{
"NDC": [
{
"NDCCode": "69238-2577-9",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-9) ",
"NDC11Code": "69238-2577-09",
"ProductNDC": "69238-2577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "68071-2577-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68071-2577-9) ",
"NDC11Code": "68071-2577-09",
"ProductNDC": "68071-2577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076143",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250123",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)].",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.21 g/mol. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white to off-white crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride is supplied for oral administration as 75-mg (orange) and 100-mg (purple) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients:. 75-mg tablet –colloidal silicon dioxide, crospovidone, FD&C Yellow #6 Aluminum Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. 100-mg tablet –colloidal silicon dioxide, crospovidone, D&C Red #7 Calcium Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "69238-2577-1",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-1) ",
"NDC11Code": "69238-2577-01",
"ProductNDC": "69238-2577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "69238-2577-2",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-2) ",
"NDC11Code": "69238-2577-02",
"ProductNDC": "69238-2577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "69238-2577-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-3) ",
"NDC11Code": "69238-2577-03",
"ProductNDC": "69238-2577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "57520-1276-4",
"PackageDescription": "2577 mL in 1 JUG (57520-1276-4)",
"NDC11Code": "57520-1276-04",
"ProductNDC": "57520-1276",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Calcarea Sulphurica, Calcarea Fluorica, Silicea, Calcarea Phosphorica,",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20140514",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Apotheca Company",
"SubstanceName": "CALCIUM SULFATE ANHYDROUS; CALCIUM FLUORIDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "6; 9; 9; 9",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71335-2577-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (71335-2577-1) ",
"NDC11Code": "71335-2577-01",
"ProductNDC": "71335-2577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210683",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250205",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of. paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of. Documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, USP, their use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate tablets, USP should not be used in patients with recent myocardial infarction. (See BOXED WARNINGS.). Use of flecainide acetate tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See BOXED WARNINGS.). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, USP favorably affect survival or the incidence of sudden death.",
"Description": "Flecainide acetate tablets, USP are an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, and pregelatinized starch."
},
{
"NDCCode": "71335-2577-2",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-2577-2) ",
"NDC11Code": "71335-2577-02",
"ProductNDC": "71335-2577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210683",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250205",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of. paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of. Documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, USP, their use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate tablets, USP should not be used in patients with recent myocardial infarction. (See BOXED WARNINGS.). Use of flecainide acetate tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See BOXED WARNINGS.). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, USP favorably affect survival or the incidence of sudden death.",
"Description": "Flecainide acetate tablets, USP are an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, and pregelatinized starch."
},
{
"NDCCode": "71335-2577-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-2577-3) ",
"NDC11Code": "71335-2577-03",
"ProductNDC": "71335-2577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210683",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250205",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of. paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of. Documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, USP, their use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate tablets, USP should not be used in patients with recent myocardial infarction. (See BOXED WARNINGS.). Use of flecainide acetate tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See BOXED WARNINGS.). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, USP favorably affect survival or the incidence of sudden death.",
"Description": "Flecainide acetate tablets, USP are an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, and pregelatinized starch."
},
{
"NDCCode": "71335-2577-4",
"PackageDescription": "180 TABLET in 1 BOTTLE (71335-2577-4) ",
"NDC11Code": "71335-2577-04",
"ProductNDC": "71335-2577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210683",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250205",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of. paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of. Documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, USP, their use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate tablets, USP should not be used in patients with recent myocardial infarction. (See BOXED WARNINGS.). Use of flecainide acetate tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See BOXED WARNINGS.). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, USP favorably affect survival or the incidence of sudden death.",
"Description": "Flecainide acetate tablets, USP are an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, and pregelatinized starch."
},
{
"NDCCode": "71335-2577-5",
"PackageDescription": "100 TABLET in 1 BOTTLE (71335-2577-5) ",
"NDC11Code": "71335-2577-05",
"ProductNDC": "71335-2577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210683",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250205",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of. paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of. Documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, USP, their use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate tablets, USP should not be used in patients with recent myocardial infarction. (See BOXED WARNINGS.). Use of flecainide acetate tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See BOXED WARNINGS.). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, USP favorably affect survival or the incidence of sudden death.",
"Description": "Flecainide acetate tablets, USP are an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, and pregelatinized starch."
