RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "65197-297-16",
      "PackageDescription": "2 BLISTER PACK in 1 BOX (65197-297-16)  / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "65197-0297-16",
      "ProductNDC": "65197-297",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bonine",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2026-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250401",
      "SamplePackage": "N",
      "IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
    },
    {
      "NDCCode": "11673-297-16",
      "PackageDescription": "59.1 mL in 1 BOTTLE, DISPENSING (11673-297-16) ",
      "NDC11Code": "11673-0297-16",
      "ProductNDC": "11673-297",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141008",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Target Corporation",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "567",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20141008",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "29300-297-16",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-297-16) ",
      "NDC11Code": "29300-0297-16",
      "ProductNDC": "29300-297",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ranolazine",
      "NonProprietaryName": "Ranolazine",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230316",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213083",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "RANOLAZINE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-11-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230715",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
      "Description": "Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, sodium hydroxide and sodium lauryl sulfate. The film coating contains ferrosoferric oxide (1000 mg only), iron oxide red (1000 mg only), iron oxide yellow (1000 mg only), polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
    },
    {
      "NDCCode": "65197-297-08",
      "PackageDescription": "1 BLISTER PACK in 1 BOX (65197-297-08)  / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "65197-0297-08",
      "ProductNDC": "65197-297",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bonine",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2026-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250401",
      "SamplePackage": "N",
      "IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
    },
    {
      "NDCCode": "65197-297-12",
      "PackageDescription": "1 BOTTLE in 1 BOX (65197-297-12)  / 12 TABLET, CHEWABLE in 1 BOTTLE",
      "NDC11Code": "65197-0297-12",
      "ProductNDC": "65197-297",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bonine",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2026-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250401",
      "SamplePackage": "N",
      "IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
    },
    {
      "NDCCode": "65197-297-24",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (65197-297-24)  / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "65197-0297-24",
      "ProductNDC": "65197-297",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bonine",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2026-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250401",
      "SamplePackage": "N",
      "IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
    },
    {
      "NDCCode": "65197-297-48",
      "PackageDescription": "2 CARTON in 1 CARTON (65197-297-48)  / 3 BLISTER PACK in 1 CARTON / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "65197-0297-48",
      "ProductNDC": "65197-297",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bonine",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260531",
      "SamplePackage": "N",
      "IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
    },
    {
      "NDCCode": "65197-275-16",
      "PackageDescription": "2 BLISTER PACK in 1 BOX (65197-275-16)  / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "65197-0275-16",
      "ProductNDC": "65197-275",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bonine",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141215",
      "EndMarketingDate": "20261231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2025-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20141215",
      "EndMarketingDatePackage": "20261231",
      "SamplePackage": "N",
      "IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
    },
    {
      "NDCCode": "65197-296-16",
      "PackageDescription": "2 BLISTER PACK in 1 BOX (65197-296-16)  / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "65197-0296-16",
      "ProductNDC": "65197-296",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bonine",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230215",
      "EndMarketingDate": "20261231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2025-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230215",
      "EndMarketingDatePackage": "20261231",
      "SamplePackage": "N",
      "IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
    },
    {
      "NDCCode": "65197-402-16",
      "PackageDescription": "454 g in 1 JAR (65197-402-16) ",
      "NDC11Code": "65197-0402-16",
      "ProductNDC": "65197-402",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ad Treat Diaper Rash Cream With Dimethicone And Zinc Oxide",
      "NonProprietaryName": "Ad Treat Diaper Rash Cream With Dimethicone And Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230919",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "DIMETHICONE; ZINC OXIDE",
      "StrengthNumber": "1; 10",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250615",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps treat and prevent diaper rash. protects minor skin irritation due to diaper rash and helps seal out wetness."
    },
    {
      "NDCCode": "65197-407-16",
      "PackageDescription": "454 g in 1 JAR (65197-407-16) ",
      "NDC11Code": "65197-0407-16",
      "ProductNDC": "65197-407",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ad Incontinence Support",
      "NonProprietaryName": "Ad Incontinence Support",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250120",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "LANOLIN; PETROLATUM",
      "StrengthNumber": "15.5; 53.4",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250315",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps treat and prevent incontinence rash. protects chafed skin associated with incontinence rash and helps seal out wetness. temporarily protects and helps relieve chapped or cracked skin and lips."
