{
"NDC": [
{
"NDCCode": "62128-0383-6",
"PackageDescription": "9 PAIL in 1 BOX (62128-0383-6) / 9 kg in 1 PAIL",
"NDC11Code": "62128-0383-06",
"ProductNDC": "62128-0383",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Gemcitabine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "EXPORT ONLY",
"LabelerName": "Evonik Corporation",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-09-21",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-DEC-24"
},
{
"NDCCode": "62128-0383-1",
"PackageDescription": "3 PAIL in 1 DRUM (62128-0383-1) / 15 kg in 1 PAIL",
"NDC11Code": "62128-0383-01",
"ProductNDC": "62128-0383",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Gemcitabine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "EXPORT ONLY",
"LabelerName": "Evonik Corporation",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-09-21",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-DEC-24"
},
{
"NDCCode": "62128-0383-2",
"PackageDescription": "8 PAIL in 1 BOX (62128-0383-2) > 9 kg in 1 PAIL",
"NDC11Code": "62128-0383-02",
"ProductNDC": "62128-0383",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Gemcitabine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "19960501",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Evonik Corporation",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "01-MAY-96"
},
{
"NDCCode": "0078-0383-34",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0078-0383-34) ",
"NDC11Code": "00078-0383-34",
"ProductNDC": "0078-0383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diovan Hct",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980306",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020818",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "VALSARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "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": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980306",
"SamplePackage": "N",
"IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "11673-383-03",
"PackageDescription": "1478 mL in 1 BOTTLE, PUMP (11673-383-03)",
"NDC11Code": "11673-0383-03",
"ProductNDC": "11673-383",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foaming Hand Wash Antibacterial",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930319",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Target Corporation",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11673-383-96",
"PackageDescription": ".221 mL in 1 PACKAGE (11673-383-96)",
"NDC11Code": "11673-0383-96",
"ProductNDC": "11673-383",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foaming Hand Wash Antibacterial",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930319",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Target Corporation",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "13668-383-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13668-383-05) ",
"NDC11Code": "13668-0383-05",
"ProductNDC": "13668-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/10/12.5 Mg",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/10/12.5 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203580",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 12.5; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20161026",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).",
"Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
},
{
"NDCCode": "13668-383-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-383-30) ",
"NDC11Code": "13668-0383-30",
"ProductNDC": "13668-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/10/12.5 Mg",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/10/12.5 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203580",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 12.5; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20161026",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).",
"Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
},
{
"NDCCode": "13668-383-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (13668-383-90) ",
"NDC11Code": "13668-0383-90",
"ProductNDC": "13668-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/10/12.5 Mg",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/10/12.5 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203580",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 12.5; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20161026",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).",
"Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
},
{
"NDCCode": "42973-383-20",
"PackageDescription": ".6 kg in 1 PACKAGE (42973-383-20) ",
"NDC11Code": "42973-0383-20",
"ProductNDC": "42973-383",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240611",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Apicore Pharmaceuticals Private Limited",
"SubstanceName": "TIRZEPATIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-31",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "11-JUN-24"
},
{
"NDCCode": "43063-383-06",
"PackageDescription": "6 TABLET in 1 BOTTLE, PLASTIC (43063-383-06) ",
"NDC11Code": "43063-0383-06",
"ProductNDC": "43063-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anastrozole",
"NonProprietaryName": "Anastrozole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079220",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ANASTROZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180823",
"SamplePackage": "N",
"IndicationAndUsage": "Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets ( 1.3) .",
"Description": "Anastrozole Tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "45802-383-01",
"PackageDescription": "50 g in 1 BOTTLE, PUMP (45802-383-01) ",
"NDC11Code": "45802-0383-01",
"ProductNDC": "45802-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate And Benzoyl Peroxide",
"NonProprietaryName": "Clindamycin Phosphate And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209610",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE",
"StrengthNumber": "10; 37.5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240920",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/3.75% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C18H34ClN2O8PS. Molecular Weight: 504.97. Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C14H10O4. Molecular Weight: 242.23. Clindamycin phosphate and benzoyl peroxide gel contains the following inactive ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water. Each gram of clindamycin phosphate and benzoyl peroxide gel contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin, and 37.5 mg (3.75%) benzoyl peroxide."
