RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "62756-915-73",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (62756-915-73)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60) ",
      "NDC11Code": "62756-0915-73",
      "ProductNDC": "62756-915",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
      "NonProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120929",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090922",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "5; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-11-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120929",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "62756-915-62",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (62756-915-62)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60) ",
      "NDC11Code": "62756-0915-62",
      "ProductNDC": "62756-915",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
      "NonProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120929",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090922",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "5; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-11-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120929",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "62756-915-63",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (62756-915-63)  > 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60) ",
      "NDC11Code": "62756-0915-63",
      "ProductNDC": "62756-915",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
      "NonProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120929",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090922",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "5; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20120929",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "62756-915-83",
      "PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62756-915-83) ",
      "NDC11Code": "62756-0915-83",
      "ProductNDC": "62756-915",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
      "NonProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120929",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090922",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "5; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20120929",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "62756-368-08",
      "PackageDescription": "100 TABLET in 1 BOTTLE (62756-368-08) ",
      "NDC11Code": "62756-0368-08",
      "ProductNDC": "62756-368",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "NonProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090654",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "100; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
    },
    {
      "NDCCode": "62756-368-18",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (62756-368-18) ",
      "NDC11Code": "62756-0368-18",
      "ProductNDC": "62756-368",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "NonProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090654",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "100; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
    },
    {
      "NDCCode": "62756-368-83",
      "PackageDescription": "30 TABLET in 1 BOTTLE (62756-368-83) ",
      "NDC11Code": "62756-0368-83",
      "ProductNDC": "62756-368",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "NonProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090654",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "100; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
    },
    {
      "NDCCode": "62756-368-88",
      "PackageDescription": "100 TABLET in 1 BOTTLE (62756-368-88) ",
      "NDC11Code": "62756-0368-88",
      "ProductNDC": "62756-368",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "NonProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090654",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "100; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
    },
    {
      "NDCCode": "62756-369-08",
      "PackageDescription": "100 TABLET in 1 BOTTLE (62756-369-08) ",
      "NDC11Code": "62756-0369-08",
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      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
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    {
      "NDCCode": "62756-369-18",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (62756-369-18) ",
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      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
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      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
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    {
      "NDCCode": "62756-369-83",
      "PackageDescription": "30 TABLET in 1 BOTTLE (62756-369-83) ",
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      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
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      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
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      "NDCCode": "62756-369-88",
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      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
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      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
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      "SamplePackage": "N",
      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
    },
    {
      "NDCCode": "62756-370-83",
      "PackageDescription": "30 TABLET in 1 BOTTLE (62756-370-83) ",
      "NDC11Code": "62756-0370-83",
      "ProductNDC": "62756-370",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "NonProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090654",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "50; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
    },
    {
      "NDCCode": "62756-370-88",
      "PackageDescription": "100 TABLET in 1 BOTTLE (62756-370-88) ",
      "NDC11Code": "62756-0370-88",
      "ProductNDC": "62756-370",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "NonProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090654",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "50; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (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. Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Limitation of Use. Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.",
      "Description": "Metoprolol tartrate and hydrochlorothiazide tablets, USP has the antihypertensive effect of metoprolol tartrate, a beta adrenoreceptor blocker, and hydrochlorothiazide, a thiazide diruetic. It is available as tablets for oral administration. The 50 mg/25 mg tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100 mg/25 mg tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100 mg/50 mg tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP. Metoprolol tartrate USP is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Its molecular weight is 684.82. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1,2,4-benzothiadiazine-7- sulfonamide 1,1- dioxide, and its structural formula is. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; slightly soluble in water; and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, lactose monohydrate, pregelatinized starch, corn starch, compressible sugar, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow No. 10 (50 mg/25 mg and 100 mg/50 mg  tablets), and FD&C Red No. 40 and FD&C Yellow No. 6 (100 mg/25 mg tablets)."
    },
    {
      "NDCCode": "62756-430-08",
      "PackageDescription": "100 TABLET in 1 BOTTLE (62756-430-08) ",
      "NDC11Code": "62756-0430-08",
      "ProductNDC": "62756-430",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lithium Carbonate",
      "NonProprietaryName": "Lithium Carbonate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100708",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091027",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "LITHIUM CARBONATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Mood Stabilizer [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20100708",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:.",
      "Description": "Each tablet for oral administration contains lithium carbonate USP, 300 mg and the following inactive ingredients: microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate type A, colloidal silicon dioxide and calcium stearate. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. The molecular formula for Lithium Citrate is C6H5Li3O7; molecular weight 209.93. Lithium acts as an antimanic. Lithium carbonate USP is a white, light, alkaline powder with molecular formula Li2CO3 and molecular weight 73.89."
    },
    {
      "NDCCode": "62756-430-18",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (62756-430-18) ",
      "NDC11Code": "62756-0430-18",
      "ProductNDC": "62756-430",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lithium Carbonate",
      "NonProprietaryName": "Lithium Carbonate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100708",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091027",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "LITHIUM CARBONATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Mood Stabilizer [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20100708",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:.",
      "Description": "Each tablet for oral administration contains lithium carbonate USP, 300 mg and the following inactive ingredients: microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate type A, colloidal silicon dioxide and calcium stearate. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. The molecular formula for Lithium Citrate is C6H5Li3O7; molecular weight 209.93. Lithium acts as an antimanic. Lithium carbonate USP is a white, light, alkaline powder with molecular formula Li2CO3 and molecular weight 73.89."