    },
    {
      "NDCCode": "65197-470-16",
      "PackageDescription": "454 g in 1 JAR (65197-470-16) ",
      "NDC11Code": "65197-0470-16",
      "ProductNDC": "65197-470",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ad Skin Protectant",
      "NonProprietaryName": "Ad Skin Protectant",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250120",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "LANOLIN; PETROLATUM",
      "StrengthNumber": "15.5; 53.4",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2026-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250315",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps treat and prevent incontinence rash. protects chafed skin associated with incontinence rash and helps seal out wetness. temporarily protects and helps relieve chapped or cracked skin and lips."
    },
    {
      "NDCCode": "65197-520-16",
      "PackageDescription": "2 BLISTER PACK in 1 BOX (65197-520-16)  / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "65197-0520-16",
      "ProductNDC": "65197-520",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bonine Max",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230324",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2025-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230324",
      "SamplePackage": "N",
      "IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
    },
    {
      "NDCCode": "65197-616-16",
      "PackageDescription": "2 BLISTER PACK in 1 BOX (65197-616-16)  / 8 TABLET in 1 BLISTER PACK",
      "NDC11Code": "65197-0616-16",
      "ProductNDC": "65197-616",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bonine",
      "ProprietaryNameSuffix": "Faster-acting",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230501",
      "EndMarketingDate": "20260430",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230501",
      "EndMarketingDatePackage": "20260430",
      "SamplePackage": "N",
      "IndicationAndUsage": "for prevention and treatment of nausea, vomiting, Uses or dizziness associated with motion sickness."
    },
    {
      "NDCCode": "0078-0314-34",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0078-0314-34) ",
      "NDC11Code": "00078-0314-34",
      "ProductNDC": "0078-0314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diovan Hct",
      "NonProprietaryName": "Valsartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980306",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020818",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "VALSARTAN; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "80; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980306",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
      "Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
    },
    {
      "NDCCode": "0078-0315-34",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0078-0315-34) ",
      "NDC11Code": "00078-0315-34",
      "ProductNDC": "0078-0315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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      "IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
      "Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
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      "IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
      "Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
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      "IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
      "Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
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      "IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
      "Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
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      "IndicationAndUsage": "Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. Exforge HCT is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].",
      "Description": "Exforge HCT is a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Exforge HCT contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) is available as film-coated tablets containing amlodipine besylate (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively), with valsartan 160 mg or 320 mg, and hydrochlorothiazide 12.5 mg or 25 mg, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg. The inactive ingredients for all strengths of the tablets include microcrystalline cellulose; crospovidone; colloidal anhydrous silica; magnesium stearate; hypromellose, macrogol 4000, and talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide."
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      "Description": "Exforge HCT is a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Exforge HCT contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) is available as film-coated tablets containing amlodipine besylate (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively), with valsartan 160 mg or 320 mg, and hydrochlorothiazide 12.5 mg or 25 mg, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg. The inactive ingredients for all strengths of the tablets include microcrystalline cellulose; crospovidone; colloidal anhydrous silica; magnesium stearate; hypromellose, macrogol 4000, and talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide."
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      "Description": "Exforge HCT is a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Exforge HCT contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) is available as film-coated tablets containing amlodipine besylate (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively), with valsartan 160 mg or 320 mg, and hydrochlorothiazide 12.5 mg or 25 mg, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg. The inactive ingredients for all strengths of the tablets include microcrystalline cellulose; crospovidone; colloidal anhydrous silica; magnesium stearate; hypromellose, macrogol 4000, and talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide."
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      "IndicationAndUsage": "Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. Exforge HCT is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].",
      "Description": "Exforge HCT is a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Exforge HCT contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) is available as film-coated tablets containing amlodipine besylate (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively), with valsartan 160 mg or 320 mg, and hydrochlorothiazide 12.5 mg or 25 mg, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg. The inactive ingredients for all strengths of the tablets include microcrystalline cellulose; crospovidone; colloidal anhydrous silica; magnesium stearate; hypromellose, macrogol 4000, and talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide."
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      "IndicationAndUsage": "Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. Exforge HCT is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].",
      "Description": "Exforge HCT is a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Exforge HCT contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) is available as film-coated tablets containing amlodipine besylate (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively), with valsartan 160 mg or 320 mg, and hydrochlorothiazide 12.5 mg or 25 mg, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg. The inactive ingredients for all strengths of the tablets include microcrystalline cellulose; crospovidone; colloidal anhydrous silica; magnesium stearate; hypromellose, macrogol 4000, and talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide."
