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"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "PRAZOSIN HYDROCHLORIDE",
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"IndicationAndUsage": "Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP."
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{
"NDCCode": "76420-525-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (76420-525-01) ",
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"IndicationAndUsage": "Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP."
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"PackageDescription": "10 CAPSULE in 1 BOTTLE (76420-525-10) ",
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"IndicationAndUsage": "Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP."
},
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"NDCCode": "76420-525-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (76420-525-20) ",
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"LabelerName": "ASCLEMED USA INC.",
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"IndicationAndUsage": "Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "76420-525-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (76420-525-30) ",
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"IndicationAndUsage": "Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP."
},
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"NDCCode": "76420-525-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (76420-525-60) ",
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"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "10135-525-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (10135-525-90)",
"NDC11Code": "10135-0525-90",
"ProductNDC": "10135-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078552",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "31722-525-90",
"PackageDescription": "12 BOTTLE in 1 CASE (31722-525-90) / 90 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "31722-0525-90",
"ProductNDC": "31722-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finasteride",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090061",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Finasteride tablets, are a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) (1.2). Limitations of Use:Finasteride tablets are not approved for the prevention of prostate cancer (1.3).",
"Description": "Finasteride USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-, (5α,17β)-. The empirical formula of finasteride is C 23H 36N 2O 2and its molecular weight is 372.55. Its structural formula is:. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets USP for oral administration are film-coated tablets that contain 5 mg of finasteride USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, opadry blue (FD&C Blue # 2 aluminum lake, hypromellose, talc, titanium dioxide, yellow iron oxide). The botanical source of the Pregelatinized Starch is Maize."
},
{
"NDCCode": "33342-525-10",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-525-10) ",
"NDC11Code": "33342-0525-10",
"ProductNDC": "33342-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218744",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230623",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3¬ (acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: acetyl tributyl citrate, Ethyl Cellulose, hydroxypropyl methyl cellulose (Methocel E3 Premium LV), hydroxypropyl methyl cellulose (Methocel E5 Premium LV), microcrystalline cellulose, Talc. The capsule shells contain FD&C Blue #1, gelatin and titanium dioxide black iron oxide (300 mg). The capsules are imprinted with black TekPrint TM SW-0012 White Ink or TekPrint TM SB-6018 Blue Ink which contains FD & C Blue # 2 Aluminum Lake - E 132, potassium hydroxide, propylene glycol, titanium Dioxide and shellac. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "43063-525-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (43063-525-90)",
"NDC11Code": "43063-0525-90",
"ProductNDC": "43063-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020701",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075994",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43547-525-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (43547-525-09) ",
"NDC11Code": "43547-0525-09",
"ProductNDC": "43547-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212682",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "NEBIVOLOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg)."
},
{
"NDCCode": "51407-525-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (51407-525-90) ",
"NDC11Code": "51407-0525-90",
"ProductNDC": "51407-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074569",
"LabelerName": "Golden State Medical Supply Inc.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180220",
"SamplePackage": "N"
},
{
"NDCCode": "60429-525-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (60429-525-90) ",
"NDC11Code": "60429-0525-90",
"ProductNDC": "60429-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074869",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2022-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131018",
"SamplePackage": "N"
},
{
"NDCCode": "62135-525-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-525-90) ",
"NDC11Code": "62135-0525-90",
"ProductNDC": "62135-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terbutaline Sulfate",
"NonProprietaryName": "Terbutaline Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077152",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "TERBUTALINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230228",
"SamplePackage": "N",
"IndicationAndUsage": "Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.",
"Description": "Terbutaline sulfate USP is a beta-adrenergic agonist bronchodilator available as tablets of 2.5 mg (2.05 mg of the free base) and 5 mg (4.1 mg of the free base) for oral administration. Terbutaline sulfate is ±-α-[( tert –butylamino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The molecular formula is (C 12H 19NO 3) 2 H 2SO 4 and the structural formula is. Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. Inactive Ingredients: anhydrous lactose, pregelatinized corn starch, microcrystalline cellulose, povidone, and magnesium stearate."
},
{
"NDCCode": "64175-525-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (64175-525-90)",
"NDC11Code": "64175-0525-90",
"ProductNDC": "64175-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menopause",
"ProprietaryNameSuffix": "Hf",
"NonProprietaryName": "Cimicifuga Racemosa, Trifolium Pratense, Magnesia Carbonica, Agnus Castus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Foster Regal Laboratories",
"SubstanceName": "BLACK COHOSH; RED CLOVER; MAGNESIUM CARBONATE; CHASTE TREE",
"StrengthNumber": "1; 1; 1; 1",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68382-525-16",
"PackageDescription": "90 TABLET in 1 BOTTLE (68382-525-16) ",
"NDC11Code": "68382-0525-16",
"ProductNDC": "68382-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202900",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180501",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide is a loop diuretic, available as scored tablets. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula."