    },
    {
      "NDCCode": "62756-430-83",
      "PackageDescription": "30 TABLET in 1 BOTTLE (62756-430-83) ",
      "NDC11Code": "62756-0430-83",
      "ProductNDC": "62756-430",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lithium Carbonate",
      "NonProprietaryName": "Lithium Carbonate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100708",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091027",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "LITHIUM CARBONATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Mood Stabilizer [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20100708",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:.",
      "Description": "Each tablet for oral administration contains lithium carbonate USP, 300 mg and the following inactive ingredients: microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate type A, colloidal silicon dioxide and calcium stearate. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. The molecular formula for Lithium Citrate is C6H5Li3O7; molecular weight 209.93. Lithium acts as an antimanic. Lithium carbonate USP is a white, light, alkaline powder with molecular formula Li2CO3 and molecular weight 73.89."
    },
    {
      "NDCCode": "62756-430-88",
      "PackageDescription": "100 TABLET in 1 BOTTLE (62756-430-88) ",
      "NDC11Code": "62756-0430-88",
      "ProductNDC": "62756-430",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lithium Carbonate",
      "NonProprietaryName": "Lithium Carbonate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100708",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091027",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "LITHIUM CARBONATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Mood Stabilizer [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20100708",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:.",
      "Description": "Each tablet for oral administration contains lithium carbonate USP, 300 mg and the following inactive ingredients: microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate type A, colloidal silicon dioxide and calcium stearate. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. The molecular formula for Lithium Citrate is C6H5Li3O7; molecular weight 209.93. Lithium acts as an antimanic. Lithium carbonate USP is a white, light, alkaline powder with molecular formula Li2CO3 and molecular weight 73.89."
    },
    {
      "NDCCode": "62756-967-18",
      "PackageDescription": "1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-967-18) ",
      "NDC11Code": "62756-0967-18",
      "ProductNDC": "62756-967",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcitriol",
      "NonProprietaryName": "Calcitriol",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204556",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "CALCITRIOL",
      "StrengthNumber": ".25",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-01-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Predialysis PatientsCalcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.Dialysis PatientsCalcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.Hypoparathyroidism PatientsCalcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
      "Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol, USP. Each capsule contains butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants, and medium-chain triglycerides. Gelatin capsule shells contain gelatin, glycerin, noncrystallizing sorbitol solution, methyl paraben and propyl paraben with the following dye systems. 0.25 mcg –ferric oxide red, ferric oxide yellow and titanium dioxide; 0.5 mcg –ferric oxide red and titanium dioxide. The imprinting ink contains shellac, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is practically insoluble in water, soluble in alcohol and fatty oils. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
    },
    {
      "NDCCode": "62756-967-83",
      "PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-967-83) ",
      "NDC11Code": "62756-0967-83",
      "ProductNDC": "62756-967",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcitriol",
      "NonProprietaryName": "Calcitriol",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204556",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "CALCITRIOL",
      "StrengthNumber": ".25",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-01-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Predialysis PatientsCalcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.Dialysis PatientsCalcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.Hypoparathyroidism PatientsCalcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
      "Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol, USP. Each capsule contains butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants, and medium-chain triglycerides. Gelatin capsule shells contain gelatin, glycerin, noncrystallizing sorbitol solution, methyl paraben and propyl paraben with the following dye systems. 0.25 mcg –ferric oxide red, ferric oxide yellow and titanium dioxide; 0.5 mcg –ferric oxide red and titanium dioxide. The imprinting ink contains shellac, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is practically insoluble in water, soluble in alcohol and fatty oils. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
    },
    {
      "NDCCode": "62756-967-88",
      "PackageDescription": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-967-88) ",
      "NDC11Code": "62756-0967-88",
      "ProductNDC": "62756-967",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcitriol",
      "NonProprietaryName": "Calcitriol",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204556",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "CALCITRIOL",
      "StrengthNumber": ".25",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-01-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Predialysis PatientsCalcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.Dialysis PatientsCalcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.Hypoparathyroidism PatientsCalcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
      "Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol, USP. Each capsule contains butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants, and medium-chain triglycerides. Gelatin capsule shells contain gelatin, glycerin, noncrystallizing sorbitol solution, methyl paraben and propyl paraben with the following dye systems. 0.25 mcg –ferric oxide red, ferric oxide yellow and titanium dioxide; 0.5 mcg –ferric oxide red and titanium dioxide. The imprinting ink contains shellac, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is practically insoluble in water, soluble in alcohol and fatty oils. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
    },
    {
      "NDCCode": "62756-968-18",
      "PackageDescription": "1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-18) ",
      "NDC11Code": "62756-0968-18",
      "ProductNDC": "62756-968",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcitriol",
      "NonProprietaryName": "Calcitriol",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204556",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "CALCITRIOL",
      "StrengthNumber": ".5",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-01-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Predialysis PatientsCalcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.Dialysis PatientsCalcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.Hypoparathyroidism PatientsCalcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
