{
"NDC": [
{
"NDCCode": "62756-260-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (62756-260-05) ",
"NDC11Code": "62756-0260-05",
"ProductNDC": "62756-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077634",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060317",
"SamplePackage": "N",
"IndicationAndUsage": "Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C 8H 8N 2O 3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains. 50 mg : Black iron oxide. 100 mg : FD&C Blue #1 and FD&C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide."
},
{
"NDCCode": "62756-137-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (62756-137-05) ",
"NDC11Code": "62756-0137-05",
"ProductNDC": "62756-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077242",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220201",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules, and tablets is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: calcium carbonate, calcium sulfate dihydrate, glyceryl behenate, and pregelatinized maize starch. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, yellow iron oxide (300 mg and 400 mg) and red iron oxide (400 mg). The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: glyceryl behenate, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, talc, pregelatinized maize starch and Opadry YS-1-18111 (talc and hydroxypropyl cellulose)."
},
{
"NDCCode": "62756-138-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (62756-138-05) ",
"NDC11Code": "62756-0138-05",
"ProductNDC": "62756-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077242",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220201",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules, and tablets is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: calcium carbonate, calcium sulfate dihydrate, glyceryl behenate, and pregelatinized maize starch. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, yellow iron oxide (300 mg and 400 mg) and red iron oxide (400 mg). The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: glyceryl behenate, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, talc, pregelatinized maize starch and Opadry YS-1-18111 (talc and hydroxypropyl cellulose)."
},
{
"NDCCode": "62756-139-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (62756-139-05) ",
"NDC11Code": "62756-0139-05",
"ProductNDC": "62756-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077242",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220201",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules, and tablets is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: calcium carbonate, calcium sulfate dihydrate, glyceryl behenate, and pregelatinized maize starch. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, yellow iron oxide (300 mg and 400 mg) and red iron oxide (400 mg). The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: glyceryl behenate, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, talc, pregelatinized maize starch and Opadry YS-1-18111 (talc and hydroxypropyl cellulose)."
},
{
"NDCCode": "62756-446-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (62756-446-05)",
"NDC11Code": "62756-0446-05",
"ProductNDC": "62756-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070227",
"EndMarketingDate": "20190331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040755",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-04-02",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "62756-260-01",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (62756-260-01) ",
"NDC11Code": "62756-0260-01",
"ProductNDC": "62756-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077634",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060317",
"SamplePackage": "N",
"IndicationAndUsage": "Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C 8H 8N 2O 3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains. 50 mg : Black iron oxide. 100 mg : FD&C Blue #1 and FD&C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide."
},
{
"NDCCode": "62756-260-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (62756-260-02) ",
"NDC11Code": "62756-0260-02",
"ProductNDC": "62756-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077634",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060317",
"SamplePackage": "N",
"IndicationAndUsage": "Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains. 50 mg : Black iron oxide. 100 mg : FD&C Blue #1 and FD&C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide."
},
{
"NDCCode": "62756-260-03",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (62756-260-03) ",
"NDC11Code": "62756-0260-03",
"ProductNDC": "62756-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077634",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060317",
"SamplePackage": "N",
"IndicationAndUsage": "Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C 8H 8N 2O 3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains. 50 mg : Black iron oxide. 100 mg : FD&C Blue #1 and FD&C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide."
},
{
"NDCCode": "62756-260-04",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (62756-260-04) ",
"NDC11Code": "62756-0260-04",
"ProductNDC": "62756-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077634",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060317",
"SamplePackage": "N",
"IndicationAndUsage": "Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C 8H 8N 2O 3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains. 50 mg : Black iron oxide. 100 mg : FD&C Blue #1 and FD&C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide."
