{
"NDC": [
{
"NDCCode": "78502-7000-6",
"PackageDescription": "100 g in 1 BAG (78502-7000-6) ",
"NDC11Code": "78502-7000-06",
"ProductNDC": "78502-7000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bcp",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200704",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BELSKIN S. DE, R.L. DE C.V",
"SubstanceName": "ALCOHOL; BENZALKONIUM CHLORIDE",
"StrengthNumber": "5; .25",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200704",
"SamplePackage": "N",
"IndicationAndUsage": "APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING."
},
{
"NDCCode": "78502-6000-6",
"PackageDescription": "40 g in 1 BAG (78502-6000-6) ",
"NDC11Code": "78502-6000-06",
"ProductNDC": "78502-6000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medically Minded",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200628",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BELSKIN S. DE, R.L. DE C.V",
"SubstanceName": "BENZALKONIUM CHLORIDE; ALCOHOL",
"StrengthNumber": ".25; 5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200628",
"SamplePackage": "N",
"IndicationAndUsage": "APPLY TO HANDS. ALLOW TO DRY WITHOUT WIPING."
},
{
"NDCCode": "14222-7000-1",
"PackageDescription": "1 KIT in 1 CARTON (14222-7000-1) * 5 mL in 1 TUBE (14222-3000-6) * 8 mL in 1 BOTTLE, PUMP (14222-2120-4) * 30 mL in 1 JAR (14222-2251-5) * 12 mL in 1 TUBE (14222-2430-4) * 5 mL in 1 TUBE (14222-3000-5) ",
"NDC11Code": "14222-7000-01",
"ProductNDC": "14222-7000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "12 Days Of Derm-loved Skincare",
"NonProprietaryName": "Octinoxate, Zinc Oxide, Oatmeal, Benzoyl Peroxide, Avobenzone, Octisalate, Octocrylene",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Rodan & Fields",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251001",
"SamplePackage": "N"
},
{
"NDCCode": "62795-7000-6",
"PackageDescription": "1 TUBE in 1 CARTON (62795-7000-6) > 50 g in 1 TUBE",
"NDC11Code": "62795-7000-06",
"ProductNDC": "62795-7000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief",
"NonProprietaryName": "Aconitum Napellus, Arnica Montana Root, Baptisia Tinctoria Root, Atropa Belladonna,bellis Perennis,calendula Officinalis Flowering Top, Matricaria Recutita,echinacea, Unspecified,hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium,ruta Graveolens Flowering Top, And Comfrey Root",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140830",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT",
"StrengthNumber": "1; 1; 4; 2; 2; 1; 2; 1; 2; 6; 2; 2; 4",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68788-7000-6",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (68788-7000-6)",
"NDC11Code": "68788-7000-06",
"ProductNDC": "68788-7000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076635",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "78502-7000-1",
"PackageDescription": "30 g in 1 BAG (78502-7000-1) ",
"NDC11Code": "78502-7000-01",
"ProductNDC": "78502-7000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bcp",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200704",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BELSKIN S. DE, R.L. DE C.V",
"SubstanceName": "ALCOHOL; BENZALKONIUM CHLORIDE",
"StrengthNumber": "5; .25",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200704",
"SamplePackage": "N",
"IndicationAndUsage": "APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING."
},
{
"NDCCode": "78502-7000-2",
"PackageDescription": "40 g in 1 BAG (78502-7000-2) ",
"NDC11Code": "78502-7000-02",
"ProductNDC": "78502-7000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bcp",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200704",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BELSKIN S. DE, R.L. DE C.V",
"SubstanceName": "ALCOHOL; BENZALKONIUM CHLORIDE",
"StrengthNumber": "5; .25",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200704",
"SamplePackage": "N",
"IndicationAndUsage": "APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING."
},
{
"NDCCode": "78502-7000-3",
"PackageDescription": "5 g in 1 BAG (78502-7000-3) ",
"NDC11Code": "78502-7000-03",
"ProductNDC": "78502-7000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bcp",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200704",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BELSKIN S. DE, R.L. DE C.V",
"SubstanceName": "ALCOHOL; BENZALKONIUM CHLORIDE",
"StrengthNumber": "5; .25",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200704",
"SamplePackage": "N",
"IndicationAndUsage": "APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING."
