{
"NDC": [
{
"NDCCode": "43598-101-87",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43598-101-87) ",
"NDC11Code": "43598-0101-87",
"ProductNDC": "43598-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-01",
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"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "78850-101-01",
"PackageDescription": "20 PACKAGE in 1 PACKET (78850-101-01) > 2.87 g in 1 PACKAGE",
"NDC11Code": "78850-0101-01",
"ProductNDC": "78850-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Abutol Antiseptic Wet Wipes",
"ProprietaryNameSuffix": "Lemon And Mint",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "hand wipes to decrease bacteria on the skin. recommended for repeated use. for use when soap and water are not available."
},
{
"NDCCode": "43598-101-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43598-101-05) ",
"NDC11Code": "43598-0101-05",
"ProductNDC": "43598-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-101-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (43598-101-78) / 10 TABLET in 1 BLISTER PACK (43598-101-10) ",
"NDC11Code": "43598-0101-78",
"ProductNDC": "43598-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-101-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (43598-101-90) ",
"NDC11Code": "43598-0101-90",
"ProductNDC": "43598-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-098-87",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43598-098-87) ",
"NDC11Code": "43598-0098-87",
"ProductNDC": "43598-098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-099-87",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43598-099-87) ",
"NDC11Code": "43598-0099-87",
"ProductNDC": "43598-099",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-103-87",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43598-103-87) ",
"NDC11Code": "43598-0103-87",
"ProductNDC": "43598-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-283-35",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 PACKAGE (43598-283-35) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "43598-0283-35",
"ProductNDC": "43598-283",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTABLE, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208657",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170522",
"SamplePackage": "N",
"Description": "Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, USP an anthracycline topoisomerase inhibitor, that is encapsulated in PEGYLATED liposomes for intravenous use. The chemical name of doxorubicin hydrochloride, USP is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxohexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27H29NO11HCl; its molecular weight is 579.99. The structure formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each vial contains 20 mg or 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The PEGYLATED liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH adjustment; and sucrose 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the PEGYLATED liposomes. MPEG-DSPE has the following structural formula. n=ca. 45. HSPC has the following structural formula. m,n=14 or 16. Representation of a PEGYLATED liposome."
},
{
"NDCCode": "43598-541-25",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (43598-541-25) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "43598-0541-25",
"ProductNDC": "43598-541",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTABLE, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208657",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170522",
"SamplePackage": "N",
"Description": "Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, USP an anthracycline topoisomerase inhibitor, that is encapsulated in PEGYLATED liposomes for intravenous use. The chemical name of doxorubicin hydrochloride, USP is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxohexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27H29NO11HCl; its molecular weight is 579.99. The structure formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each vial contains 20 mg or 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The PEGYLATED liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH adjustment; and sucrose 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the PEGYLATED liposomes. MPEG-DSPE has the following structural formula. n=ca. 45. HSPC has the following structural formula. m,n=14 or 16. Representation of a PEGYLATED liposome."
},
{
"NDCCode": "43598-682-35",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 PACKAGE (43598-682-35) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "43598-0682-35",
"ProductNDC": "43598-682",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTABLE, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208657",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180313",
"SamplePackage": "N",
"Description": "Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in PEGYLATED liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxohexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-nap hthacenedione hydrochloride. The molecular formula is C27H29NO11HCl; its molecular weight is 579.99. The structure formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The PEGYLATED liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH adjustment; and sucrose 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the PEGYLATED liposomes. MPEG-DSPE has the following structural formula. n=ca. 45. HSPC has the following structural formula. m,n=14 or 16. Representation of a PEGYLATED liposome."
},
{
"NDCCode": "43598-683-25",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (43598-683-25) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "43598-0683-25",
"ProductNDC": "43598-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTABLE, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208657",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180313",
"SamplePackage": "N",
"Description": "Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in PEGYLATED liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxohexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-nap hthacenedione hydrochloride. The molecular formula is C27H29NO11HCl; its molecular weight is 579.99. The structure formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The PEGYLATED liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH adjustment; and sucrose 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the PEGYLATED liposomes. MPEG-DSPE has the following structural formula. n=ca. 45. HSPC has the following structural formula. m,n=14 or 16. Representation of a PEGYLATED liposome."