},
{
"NDCCode": "24658-260-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-05) ",
"NDC11Code": "24658-0260-05",
"ProductNDC": "24658-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078012",
"LabelerName": "PuraCap Laboratories LLC dba Blu Pharmaceuticals",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110401",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.",
"Description": "Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: calcium stearate NF, carnauba wax NF, colloidal silicon dioxide NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, microcrystalline cellulose NF, polyethylene glycol 3350 NF, polyvinyl alcohol USP, pregelatinized starch NF, sodium lauryl sulfate NF, talc USP and titanium dioxide USP. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and th molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "42806-260-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42806-260-05) ",
"NDC11Code": "42806-0260-05",
"ProductNDC": "42806-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078012",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170323",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.",
"Description": "Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: calcium stearate NF, carnauba wax NF, colloidal silicon dioxide NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, microcrystalline cellulose NF, polyethylene glycol 3350 NF, polyvinyl alcohol USP, pregelatinized starch NF, sodium lauryl sulfate NF, talc USP and titanium dioxide USP. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "47993-260-05",
"PackageDescription": "237 mL in 1 BOTTLE, PUMP (47993-260-05) ",
"NDC11Code": "47993-0260-05",
"ProductNDC": "47993-260",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200715",
"SamplePackage": "N",
"IndicationAndUsage": "Uses：. Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "59011-260-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-260-05)",
"NDC11Code": "59011-0260-05",
"ProductNDC": "59011-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ms Contin",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19870701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019516",
"LabelerName": "Purdue Pharma LP",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2014-04-28"
},
{
"NDCCode": "68001-260-05",
"PackageDescription": "90 TABLET in 1 BOTTLE (68001-260-05) ",
"NDC11Code": "68001-0260-05",
"ProductNDC": "68001-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinapril",
"NonProprietaryName": "Quinapril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077690",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140718",
"SamplePackage": "N",
"IndicationAndUsage": "Quinapril tablets USP 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 quinapril tablets USP. 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. Quinapril tablets USP may be used alone or in combination with thiazide diuretics.",
"Description": "Quinapril (quinapril hydrochloride) is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1- (ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3- isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril tablets USP contain 5 mg (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each film-coated tablet also contains crospovidone, iron oxide yellow, lecithin, magnesium carbonate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, povidone, talc, titanium dioxide and xanthan gum."
},
{
"NDCCode": "68428-260-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-260-05) ",
"NDC11Code": "68428-0260-05",
"ProductNDC": "68428-260",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boldo",
"NonProprietaryName": "Peumus Boldus Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100429",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "PEUMUS BOLDUS LEAF",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20100429",
"SamplePackage": "N"
},
{
"NDCCode": "68462-260-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-260-05) ",
"NDC11Code": "68462-0260-05",
"ProductNDC": "68462-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078906",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090917",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil hydrochloride extended-release 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 this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg."
},
{
"NDCCode": "70166-260-05",
"PackageDescription": "30 SYRINGE, PLASTIC in 1 PACKAGE (70166-260-05) > 1 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "70166-0260-05",
"ProductNDC": "70166-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091383",
"LabelerName": "Lohxa",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190604",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam USP, an antianxiety agent, has the chemical formula, 2H-1,4-benzodiazepin-2-one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (±)-:. Structure. C 15H 10Cl 2N 2O 2 MW: 321.16. Lorazepam, USP is a white to almost white powder, practically insoluble in water. Each mL of lorazepam oral concentrate, USPcontains 2 mg of lorazepam. The inactive ingredients are polyethylene glycol, propylene glycol and triacetin."
},
{
"NDCCode": "70554-260-05",
"PackageDescription": "5 mL in 1 PACKET (70554-260-05) ",
"NDC11Code": "70554-0260-05",
"ProductNDC": "70554-260",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Feel Good Labs Natural Pain",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180815",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "The Feel Good Lab",
"SubstanceName": "MENTHOL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180815",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains."
},
{
"NDCCode": "71052-260-05",
"PackageDescription": "500 g in 1 CONTAINER (71052-260-05) ",
"NDC11Code": "71052-0260-05",
"ProductNDC": "71052-260",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Leflunomide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210111",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "DARMERICA, LLC",
"SubstanceName": "LEFLUNOMIDE",
"StrengthNumber": "25",
"StrengthUnit": "g/25g",
"Status": "Unfinished",
"LastUpdate": "2026-03-10",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "11-JAN-21"
},
{
"NDCCode": "72865-260-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (72865-260-05) ",
"NDC11Code": "72865-0260-05",
"ProductNDC": "72865-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torsemide",
"NonProprietaryName": "Torsemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079234",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "TORSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240910",
"SamplePackage": "N",
"IndicationAndUsage": "Torsemide tablets are a loop diuretic indicated for: the treatment of edema associated with heart failure, renal disease or hepatic disease. (1.1) the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.2).",
"Description": "Torsemide is a diuretic of the pyridine-sulfonylurea class. Its chemical name is 1-isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl]urea and its structural formula is. Its molecular formula is C 16H 20N 4O 3S, its pKa is 6.42, and its molecular weight is 348.43. Torsemide USP is a white to off-white crystalline powder. The tablets for oral administration also contain crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone."