},
{
"NDCCode": "78502-7000-4",
"PackageDescription": "12 g in 1 BAG (78502-7000-4) ",
"NDC11Code": "78502-7000-04",
"ProductNDC": "78502-7000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bcp",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200704",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BELSKIN S. DE, R.L. DE C.V",
"SubstanceName": "ALCOHOL; BENZALKONIUM CHLORIDE",
"StrengthNumber": "5; .25",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200704",
"SamplePackage": "N",
"IndicationAndUsage": "APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING."
},
{
"NDCCode": "78502-7000-5",
"PackageDescription": "20 g in 1 BAG (78502-7000-5) ",
"NDC11Code": "78502-7000-05",
"ProductNDC": "78502-7000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bcp",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200704",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BELSKIN S. DE, R.L. DE C.V",
"SubstanceName": "ALCOHOL; BENZALKONIUM CHLORIDE",
"StrengthNumber": "5; .25",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200704",
"SamplePackage": "N",
"IndicationAndUsage": "APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING."
},
{
"NDCCode": "0280-0004-01",
"PackageDescription": "7000 CAPSULE in 1 BAG (0280-0004-01) ",
"NDC11Code": "00280-0004-01",
"ProductNDC": "0280-0004",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Doxylamine Succinate, Acetaminophen, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20200114",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 6.25; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "14-JAN-20"
},
{
"NDCCode": "0280-0142-01",
"PackageDescription": "7000 CAPSULE in 1 BAG (0280-0142-01) ",
"NDC11Code": "00280-0142-01",
"ProductNDC": "0280-0142",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Doxylamine Succinate, Acetaminophen",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20240116",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 10; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "16-JAN-24"
},
{
"NDCCode": "0280-0904-05",
"PackageDescription": "7000 CAPSULE in 1 BAG (0280-0904-05) ",
"NDC11Code": "00280-0904-05",
"ProductNDC": "0280-0904",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Doxylamine Succinate, Acetaminophen, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20180701",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 6.25; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-JUL-18"
},
{
"NDCCode": "0781-5949-84",
"PackageDescription": "7000 TABLET, FILM COATED in 1 BOTTLE (0781-5949-84)",
"NDC11Code": "00781-5949-84",
"ProductNDC": "0781-5949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan And Hydrochlorothiazide",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120921",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020818",
"LabelerName": "Sandoz Inc",
"SubstanceName": "VALSARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "160; 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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Valsartan and Hydrochlorothiazide Tablets, USP are 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 ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Valsartan and Hydrochlorothiazide Tablets, USP. 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. Valsartan and Hydrochlorothiazide Tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and Hydrochlorothiazide Tablets, USP may be substituted for the titrated components. Initial Therapy. Valsartan and Hydrochlorothiazide Tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Valsartan and Hydrochlorothiazide Tablets, USP 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 Valsartan and Hydrochlorothiazide Tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Valsartan and Hydrochlorothiazide Tablets, USP 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 hydrochlorothiazide alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Valsartan and Hydrochlorothiazide Tablets, USP rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Valsartan and Hydrochlorothiazide Tablets, USP are 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. Valsartan and Hydrochlorothiazide Tablets, USP 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": "0781-5950-84",
"PackageDescription": "7000 TABLET, FILM COATED in 1 BOTTLE (0781-5950-84)",
"NDC11Code": "00781-5950-84",
"ProductNDC": "0781-5950",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan And Hydrochlorothiazide",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120921",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020818",
"LabelerName": "Sandoz Inc",