},
{
"NDCCode": "69238-1050-9",
"PackageDescription": "2 BOTTLE in 1 BLISTER PACK (69238-1050-9) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) ",
"NDC11Code": "69238-1050-09",
"ProductNDC": "69238-1050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209716",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190605",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "69238-1108-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (69238-1108-9) ",
"NDC11Code": "69238-1108-09",
"ProductNDC": "69238-1108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hcl",
"NonProprietaryName": "Clomipramine Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208632",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e. for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride (HCl) capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. C19H23ClN2 ● HCl MW = 351.31. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients: lactose monohydrate, magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 75 mg capsule shell contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69238-1109-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (69238-1109-9) ",
"NDC11Code": "69238-1109-09",
"ProductNDC": "69238-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hcl",
"NonProprietaryName": "Clomipramine Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208632",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e. for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride (HCl) capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. C19H23ClN2 ● HCl MW = 351.31. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients: lactose monohydrate, magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 75 mg capsule shell contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69238-1110-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (69238-1110-9) ",
"NDC11Code": "69238-1110-09",
"ProductNDC": "69238-1110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hcl",
"NonProprietaryName": "Clomipramine Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208632",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e. for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride (HCl) capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. C19H23ClN2 ● HCl MW = 351.31. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients: lactose monohydrate, magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 75 mg capsule shell contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69238-1123-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (69238-1123-9) ",
"NDC11Code": "69238-1123-09",
"ProductNDC": "69238-1123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nadolol",
"NonProprietaryName": "Nadolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208832",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "NADOLOL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170602",
"SamplePackage": "N",
"IndicationAndUsage": "Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.",
"Description": "Nadolol tablets, USP are a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl) oxy]-2-propanol. Structural formula. C17H27NO4 MW 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: microcrystalline cellulose, maize starch, magnesium stearate and povidone."
},
{
"NDCCode": "69238-1124-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (69238-1124-9) ",
"NDC11Code": "69238-1124-09",
"ProductNDC": "69238-1124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nadolol",
"NonProprietaryName": "Nadolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208832",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "NADOLOL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170602",
"SamplePackage": "N",
"IndicationAndUsage": "Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.",
"Description": "Nadolol tablets, USP are a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl) oxy]-2-propanol. Structural formula. C17H27NO4 MW 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: microcrystalline cellulose, maize starch, magnesium stearate and povidone."
},
{
"NDCCode": "69238-1125-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (69238-1125-9) ",
"NDC11Code": "69238-1125-09",
"ProductNDC": "69238-1125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nadolol",
"NonProprietaryName": "Nadolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208832",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "NADOLOL",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170602",
"SamplePackage": "N",
"IndicationAndUsage": "Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.",
"Description": "Nadolol tablets, USP are a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl) oxy]-2-propanol. Structural formula. C17H27NO4 MW 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: microcrystalline cellulose, maize starch, magnesium stearate and povidone."
},
{
"NDCCode": "69238-1146-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1146-9) ",
"NDC11Code": "69238-1146-09",
"ProductNDC": "69238-1146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208850",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181022",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&C Blue No. 2, FD&C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&C Yellow No. 6. Meets USP Dissolution Test 4."
},
{
"NDCCode": "69238-1147-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1147-9) ",
"NDC11Code": "69238-1147-09",
"ProductNDC": "69238-1147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208850",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181022",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&C Blue No. 2, FD&C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&C Yellow No. 6. Meets USP Dissolution Test 4."
},
{
"NDCCode": "69238-1148-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1148-9) ",
"NDC11Code": "69238-1148-09",
"ProductNDC": "69238-1148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208850",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181022",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&C Blue No. 2, FD&C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&C Yellow No. 6. Meets USP Dissolution Test 4."
},
{
"NDCCode": "69238-1149-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1149-9) ",
"NDC11Code": "69238-1149-09",
"ProductNDC": "69238-1149",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208850",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181022",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&C Blue No. 2, FD&C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&C Yellow No. 6. Meets USP Dissolution Test 4."