},
{
"NDCCode": "49035-383-45",
"PackageDescription": ".946 mL in 1 BOTTLE, PUMP (49035-383-45)",
"NDC11Code": "49035-0383-45",
"ProductNDC": "49035-383",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foaming Hand Wash Antibacterial",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930319",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Wal-Mart",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "49643-383-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-383-05) ",
"NDC11Code": "49643-0383-05",
"ProductNDC": "49643-383",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "European Olive Pollen",
"NonProprietaryName": "Olea Europea",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "OLEA EUROPAEA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-383-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-383-10) ",
"NDC11Code": "49643-0383-10",
"ProductNDC": "49643-383",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "European Olive Pollen",
"NonProprietaryName": "Olea Europea",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "OLEA EUROPAEA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-383-30",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49643-383-30) ",
"NDC11Code": "49643-0383-30",
"ProductNDC": "49643-383",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "European Olive Pollen",
"NonProprietaryName": "Olea Europea",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "OLEA EUROPAEA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-383-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49643-383-50) ",
"NDC11Code": "49643-0383-50",
"ProductNDC": "49643-383",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "European Olive Pollen",
"NonProprietaryName": "Olea Europea",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "OLEA EUROPAEA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "50742-383-12",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (50742-383-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50742-383-06) ",
"NDC11Code": "50742-0383-12",
"ProductNDC": "50742-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone Sodium Phosphate",
"ProprietaryNameSuffix": "Odt",
"NonProprietaryName": "Prednisolone Sodium Phosphate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20250915",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021959",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "PREDNISOLONE SODIUM PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250915",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisolone sodium phosphate orally disintegrating tablets are indicated in the treatment of the following diseases or conditions.",
"Description": "Prednisolone sodium phosphate orally disintegrating tablets are a sodium salt of the phosphoester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is pregna-1, 4-diene-3, 20-dione, 11, 17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11ß)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. Its chemical structure is. Each orally disintegrating tablet also contains the following inactive ingredients: citric acid, colloidal silicon dioxide, crospovidone, grape flavor, hypromellose, magnesium stearate, mannitol, methacrylate copolymer, microcrystalline cellulose, sodium bicarbonate, sucralose, and sucrose."
},
{
"NDCCode": "51346-383-01",
"PackageDescription": "130 mL in 1 CONTAINER (51346-383-01)",
"NDC11Code": "51346-0383-01",
"ProductNDC": "51346-383",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Greek Yogurt Pack Blue Berry",
"NonProprietaryName": "Glycerin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160302",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "6.5",
"StrengthUnit": "g/130mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "51407-383-35",
"PackageDescription": "1 TUBE in 1 CARTON (51407-383-35) / 35.44 g in 1 TUBE",
"NDC11Code": "51407-0383-35",
"ProductNDC": "51407-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19820101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086724",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210202",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.",
"Description": "Lidocaine Ointment USP, 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGEfor specific uses. Lidocaine Ointment USP, 5% contains lidocaine, which is chemically designated as acetamide, 2-(diethylamino) -N-(2,6-dimethylphenyl)-, and has the following structural formula:. Composition of Lidocaine Ointment USP, 5%: Each gram contains lidocaine USP, 5% in a water soluble base containing polyethylene glycol 400, polyethylene glycol 3350, and propylene glycol."