"SubstanceName": "VALSARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "160; 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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Valsartan and Hydrochlorothiazide Tablets, USP are 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 ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Valsartan and Hydrochlorothiazide Tablets, USP. 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. Valsartan and Hydrochlorothiazide Tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and Hydrochlorothiazide Tablets, USP may be substituted for the titrated components. Initial Therapy. Valsartan and Hydrochlorothiazide Tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Valsartan and Hydrochlorothiazide Tablets, USP 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 Valsartan and Hydrochlorothiazide Tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Valsartan and Hydrochlorothiazide Tablets, USP 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 hydrochlorothiazide alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Valsartan and Hydrochlorothiazide Tablets, USP rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Valsartan and Hydrochlorothiazide Tablets, USP are 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. Valsartan and Hydrochlorothiazide Tablets, USP 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": "11523-0524-1",
"PackageDescription": "1 BAG in 1 CASE (11523-0524-1) / 7000 CAPSULE, LIQUID FILLED in 1 BAG",
"NDC11Code": "11523-0524-01",
"ProductNDC": "11523-0524",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Hydrogen Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 10; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-MAR-20"
},
{
"NDCCode": "23731-7000-5",
"PackageDescription": "12 VIAL, SINGLE-USE in 1 CASE (23731-7000-5) / 50 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "23731-7000-05",
"ProductNDC": "23731-7000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rejuvesol",
"NonProprietaryName": "Sodium Pyruvate, Inosine, Adenine, Sodium Phosphate, Dibasic, And Sodium Phosphate, Monobasic, Monohydrate",
"DosageFormName": "SOLUTION",
"RouteName": "EXTRACORPOREAL",
"StartMarketingDate": "19970226",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN950522",
"LabelerName": "Citra Labs, LLC",
"SubstanceName": "SODIUM PYRUVATE; INOSINE; ADENINE; SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
"StrengthNumber": ".55; 1.34; .034; .73; .311",
"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL; g/50mL",
"Status": "Active",
"LastUpdate": "2023-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19970226",
"SamplePackage": "N",
"IndicationAndUsage": "Rejuvesol ® Solution is intended only to be used as an in vitro processing solution for the rejuvenation of a unit of RBC. RBC may be rejuvenated after storage in CPD (non-leukocyte reduced), CPDA-1, (non-leukocyte reduced), CPD/ADSOL ® (CPD/AS-1 leukocyte reduced), or CP2D/Nutricel ® (CP2D/AS-3, leukocyte reduced). The final concentration of ATP and 2,3-DPG achieved after rejuvenation will vary depending on the number of days of liquid storage at 1-6 °C prior to rejuvenation. NOTE: For simplicity, RBC stored in CPD (non-leukocyte reduced), CPDA-1 (non-leukocyte reduced), CPD/ADSOL ® (CPD/AS-1 leukocyte reduced), CP2D/Nutricel ® (CP2D/AS-3, leukocyte reduced) are referred to hereafter as CPD, CPDA-1, CPD/AS-1, and CP2D/AS-3, respectively. Citra Labs, LLC, recommends that rejuvenation of RBC be performed after 14 days or longer of liquid storage. RBC (CPD, CPDA-1, CPD/AS-1, and CP2D/AS-3) rejuvenated before 6 days of storage may achieve 2,3-DPG levels in excess of 2 times normal and ATP levels in excess of 1.5 times normal 5,6 (See Warning and Contraindications).",
"Description": "Rejuvesol ® Red Blood Cell Processing Solution ( rejuvesol ® Solution) is a sterile, non-pyrogenic solution of sodium pyruvate, inosine, adenine, dibasic sodium phosphate, and monobasic sodium phosphate in water for injection intended only for use in the extracorporeal rejuvenation of a unit of red blood cell concentrate (RBC). Each 50 mL of rejuvesol ® Solution contains sodium pyruvate 0.550 g, inosine 1.34 g, adenine 0.034 g, dibasic sodium phosphate (heptahydrate) 0.730 g, and monobasic sodium phosphate (monohydrate) 0.311 g, in water for injection, pH 6.7-7.4."
},
{
"NDCCode": "48951-7000-1",
"PackageDescription": "10 AMPULE in 1 BOX (48951-7000-1) / 1 mL in 1 AMPULE",
"NDC11Code": "48951-7000-01",
"ProductNDC": "48951-7000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesite Viscum",
"NonProprietaryName": "Magnesite Viscum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "VISCUM ALBUM FRUITING TOP; APIS MELLIFERA; SUS SCROFA UMBILICAL CORD; BOS TAURUS PITUITARY GLAND; BOS TAURUS MAMMARY GLAND; MAGNESITE",
"StrengthNumber": "5; 6; 6; 6; 6; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "FOR ORAL USE ONLY."