},
{
"NDCCode": "69238-1154-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (69238-1154-9) ",
"NDC11Code": "69238-1154-09",
"ProductNDC": "69238-1154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe",
"NonProprietaryName": "Ezetimibe",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208803",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "EZETIMIBE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170612",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)., 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH., 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia., 4 In combination with a statin and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH)., 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.",
"Description": "Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4- fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe tablets, USP are available as a tablet for oral use containing 10 mg of ezetimibe, USP and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate."
},
{
"NDCCode": "69238-1155-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (69238-1155-9) ",
"NDC11Code": "69238-1155-09",
"ProductNDC": "69238-1155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208831",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171121",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .",
"Description": "Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate."
},
{
"NDCCode": "69238-1156-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (69238-1156-9) ",
"NDC11Code": "69238-1156-09",
"ProductNDC": "69238-1156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208831",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171121",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .",
"Description": "Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate."
},
{
"NDCCode": "69238-1157-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (69238-1157-9) ",
"NDC11Code": "69238-1157-09",
"ProductNDC": "69238-1157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208831",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171121",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .",
"Description": "Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate."
},
{
"NDCCode": "69238-1158-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (69238-1158-9) ",
"NDC11Code": "69238-1158-09",
"ProductNDC": "69238-1158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208831",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171121",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .",
"Description": "Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate."
},
{
"NDCCode": "69238-1166-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (69238-1166-9) ",
"NDC11Code": "69238-1166-09",
"ProductNDC": "69238-1166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207482",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170628",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84 g/mol. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.52 mg, 84.79 mg and 113.05 mg of doxepin hydrochloride, USP respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The hard gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 75 mg and 100 mg hard gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69238-1170-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (69238-1170-9) ",
"NDC11Code": "69238-1170-09",
"ProductNDC": "69238-1170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207482",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170628",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84 g/mol. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.52 mg, 84.79 mg and 113.05 mg of doxepin hydrochloride, USP respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The hard gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 75 mg and 100 mg hard gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69238-1171-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (69238-1171-9) ",
"NDC11Code": "69238-1171-09",
"ProductNDC": "69238-1171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207482",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170628",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84 g/mol. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.52 mg, 84.79 mg and 113.05 mg of doxepin hydrochloride, USP respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The hard gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 75 mg and 100 mg hard gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
}
]
}
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<NDCList>
<NDC>
<NDCCode>69238-2577-9</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-9) </PackageDescription>
<NDC11Code>69238-2577-09</NDC11Code>
<ProductNDC>69238-2577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68071-2577-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68071-2577-9) </PackageDescription>
<NDC11Code>68071-2577-09</NDC11Code>
<ProductNDC>68071-2577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076143</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)].</IndicationAndUsage>
<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.21 g/mol. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white to off-white crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride is supplied for oral administration as 75-mg (orange) and 100-mg (purple) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients:. 75-mg tablet –colloidal silicon dioxide, crospovidone, FD&C Yellow #6 Aluminum Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. 100-mg tablet –colloidal silicon dioxide, crospovidone, D&C Red #7 Calcium Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69238-2577-1</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-1) </PackageDescription>
<NDC11Code>69238-2577-01</NDC11Code>
<ProductNDC>69238-2577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69238-2577-2</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-2) </PackageDescription>
<NDC11Code>69238-2577-02</NDC11Code>
<ProductNDC>69238-2577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69238-2577-3</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-3) </PackageDescription>
<NDC11Code>69238-2577-03</NDC11Code>
<ProductNDC>69238-2577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
<NDC>
<NDCCode>57520-1276-4</NDCCode>
<PackageDescription>2577 mL in 1 JUG (57520-1276-4)</PackageDescription>
<NDC11Code>57520-1276-04</NDC11Code>
<ProductNDC>57520-1276</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Calcarea Sulphurica, Calcarea Fluorica, Silicea, Calcarea Phosphorica,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20140514</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Apotheca Company</LabelerName>
<SubstanceName>CALCIUM SULFATE ANHYDROUS; CALCIUM FLUORIDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>6; 9; 9; 9</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71335-2577-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71335-2577-1) </PackageDescription>
<NDC11Code>71335-2577-01</NDC11Code>