},
{
"NDCCode": "52544-383-28",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (52544-383-28) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "52544-0383-28",
"ProductNDC": "52544-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zovia 1/35e-28",
"NonProprietaryName": "Ethynodiol Diacetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "19951206",
"EndMarketingDate": "20170531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072721",
"LabelerName": "Actavis Pharma, Inc.",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "54092-383-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-383-01) ",
"NDC11Code": "54092-0383-01",
"ProductNDC": "54092-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adderall",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20011011",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021303",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
"StrengthNumber": "2.5; 2.5; 2.5; 2.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020522",
"SamplePackage": "N",
"IndicationAndUsage": "ADDERALL XR, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. (1). Limitations of UseThe use of ADDERALL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4).",
"Description": "ADDERALL XR extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. ADDERALL XR contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo-amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. ADDERALL XR contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the ADDERALL (immediate-release) tablet formulation. Each capsule contains."
},
{
"NDCCode": "54860-383-01",
"PackageDescription": "30 g in 1 BOTTLE, PLASTIC (54860-383-01) ",
"NDC11Code": "54860-0383-01",
"ProductNDC": "54860-383",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quiksilver Spf 30 Sunscreen",
"ProprietaryNameSuffix": "01",
"NonProprietaryName": "Avobenzone,ethylhexyl Methoxycinnamate,homosalate,octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210914",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Shenzhen Lantern Scicence Co.,Ltd.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE",
"StrengthNumber": "1; 2; 8; 2",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210914",
"SamplePackage": "Y",
"IndicationAndUsage": "Apply liberaaly 15 minutes before sun exposure. Children under 6 months; Ask a doctor."
},
{
"NDCCode": "55700-383-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (55700-383-30) ",
"NDC11Code": "55700-0383-30",
"ProductNDC": "55700-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Movantik",
"NonProprietaryName": "Naloxegol Oxalate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150306",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204760",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "NALOXEGOL OXALATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160826",
"SamplePackage": "N",
"IndicationAndUsage": "MOVANTIK® (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.",
"Description": "MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.). The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is. The empirical formula for naloxegol oxalate is C34H53NO11.C2H2O4 and the molecular weight is 742. Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range. MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively equivalent to 12.5 mg and 25 mg of naloxegol. Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate. Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black."
},
{
"NDCCode": "59368-383-01",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59368-383-01) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "59368-0383-01",
"ProductNDC": "59368-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Micardis",
"NonProprietaryName": "Telmisartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20001201",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020850",
"LabelerName": "Praxis, LLC",
"SubstanceName": "TELMISARTAN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20001201",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"Description": "MICARDIS is a non-peptide angiotensin II receptor (type AT 1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C 33H 30N 4O 2, its molecular weight is 514.63, and its structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. MICARDIS is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, sorbitol, and magnesium stearate. MICARDIS tablets are hygroscopic and require protection from moisture."
},
{
"NDCCode": "59651-383-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (59651-383-01) ",
"NDC11Code": "59651-0383-01",
"ProductNDC": "59651-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216440",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230320",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25 mg, 50 mg, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or faintly yellow crystalline powder. It is very soluble in water, freely soluble in methylene chloride, soluble in ethanol (96%). Inactive Ingredients: magnesium stearate and pregelatinized starch (maize). The hard gelatin capsule shells contains the following inactive ingredients: gelatin, titanium dioxide. In addition the 25 mg hard gelatin capsule shell contains D&C red 33, D&C yellow 10 and FD&C yellow 6, 50 mg hard gelatin capsule shell contains FD&C blue 1, 75 mg hard gelatin capsule shell contains D&C yellow 10 and FD&C yellow 6. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac."
},
{
"NDCCode": "59651-383-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (59651-383-30) ",
"NDC11Code": "59651-0383-30",
"ProductNDC": "59651-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216440",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230320",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25 mg, 50 mg, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or faintly yellow crystalline powder. It is very soluble in water, freely soluble in methylene chloride, soluble in ethanol (96%). Inactive Ingredients: magnesium stearate and pregelatinized starch (maize). The hard gelatin capsule shells contains the following inactive ingredients: gelatin, titanium dioxide. In addition the 25 mg hard gelatin capsule shell contains D&C red 33, D&C yellow 10 and FD&C yellow 6, 50 mg hard gelatin capsule shell contains FD&C blue 1, 75 mg hard gelatin capsule shell contains D&C yellow 10 and FD&C yellow 6. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac."