},
{
"NDCCode": "50090-7000-0",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (50090-7000-0) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50090-7000-00",
"ProductNDC": "50090-7000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20211126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215624",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231228",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine sulfate ophthalmic solution, 1% is indicated for:.",
"Description": "Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.84 g/mol. Atropine sulfate appears as white or almost white, crystalline powder, or colorless crystals. It is very soluble in water and freely soluble in ethanol (96%). Atropine sulfate ophthalmic solution, USP 1% is a clear, colorless, slightly viscous solution. Each mL of Atropine Sulfate Ophthalmic Solution, USP 1% contains: Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), edetate disodium dihydrate, hypromellose (methocel E4M premium), sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP."
},
{
"NDCCode": "51672-4136-0",
"PackageDescription": "3785 mL in 1 BOTTLE (51672-4136-0) ",
"NDC11Code": "51672-4136-00",
"ProductNDC": "51672-4136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078774",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090210",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) , 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) .",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51672-4136-7",
"PackageDescription": "100 mL in 1 BOTTLE (51672-4136-7) ",
"NDC11Code": "51672-4136-07",
"ProductNDC": "51672-4136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078774",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090210",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) , 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) .",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51672-4136-9",
"PackageDescription": "473 mL in 1 BOTTLE (51672-4136-9) ",
"NDC11Code": "51672-4136-09",
"ProductNDC": "51672-4136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078774",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090210",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) , 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) .",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51672-4141-0",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (51672-4141-0) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "51672-4141-00",
"ProductNDC": "51672-4141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078960",
"LabelerName": "Taro Pharmaceuticals U.S.A., Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100201",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51672-4142-0",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (51672-4142-0) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "51672-4142-00",
"ProductNDC": "51672-4142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078960",
"LabelerName": "Taro Pharmaceuticals U.S.A., Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100201",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51672-4143-0",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (51672-4143-0) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "51672-4143-00",
"ProductNDC": "51672-4143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078960",
"LabelerName": "Taro Pharmaceuticals U.S.A., Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100201",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "53808-1128-1",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (53808-1128-1) ",
"NDC11Code": "53808-1128-01",
"ProductNDC": "53808-1128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090742",
"LabelerName": "DOH CENTRAL PHARMACY",
"SubstanceName": "TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180424",
"SamplePackage": "N",
"IndicationAndUsage": "Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. : 1 Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. (1), 2 Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. (1).",
"Description": "Tenofovir disoproxil fumarate (a prodrug of tenofovir) is a fumaric acid salt of bisisopropoxycarbonyloxymethyl ester derivative of tenofovir. In vivo tenofovir disoproxil fumarate is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarate is 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in distilled water at 25 °C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25 °C. Tenofovir disoproxil fumarate is available as tablets. Tenofovir disoproxil fumarate tablets are for oral administration in strength of 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The tablets are coated with Opadry White Y-1-7000, which contains Hypromellose, Titanium dioxide USP & Polyethylene glycol 400 (Macrogol) USP. In this insert, all dosages are expressed in terms of tenofovir disoproxil fumarate except where otherwise noted."
},
{
"NDCCode": "60505-2657-7",
"PackageDescription": "7000 TABLET in 1 BOTTLE (60505-2657-7) ",
"NDC11Code": "60505-2657-07",
"ProductNDC": "60505-2657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071251",
"LabelerName": "Apotex Corp.",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "75; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090921",
"SamplePackage": "N",
"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). .",
"Description": "Triamterene and hydrochlorothiazide combines triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP contains 37.5 mg of Triamterene, USP and 25 mg of Hydrochlorothiazide, USP. Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP contains 75 mg of Triamterene, USP and 50 mg of Hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. In addition, the 37.5 mg/25 mg tablets contain D&C Yellow No.10 Aluminum Lake and FD&C Blue No.1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. The following is the structural formula. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. The following is the structural formula."
