RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "42571-245-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42571-245-05) ",
      "NDC11Code": "42571-0245-05",
      "ProductNDC": "42571-245",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207437",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 5; 12.5",
      "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": "Active",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation,  and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5­ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.  Its molecular formula is C 29H 30N 6O 6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 3-ethyl-5­methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5­pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil is:. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil USP, a white to off-white, crystalline powder, amlodipine besylate USP, a white to almost white powder, and hydrochlorothiazide USP, a white or practically white, practically odorless, 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 freely soluble in methanol, sparingly soluble in ethanol and slightly soluble in 2-propanol and in water. Hydrochlorothiazide is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; slightly soluble in water; sparingly soluble in methanol; insoluble in ether, in chloroform and in dilute mineral acid. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide also contains the following inactive ingredients. 20 /5 /12.5 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide black, iron oxide red and iron oxide yellow (opadry II white). 40 /5 /12.5 mg and 40 /5 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc and iron oxide yellow (opadry II yellow). 40 /10 /12.5 mg and 40 /10 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide yellow and iron oxide red (opadry II pink)."
    },
    {
      "NDCCode": "42571-245-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (42571-245-10) ",
      "NDC11Code": "42571-0245-10",
      "ProductNDC": "42571-245",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207437",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 5; 12.5",
      "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": "Active",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation,  and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5­ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.  Its molecular formula is C 29H 30N 6O 6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 3-ethyl-5­methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5­pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil is:. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil USP, a white to off-white, crystalline powder, amlodipine besylate USP, a white to almost white powder, and hydrochlorothiazide USP, a white or practically white, practically odorless, 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 freely soluble in methanol, sparingly soluble in ethanol and slightly soluble in 2-propanol and in water. Hydrochlorothiazide is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; slightly soluble in water; sparingly soluble in methanol; insoluble in ether, in chloroform and in dilute mineral acid. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide also contains the following inactive ingredients. 20 /5 /12.5 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide black, iron oxide red and iron oxide yellow (opadry II white). 40 /5 /12.5 mg and 40 /5 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc and iron oxide yellow (opadry II yellow). 40 /10 /12.5 mg and 40 /10 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide yellow and iron oxide red (opadry II pink)."
    },
    {
      "NDCCode": "42571-245-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42571-245-30) ",
      "NDC11Code": "42571-0245-30",
      "ProductNDC": "42571-245",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207437",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 5; 12.5",
      "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": "Active",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation,  and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5­ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.  Its molecular formula is C 29H 30N 6O 6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 3-ethyl-5­methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5­pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil is:. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil USP, a white to off-white, crystalline powder, amlodipine besylate USP, a white to almost white powder, and hydrochlorothiazide USP, a white or practically white, practically odorless, 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 freely soluble in methanol, sparingly soluble in ethanol and slightly soluble in 2-propanol and in water. Hydrochlorothiazide is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; slightly soluble in water; sparingly soluble in methanol; insoluble in ether, in chloroform and in dilute mineral acid. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide also contains the following inactive ingredients. 20 /5 /12.5 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide black, iron oxide red and iron oxide yellow (opadry II white). 40 /5 /12.5 mg and 40 /5 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc and iron oxide yellow (opadry II yellow). 40 /10 /12.5 mg and 40 /10 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide yellow and iron oxide red (opadry II pink)."
    },
    {
      "NDCCode": "42571-245-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42571-245-90) ",
      "NDC11Code": "42571-0245-90",
      "ProductNDC": "42571-245",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207437",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 5; 12.5",
      "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": "Active",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation,  and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5­ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.  Its molecular formula is C 29H 30N 6O 6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 3-ethyl-5­methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5­pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil is:. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil USP, a white to off-white, crystalline powder, amlodipine besylate USP, a white to almost white powder, and hydrochlorothiazide USP, a white or practically white, practically odorless, 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 freely soluble in methanol, sparingly soluble in ethanol and slightly soluble in 2-propanol and in water. Hydrochlorothiazide is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; slightly soluble in water; sparingly soluble in methanol; insoluble in ether, in chloroform and in dilute mineral acid. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide also contains the following inactive ingredients. 20 /5 /12.5 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide black, iron oxide red and iron oxide yellow (opadry II white). 40 /5 /12.5 mg and 40 /5 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc and iron oxide yellow (opadry II yellow). 40 /10 /12.5 mg and 40 /10 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide yellow and iron oxide red (opadry II pink)."