},
{
"NDCCode": "59651-383-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (59651-383-90) ",
"NDC11Code": "59651-0383-90",
"ProductNDC": "59651-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216440",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230320",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25 mg, 50 mg, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or faintly yellow crystalline powder. It is very soluble in water, freely soluble in methylene chloride, soluble in ethanol (96%). Inactive Ingredients: magnesium stearate and pregelatinized starch (maize). The hard gelatin capsule shells contains the following inactive ingredients: gelatin, titanium dioxide. In addition the 25 mg hard gelatin capsule shell contains D&C red 33, D&C yellow 10 and FD&C yellow 6, 50 mg hard gelatin capsule shell contains FD&C blue 1, 75 mg hard gelatin capsule shell contains D&C yellow 10 and FD&C yellow 6. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac."
},
{
"NDCCode": "59746-383-06",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (59746-383-06) ",
"NDC11Code": "59746-0383-06",
"ProductNDC": "59746-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075317",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20041220",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name,molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride.C19H26ClN5O4. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Each capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochlolde. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 1 mg shell also contains black iron oxide; the 2 mg capsule shell also contains D&C Yellow #10; the 5 mg capsule shell also contains D&C Yellow #10, FD&C Red #40 and D&C Red #28; the 10 mg capsule shell also contains FD&C Green #3 and D&C Yellow#10."
},
{
"NDCCode": "59746-383-09",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (59746-383-09) ",
"NDC11Code": "59746-0383-09",
"ProductNDC": "59746-383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075317",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20041220",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name,molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride.C19H26ClN5O4. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Each capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochlolde. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 1 mg shell also contains black iron oxide; the 2 mg capsule shell also contains D&C Yellow #10; the 5 mg capsule shell also contains D&C Yellow #10, FD&C Red #40 and D&C Red #28; the 10 mg capsule shell also contains FD&C Green #3 and D&C Yellow#10."
}
]
}
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<NDC>
<NDCCode>62128-0383-6</NDCCode>
<PackageDescription>9 PAIL in 1 BOX (62128-0383-6) / 9 kg in 1 PAIL</PackageDescription>
<NDC11Code>62128-0383-06</NDC11Code>
<ProductNDC>62128-0383</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Gemcitabine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
<LabelerName>Evonik Corporation</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-09-21</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-DEC-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62128-0383-1</NDCCode>
<PackageDescription>3 PAIL in 1 DRUM (62128-0383-1) / 15 kg in 1 PAIL</PackageDescription>
<NDC11Code>62128-0383-01</NDC11Code>
<ProductNDC>62128-0383</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Gemcitabine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
<LabelerName>Evonik Corporation</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-09-21</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-DEC-24</StartMarketingDatePackage>
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<NDC>
<NDCCode>62128-0383-2</NDCCode>
<PackageDescription>8 PAIL in 1 BOX (62128-0383-2) > 9 kg in 1 PAIL</PackageDescription>
<NDC11Code>62128-0383-02</NDC11Code>
<ProductNDC>62128-0383</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Gemcitabine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19960501</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Evonik Corporation</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAY-96</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0078-0383-34</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0078-0383-34) </PackageDescription>
<NDC11Code>00078-0383-34</NDC11Code>
<ProductNDC>0078-0383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diovan Hct</ProprietaryName>
<NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980306</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020818</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<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>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>11673-383-03</NDCCode>
<PackageDescription>1478 mL in 1 BOTTLE, PUMP (11673-383-03)</PackageDescription>
<NDC11Code>11673-0383-03</NDC11Code>
<ProductNDC>11673-383</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foaming Hand Wash Antibacterial</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930319</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11673-383-96</NDCCode>
<PackageDescription>.221 mL in 1 PACKAGE (11673-383-96)</PackageDescription>
<NDC11Code>11673-0383-96</NDC11Code>
<ProductNDC>11673-383</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foaming Hand Wash Antibacterial</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930319</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13668-383-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13668-383-05) </PackageDescription>