},
{
"NDCCode": "73377-260-05",
"PackageDescription": "500 g in 1 JAR (73377-260-05) ",
"NDC11Code": "73377-0260-05",
"ProductNDC": "73377-260",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mebendazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20231130",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "AX Pharmaceutical Corp",
"SubstanceName": "MEBENDAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-09-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19-DEC-24"
},
{
"NDCCode": "74658-010-05",
"PackageDescription": "260 mL in 1 BOTTLE (74658-010-05) ",
"NDC11Code": "74658-0010-05",
"ProductNDC": "74658-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200902",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "GUANGZHOU XUELEI COSMETIC CO.,LTD.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200902",
"SamplePackage": "N",
"IndicationAndUsage": "help decrease bacteria on the hands."
},
{
"NDCCode": "78436-306-05",
"PackageDescription": "260 mL in 1 CAN (78436-306-05) ",
"NDC11Code": "78436-0306-05",
"ProductNDC": "78436-306",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiblitz Antiseptic Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "PROVABLE COSMETICS KIMYA URUNLERI SANAYI DIS TICARET LIMITED SIRKETI ANKARA SUBESI",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "72",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201101",
"SamplePackage": "N"
},
{
"NDCCode": "84756-260-05",
"PackageDescription": "100 mL in 1 BOTTLE (84756-260-05) ",
"NDC11Code": "84756-0260-05",
"ProductNDC": "84756-260",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Beard Oil Natural Ingredients",
"NonProprietaryName": "Beard Oil Natural Ingredients",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "85766-260-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (85766-260-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "85766-0260-05",
"ProductNDC": "85766-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Besivance",
"NonProprietaryName": "Besifloxacin",
"DosageFormName": "SUSPENSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022308",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "BESIFLOXACIN",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260728",
"SamplePackage": "N",
"IndicationAndUsage": "Besifloxacin ophthalmic suspension 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: 1 Aerococcus viridans* , 2 CDC coryneform group G, 3 Corynebacterium pseudodiphtheriticum*, 4 Corynebacterium striatum*, 5 Haemophilus influenzae, 6 Moraxella catarrhalis*, 7 Moraxella lacunata*, 8 Pseudomonas aeruginosa*, 9 Staphylococcus aureus, 10 Staphylococcus epidermidis, 11 Staphylococcus hominis*, 12 Staphylococcus lugdunensis*, 13 Staphylococcus warneri*, 14 Streptococcus mitisgroup , 15 Streptococcus oralis, 16 Streptococcus pneumoniae.",
"Description": "Besifloxacin ophthalmic suspension 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite ®†(polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection). Each mL of besifloxacin ophthalmic suspension contains 6.63 mg besifloxacin hydrochloride equivalent to 6 mg besifloxacin base. It is an 8‑chloro fluoroquinolone anti-infective for topical ophthalmic use. Chemical Name: (+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride. Besifloxacin hydrochloride is a white to pale yellowish-white powder. Each mL contains. Active:besifloxacin 0.6% (6 mg/mL);. Inactives:polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide, and water for injection. Preservative:benzalkonium chloride 0.01%. Besifloxacin ophthalmic suspension is an isotonic suspension with an osmolality of approximately 290 mOsm/kg."
},
{
"NDCCode": "87638-002-05",
"PackageDescription": "260 mL in 1 BOTTLE (87638-002-05) ",
"NDC11Code": "87638-0002-05",
"ProductNDC": "87638-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anzoon Antibacterial Mouth Wash",
"NonProprietaryName": "Cetylpyridinium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260428",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Shandong AZC Biotechnology Co.,Ltd.",
"SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
"StrengthNumber": ".027",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260428",
"SamplePackage": "N",
"IndicationAndUsage": "Antigingivitis, Antiplaque, Anti-caries."