    },
    {
      "NDCCode": "13537-245-06",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (13537-245-06)  > 4.5 mL in 1 BOTTLE, PLASTIC (13537-245-05)",
      "NDC11Code": "13537-0245-06",
      "ProductNDC": "13537-245",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Natural Finish Moisturizing Foundation Spf 25",
      "ProprietaryNameSuffix": "(medium 5) - Brown",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131216",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": ".065; .016",
      "StrengthUnit": "g/mL; g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "14783-245-06",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (14783-245-06)  > 4.5 mL in 1 BOTTLE, PLASTIC (14783-245-05)",
      "NDC11Code": "14783-0245-06",
      "ProductNDC": "14783-245",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Natural Finish Moisturizing Foundation Spf 25",
      "ProprietaryNameSuffix": "(medium 5) - Brown",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131216",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura International LTD",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": ".065; .016",
      "StrengthUnit": "g/mL; g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "29300-245-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (29300-245-05) ",
      "NDC11Code": "29300-0245-05",
      "ProductNDC": "29300-245",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Buspirone Hydrochloride",
      "NonProprietaryName": "Buspirone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210907",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "BUSPIRONE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2023-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191120",
      "SamplePackage": "N",
      "IndicationAndUsage": "Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
      "Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is N-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
    },
    {
      "NDCCode": "55118-245-05",
      "PackageDescription": "500 mL in 1 BAG (55118-245-05)",
      "NDC11Code": "55118-0245-05",
      "ProductNDC": "55118-245",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Scott Antiseptic Skin Cleanser",
      "NonProprietaryName": "Chloroxylenol",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120301",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Kimberly-Clark Corporation",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": "1.25",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "55700-245-05",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (55700-245-05)  > 5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "55700-0245-05",
      "ProductNDC": "55700-245",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprofloxacin",
      "NonProprietaryName": "Ciprofloxacin Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20090724",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076555",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "IndicationAndUsage": "Ciprofloxacin Ophthalmic Solution, USP is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
      "Description": "Ciprofloxacin Ophthalmic Solution, USP is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin Ophthalmic Solution, USP contains:Active: Ciprofloxacin HCl, USP 3.5 mg equivalent to 3 mg base.Preservative: Benzalkonium Chloride 0.006%.Inactives: Acetic Acid, Edetate Disodium 0.05%, Mannitol 4.6%, Sodium Acetate, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH) and Water for Injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm."
    },
    {
      "NDCCode": "59746-245-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (59746-245-05) ",
      "NDC11Code": "59746-0245-05",
      "ProductNDC": "59746-245",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lamotrigine",
      "NonProprietaryName": "Lamotrigine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090127",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079132",
      "LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
      "SubstanceName": "LAMOTRIGINE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-10-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090127",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65862-245-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65862-245-05) ",
      "NDC11Code": "65862-0245-05",
      "ProductNDC": "65862-245",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078993",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-04-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
      "Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration.The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water.  In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red.Meets USP dissolution test 2."
    },
    {
      "NDCCode": "67777-245-05",
      "PackageDescription": "750 BOX in 1 CASE (67777-245-05)  / 25 PACKET in 1 BOX (67777-245-15)  / .55 mL in 1 PACKET",
      "NDC11Code": "67777-0245-05",
      "ProductNDC": "67777-245",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bzk Pads",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "SWAB",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110405",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Dynarex Corporation",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110405",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent skin infection in minor cuts, scrapes, and burns."
