and purified water). Inactive ingredients are hydroxypropyl methylcellulose, polyethylene glycol, hypromellose, gelatin, titanium dioxide, D&amp;C Red No. 22, FD&amp;C Blue No. 1, and D&amp;C Red No. 28. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>47219-204-20</NDCCode>
    <PackageDescription>1 BOTTLE, DISPENSING in 1 BOX (47219-204-20)  &gt; 30 mL in 1 BOTTLE, DISPENSING</PackageDescription>
    <NDC11Code>47219-0204-20</NDC11Code>
    <ProductNDC>47219-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nyloxin</ProprietaryName>
    <ProprietaryNameSuffix>Stage 2 Pain Relief</ProprietaryNameSuffix>
    <NonProprietaryName>Naja Naja Venom</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090825</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>RECEPTOPHARM INC</LabelerName>
    <SubstanceName>NAJA NAJA VENOM</SubstanceName>
    <StrengthNumber>.02</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses: Temporarily relieves joint pain associated with overuse and pain associated with arthritis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49349-204-02</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BLISTER PACK (49349-204-02)</PackageDescription>
    <NDC11Code>49349-0204-02</NDC11Code>
    <ProductNDC>49349-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110421</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071745</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-03-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49702-204-13</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (49702-204-13) </PackageDescription>
    <NDC11Code>49702-0204-13</NDC11Code>
    <ProductNDC>49702-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epivir</ProprietaryName>
    <NonProprietaryName>Lamivudine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101004</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020564</ApplicationNumber>
    <LabelerName>ViiV Healthcare Company</LabelerName>
    <SubstanceName>LAMIVUDINE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101004</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use: 1 The dosage of this product is for HIV‑1 and not for HBV.</IndicationAndUsage>
    <Description>EPIVIR (also known as 3TC) is a brand name for lamivudine, a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. EPIVIR tablets are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Each 300-mg film-coated tablet contains 300 mg of lamivudine and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. EPIVIR oral solution is for oral administration. One milliliter (1 mL) of EPIVIR oral solution contains 10 mg of lamivudine (10 mg per mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>50390-204-30</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50390-204-30)  / 30 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>50390-0204-30</NDC11Code>
    <ProductNDC>50390-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Artistry Exact Fit Longwearing Foundation Shade Cream</ProprietaryName>
    <ProprietaryNameSuffix>L1w2</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Amway Corp</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>40.25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51060-204-01</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (51060-204-01)  / 30 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>51060-0204-01</NDC11Code>
    <ProductNDC>51060-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Foundcealer Multi-tasking Foundation Broad Spectrum Spf 20 Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>22n Light Neutral</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190321</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Tarte, Inc.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>74.7; 47.5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190321</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51206-204-01</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (51206-204-01) </PackageDescription>
    <NDC11Code>51206-0204-01</NDC11Code>
    <ProductNDC>51206-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ultracare Oral Anesthetic Pina Colada</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>19860601</StartMarketingDate>
    <EndMarketingDate>20190830</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Ultradent Products, Inc.</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19860601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190830</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51316-204-01</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (51316-204-01)  *  30 g in 1 TUBE (51316-206-01) </PackageDescription>
    <NDC11Code>51316-0204-01</NDC11Code>
    <ProductNDC>51316-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cvs Hemorrhoidal Lidocaine 5 Rapid Pain Relief With 10 Finger Cots</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20251130</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M015</ApplicationNumber>
    <LabelerName>CVS PHARMACY, INC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51706-204-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (51706-204-02)  &gt; 30 mL in 1 BOTTLE (51706-204-01)</PackageDescription>
    <NDC11Code>51706-0204-02</NDC11Code>