},
{
"NDCCode": "68682-525-01",
"PackageDescription": "90 TABLET in 1 BOTTLE (68682-525-01)",
"NDC11Code": "68682-0525-01",
"ProductNDC": "68682-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120625",
"EndMarketingDate": "20150930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090715",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "48",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "69101-525-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (69101-525-90) ",
"NDC11Code": "69101-0525-90",
"ProductNDC": "69101-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Conjupri",
"NonProprietaryName": "Levamlodipine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200901",
"EndMarketingDate": "20220811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212895",
"LabelerName": "Burke Therapeutics, LLC",
"SubstanceName": "LEVAMLODIPINE MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200901",
"EndMarketingDatePackage": "20220811",
"SamplePackage": "N"
},
{
"NDCCode": "71205-525-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-525-90) ",
"NDC11Code": "71205-0525-90",
"ProductNDC": "71205-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090776",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210122",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine Delayed-Release Capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl cellulose, hydroxypropyl methylcellulose phthalate, hypromellose, potassium hydroxide, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "71610-525-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-525-60) ",
"NDC11Code": "71610-0525-60",
"ProductNDC": "71610-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071523",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210407",
"SamplePackage": "N",
"IndicationAndUsage": "Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Trazodone hydrochloride tablets, USP for oral administration contain trazodone hydrochloride, USP a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4, 3-a]pyridin-3(2 H)-one hydrochloride. It is a white, odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. C 19H 22CIN 5O HCl M.W. 408.32. Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "76420-009-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (76420-009-90) ",
"NDC11Code": "76420-0009-90",
"ProductNDC": "76420-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204590",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230902",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 200 mg celecoxib USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, hydroxypropyl cellulose, crospovidone and titanium dioxide. The imprinting ink of capsule shell of the 200 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and yellow iron oxide."
},
{
"NDCCode": "76420-010-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (76420-010-90) ",
"NDC11Code": "76420-0010-90",
"ProductNDC": "76420-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078722",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221021",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pK aof 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are supplied as 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide."
},
{
"NDCCode": "76420-011-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (76420-011-90) ",
"NDC11Code": "76420-0011-90",
"ProductNDC": "76420-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208170",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220810",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide."
},
{
"NDCCode": "76420-015-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (76420-015-90) ",
"NDC11Code": "76420-0015-90",
"ProductNDC": "76420-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075350",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2022-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200123",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin, USP is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule contains 100 mg, or 300 mg of gabapentin, USP and the following inactive ingredients: black iron oxide, corn starch, D&C Yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, mannitol, pharmaceutical glaze, propylene glycol, red iron oxide T3469, silicon dioxide, sodium lauryl sulfate, synthetic black iron oxide, talc, titanium dioxide, and yellow iron oxide T3506."
},
{
"NDCCode": "76420-019-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (76420-019-90) ",
"NDC11Code": "76420-0019-90",
"ProductNDC": "76420-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078722",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200604",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pK a of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d] cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide."
},
{
"NDCCode": "76420-020-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (76420-020-90) ",
"NDC11Code": "76420-0020-90",
"ProductNDC": "76420-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2020-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200610",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 300 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "76420-021-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (76420-021-90) ",
"NDC11Code": "76420-0021-90",
"ProductNDC": "76420-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040275",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191216",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. , 5 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). , 6 Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies). .",
"Description": "Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "76420-022-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (76420-022-90) ",
"NDC11Code": "76420-0022-90",
"ProductNDC": "76420-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040275",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191216",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. , 5 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). , 6 Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies). .",
"Description": "Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "76420-023-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (76420-023-90) ",
"NDC11Code": "76420-0023-90",
"ProductNDC": "76420-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040275",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191216",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. , 5 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). , 6 Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies). .",
"Description": "Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "76420-024-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (76420-024-90) ",
"NDC11Code": "76420-0024-90",
"ProductNDC": "76420-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202929",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200617",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "Eszopiclone, USP is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1carboxylate. Its molecular weight is 388.81, and its empirical formula is C 17H 17C lN 6O 3. Eszopiclone, USP has a single chiral center with an (S)-configuration. It has the following chemical structure:. Eszopiclone, USP is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone, USP is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone, USP and the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2."