    },
    {
      "NDCCode": "68382-245-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68382-245-05) ",
      "NDC11Code": "68382-0245-05",
      "ProductNDC": "68382-245",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Imatinib Mesylate",
      "NonProprietaryName": "Imatinib Mesylate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210121",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210658",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "IMATINIB MESYLATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20210121",
      "SamplePackage": "N",
      "IndicationAndUsage": "Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRαfusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRαfusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).",
      "Description": "Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets contain imatinib mesylate equivalent to 100 mg or 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is a pale yellow to light green powder. Its molecular formula is. C29H31N7OCH4SO3 and its molecular weight is 589.7. It is freely soluble in water and sparingly soluble in methanol. Each film-coated imatinib mesylate tablet contains 100 mg or 400 mg of imatinib free base and contains following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone (Type A), hypromellose, magnesium stearate, mannitol and microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide and yellow iron oxide."
    },
    {
      "NDCCode": "68428-245-05",
      "PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-245-05) ",
      "NDC11Code": "68428-0245-05",
      "ProductNDC": "68428-245",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Azadirachta Indica",
      "NonProprietaryName": "Azadirachta Indica Bark",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100429",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "AZADIRACHTA INDICA BARK",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100429",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69842-245-05",
      "PackageDescription": "1 POUCH in 1 BOX (69842-245-05)  / 5 PATCH in 1 POUCH",
      "NDC11Code": "69842-0245-05",
      "ProductNDC": "69842-245",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Cold And Hot",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201002",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201002",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions: 1 open pouch and remove patch, 2 carefully peel off protective backing and apply sticky side to affected area, 3 adults and children 12 years of age and older:, 4 do not wear patch for more than 8 hours, 5 apply to affected area no more than 3 times daily, 6 children under 12 years of age: consult a doctor."
    },
    {
      "NDCCode": "75834-245-05",
      "PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75834-245-05) ",
      "NDC11Code": "75834-0245-05",
      "ProductNDC": "75834-245",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam Extended Release",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200916",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201464",
      "LabelerName": "Nivagen Pharmaceuticals, Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200916",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam Extended-Release Tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.",
      "Description": "Levetiracetam Extended-Release Tablets are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam Extended-Release Tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, ethylcellulose, magnesium stearate, microcrystalline cellulose and talc. The imprinting ink contains ammonium hydroxide, black iron oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze. Contains no ingredients made from a gluten-containing grain (wheat, barley, or rye). The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
    },
    {
      "NDCCode": "42571-005-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-005-05) ",
      "NDC11Code": "42571-0005-05",
      "ProductNDC": "42571-005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090383",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simvastatin tablets are indicated:  To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):       o In adults with primary hyperlipidemia.       o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with:       o Primary dysbetalipoproteinemia.       o Hypertriglyceridemia.",
      "Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
    },
    {
      "NDCCode": "42571-010-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-010-05) ",
      "NDC11Code": "42571-0010-05",
      "ProductNDC": "42571-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090383",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simvastatin tablets are indicated:  To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):       o In adults with primary hyperlipidemia.       o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with:       o Primary dysbetalipoproteinemia.       o Hypertriglyceridemia.",
      "Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
    },
    {
      "NDCCode": "42571-020-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-020-05) ",
      "NDC11Code": "42571-0020-05",
      "ProductNDC": "42571-020",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090383",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simvastatin tablets are indicated:  To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):       o In adults with primary hyperlipidemia.       o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with:       o Primary dysbetalipoproteinemia.       o Hypertriglyceridemia.",
      "Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
    },
    {
      "NDCCode": "42571-040-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-040-05) ",
      "NDC11Code": "42571-0040-05",
      "ProductNDC": "42571-040",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090383",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simvastatin tablets are indicated:  To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):       o In adults with primary hyperlipidemia.       o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with:       o Primary dysbetalipoproteinemia.       o Hypertriglyceridemia.",
      "Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
    },
    {
      "NDCCode": "42571-080-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-080-05) ",
      "NDC11Code": "42571-0080-05",
      "ProductNDC": "42571-080",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090383",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simvastatin tablets are indicated:  To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):       o In adults with primary hyperlipidemia.       o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with:       o Primary dysbetalipoproteinemia.       o Hypertriglyceridemia.",
      "Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
    },
    {
      "NDCCode": "42571-100-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-100-05) ",
      "NDC11Code": "42571-0100-05",
      "ProductNDC": "42571-100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glimepiride",
      "NonProprietaryName": "Glimepiride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091220",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "GLIMEPIRIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [seeClinical Studies (14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
      "Description": "Glimepiride tablets, USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:.  Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red, Glimepiride 2 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Ferric Oxide Yellow, Glimepiride 3 mg tablets contain Ferric Oxide Yellow, Glimepiride 4 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Glimepiride 6 mg tablets contain Ferric Oxide Red."