    },
    {
      "NDCCode": "0378-3001-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (0378-3001-05) ",
      "NDC11Code": "00378-3001-05",
      "ProductNDC": "0378-3001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
      "NonProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090704",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "16; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-08-03",
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      "SamplePackage": "N",
      "IndicationAndUsage": "Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
      "Description": "Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)2-Ethoxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester. Its molecular formula is C33H34N6O6, and its structural formula is:. Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.66. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-,1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, practically odorless crystalline powder with a molecular weight of 297.7, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Candesartan cilexetil and hydrochlorothiazide tablets are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The inactive ingredients of the tablets are carboxymethylcellulose calcium, corn starch, glyceryl stearate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and yellow iron oxide. The 16 mg/12.5 mg tablet and 32 mg/25 mg tablet also contain red iron oxide as a colorant."
    },
    {
      "NDCCode": "0378-3001-77",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (0378-3001-77) ",
      "NDC11Code": "00378-3001-77",
      "ProductNDC": "0378-3001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
      "NonProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121204",
      "EndMarketingDate": "20270228",
      "MarketingCategoryName": "ANDA",
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      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "16; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-23",
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      "IndicationAndUsage": "Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
      "Description": "Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)2-Ethoxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester. Its molecular formula is C33H34N6O6, and its structural formula is:. Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.66. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-,1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, practically odorless crystalline powder with a molecular weight of 297.7, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Candesartan cilexetil and hydrochlorothiazide tablets are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The inactive ingredients of the tablets are carboxymethylcellulose calcium, corn starch, glyceryl stearate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and yellow iron oxide. The 16 mg/12.5 mg tablet and 32 mg/25 mg tablet also contain red iron oxide as a colorant."
    },
    {
      "NDCCode": "0378-3002-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (0378-3002-05) ",
      "NDC11Code": "00378-3002-05",
      "ProductNDC": "0378-3002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
      "NonProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121204",
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      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-08-03",
      "PackageNdcExcludeFlag": "N",
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      "IndicationAndUsage": "Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
      "Description": "Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)2-Ethoxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester. Its molecular formula is C33H34N6O6, and its structural formula is:. Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.66. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-,1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, practically odorless crystalline powder with a molecular weight of 297.7, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Candesartan cilexetil and hydrochlorothiazide tablets are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The inactive ingredients of the tablets are carboxymethylcellulose calcium, corn starch, glyceryl stearate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and yellow iron oxide. The 16 mg/12.5 mg tablet and 32 mg/25 mg tablet also contain red iron oxide as a colorant."
    },
    {
      "NDCCode": "0378-3002-77",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (0378-3002-77) ",
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      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
      "NonProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
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      "StrengthUnit": "mg/1; mg/1",
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      "IndicationAndUsage": "Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
      "Description": "Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)2-Ethoxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester. Its molecular formula is C33H34N6O6, and its structural formula is:. Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.66. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-,1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, practically odorless crystalline powder with a molecular weight of 297.7, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Candesartan cilexetil and hydrochlorothiazide tablets are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The inactive ingredients of the tablets are carboxymethylcellulose calcium, corn starch, glyceryl stearate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and yellow iron oxide. The 16 mg/12.5 mg tablet and 32 mg/25 mg tablet also contain red iron oxide as a colorant."
    },
    {
      "NDCCode": "0378-3003-05",
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      "ProductNDC": "0378-3003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
      "NonProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
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      "StartMarketingDate": "20121204",
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      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
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      "EndMarketingDatePackage": "20220131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
      "Description": "Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)2-Ethoxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester. Its molecular formula is C33H34N6O6, and its structural formula is:. Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.66. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-,1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, practically odorless crystalline powder with a molecular weight of 297.7, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Candesartan cilexetil and hydrochlorothiazide tablets are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The inactive ingredients of the tablets are carboxymethylcellulose calcium, corn starch, glyceryl stearate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and yellow iron oxide. The 16 mg/12.5 mg tablet and 32 mg/25 mg tablet also contain red iron oxide as a colorant."
    },
    {
      "NDCCode": "0378-3003-77",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (0378-3003-77) ",
      "NDC11Code": "00378-3003-77",
      "ProductNDC": "0378-3003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
      "NonProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121204",
      "EndMarketingDate": "20260831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090704",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "32; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20121204",
      "EndMarketingDatePackage": "20260831",
      "SamplePackage": "N",
      "IndicationAndUsage": "Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
      "Description": "Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)2-Ethoxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester. Its molecular formula is C33H34N6O6, and its structural formula is:. Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.66. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-,1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, practically odorless crystalline powder with a molecular weight of 297.7, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Candesartan cilexetil and hydrochlorothiazide tablets are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The inactive ingredients of the tablets are carboxymethylcellulose calcium, corn starch, glyceryl stearate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and yellow iron oxide. The 16 mg/12.5 mg tablet and 32 mg/25 mg tablet also contain red iron oxide as a colorant."
    }
  ]
}
                    

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