    <ProductNDC>51706-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bodycology</ProprietaryName>
    <ProprietaryNameSuffix>Sweet Petals Hand Sanitizer</ProprietaryNameSuffix>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100625</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333</ApplicationNumber>
    <LabelerName>Landy International</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses: to decrease bacteria on the skin that could cause disease. Directions: wet hands, apply palmful to hands, scrub thoroughly for 30 seconds, rinse.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52125-204-02</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (52125-204-02)</PackageDescription>
    <NDC11Code>52125-0204-02</NDC11Code>
    <ProductNDC>52125-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202152</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-10</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52810-204-11</NDCCode>
    <PackageDescription>30 mL in 1 JAR (52810-204-11) </PackageDescription>
    <NDC11Code>52810-0204-11</NDC11Code>
    <ProductNDC>52810-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Intensive Skin Repair</ProprietaryName>
    <NonProprietaryName>Sambucus Nigra Flower Calendula Officinalis Flower Pinus Lambertiana Resin Abies Balsamea Leaf Oil</NonProprietaryName>
    <DosageFormName>SALVE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20121018</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PUREMEDY</LabelerName>
    <SubstanceName>ABIES BALSAMEA LEAF OIL; CALENDULA OFFICINALIS FLOWER; PINUS LAMBERTIANA RESIN; SAMBUCUS NIGRA FLOWER</SubstanceName>
    <StrengthNumber>1; 1; 1; 1</StrengthNumber>
    <StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH EXTREMELY DRY, DAMAGED, OR AGING SKIN.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52959-204-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (52959-204-30)</PackageDescription>
    <NDC11Code>52959-0204-30</NDC11Code>
    <ProductNDC>52959-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol</ProprietaryName>
    <NonProprietaryName>Carvedilol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070905</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078251</ApplicationNumber>
    <LabelerName>H.J. Harkins Company, Inc.</LabelerName>
    <SubstanceName>CARVEDILOL</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2) , 2 Hypertension (1.3) .</IndicationAndUsage>
    <Description>Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film coated circular shaped tablets. The 12.5 mg tablets are white film coated capsule shaped tablets. Inactive ingredients: consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>53217-204-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53217-204-30)</PackageDescription>
    <NDC11Code>53217-0204-30</NDC11Code>
    <ProductNDC>53217-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130902</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078155</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.</IndicationAndUsage>
    <Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of  HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole , ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>54766-204-01</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (54766-204-01) </PackageDescription>
    <NDC11Code>54766-0204-01</NDC11Code>
    <ProductNDC>54766-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pexeva</ProprietaryName>
    <NonProprietaryName>Paroxetine Mesylate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170602</StartMarketingDate>
    <EndMarketingDate>20240531</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021299</ApplicationNumber>
    <LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PAROXETINE MESYLATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170602</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PEXEVA is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Generalized anxiety disorder (GAD).</IndicationAndUsage>
    <Description>PEXEVA contains paroxetine mesylate, an SSRI. It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C 19H 20FNO 3CH 3SO 3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:. Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water. PEXEVA tablets are intended for oral administration. Each oval, film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg paroxetine equivalent to 12.9 mg, 25.8 mg, 38.8 mg, or 51.7 mg paroxetine mesylate, respectively. Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only).</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-204-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (55700-204-30)</PackageDescription>
    <NDC11Code>55700-0204-30</NDC11Code>
    <ProductNDC>55700-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zonisamide</ProprietaryName>
    <NonProprietaryName>Zonisamide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077637</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>ZONISAMIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-07-12</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55910-204-30</NDCCode>
    <PackageDescription>5 CELLO PACK in 1 CARTON (55910-204-30)  / 6 TABLET, CHEWABLE in 1 CELLO PACK</PackageDescription>
    <NDC11Code>55910-0204-30</NDC11Code>