    },
    {
      "NDCCode": "42571-101-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-101-05) ",
      "NDC11Code": "42571-0101-05",
      "ProductNDC": "42571-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glimepiride",
      "NonProprietaryName": "Glimepiride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091220",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "GLIMEPIRIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [seeClinical Studies (14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
      "Description": "Glimepiride tablets, USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:.  Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red, Glimepiride 2 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Ferric Oxide Yellow, Glimepiride 3 mg tablets contain Ferric Oxide Yellow, Glimepiride 4 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Glimepiride 6 mg tablets contain Ferric Oxide Red."
    },
    {
      "NDCCode": "42571-102-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-102-05) ",
      "NDC11Code": "42571-0102-05",
      "ProductNDC": "42571-102",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glimepiride",
      "NonProprietaryName": "Glimepiride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091220",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "GLIMEPIRIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [seeClinical Studies (14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
      "Description": "Glimepiride tablets, USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:.  Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red, Glimepiride 2 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Ferric Oxide Yellow, Glimepiride 3 mg tablets contain Ferric Oxide Yellow, Glimepiride 4 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Glimepiride 6 mg tablets contain Ferric Oxide Red."
    },
    {
      "NDCCode": "42571-103-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-103-05) ",
      "NDC11Code": "42571-0103-05",
      "ProductNDC": "42571-103",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glimepiride",
      "NonProprietaryName": "Glimepiride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091220",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "GLIMEPIRIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [seeClinical Studies (14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
      "Description": "Glimepiride tablets, USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:.  Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red, Glimepiride 2 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Ferric Oxide Yellow, Glimepiride 3 mg tablets contain Ferric Oxide Yellow, Glimepiride 4 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Glimepiride 6 mg tablets contain Ferric Oxide Red."
    },
    {
      "NDCCode": "42571-104-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-104-05) ",
      "NDC11Code": "42571-0104-05",
      "ProductNDC": "42571-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glimepiride",
      "NonProprietaryName": "Glimepiride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091220",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "GLIMEPIRIDE",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [seeClinical Studies (14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
      "Description": "Glimepiride tablets, USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:.  Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red, Glimepiride 2 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Ferric Oxide Yellow, Glimepiride 3 mg tablets contain Ferric Oxide Yellow, Glimepiride 4 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Glimepiride 6 mg tablets contain Ferric Oxide Red."
    },
    {
      "NDCCode": "42571-105-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-105-05) ",
      "NDC11Code": "42571-0105-05",
      "ProductNDC": "42571-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glimepiride",
      "NonProprietaryName": "Glimepiride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091220",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "GLIMEPIRIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [seeClinical Studies (14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
      "Description": "Glimepiride tablets, USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:.  Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red, Glimepiride 2 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Ferric Oxide Yellow, Glimepiride 3 mg tablets contain Ferric Oxide Yellow, Glimepiride 4 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Glimepiride 6 mg tablets contain Ferric Oxide Red."