},
{
"NDCCode": "62756-029-11",
"PackageDescription": "25 kg in 1 DRUM (62756-029-11) ",
"NDC11Code": "62756-0029-11",
"ProductNDC": "62756-029",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "POWDER",
"StartMarketingDate": "20151005",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Unfinished",
"LastUpdate": "2026-04-20",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "05-OCT-15"
},
{
"NDCCode": "62756-031-11",
"PackageDescription": "25 kg in 1 DRUM (62756-031-11) ",
"NDC11Code": "62756-0031-11",
"ProductNDC": "62756-031",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "S Flurbiprofen",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230105",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "ESFLURBIPROFEN",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-30",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "05-JAN-23"
},
{
"NDCCode": "62756-160-08",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (62756-160-08) ",
"NDC11Code": "62756-0160-08",
"ProductNDC": "62756-160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090931",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100715",
"SamplePackage": "N",
"IndicationAndUsage": "Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.",
"Description": "Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white or almost white crystalline powder that melts with decomposition at approximately 230°C. It is slightly soluble in water, freely soluble in formic acid, slightly soluble in anhydrous ethanol, sparingly soluble in methanol, slightly soluble in glacial acetic acid, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C20H28N2O5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule USP for oral administration contains tamsulosin hydrochloride USP 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, methacrylic acid copolymer dispersion, hypromellose acetate succinate, triethyl citrate, talc, and sodium lauryl sulfate. The capsule shell contains gelatin, sodium lauryl sulfate, FD&C blue No. 2, ferric oxide red, ferric oxide yellow, and titanium dioxide.Imprinting black ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. It meets USP Dissolution Test 9."
},
{
"NDCCode": "62756-160-13",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (62756-160-13) ",
"NDC11Code": "62756-0160-13",
"ProductNDC": "62756-160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090931",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100715",
"SamplePackage": "N",
"IndicationAndUsage": "Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.",
"Description": "Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white or almost white crystalline powder that melts with decomposition at approximately 230°C. It is slightly soluble in water, freely soluble in formic acid, slightly soluble in anhydrous ethanol, sparingly soluble in methanol, slightly soluble in glacial acetic acid, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C20H28N2O5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule USP for oral administration contains tamsulosin hydrochloride USP 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, methacrylic acid copolymer dispersion, hypromellose acetate succinate, triethyl citrate, talc, and sodium lauryl sulfate. The capsule shell contains gelatin, sodium lauryl sulfate, FD&C blue No. 2, ferric oxide red, ferric oxide yellow, and titanium dioxide.Imprinting black ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. It meets USP Dissolution Test 9."
}
]
}
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<NDC>
<NDCCode>62756-260-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (62756-260-05) </PackageDescription>
<NDC11Code>62756-0260-05</NDC11Code>
<ProductNDC>62756-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
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<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077634</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C 8H 8N 2O 3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains. 50 mg : Black iron oxide. 100 mg : FD&C Blue #1 and FD&C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide.</Description>
</NDC>
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<NDCCode>62756-137-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (62756-137-05) </PackageDescription>
<NDC11Code>62756-0137-05</NDC11Code>
<ProductNDC>62756-137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules, and tablets is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: calcium carbonate, calcium sulfate dihydrate, glyceryl behenate, and pregelatinized maize starch. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, yellow iron oxide (300 mg and 400 mg) and red iron oxide (400 mg). The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: glyceryl behenate, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, talc, pregelatinized maize starch and Opadry YS-1-18111 (talc and hydroxypropyl cellulose).</Description>
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<NDC>
<NDCCode>62756-138-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (62756-138-05) </PackageDescription>
<NDC11Code>62756-0138-05</NDC11Code>
<ProductNDC>62756-138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077242</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
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</NDC>
<NDC>
<NDCCode>62756-139-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (62756-139-05) </PackageDescription>
<NDC11Code>62756-0139-05</NDC11Code>
<ProductNDC>62756-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077242</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules, and tablets is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: calcium carbonate, calcium sulfate dihydrate, glyceryl behenate, and pregelatinized maize starch. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, yellow iron oxide (300 mg and 400 mg) and red iron oxide (400 mg). The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: glyceryl behenate, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, talc, pregelatinized maize starch and Opadry YS-1-18111 (talc and hydroxypropyl cellulose).</Description>