},
{
"NDCCode": "62795-7000-5",
"PackageDescription": "250 g in 1 BOTTLE (62795-7000-5)",
"NDC11Code": "62795-7000-05",
"ProductNDC": "62795-7000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief",
"NonProprietaryName": "Aconitum Napellus, Arnica Montana Root, Baptisia Tinctoria Root, Atropa Belladonna,bellis Perennis,calendula Officinalis Flowering Top, Matricaria Recutita,echinacea, Unspecified,hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium,ruta Graveolens Flowering Top, And Comfrey Root",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140830",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT",
"StrengthNumber": "1; 1; 4; 2; 2; 1; 2; 1; 2; 6; 2; 2; 4",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64380-714-04",
"PackageDescription": "30 TABLET in 1 BOTTLE (64380-714-04) ",
"NDC11Code": "64380-0714-04",
"ProductNDC": "64380-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090742",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180126",
"SamplePackage": "N",
"IndicationAndUsage": "Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. (1.1), 2 for the treatment of chronic hepatitis B in adults and pediatric patients 12 years and older. (1.2).",
"Description": "Tenofovir disoproxil fumarate (a prodrug of tenofovir) is a fumaric acid salt of bisisopropoxycarbonyloxymethyl ester derivative of tenofovir. In vivo tenofovir disoproxil fumarate is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarate is 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in distilled water at 25 °C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25 °C. Tenofovir disoproxil fumarate is available as tablets. Tenofovir disoproxil fumarate tablets are for oral administration in strength of 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The tablets are coated with Opadry White Y-1-7000, which contains Hypromellose, Titanium dioxide USP & Polyethylene glycol 400 (Macrogol) USP. In this insert, all dosages are expressed in terms of tenofovir disoproxil fumarate except where otherwise noted."
},
{
"NDCCode": "65862-143-71",
"PackageDescription": "7000 TABLET, FILM COATED in 1 BAG (65862-143-71) ",
"NDC11Code": "65862-0143-71",
"ProductNDC": "65862-143",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-06-11",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "05-SEP-07"
}
]
}
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<StrengthUnit>g/100g; g/100g</StrengthUnit>
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<LastUpdate>2020-10-20</LastUpdate>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<LabelerName>BELSKIN S. DE, R.L. DE C.V</LabelerName>
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<StrengthUnit>g/100g; g/100g</StrengthUnit>
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<LastUpdate>2022-01-04</LastUpdate>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APPLY TO HANDS. ALLOW TO DRY WITHOUT WIPING.</IndicationAndUsage>
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<PackageDescription>1 KIT in 1 CARTON (14222-7000-1) * 5 mL in 1 TUBE (14222-3000-6) * 8 mL in 1 BOTTLE, PUMP (14222-2120-4) * 30 mL in 1 JAR (14222-2251-5) * 12 mL in 1 TUBE (14222-2430-4) * 5 mL in 1 TUBE (14222-3000-5) </PackageDescription>
<NDC11Code>14222-7000-01</NDC11Code>
<ProductNDC>14222-7000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>12 Days Of Derm-loved Skincare</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide, Oatmeal, Benzoyl Peroxide, Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
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<StartMarketingDate>20251001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Rodan & Fields</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>62795-7000-6</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62795-7000-6) > 50 g in 1 TUBE</PackageDescription>
<NDC11Code>62795-7000-06</NDC11Code>
<ProductNDC>62795-7000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arnica Montana Root, Baptisia Tinctoria Root, Atropa Belladonna,bellis Perennis,calendula Officinalis Flowering Top, Matricaria Recutita,echinacea, Unspecified,hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium,ruta Graveolens Flowering Top, And Comfrey Root</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
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<NDCCode>68788-7000-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68788-7000-6)</PackageDescription>
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<ProductNDC>68788-7000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076635</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
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<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
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<NDCCode>78502-7000-1</NDCCode>
<PackageDescription>30 g in 1 BAG (78502-7000-1) </PackageDescription>
<NDC11Code>78502-7000-01</NDC11Code>
<ProductNDC>78502-7000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bcp</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200704</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>BELSKIN S. DE, R.L. DE C.V</LabelerName>
<SubstanceName>ALCOHOL; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>5; .25</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200704</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78502-7000-2</NDCCode>
<PackageDescription>40 g in 1 BAG (78502-7000-2) </PackageDescription>
<NDC11Code>78502-7000-02</NDC11Code>
<ProductNDC>78502-7000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bcp</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200704</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>BELSKIN S. DE, R.L. DE C.V</LabelerName>