<NDC11Code>13668-0383-05</NDC11Code>
<ProductNDC>13668-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/10/12.5 Mg</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/10/12.5 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203580</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 12.5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients.</Description>
</NDC>
<NDC>
<NDCCode>13668-383-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-383-30) </PackageDescription>
<NDC11Code>13668-0383-30</NDC11Code>
<ProductNDC>13668-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/10/12.5 Mg</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/10/12.5 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203580</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 12.5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients.</Description>
</NDC>
<NDC>
<NDCCode>13668-383-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (13668-383-90) </PackageDescription>
<NDC11Code>13668-0383-90</NDC11Code>
<ProductNDC>13668-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/10/12.5 Mg</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/10/12.5 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203580</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 12.5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients.</Description>
</NDC>
<NDC>
<NDCCode>42973-383-20</NDCCode>
<PackageDescription>.6 kg in 1 PACKAGE (42973-383-20) </PackageDescription>
<NDC11Code>42973-0383-20</NDC11Code>
<ProductNDC>42973-383</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240611</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Apicore Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-31</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-JUN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43063-383-06</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE, PLASTIC (43063-383-06) </PackageDescription>
<NDC11Code>43063-0383-06</NDC11Code>
<ProductNDC>43063-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anastrozole</ProprietaryName>
<NonProprietaryName>Anastrozole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079220</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ANASTROZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets ( 1.3) .</IndicationAndUsage>
<Description>Anastrozole Tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>45802-383-01</NDCCode>
<PackageDescription>50 g in 1 BOTTLE, PUMP (45802-383-01) </PackageDescription>
<NDC11Code>45802-0383-01</NDC11Code>
<ProductNDC>45802-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209610</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>10; 37.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
<Description>Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/3.75% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C18H34ClN2O8PS. Molecular Weight: 504.97. Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C14H10O4. Molecular Weight: 242.23. Clindamycin phosphate and benzoyl peroxide gel contains the following inactive ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water. Each gram of clindamycin phosphate and benzoyl peroxide gel contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin, and 37.5 mg (3.75%) benzoyl peroxide.</Description>
</NDC>
<NDC>
<NDCCode>49035-383-45</NDCCode>
<PackageDescription>.946 mL in 1 BOTTLE, PUMP (49035-383-45)</PackageDescription>
<NDC11Code>49035-0383-45</NDC11Code>
<ProductNDC>49035-383</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foaming Hand Wash Antibacterial</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930319</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Wal-Mart</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49643-383-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-383-05) </PackageDescription>
<NDC11Code>49643-0383-05</NDC11Code>
<ProductNDC>49643-383</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>European Olive Pollen</ProprietaryName>
<NonProprietaryName>Olea Europea</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>OLEA EUROPAEA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-383-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49643-383-10) </PackageDescription>
<NDC11Code>49643-0383-10</NDC11Code>
<ProductNDC>49643-383</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>European Olive Pollen</ProprietaryName>
<NonProprietaryName>Olea Europea</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>OLEA EUROPAEA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-383-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49643-383-30) </PackageDescription>
<NDC11Code>49643-0383-30</NDC11Code>
<ProductNDC>49643-383</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>European Olive Pollen</ProprietaryName>
<NonProprietaryName>Olea Europea</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>OLEA EUROPAEA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-383-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49643-383-50) </PackageDescription>
<NDC11Code>49643-0383-50</NDC11Code>
<ProductNDC>49643-383</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>European Olive Pollen</ProprietaryName>
<NonProprietaryName>Olea Europea</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>OLEA EUROPAEA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>50742-383-12</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (50742-383-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50742-383-06) </PackageDescription>
<NDC11Code>50742-0383-12</NDC11Code>
<ProductNDC>50742-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisolone Sodium Phosphate</ProprietaryName>