      "Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol, USP. Each capsule contains butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants, and medium-chain triglycerides. Gelatin capsule shells contain gelatin, glycerin, noncrystallizing sorbitol solution, methyl paraben and propyl paraben with the following dye systems. 0.25 mcg –ferric oxide red, ferric oxide yellow and titanium dioxide; 0.5 mcg –ferric oxide red and titanium dioxide. The imprinting ink contains shellac, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is practically insoluble in water, soluble in alcohol and fatty oils. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
    },
    {
      "NDCCode": "62756-968-83",
      "PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-83) ",
      "NDC11Code": "62756-0968-83",
      "ProductNDC": "62756-968",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcitriol",
      "NonProprietaryName": "Calcitriol",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204556",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "CALCITRIOL",
      "StrengthNumber": ".5",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-01-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Predialysis PatientsCalcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.Dialysis PatientsCalcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.Hypoparathyroidism PatientsCalcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
      "Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol, USP. Each capsule contains butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants, and medium-chain triglycerides. Gelatin capsule shells contain gelatin, glycerin, noncrystallizing sorbitol solution, methyl paraben and propyl paraben with the following dye systems. 0.25 mcg –ferric oxide red, ferric oxide yellow and titanium dioxide; 0.5 mcg –ferric oxide red and titanium dioxide. The imprinting ink contains shellac, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is practically insoluble in water, soluble in alcohol and fatty oils. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
    },
    {
      "NDCCode": "62756-968-88",
      "PackageDescription": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-88) ",
      "NDC11Code": "62756-0968-88",
      "ProductNDC": "62756-968",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcitriol",
      "NonProprietaryName": "Calcitriol",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204556",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "CALCITRIOL",
      "StrengthNumber": ".5",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-01-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Predialysis PatientsCalcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.Dialysis PatientsCalcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.Hypoparathyroidism PatientsCalcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
      "Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol, USP. Each capsule contains butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants, and medium-chain triglycerides. Gelatin capsule shells contain gelatin, glycerin, noncrystallizing sorbitol solution, methyl paraben and propyl paraben with the following dye systems. 0.25 mcg –ferric oxide red, ferric oxide yellow and titanium dioxide; 0.5 mcg –ferric oxide red and titanium dioxide. The imprinting ink contains shellac, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is practically insoluble in water, soluble in alcohol and fatty oils. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
    },
    {
      "NDCCode": "10056-915-55",
      "PackageDescription": "3 CARTON in 1 CARTON (10056-915-55)  > 1 BLISTER PACK in 1 CARTON > 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "10056-0915-55",
      "ProductNDC": "10056-915",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Formu Care Omeprazole",
      "NonProprietaryName": "Omeprazole",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090708",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022032",
      "LabelerName": "Access Business Group LLC",
      "SubstanceName": "OMEPRAZOLE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-20",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10202-915-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (10202-915-01)  > 14 TABLET, DELAYED RELEASE in 1 BOTTLE",
      "NDC11Code": "10202-0915-01",
      "ProductNDC": "10202-915",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Seven Select Omeprazole",
      "NonProprietaryName": "Omeprazole",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180914",
      "EndMarketingDate": "20200501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022032",
      "LabelerName": "7-Eleven",
      "SubstanceName": "OMEPRAZOLE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-05-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180914",
      "EndMarketingDatePackage": "20200501",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10544-915-10",
      "PackageDescription": "10 TABLET in 1 BOTTLE (10544-915-10)",
      "NDC11Code": "10544-0915-10",
      "ProductNDC": "10544-915",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150520",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040362",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasiaNonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitis Acute gouty arthritisPost-traumatic osteoarthritis Synovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosusSystemic derznatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic Diseases. PemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitis             Serum sickness            Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently  with appropriate antituberculous chemotherapy            Trichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1, 4-diene-3, 11, 20-trione, 17, 21-dihydroxy-. The structural formula is represented below. Molecular weight: 358.44. Prednisone Tablets, USP are available in three strengths: 5 mg, 10 mg, and 20 mg. In addition, each tablet contains the following Inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow #6 aluminum lake HT 15-18%."
    },
    {
      "NDCCode": "10544-915-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (10544-915-30)",
      "NDC11Code": "10544-0915-30",
      "ProductNDC": "10544-915",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150520",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040362",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasiaNonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitis Acute gouty arthritisPost-traumatic osteoarthritis Synovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosusSystemic derznatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic Diseases. PemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitis             Serum sickness            Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently  with appropriate antituberculous chemotherapy            Trichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1, 4-diene-3, 11, 20-trione, 17, 21-dihydroxy-. The structural formula is represented below. Molecular weight: 358.44. Prednisone Tablets, USP are available in three strengths: 5 mg, 10 mg, and 20 mg. In addition, each tablet contains the following Inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow #6 aluminum lake HT 15-18%."
    }
  ]
}
                    

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