<ProductNDC>71335-2577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210683</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of. paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of. Documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, USP, their use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate tablets, USP should not be used in patients with recent myocardial infarction. (See BOXED WARNINGS.). Use of flecainide acetate tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See BOXED WARNINGS.). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, USP favorably affect survival or the incidence of sudden death.</IndicationAndUsage>
<Description>Flecainide acetate tablets, USP are an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>71335-2577-2</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71335-2577-2) </PackageDescription>
<NDC11Code>71335-2577-02</NDC11Code>
<ProductNDC>71335-2577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210683</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of. paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of. Documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, USP, their use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate tablets, USP should not be used in patients with recent myocardial infarction. (See BOXED WARNINGS.). Use of flecainide acetate tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See BOXED WARNINGS.). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, USP favorably affect survival or the incidence of sudden death.</IndicationAndUsage>
<Description>Flecainide acetate tablets, USP are an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>71335-2577-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-2577-3) </PackageDescription>
<NDC11Code>71335-2577-03</NDC11Code>
<ProductNDC>71335-2577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210683</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of. paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of. Documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, USP, their use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate tablets, USP should not be used in patients with recent myocardial infarction. (See BOXED WARNINGS.). Use of flecainide acetate tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See BOXED WARNINGS.). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, USP favorably affect survival or the incidence of sudden death.</IndicationAndUsage>
<Description>Flecainide acetate tablets, USP are an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>71335-2577-4</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (71335-2577-4) </PackageDescription>
<NDC11Code>71335-2577-04</NDC11Code>
<ProductNDC>71335-2577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210683</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of. paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of. Documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, USP, their use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate tablets, USP should not be used in patients with recent myocardial infarction. (See BOXED WARNINGS.). Use of flecainide acetate tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See BOXED WARNINGS.). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, USP favorably affect survival or the incidence of sudden death.</IndicationAndUsage>
<Description>Flecainide acetate tablets, USP are an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>71335-2577-5</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71335-2577-5) </PackageDescription>
<NDC11Code>71335-2577-05</NDC11Code>
<ProductNDC>71335-2577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210683</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of. paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of. Documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, USP, their use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate tablets, USP should not be used in patients with recent myocardial infarction. (See BOXED WARNINGS.). Use of flecainide acetate tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See BOXED WARNINGS.). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, USP favorably affect survival or the incidence of sudden death.</IndicationAndUsage>
<Description>Flecainide acetate tablets, USP are an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>69238-1050-9</NDCCode>
<PackageDescription>2 BOTTLE in 1 BLISTER PACK (69238-1050-9) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) </PackageDescription>
<NDC11Code>69238-1050-09</NDC11Code>
<ProductNDC>69238-1050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209716</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69238-1108-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1108-9) </PackageDescription>
<NDC11Code>69238-1108-09</NDC11Code>
<ProductNDC>69238-1108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hcl</ProprietaryName>
<NonProprietaryName>Clomipramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208632</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e. for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride (HCl) capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. C19H23ClN2 ● HCl MW = 351.31. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients: lactose monohydrate, magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 75 mg capsule shell contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69238-1109-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1109-9) </PackageDescription>
<NDC11Code>69238-1109-09</NDC11Code>
<ProductNDC>69238-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hcl</ProprietaryName>
<NonProprietaryName>Clomipramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208632</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e. for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride (HCl) capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. C19H23ClN2 ● HCl MW = 351.31. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients: lactose monohydrate, magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 75 mg capsule shell contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69238-1110-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1110-9) </PackageDescription>
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<ProductNDC>69238-1110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hcl</ProprietaryName>
<NonProprietaryName>Clomipramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208632</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e. for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride (HCl) capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. C19H23ClN2 ● HCl MW = 351.31. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients: lactose monohydrate, magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 75 mg capsule shell contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69238-1123-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (69238-1123-9) </PackageDescription>
<NDC11Code>69238-1123-09</NDC11Code>
<ProductNDC>69238-1123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nadolol</ProprietaryName>
<NonProprietaryName>Nadolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208832</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>NADOLOL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