<ProprietaryNameSuffix>Odt</ProprietaryNameSuffix>
<NonProprietaryName>Prednisolone Sodium Phosphate</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250915</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021959</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PREDNISOLONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisolone sodium phosphate orally disintegrating tablets are indicated in the treatment of the following diseases or conditions.</IndicationAndUsage>
<Description>Prednisolone sodium phosphate orally disintegrating tablets are a sodium salt of the phosphoester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is pregna-1, 4-diene-3, 20-dione, 11, 17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11ß)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. Its chemical structure is. Each orally disintegrating tablet also contains the following inactive ingredients: citric acid, colloidal silicon dioxide, crospovidone, grape flavor, hypromellose, magnesium stearate, mannitol, methacrylate copolymer, microcrystalline cellulose, sodium bicarbonate, sucralose, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>51346-383-01</NDCCode>
<PackageDescription>130 mL in 1 CONTAINER (51346-383-01)</PackageDescription>
<NDC11Code>51346-0383-01</NDC11Code>
<ProductNDC>51346-383</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Greek Yogurt Pack Blue Berry</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160302</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>GLYCERIN</SubstanceName>
<StrengthNumber>6.5</StrengthNumber>
<StrengthUnit>g/130mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51407-383-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51407-383-35) / 35.44 g in 1 TUBE</PackageDescription>
<NDC11Code>51407-0383-35</NDC11Code>
<ProductNDC>51407-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19820101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086724</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.</IndicationAndUsage>
<Description>Lidocaine Ointment USP, 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGEfor specific uses. Lidocaine Ointment USP, 5% contains lidocaine, which is chemically designated as acetamide, 2-(diethylamino) -N-(2,6-dimethylphenyl)-, and has the following structural formula:. Composition of Lidocaine Ointment USP, 5%: Each gram contains lidocaine USP, 5% in a water soluble base containing polyethylene glycol 400, polyethylene glycol 3350, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>52544-383-28</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (52544-383-28) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>52544-0383-28</NDC11Code>
<ProductNDC>52544-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zovia 1/35e-28</ProprietaryName>
<NonProprietaryName>Ethynodiol Diacetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951206</StartMarketingDate>
<EndMarketingDate>20170531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072721</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>54092-383-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-383-01) </PackageDescription>
<NDC11Code>54092-0383-01</NDC11Code>
<ProductNDC>54092-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adderall</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011011</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021303</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>2.5; 2.5; 2.5; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADDERALL XR, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. (1). Limitations of UseThe use of ADDERALL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4).</IndicationAndUsage>
<Description>ADDERALL XR extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. ADDERALL XR contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo-amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. ADDERALL XR contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the ADDERALL (immediate-release) tablet formulation. Each capsule contains.</Description>
</NDC>
<NDC>
<NDCCode>54860-383-01</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PLASTIC (54860-383-01) </PackageDescription>
<NDC11Code>54860-0383-01</NDC11Code>
<ProductNDC>54860-383</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quiksilver Spf 30 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>01</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone,ethylhexyl Methoxycinnamate,homosalate,octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Shenzhen Lantern Scicence Co.,Ltd.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1; 2; 8; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210914</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Apply liberaaly 15 minutes before sun exposure. Children under 6 months; Ask a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55700-383-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (55700-383-30) </PackageDescription>
<NDC11Code>55700-0383-30</NDC11Code>
<ProductNDC>55700-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Movantik</ProprietaryName>
<NonProprietaryName>Naloxegol Oxalate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150306</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204760</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>NALOXEGOL OXALATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MOVANTIK® (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.</IndicationAndUsage>