    },
    {
      "NDCCode": "42571-119-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42571-119-05) ",
      "NDC11Code": "42571-0119-05",
      "ProductNDC": "42571-119",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201952",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "325; 37.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20121215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less.",
      "Description": "Tramadol hydrochloride and acetaminophen tablet USP combines two analgesics, tramadol hydrochloride and opioid agonist, and acetaminophen. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its  structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are light yellow in color.  Inactive ingredients in the tablets are powdered cellulose, pregelatinized starch, sodium starch glycolate, corn starch, magnesium stearate and OPADRY ®Light Yellow. OPADRY ®Light Yellow consists of the following ingredients:. Hypromellose 2910. Titanium Dioxide. Polyethylene Glycol 400. Iron oxide yellow. Polysorbate 80. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "42571-122-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42571-122-05) ",
      "NDC11Code": "42571-0122-05",
      "ProductNDC": "42571-122",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levocetirizine Dihydrochloride",
      "NonProprietaryName": "Levocetirizine Dihydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202046",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-10-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130930",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levocetirizine dihydrochloride is a histamine H 1-receptor antagonist indicated for:.",
      "Description": "Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablet USP, is an orally active H 1-receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The molecular formula of levocetirizine dihydrochloride is C 21H 25ClN 2O 32HCl.  The molecular weight is 461.82 and the chemical structure is shown below:. Levocetirizine dihydrochloride is a white to off white powder and is freely soluble in water and in methanol.  Levocetirizine dihydrochloride tablets USP, 5 mg are formulated as immediate release, white to off white, oval shaped biconvex, film-coated tablet for oral administration. The tablets are debossed with 'I' and '12' on one side and score line on the other side. Inactive ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol."
    },
    {
      "NDCCode": "42571-142-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (42571-142-05) ",
      "NDC11Code": "42571-0142-05",
      "ProductNDC": "42571-142",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204776",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib is indicated.",
      "Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is soluble in ethanol and in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"42571-245-05","ProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide"},{"NDCCode":"42571-245-10","ProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide"},{"NDCCode":"42571-245-30","ProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide"},{"NDCCode":"42571-245-90","ProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide"},{"NDCCode":"13537-245-06","ProprietaryName":"Lbel Natural Finish Moisturizing Foundation Spf 25","NonProprietaryName":"Octinoxate And Titanium Dioxide"},{"NDCCode":"14783-245-06","ProprietaryName":"Lbel Natural Finish Moisturizing Foundation Spf 25","NonProprietaryName":"Octinoxate And Titanium Dioxide"},{"NDCCode":"29300-245-05","ProprietaryName":"Buspirone Hydrochloride","NonProprietaryName":"Buspirone Hydrochloride"},{"NDCCode":"55118-245-05","ProprietaryName":"Scott Antiseptic Skin Cleanser","NonProprietaryName":"Chloroxylenol"},{"NDCCode":"55700-245-05","ProprietaryName":"Ciprofloxacin","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"59746-245-05","ProprietaryName":"Lamotrigine","NonProprietaryName":"Lamotrigine"},{"NDCCode":"65862-245-05","ProprietaryName":"Levetiracetam","NonProprietaryName":"Levetiracetam"},{"NDCCode":"67777-245-05","ProprietaryName":"Bzk Pads","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"68382-245-05","ProprietaryName":"Imatinib Mesylate","NonProprietaryName":"Imatinib Mesylate"},{"NDCCode":"68428-245-05","ProprietaryName":"Azadirachta Indica","NonProprietaryName":"Azadirachta Indica Bark"},{"NDCCode":"69842-245-05","ProprietaryName":"Cvs Cold And Hot","NonProprietaryName":"Menthol"},{"NDCCode":"75834-245-05","ProprietaryName":"Levetiracetam Extended