<Description>Nadolol tablets, USP are a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl) oxy]-2-propanol. Structural formula. C17H27NO4 MW 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: microcrystalline cellulose, maize starch, magnesium stearate and povidone.</Description>
</NDC>
<NDC>
<NDCCode>69238-1124-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (69238-1124-9) </PackageDescription>
<NDC11Code>69238-1124-09</NDC11Code>
<ProductNDC>69238-1124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nadolol</ProprietaryName>
<NonProprietaryName>Nadolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208832</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>NADOLOL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
<Description>Nadolol tablets, USP are a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl) oxy]-2-propanol. Structural formula. C17H27NO4 MW 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: microcrystalline cellulose, maize starch, magnesium stearate and povidone.</Description>
</NDC>
<NDC>
<NDCCode>69238-1125-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (69238-1125-9) </PackageDescription>
<NDC11Code>69238-1125-09</NDC11Code>
<ProductNDC>69238-1125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nadolol</ProprietaryName>
<NonProprietaryName>Nadolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208832</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>NADOLOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
<Description>Nadolol tablets, USP are a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl) oxy]-2-propanol. Structural formula. C17H27NO4 MW 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: microcrystalline cellulose, maize starch, magnesium stearate and povidone.</Description>
</NDC>
<NDC>
<NDCCode>69238-1146-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1146-9) </PackageDescription>
<NDC11Code>69238-1146-09</NDC11Code>
<ProductNDC>69238-1146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208850</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&C Blue No. 2, FD&C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&C Yellow No. 6. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>69238-1147-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1147-9) </PackageDescription>
<NDC11Code>69238-1147-09</NDC11Code>
<ProductNDC>69238-1147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208850</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&C Blue No. 2, FD&C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&C Yellow No. 6. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>69238-1148-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1148-9) </PackageDescription>
<NDC11Code>69238-1148-09</NDC11Code>
<ProductNDC>69238-1148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208850</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&C Blue No. 2, FD&C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&C Yellow No. 6. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>69238-1149-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1149-9) </PackageDescription>
<NDC11Code>69238-1149-09</NDC11Code>
<ProductNDC>69238-1149</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208850</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&C Blue No. 2, FD&C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&C Yellow No. 6. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>69238-1154-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (69238-1154-9) </PackageDescription>
<NDC11Code>69238-1154-09</NDC11Code>
<ProductNDC>69238-1154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe</ProprietaryName>
<NonProprietaryName>Ezetimibe</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208803</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>EZETIMIBE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)., 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH., 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia., 4 In combination with a statin and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH)., 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.</IndicationAndUsage>
<Description>Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4- fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe tablets, USP are available as a tablet for oral use containing 10 mg of ezetimibe, USP and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>69238-1155-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (69238-1155-9) </PackageDescription>
<NDC11Code>69238-1155-09</NDC11Code>
<ProductNDC>69238-1155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208831</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
</NDC>
<NDC>
<NDCCode>69238-1156-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (69238-1156-9) </PackageDescription>
<NDC11Code>69238-1156-09</NDC11Code>
<ProductNDC>69238-1156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208831</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
</NDC>
<NDC>
<NDCCode>69238-1157-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (69238-1157-9) </PackageDescription>
<NDC11Code>69238-1157-09</NDC11Code>
<ProductNDC>69238-1157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208831</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
</NDC>
<NDC>
<NDCCode>69238-1158-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (69238-1158-9) </PackageDescription>
<NDC11Code>69238-1158-09</NDC11Code>
<ProductNDC>69238-1158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208831</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
</NDC>
<NDC>
<NDCCode>69238-1166-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1166-9) </PackageDescription>
<NDC11Code>69238-1166-09</NDC11Code>
<ProductNDC>69238-1166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207482</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84 g/mol. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.52 mg, 84.79 mg and 113.05 mg of doxepin hydrochloride, USP respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The hard gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 75 mg and 100 mg hard gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69238-1170-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1170-9) </PackageDescription>
<NDC11Code>69238-1170-09</NDC11Code>
<ProductNDC>69238-1170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207482</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84 g/mol. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.52 mg, 84.79 mg and 113.05 mg of doxepin hydrochloride, USP respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The hard gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 75 mg and 100 mg hard gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69238-1171-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1171-9) </PackageDescription>
<NDC11Code>69238-1171-09</NDC11Code>
<ProductNDC>69238-1171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207482</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84 g/mol. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.52 mg, 84.79 mg and 113.05 mg of doxepin hydrochloride, USP respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The hard gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 75 mg and 100 mg hard gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
</NDC>
</NDCList>