    <ProductNDC>55910-204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Regular Strength Stomach Relief</ProprietaryName>
    <NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230918</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M008</ApplicationNumber>
    <LabelerName>DOLGENCORP, INC.</LabelerName>
    <SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
    <StrengthNumber>262</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-02-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230918</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: o heartburn o indigestion o nausea o gas o belching o fullness.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>98132-204-30</NDCCode><ProprietaryName>Bareminerals Barepro Performance Wear Liquid Foundation Broad Spectrum Spf 20</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>98132-204-03</NDCCode><ProprietaryName>Bareminerals Barepro Performance Wear Liquid Foundation Broad Spectrum Spf 20</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>10544-204-30</NDCCode><ProprietaryName>Acyclovir</ProprietaryName><NonProprietaryName>Acyclovir</NonProprietaryName></NDC><NDC><NDCCode>13537-204-18</NDCCode><ProprietaryName>Lbel Filling Effect Foundation Spf 10</ProprietaryName><NonProprietaryName>Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>13668-204-30</NDCCode><ProprietaryName>Amlodipine And Valsartan</ProprietaryName><NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName></NDC><NDC><NDCCode>14783-204-18</NDCCode><ProprietaryName>Lbel Filling Effect Foundation Spf 10</ProprietaryName><NonProprietaryName>Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>27241-204-30</NDCCode><ProprietaryName>Brexpiprazole</ProprietaryName><NonProprietaryName>Brexpiprazole</NonProprietaryName></NDC><NDC><NDCCode>40104-204-02</NDCCode><ProprietaryName>My Little Pony Antibacterial Hand Sanitizer With Moisturizers</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>42002-204-01</NDCCode><ProprietaryName>Visine</ProprietaryName><NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42211-204-23</NDCCode><ProprietaryName>Zorvolex</ProprietaryName><NonProprietaryName>Diclofenac</NonProprietaryName></NDC><NDC><NDCCode>42254-204-30</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC><NDC><NDCCode>42708-204-30</NDCCode><ProprietaryName>Amlodipine Besylate</ProprietaryName><NonProprietaryName>Amlodipine Besylate</NonProprietaryName></NDC><NDC><NDCCode>43744-204-30</NDCCode><NonProprietaryName>Clemastine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>46122-204-30</NDCCode><ProprietaryName>Good Neighbor Pharmacy Sleep Time</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>46708-204-30</NDCCode><ProprietaryName>Itraconazole</ProprietaryName><NonProprietaryName>Itraconazole</NonProprietaryName></NDC><NDC><NDCCode>47219-204-20</NDCCode><ProprietaryName>Nyloxin</ProprietaryName><NonProprietaryName>Naja Naja Venom</NonProprietaryName></NDC><NDC><NDCCode>49349-204-02</NDCCode><ProprietaryName>Prazosin Hydrochloride</ProprietaryName><NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49702-204-13</NDCCode><ProprietaryName>Epivir</ProprietaryName><NonProprietaryName>Lamivudine</NonProprietaryName></NDC><NDC><NDCCode>50390-204-30</NDCCode><ProprietaryName>Artistry Exact Fit Longwearing Foundation Shade Cream</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>51060-204-01</NDCCode><ProprietaryName>Foundcealer Multi-tasking Foundation Broad Spectrum Spf 20 Sunscreen</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>51206-204-01</NDCCode><ProprietaryName>Ultracare Oral Anesthetic Pina Colada</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>51316-204-01</NDCCode><ProprietaryName>Cvs Hemorrhoidal Lidocaine 5 Rapid Pain Relief With 10 Finger Cots</ProprietaryName><NonProprietaryName>Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>51706-204-02</NDCCode><ProprietaryName>Bodycology</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>52125-204-02</NDCCode><ProprietaryName>Quetiapine Fumarate</ProprietaryName><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>52810-204-11</NDCCode><ProprietaryName>Intensive Skin Repair</ProprietaryName><NonProprietaryName>Sambucus Nigra Flower Calendula Officinalis Flower Pinus Lambertiana Resin Abies Balsamea Leaf Oil</NonProprietaryName></NDC><NDC><NDCCode>52959-204-30</NDCCode><ProprietaryName>Carvedilol</ProprietaryName><NonProprietaryName>Carvedilol</NonProprietaryName></NDC><NDC><NDCCode>53217-204-30</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>54766-204-01</NDCCode><ProprietaryName>Pexeva</ProprietaryName><NonProprietaryName>Paroxetine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>55700-204-30</NDCCode><ProprietaryName>Zonisamide</ProprietaryName><NonProprietaryName>Zonisamide</NonProprietaryName></NDC><NDC><NDCCode>55910-204-30</NDCCode><ProprietaryName>Regular Strength Stomach Relief</ProprietaryName><NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
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    },
    {
      "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",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
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}
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