<SubstanceName>ALCOHOL; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>5; .25</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200704</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78502-7000-3</NDCCode>
<PackageDescription>5 g in 1 BAG (78502-7000-3) </PackageDescription>
<NDC11Code>78502-7000-03</NDC11Code>
<ProductNDC>78502-7000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bcp</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200704</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>BELSKIN S. DE, R.L. DE C.V</LabelerName>
<SubstanceName>ALCOHOL; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>5; .25</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200704</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78502-7000-4</NDCCode>
<PackageDescription>12 g in 1 BAG (78502-7000-4) </PackageDescription>
<NDC11Code>78502-7000-04</NDC11Code>
<ProductNDC>78502-7000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bcp</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200704</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>BELSKIN S. DE, R.L. DE C.V</LabelerName>
<SubstanceName>ALCOHOL; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>5; .25</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200704</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78502-7000-5</NDCCode>
<PackageDescription>20 g in 1 BAG (78502-7000-5) </PackageDescription>
<NDC11Code>78502-7000-05</NDC11Code>
<ProductNDC>78502-7000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bcp</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200704</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>BELSKIN S. DE, R.L. DE C.V</LabelerName>
<SubstanceName>ALCOHOL; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>5; .25</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200704</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0004-01</NDCCode>
<PackageDescription>7000 CAPSULE in 1 BAG (0280-0004-01) </PackageDescription>
<NDC11Code>00280-0004-01</NDC11Code>
<ProductNDC>0280-0004</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Doxylamine Succinate, Acetaminophen, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20200114</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 6.25; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-JAN-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0280-0142-01</NDCCode>
<PackageDescription>7000 CAPSULE in 1 BAG (0280-0142-01) </PackageDescription>
<NDC11Code>00280-0142-01</NDC11Code>
<ProductNDC>0280-0142</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Doxylamine Succinate, Acetaminophen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20240116</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 10; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-JAN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0280-0904-05</NDCCode>
<PackageDescription>7000 CAPSULE in 1 BAG (0280-0904-05) </PackageDescription>
<NDC11Code>00280-0904-05</NDC11Code>
<ProductNDC>0280-0904</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Doxylamine Succinate, Acetaminophen, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20180701</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 6.25; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUL-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0781-5949-84</NDCCode>
<PackageDescription>7000 TABLET, FILM COATED in 1 BOTTLE (0781-5949-84)</PackageDescription>
<NDC11Code>00781-5949-84</NDC11Code>
<ProductNDC>0781-5949</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120921</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020818</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>160; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Valsartan and Hydrochlorothiazide Tablets, USP are 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 ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Valsartan and Hydrochlorothiazide Tablets, USP. 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. Valsartan and Hydrochlorothiazide Tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and Hydrochlorothiazide Tablets, USP may be substituted for the titrated components. Initial Therapy. Valsartan and Hydrochlorothiazide Tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Valsartan and Hydrochlorothiazide Tablets, USP 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 Valsartan and Hydrochlorothiazide Tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Valsartan and Hydrochlorothiazide Tablets, USP 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 hydrochlorothiazide alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Valsartan and Hydrochlorothiazide Tablets, USP rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Valsartan and Hydrochlorothiazide Tablets, USP are 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. Valsartan and Hydrochlorothiazide Tablets, USP 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.</Description>
</NDC>
<NDC>
<NDCCode>0781-5950-84</NDCCode>
<PackageDescription>7000 TABLET, FILM COATED in 1 BOTTLE (0781-5950-84)</PackageDescription>
<NDC11Code>00781-5950-84</NDC11Code>
<ProductNDC>0781-5950</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
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<StartMarketingDate>20120921</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020818</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