Release","NonProprietaryName":"Levetiracetam"},{"NDCCode":"42571-005-05","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"42571-010-05","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"42571-020-05","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"42571-040-05","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"42571-080-05","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"42571-100-05","ProprietaryName":"Glimepiride","NonProprietaryName":"Glimepiride"},{"NDCCode":"42571-101-05","ProprietaryName":"Glimepiride","NonProprietaryName":"Glimepiride"},{"NDCCode":"42571-102-05","ProprietaryName":"Glimepiride","NonProprietaryName":"Glimepiride"},{"NDCCode":"42571-103-05","ProprietaryName":"Glimepiride","NonProprietaryName":"Glimepiride"},{"NDCCode":"42571-104-05","ProprietaryName":"Glimepiride","NonProprietaryName":"Glimepiride"},{"NDCCode":"42571-105-05","ProprietaryName":"Glimepiride","NonProprietaryName":"Glimepiride"},{"NDCCode":"42571-119-05","ProprietaryName":"Tramadol Hydrochloride And Acetaminophen","NonProprietaryName":"Tramadol Hydrochloride And Acetaminophen"},{"NDCCode":"42571-122-05","ProprietaryName":"Levocetirizine Dihydrochloride","NonProprietaryName":"Levocetirizine Dihydrochloride"},{"NDCCode":"42571-142-05","ProprietaryName":"Celecoxib","NonProprietaryName":"Celecoxib"}]}
                    

<NDCList><NDC><NDCCode>42571-245-05</NDCCode><ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>42571-245-10</NDCCode><ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>42571-245-30</NDCCode><ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>42571-245-90</NDCCode><ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>13537-245-06</NDCCode><ProprietaryName>Lbel Natural Finish Moisturizing Foundation Spf 25</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>14783-245-06</NDCCode><ProprietaryName>Lbel Natural Finish Moisturizing Foundation Spf 25</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>29300-245-05</NDCCode><ProprietaryName>Buspirone Hydrochloride</ProprietaryName><NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55118-245-05</NDCCode><ProprietaryName>Scott Antiseptic Skin Cleanser</ProprietaryName><NonProprietaryName>Chloroxylenol</NonProprietaryName></NDC><NDC><NDCCode>55700-245-05</NDCCode><ProprietaryName>Ciprofloxacin</ProprietaryName><NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>59746-245-05</NDCCode><ProprietaryName>Lamotrigine</ProprietaryName><NonProprietaryName>Lamotrigine</NonProprietaryName></NDC><NDC><NDCCode>65862-245-05</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>67777-245-05</NDCCode><ProprietaryName>Bzk Pads</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>68382-245-05</NDCCode><ProprietaryName>Imatinib Mesylate</ProprietaryName><NonProprietaryName>Imatinib Mesylate</NonProprietaryName></NDC><NDC><NDCCode>68428-245-05</NDCCode><ProprietaryName>Azadirachta Indica</ProprietaryName><NonProprietaryName>Azadirachta Indica Bark</NonProprietaryName></NDC><NDC><NDCCode>69842-245-05</NDCCode><ProprietaryName>Cvs Cold And Hot</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>75834-245-05</NDCCode><ProprietaryName>Levetiracetam Extended Release</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>42571-005-05</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>42571-010-05</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>42571-020-05</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>42571-040-05</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>42571-080-05</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>42571-100-05</NDCCode><ProprietaryName>Glimepiride</ProprietaryName><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>42571-101-05</NDCCode><ProprietaryName>Glimepiride</ProprietaryName><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>42571-102-05</NDCCode><ProprietaryName>Glimepiride</ProprietaryName><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>42571-103-05</NDCCode><ProprietaryName>Glimepiride</ProprietaryName><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>42571-104-05</NDCCode><ProprietaryName>Glimepiride</ProprietaryName><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>42571-105-05</NDCCode><ProprietaryName>Glimepiride</ProprietaryName><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>42571-119-05</NDCCode><ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>42571-122-05</NDCCode><ProprietaryName>Levocetirizine Dihydrochloride</ProprietaryName><NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-142-05</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC></NDCList>