</NDC>
<NDC>
<NDCCode>62756-446-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (62756-446-05)</PackageDescription>
<NDC11Code>62756-0446-05</NDC11Code>
<ProductNDC>62756-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070227</StartMarketingDate>
<EndMarketingDate>20190331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040755</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-04-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>62756-260-01</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (62756-260-01) </PackageDescription>
<NDC11Code>62756-0260-01</NDC11Code>
<ProductNDC>62756-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077634</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C 8H 8N 2O 3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains. 50 mg : Black iron oxide. 100 mg : FD&C Blue #1 and FD&C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>62756-260-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (62756-260-02) </PackageDescription>
<NDC11Code>62756-0260-02</NDC11Code>
<ProductNDC>62756-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077634</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains. 50 mg : Black iron oxide. 100 mg : FD&C Blue #1 and FD&C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide.</Description>
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<PackageDescription>100 CAPSULE in 1 BOTTLE (62756-260-03) </PackageDescription>
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<ProductNDC>62756-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20060317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077634</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C 8H 8N 2O 3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains. 50 mg : Black iron oxide. 100 mg : FD&C Blue #1 and FD&C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide.</Description>
</NDC>
<NDC>
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<PackageDescription>1000 CAPSULE in 1 BOTTLE (62756-260-04) </PackageDescription>
<NDC11Code>62756-0260-04</NDC11Code>
<ProductNDC>62756-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077634</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C 8H 8N 2O 3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains. 50 mg : Black iron oxide. 100 mg : FD&C Blue #1 and FD&C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>24658-260-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-05) </PackageDescription>
<NDC11Code>24658-0260-05</NDC11Code>
<ProductNDC>24658-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078012</ApplicationNumber>
<LabelerName>PuraCap Laboratories LLC dba Blu Pharmaceuticals</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: calcium stearate NF, carnauba wax NF, colloidal silicon dioxide NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, microcrystalline cellulose NF, polyethylene glycol 3350 NF, polyvinyl alcohol USP, pregelatinized starch NF, sodium lauryl sulfate NF, talc USP and titanium dioxide USP. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and th molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
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<NDCCode>42806-260-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42806-260-05) </PackageDescription>
<NDC11Code>42806-0260-05</NDC11Code>
<ProductNDC>42806-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078012</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: calcium stearate NF, carnauba wax NF, colloidal silicon dioxide NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, microcrystalline cellulose NF, polyethylene glycol 3350 NF, polyvinyl alcohol USP, pregelatinized starch NF, sodium lauryl sulfate NF, talc USP and titanium dioxide USP. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>47993-260-05</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PUMP (47993-260-05) </PackageDescription>
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<ProductNDC>47993-260</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses：. Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59011-260-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-260-05)</PackageDescription>
<NDC11Code>59011-0260-05</NDC11Code>
<ProductNDC>59011-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ms Contin</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19870701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019516</ApplicationNumber>
<LabelerName>Purdue Pharma LP</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-04-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>68001-260-05</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68001-260-05) </PackageDescription>
<NDC11Code>68001-0260-05</NDC11Code>
<ProductNDC>68001-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinapril</ProprietaryName>
<NonProprietaryName>Quinapril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077690</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>QUINAPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quinapril tablets USP 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 quinapril tablets USP. 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. Quinapril tablets USP may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>Quinapril (quinapril hydrochloride) is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1- (ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3- isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril tablets USP contain 5 mg (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each film-coated tablet also contains crospovidone, iron oxide yellow, lecithin, magnesium carbonate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, povidone, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