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<StrengthNumber>160; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Valsartan and Hydrochlorothiazide Tablets, USP are 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 ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Valsartan and Hydrochlorothiazide Tablets, USP. 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. Valsartan and Hydrochlorothiazide Tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and Hydrochlorothiazide Tablets, USP may be substituted for the titrated components. Initial Therapy. Valsartan and Hydrochlorothiazide Tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Valsartan and Hydrochlorothiazide Tablets, USP 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 Valsartan and Hydrochlorothiazide Tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Valsartan and Hydrochlorothiazide Tablets, USP 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 hydrochlorothiazide alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Valsartan and Hydrochlorothiazide Tablets, USP rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Valsartan and Hydrochlorothiazide Tablets, USP are 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. Valsartan and Hydrochlorothiazide Tablets, USP 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.</Description>
</NDC>
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<LabelerName>Bayer HealthCare LLC.</LabelerName>
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<StartMarketingDatePackage>19970226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rejuvesol ® Solution is intended only to be used as an in vitro processing solution for the rejuvenation of a unit of RBC. RBC may be rejuvenated after storage in CPD (non-leukocyte reduced), CPDA-1, (non-leukocyte reduced), CPD/ADSOL ® (CPD/AS-1 leukocyte reduced), or CP2D/Nutricel ® (CP2D/AS-3, leukocyte reduced). The final concentration of ATP and 2,3-DPG achieved after rejuvenation will vary depending on the number of days of liquid storage at 1-6 °C prior to rejuvenation. NOTE: For simplicity, RBC stored in CPD (non-leukocyte reduced), CPDA-1 (non-leukocyte reduced), CPD/ADSOL ® (CPD/AS-1 leukocyte reduced), CP2D/Nutricel ® (CP2D/AS-3, leukocyte reduced) are referred to hereafter as CPD, CPDA-1, CPD/AS-1, and CP2D/AS-3, respectively. Citra Labs, LLC, recommends that rejuvenation of RBC be performed after 14 days or longer of liquid storage. RBC (CPD, CPDA-1, CPD/AS-1, and CP2D/AS-3) rejuvenated before 6 days of storage may achieve 2,3-DPG levels in excess of 2 times normal and ATP levels in excess of 1.5 times normal 5,6 (See Warning and Contraindications).</IndicationAndUsage>
<Description>Rejuvesol ® Red Blood Cell Processing Solution ( rejuvesol ® Solution) is a sterile, non-pyrogenic solution of sodium pyruvate, inosine, adenine, dibasic sodium phosphate, and monobasic sodium phosphate in water for injection intended only for use in the extracorporeal rejuvenation of a unit of red blood cell concentrate (RBC). Each 50 mL of rejuvesol ® Solution contains sodium pyruvate 0.550 g, inosine 1.34 g, adenine 0.034 g, dibasic sodium phosphate (heptahydrate) 0.730 g, and monobasic sodium phosphate (monohydrate) 0.311 g, in water for injection, pH 6.7-7.4.</Description>
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<NDC11Code>48951-7000-01</NDC11Code>
<ProductNDC>48951-7000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesite Viscum</ProprietaryName>
<NonProprietaryName>Magnesite Viscum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>VISCUM ALBUM FRUITING TOP; APIS MELLIFERA; SUS SCROFA UMBILICAL CORD; BOS TAURUS PITUITARY GLAND; BOS TAURUS MAMMARY GLAND; MAGNESITE</SubstanceName>
<StrengthNumber>5; 6; 6; 6; 6; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (50090-7000-0) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>50090-7000-00</NDC11Code>
<ProductNDC>50090-7000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20211126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215624</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine sulfate ophthalmic solution, 1% is indicated for:.</IndicationAndUsage>
<Description>Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.84 g/mol. Atropine sulfate appears as white or almost white, crystalline powder, or colorless crystals. It is very soluble in water and freely soluble in ethanol (96%). Atropine sulfate ophthalmic solution, USP 1% is a clear, colorless, slightly viscous solution. Each mL of Atropine Sulfate Ophthalmic Solution, USP 1% contains: Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), edetate disodium dihydrate, hypromellose (methocel E4M premium), sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP.</Description>
</NDC>
<NDC>
<NDCCode>51672-4136-0</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE (51672-4136-0) </PackageDescription>
<NDC11Code>51672-4136-00</NDC11Code>
<ProductNDC>51672-4136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078774</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) , 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) .</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51672-4136-7</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (51672-4136-7) </PackageDescription>
<NDC11Code>51672-4136-07</NDC11Code>
<ProductNDC>51672-4136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078774</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) , 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) .</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2.</Description>
</NDC>
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<NDCCode>51672-4136-9</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (51672-4136-9) </PackageDescription>
<NDC11Code>51672-4136-09</NDC11Code>
<ProductNDC>51672-4136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078774</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) , 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) .</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51672-4141-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (51672-4141-0) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51672-4141-00</NDC11Code>
<ProductNDC>51672-4141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078960</ApplicationNumber>