}
]
}
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<NDCCode>76420-525-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (76420-525-90) </PackageDescription>
<NDC11Code>76420-0525-90</NDC11Code>
<ProductNDC>76420-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
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<LabelerName>ASCLEMED USA INC.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
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<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<LabelerName>ASCLEMED USA INC.</LabelerName>
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<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251015</StartMarketingDatePackage>
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<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
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<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<ProductNDC>76420-525</ProductNDC>
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<ApplicationNumber>ANDA215697</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
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<LastUpdate>2025-10-18</LastUpdate>
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<StartMarketingDatePackage>20251015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<PackageDescription>30 CAPSULE in 1 BOTTLE (76420-525-30) </PackageDescription>
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<ProductNDC>76420-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215697</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC>
<NDCCode>76420-525-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (76420-525-60) </PackageDescription>
<NDC11Code>76420-0525-60</NDC11Code>
<ProductNDC>76420-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215697</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC>
<NDCCode>10135-525-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (10135-525-90)</PackageDescription>
<NDC11Code>10135-0525-90</NDC11Code>
<ProductNDC>10135-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078552</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate.</Description>
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<PackageDescription>12 BOTTLE in 1 CASE (31722-525-90) / 90 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0525-90</NDC11Code>
<ProductNDC>31722-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finasteride</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090061</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finasteride tablets, are a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) (1.2). Limitations of Use:Finasteride tablets are not approved for the prevention of prostate cancer (1.3).</IndicationAndUsage>
<Description>Finasteride USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-, (5α,17β)-. The empirical formula of finasteride is C 23H 36N 2O 2and its molecular weight is 372.55. Its structural formula is:. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets USP for oral administration are film-coated tablets that contain 5 mg of finasteride USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, opadry blue (FD&C Blue # 2 aluminum lake, hypromellose, talc, titanium dioxide, yellow iron oxide). The botanical source of the Pregelatinized Starch is Maize.</Description>
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<NDC>
<NDCCode>33342-525-10</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-525-10) </PackageDescription>
<NDC11Code>33342-0525-10</NDC11Code>
<ProductNDC>33342-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218744</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3¬ (acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: acetyl tributyl citrate, Ethyl Cellulose, hydroxypropyl methyl cellulose (Methocel E3 Premium LV), hydroxypropyl methyl cellulose (Methocel E5 Premium LV), microcrystalline cellulose, Talc. The capsule shells contain FD&C Blue #1, gelatin and titanium dioxide black iron oxide (300 mg). The capsules are imprinted with black TekPrint TM SW-0012 White Ink or TekPrint TM SB-6018 Blue Ink which contains FD & C Blue # 2 Aluminum Lake - E 132, potassium hydroxide, propylene glycol, titanium Dioxide and shellac. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43063-525-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (43063-525-90)</PackageDescription>
<NDC11Code>43063-0525-90</NDC11Code>
<ProductNDC>43063-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<EndMarketingDate>20171231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075994</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43547-525-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (43547-525-09) </PackageDescription>
<NDC11Code>43547-0525-09</NDC11Code>
<ProductNDC>43547-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212682</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>NEBIVOLOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg).</Description>
</NDC>
<NDC>
<NDCCode>51407-525-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (51407-525-90) </PackageDescription>
<NDC11Code>51407-0525-90</NDC11Code>
<ProductNDC>51407-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074569</ApplicationNumber>
<LabelerName>Golden State Medical Supply Inc.</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60429-525-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (60429-525-90) </PackageDescription>
<NDC11Code>60429-0525-90</NDC11Code>
<ProductNDC>60429-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074869</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62135-525-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-525-90) </PackageDescription>
<NDC11Code>62135-0525-90</NDC11Code>
<ProductNDC>62135-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terbutaline Sulfate</ProprietaryName>
<NonProprietaryName>Terbutaline Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077152</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>TERBUTALINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.</IndicationAndUsage>
<Description>Terbutaline sulfate USP is a beta-adrenergic agonist bronchodilator available as tablets of 2.5 mg (2.05 mg of the free base) and 5 mg (4.1 mg of the free base) for oral administration. Terbutaline sulfate is ±-α-[( tert –butylamino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The molecular formula is (C 12H 19NO 3) 2 H 2SO 4 and the structural formula is. Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. Inactive Ingredients: anhydrous lactose, pregelatinized corn starch, microcrystalline cellulose, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>64175-525-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (64175-525-90)</PackageDescription>
<NDC11Code>64175-0525-90</NDC11Code>
<ProductNDC>64175-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menopause</ProprietaryName>
<ProprietaryNameSuffix>Hf</ProprietaryNameSuffix>
<NonProprietaryName>Cimicifuga Racemosa, Trifolium Pratense, Magnesia Carbonica, Agnus Castus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Foster Regal Laboratories</LabelerName>
<SubstanceName>BLACK COHOSH; RED CLOVER; MAGNESIUM CARBONATE; CHASTE TREE</SubstanceName>
<StrengthNumber>1; 1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68382-525-16</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68382-525-16) </PackageDescription>