<Description>MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.). The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is. The empirical formula for naloxegol oxalate is C34H53NO11.C2H2O4 and the molecular weight is 742. Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range. MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively equivalent to 12.5 mg and 25 mg of naloxegol. Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate. Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>59368-383-01</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59368-383-01) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59368-0383-01</NDC11Code>
<ProductNDC>59368-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Micardis</ProprietaryName>
<NonProprietaryName>Telmisartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001201</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020850</ApplicationNumber>
<LabelerName>Praxis, LLC</LabelerName>
<SubstanceName>TELMISARTAN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20001201</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>MICARDIS is a non-peptide angiotensin II receptor (type AT 1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C 33H 30N 4O 2, its molecular weight is 514.63, and its structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. MICARDIS is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, sorbitol, and magnesium stearate. MICARDIS tablets are hygroscopic and require protection from moisture.</Description>
</NDC>
<NDC>
<NDCCode>59651-383-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (59651-383-01) </PackageDescription>
<NDC11Code>59651-0383-01</NDC11Code>
<ProductNDC>59651-383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216440</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25 mg, 50 mg, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or faintly yellow crystalline powder. It is very soluble in water, freely soluble in methylene chloride, soluble in ethanol (96%). Inactive Ingredients: magnesium stearate and pregelatinized starch (maize). The hard gelatin capsule shells contains the following inactive ingredients: gelatin, titanium dioxide. In addition the 25 mg hard gelatin capsule shell contains D&C red 33, D&C yellow 10 and FD&C yellow 6, 50 mg hard gelatin capsule shell contains FD&C blue 1, 75 mg hard gelatin capsule shell contains D&C yellow 10 and FD&C yellow 6. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac.</Description>
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<IndicationAndUsage>Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25 mg, 50 mg, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or faintly yellow crystalline powder. It is very soluble in water, freely soluble in methylene chloride, soluble in ethanol (96%). Inactive Ingredients: magnesium stearate and pregelatinized starch (maize). The hard gelatin capsule shells contains the following inactive ingredients: gelatin, titanium dioxide. In addition the 25 mg hard gelatin capsule shell contains D&C red 33, D&C yellow 10 and FD&C yellow 6, 50 mg hard gelatin capsule shell contains FD&C blue 1, 75 mg hard gelatin capsule shell contains D&C yellow 10 and FD&C yellow 6. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac.</Description>
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<IndicationAndUsage>Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25 mg, 50 mg, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or faintly yellow crystalline powder. It is very soluble in water, freely soluble in methylene chloride, soluble in ethanol (96%). Inactive Ingredients: magnesium stearate and pregelatinized starch (maize). The hard gelatin capsule shells contains the following inactive ingredients: gelatin, titanium dioxide. In addition the 25 mg hard gelatin capsule shell contains D&C red 33, D&C yellow 10 and FD&C yellow 6, 50 mg hard gelatin capsule shell contains FD&C blue 1, 75 mg hard gelatin capsule shell contains D&C yellow 10 and FD&C yellow 6. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac.</Description>
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<StartMarketingDate>20041220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075317</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
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<IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name,molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride.C19H26ClN5O4. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Each capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochlolde. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 1 mg shell also contains black iron oxide; the 2 mg capsule shell also contains D&C Yellow #10; the 5 mg capsule shell also contains D&C Yellow #10, FD&C Red #40 and D&C Red #28; the 10 mg capsule shell also contains FD&C Green #3 and D&C Yellow#10.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075317</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
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<IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name,molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride.C19H26ClN5O4. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Each capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochlolde. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 1 mg shell also contains black iron oxide; the 2 mg capsule shell also contains D&C Yellow #10; the 5 mg capsule shell also contains D&C Yellow #10, FD&C Red #40 and D&C Red #28; the 10 mg capsule shell also contains FD&C Green #3 and D&C Yellow#10.</Description>
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