<LabelerName>Taro Pharmaceuticals U.S.A., Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51672-4142-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (51672-4142-0) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51672-4142-00</NDC11Code>
<ProductNDC>51672-4142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078960</ApplicationNumber>
<LabelerName>Taro Pharmaceuticals U.S.A., Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51672-4143-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (51672-4143-0) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51672-4143-00</NDC11Code>
<ProductNDC>51672-4143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078960</ApplicationNumber>
<LabelerName>Taro Pharmaceuticals U.S.A., Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below. 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide). 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide). 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide). Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2.</Description>
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<PackageDescription>30 TABLET in 1 BLISTER PACK (53808-1128-1) </PackageDescription>
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<ProductNDC>53808-1128</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090742</ApplicationNumber>
<LabelerName>DOH CENTRAL PHARMACY</LabelerName>
<SubstanceName>TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. : 1 Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. (1), 2 Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. (1).</IndicationAndUsage>
<Description>Tenofovir disoproxil fumarate (a prodrug of tenofovir) is a fumaric acid salt of bisisopropoxycarbonyloxymethyl ester derivative of tenofovir. In vivo tenofovir disoproxil fumarate is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarate is 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in distilled water at 25 °C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25 °C. Tenofovir disoproxil fumarate is available as tablets. Tenofovir disoproxil fumarate tablets are for oral administration in strength of 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The tablets are coated with Opadry White Y-1-7000, which contains Hypromellose, Titanium dioxide USP & Polyethylene glycol 400 (Macrogol) USP. In this insert, all dosages are expressed in terms of tenofovir disoproxil fumarate except where otherwise noted.</Description>
</NDC>
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<NDCCode>60505-2657-7</NDCCode>
<PackageDescription>7000 TABLET in 1 BOTTLE (60505-2657-7) </PackageDescription>
<NDC11Code>60505-2657-07</NDC11Code>
<ProductNDC>60505-2657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071251</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>75; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). .</IndicationAndUsage>
<Description>Triamterene and hydrochlorothiazide combines triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP contains 37.5 mg of Triamterene, USP and 25 mg of Hydrochlorothiazide, USP. Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP contains 75 mg of Triamterene, USP and 50 mg of Hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. In addition, the 37.5 mg/25 mg tablets contain D&C Yellow No.10 Aluminum Lake and FD&C Blue No.1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. The following is the structural formula. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. The following is the structural formula.</Description>
</NDC>
<NDC>
<NDCCode>62795-7000-5</NDCCode>
<PackageDescription>250 g in 1 BOTTLE (62795-7000-5)</PackageDescription>
<NDC11Code>62795-7000-05</NDC11Code>
<ProductNDC>62795-7000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arnica Montana Root, Baptisia Tinctoria Root, Atropa Belladonna,bellis Perennis,calendula Officinalis Flowering Top, Matricaria Recutita,echinacea, Unspecified,hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium,ruta Graveolens Flowering Top, And Comfrey Root</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT</SubstanceName>
<StrengthNumber>1; 1; 4; 2; 2; 1; 2; 1; 2; 6; 2; 2; 4</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64380-714-04</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64380-714-04) </PackageDescription>
<NDC11Code>64380-0714-04</NDC11Code>
<ProductNDC>64380-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090742</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. (1.1), 2 for the treatment of chronic hepatitis B in adults and pediatric patients 12 years and older. (1.2).</IndicationAndUsage>
<Description>Tenofovir disoproxil fumarate (a prodrug of tenofovir) is a fumaric acid salt of bisisopropoxycarbonyloxymethyl ester derivative of tenofovir. In vivo tenofovir disoproxil fumarate is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarate is 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in distilled water at 25 °C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25 °C. Tenofovir disoproxil fumarate is available as tablets. Tenofovir disoproxil fumarate tablets are for oral administration in strength of 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The tablets are coated with Opadry White Y-1-7000, which contains Hypromellose, Titanium dioxide USP & Polyethylene glycol 400 (Macrogol) USP. In this insert, all dosages are expressed in terms of tenofovir disoproxil fumarate except where otherwise noted.</Description>
</NDC>
<NDC>
<NDCCode>65862-143-71</NDCCode>
<PackageDescription>7000 TABLET, FILM COATED in 1 BAG (65862-143-71) </PackageDescription>
<NDC11Code>65862-0143-71</NDC11Code>
<ProductNDC>65862-143</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-06-11</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-SEP-07</StartMarketingDatePackage>
</NDC>
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