<NDC11Code>68382-0525-16</NDC11Code>
<ProductNDC>68382-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202900</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as scored tablets. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>68682-525-01</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68682-525-01)</PackageDescription>
<NDC11Code>68682-0525-01</NDC11Code>
<ProductNDC>68682-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120625</StartMarketingDate>
<EndMarketingDate>20150930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090715</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>48</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>69101-525-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (69101-525-90) </PackageDescription>
<NDC11Code>69101-0525-90</NDC11Code>
<ProductNDC>69101-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Conjupri</ProprietaryName>
<NonProprietaryName>Levamlodipine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<EndMarketingDate>20220811</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212895</ApplicationNumber>
<LabelerName>Burke Therapeutics, LLC</LabelerName>
<SubstanceName>LEVAMLODIPINE MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<EndMarketingDatePackage>20220811</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-525-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-525-90) </PackageDescription>
<NDC11Code>71205-0525-90</NDC11Code>
<ProductNDC>71205-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090776</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine Delayed-Release Capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl cellulose, hydroxypropyl methylcellulose phthalate, hypromellose, potassium hydroxide, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>71610-525-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-525-60) </PackageDescription>
<NDC11Code>71610-0525-60</NDC11Code>
<ProductNDC>71610-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071523</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Trazodone hydrochloride tablets, USP for oral administration contain trazodone hydrochloride, USP a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4, 3-a]pyridin-3(2 H)-one hydrochloride. It is a white, odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. C 19H 22CIN 5O HCl M.W. 408.32. Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>76420-009-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (76420-009-90) </PackageDescription>
<NDC11Code>76420-0009-90</NDC11Code>
<ProductNDC>76420-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204590</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 200 mg celecoxib USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, hydroxypropyl cellulose, crospovidone and titanium dioxide. The imprinting ink of capsule shell of the 200 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>76420-010-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (76420-010-90) </PackageDescription>
<NDC11Code>76420-0010-90</NDC11Code>
<ProductNDC>76420-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078722</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pK aof 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are supplied as 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76420-011-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (76420-011-90) </PackageDescription>
<NDC11Code>76420-0011-90</NDC11Code>
<ProductNDC>76420-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208170</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76420-015-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (76420-015-90) </PackageDescription>
<NDC11Code>76420-0015-90</NDC11Code>
<ProductNDC>76420-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075350</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin, USP is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule contains 100 mg, or 300 mg of gabapentin, USP and the following inactive ingredients: black iron oxide, corn starch, D&C Yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, mannitol, pharmaceutical glaze, propylene glycol, red iron oxide T3469, silicon dioxide, sodium lauryl sulfate, synthetic black iron oxide, talc, titanium dioxide, and yellow iron oxide T3506.</Description>
</NDC>
<NDC>
<NDCCode>76420-019-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (76420-019-90) </PackageDescription>
<NDC11Code>76420-0019-90</NDC11Code>
<ProductNDC>76420-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078722</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pK a of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d] cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76420-020-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (76420-020-90) </PackageDescription>
<NDC11Code>76420-0020-90</NDC11Code>
<ProductNDC>76420-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 300 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76420-021-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (76420-021-90) </PackageDescription>
<NDC11Code>76420-0021-90</NDC11Code>
<ProductNDC>76420-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040275</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. , 5 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). , 6 Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies). .</IndicationAndUsage>
<Description>Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>76420-022-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (76420-022-90) </PackageDescription>
<NDC11Code>76420-0022-90</NDC11Code>
<ProductNDC>76420-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040275</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. , 5 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). , 6 Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies). .</IndicationAndUsage>
<Description>Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>76420-023-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (76420-023-90) </PackageDescription>
<NDC11Code>76420-0023-90</NDC11Code>
<ProductNDC>76420-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040275</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. , 5 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). , 6 Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies). .</IndicationAndUsage>
<Description>Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>76420-024-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (76420-024-90) </PackageDescription>
<NDC11Code>76420-0024-90</NDC11Code>
<ProductNDC>76420-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eszopiclone</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202929</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
<Description>Eszopiclone, USP is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1carboxylate. Its molecular weight is 388.81, and its empirical formula is C 17H 17C lN 6O 3. Eszopiclone, USP has a single chiral center with an (S)-configuration. It has the following chemical structure:. Eszopiclone, USP is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone, USP is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone, USP and the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.</Description>
</NDC>
</NDCList>