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<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-260-05) </PackageDescription>
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<ProductNDC>68428-260</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boldo</ProprietaryName>
<NonProprietaryName>Peumus Boldus Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100429</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>PEUMUS BOLDUS LEAF</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68462-260-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-260-05) </PackageDescription>
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<ProductNDC>68462-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078906</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil hydrochloride extended-release 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 this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg.</Description>
</NDC>
<NDC>
<NDCCode>70166-260-05</NDCCode>
<PackageDescription>30 SYRINGE, PLASTIC in 1 PACKAGE (70166-260-05) > 1 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>70166-0260-05</NDC11Code>
<ProductNDC>70166-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091383</ApplicationNumber>
<LabelerName>Lohxa</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 2H-1,4-benzodiazepin-2-one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (±)-:. Structure. C 15H 10Cl 2N 2O 2 MW: 321.16. Lorazepam, USP is a white to almost white powder, practically insoluble in water. Each mL of lorazepam oral concentrate, USPcontains 2 mg of lorazepam. The inactive ingredients are polyethylene glycol, propylene glycol and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>70554-260-05</NDCCode>
<PackageDescription>5 mL in 1 PACKET (70554-260-05) </PackageDescription>
<NDC11Code>70554-0260-05</NDC11Code>
<ProductNDC>70554-260</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Feel Good Labs Natural Pain</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180815</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>The Feel Good Lab</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71052-260-05</NDCCode>
<PackageDescription>500 g in 1 CONTAINER (71052-260-05) </PackageDescription>
<NDC11Code>71052-0260-05</NDC11Code>
<ProductNDC>71052-260</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Leflunomide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210111</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DARMERICA, LLC</LabelerName>
<SubstanceName>LEFLUNOMIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/25g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-10</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-JAN-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>72865-260-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (72865-260-05) </PackageDescription>
<NDC11Code>72865-0260-05</NDC11Code>
<ProductNDC>72865-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torsemide</ProprietaryName>
<NonProprietaryName>Torsemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079234</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TORSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Torsemide tablets are a loop diuretic indicated for: the treatment of edema associated with heart failure, renal disease or hepatic disease. (1.1) the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.2).</IndicationAndUsage>
<Description>Torsemide is a diuretic of the pyridine-sulfonylurea class. Its chemical name is 1-isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl]urea and its structural formula is. Its molecular formula is C 16H 20N 4O 3S, its pKa is 6.42, and its molecular weight is 348.43. Torsemide USP is a white to off-white crystalline powder. The tablets for oral administration also contain crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone.</Description>
</NDC>
<NDC>
<NDCCode>73377-260-05</NDCCode>
<PackageDescription>500 g in 1 JAR (73377-260-05) </PackageDescription>
<NDC11Code>73377-0260-05</NDC11Code>
<ProductNDC>73377-260</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mebendazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20231130</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>AX Pharmaceutical Corp</LabelerName>
<SubstanceName>MEBENDAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-09-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19-DEC-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>74658-010-05</NDCCode>
<PackageDescription>260 mL in 1 BOTTLE (74658-010-05) </PackageDescription>
<NDC11Code>74658-0010-05</NDC11Code>
<ProductNDC>74658-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200902</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>GUANGZHOU XUELEI COSMETIC CO.,LTD.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>help decrease bacteria on the hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78436-306-05</NDCCode>
<PackageDescription>260 mL in 1 CAN (78436-306-05) </PackageDescription>
<NDC11Code>78436-0306-05</NDC11Code>
<ProductNDC>78436-306</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiblitz Antiseptic Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>PROVABLE COSMETICS KIMYA URUNLERI SANAYI DIS TICARET LIMITED SIRKETI ANKARA SUBESI</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84756-260-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84756-260-05) </PackageDescription>
<NDC11Code>84756-0260-05</NDC11Code>
<ProductNDC>84756-260</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beard Oil Natural Ingredients</ProprietaryName>
<NonProprietaryName>Beard Oil Natural Ingredients</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Luoxin E� Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85766-260-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (85766-260-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>85766-0260-05</NDC11Code>
<ProductNDC>85766-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Besivance</ProprietaryName>
<NonProprietaryName>Besifloxacin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260109</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022308</ApplicationNumber>
<LabelerName>Sportpharm LLC</LabelerName>
<SubstanceName>BESIFLOXACIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Besifloxacin ophthalmic suspension 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: 1 Aerococcus viridans* , 2 CDC coryneform group G, 3 Corynebacterium pseudodiphtheriticum*, 4 Corynebacterium striatum*, 5 Haemophilus influenzae, 6 Moraxella catarrhalis*, 7 Moraxella lacunata*, 8 Pseudomonas aeruginosa*, 9 Staphylococcus aureus, 10 Staphylococcus epidermidis, 11 Staphylococcus hominis*, 12 Staphylococcus lugdunensis*, 13 Staphylococcus warneri*, 14 Streptococcus mitisgroup , 15 Streptococcus oralis, 16 Streptococcus pneumoniae.</IndicationAndUsage>
<Description>Besifloxacin ophthalmic suspension 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite ®†(polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection). Each mL of besifloxacin ophthalmic suspension contains 6.63 mg besifloxacin hydrochloride equivalent to 6 mg besifloxacin base. It is an 8‑chloro fluoroquinolone anti-infective for topical ophthalmic use. Chemical Name: (+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride. Besifloxacin hydrochloride is a white to pale yellowish-white powder. Each mL contains. Active:besifloxacin 0.6% (6 mg/mL);. Inactives:polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide, and water for injection. Preservative:benzalkonium chloride 0.01%. Besifloxacin ophthalmic suspension is an isotonic suspension with an osmolality of approximately 290 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>87638-002-05</NDCCode>
<PackageDescription>260 mL in 1 BOTTLE (87638-002-05) </PackageDescription>
<NDC11Code>87638-0002-05</NDC11Code>
<ProductNDC>87638-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anzoon Antibacterial Mouth Wash</ProprietaryName>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Shandong AZC Biotechnology Co.,Ltd.</LabelerName>
<SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>.027</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Antigingivitis, Antiplaque, Anti-caries.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62756-029-11</NDCCode>
<PackageDescription>25 kg in 1 DRUM (62756-029-11) </PackageDescription>
<NDC11Code>62756-0029-11</NDC11Code>
<ProductNDC>62756-029</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20151005</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-04-20</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-OCT-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62756-031-11</NDCCode>
<PackageDescription>25 kg in 1 DRUM (62756-031-11) </PackageDescription>
<NDC11Code>62756-0031-11</NDC11Code>
<ProductNDC>62756-031</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>S Flurbiprofen</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230105</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
<SubstanceName>ESFLURBIPROFEN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-30</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-JAN-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62756-160-08</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (62756-160-08) </PackageDescription>
<NDC11Code>62756-0160-08</NDC11Code>
<ProductNDC>62756-160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090931</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white or almost white crystalline powder that melts with decomposition at approximately 230°C. It is slightly soluble in water, freely soluble in formic acid, slightly soluble in anhydrous ethanol, sparingly soluble in methanol, slightly soluble in glacial acetic acid, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C20H28N2O5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule USP for oral administration contains tamsulosin hydrochloride USP 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, methacrylic acid copolymer dispersion, hypromellose acetate succinate, triethyl citrate, talc, and sodium lauryl sulfate. The capsule shell contains gelatin, sodium lauryl sulfate, FD&C blue No. 2, ferric oxide red, ferric oxide yellow, and titanium dioxide.Imprinting black ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. It meets USP Dissolution Test 9.</Description>
</NDC>
<NDC>
<NDCCode>62756-160-13</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (62756-160-13) </PackageDescription>
<NDC11Code>62756-0160-13</NDC11Code>
<ProductNDC>62756-160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090931</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white or almost white crystalline powder that melts with decomposition at approximately 230°C. It is slightly soluble in water, freely soluble in formic acid, slightly soluble in anhydrous ethanol, sparingly soluble in methanol, slightly soluble in glacial acetic acid, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C20H28N2O5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule USP for oral administration contains tamsulosin hydrochloride USP 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, methacrylic acid copolymer dispersion, hypromellose acetate succinate, triethyl citrate, talc, and sodium lauryl sulfate. The capsule shell contains gelatin, sodium lauryl sulfate, FD&C blue No. 2, ferric oxide red, ferric oxide yellow, and titanium dioxide.Imprinting black ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. It meets USP Dissolution Test 9.</Description>
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