},
{
"NDCCode": "43598-164-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (43598-164-01) ",
"NDC11Code": "43598-0164-01",
"ProductNDC": "43598-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-164-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-164-05) ",
"NDC11Code": "43598-0164-05",
"ProductNDC": "43598-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-164-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (43598-164-10) ",
"NDC11Code": "43598-0164-10",
"ProductNDC": "43598-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-164-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43598-164-30) ",
"NDC11Code": "43598-0164-30",
"ProductNDC": "43598-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-164-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (43598-164-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-164-79) ",
"NDC11Code": "43598-0164-78",
"ProductNDC": "43598-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-165-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (43598-165-01) ",
"NDC11Code": "43598-0165-01",
"ProductNDC": "43598-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-165-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-165-05) ",
"NDC11Code": "43598-0165-05",
"ProductNDC": "43598-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-165-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43598-165-30) ",
"NDC11Code": "43598-0165-30",
"ProductNDC": "43598-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-165-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-165-60) ",
"NDC11Code": "43598-0165-60",
"ProductNDC": "43598-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-165-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (43598-165-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-165-79) ",
"NDC11Code": "43598-0165-78",
"ProductNDC": "43598-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-166-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (43598-166-01) ",
"NDC11Code": "43598-0166-01",
"ProductNDC": "43598-166",
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"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
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"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
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"IndicationAndUsage": "Micafungin in Sodium Chloride Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved [see Use in Specific Populations (8.4)]., 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.3)].",
"Description": "Micafungin in Sodium Chloride Injection is a premixed, iso-osmotic, sterile, nonpyrogenic solution for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin in Sodium Chloride Injection is supplied as a refrigerated 50 mL, 100 mL, or 150 mL single-dose GALAXY container in the following presentations. 50 mg/50 mL (1 mg/mL): containing 50 mg of micafungin (equivalent to 50.87 mg of micafungin sodium); 36 mg citric acid, anhydrous; 450 mg sodium chloride; 92 mg sodium citrate dihydrate;. 100 mg/100 mL (1 mg/mL): containing 100 mg of micafungin (equivalent to 101.73 mg of micafungin sodium); 72 mg citric acid, anhydrous; 900 mg sodium chloride; 184 mg sodium citrate dihydrate;. 150 mg/150 mL (1 mg/mL): containing 150 mg of micafungin (equivalent to 152.60 mg of micafungin sodium); 108 mg citric acid, anhydrous; 1350 mg sodium chloride; 276 mg sodium citrate dihydrate. : 1 Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium., 2 Each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium., 3 Each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium."
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"Description": "Micafungin in Sodium Chloride Injection is a premixed, iso-osmotic, sterile, nonpyrogenic solution for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin in Sodium Chloride Injection is supplied as a refrigerated 50 mL, 100 mL, or 150 mL single-dose GALAXY container in the following presentations. 50 mg/50 mL (1 mg/mL): containing 50 mg of micafungin (equivalent to 50.87 mg of micafungin sodium); 36 mg citric acid, anhydrous; 450 mg sodium chloride; 92 mg sodium citrate dihydrate;. 100 mg/100 mL (1 mg/mL): containing 100 mg of micafungin (equivalent to 101.73 mg of micafungin sodium); 72 mg citric acid, anhydrous; 900 mg sodium chloride; 184 mg sodium citrate dihydrate;. 150 mg/150 mL (1 mg/mL): containing 150 mg of micafungin (equivalent to 152.60 mg of micafungin sodium); 108 mg citric acid, anhydrous; 1350 mg sodium chloride; 276 mg sodium citrate dihydrate. : 1 Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium., 2 Each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium., 3 Each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium."
}
]
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<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
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<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
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<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
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<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
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<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
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<NDC>
<NDCCode>43598-099-87</NDCCode>
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<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
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<ApplicationNumber>ANDA214659</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
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<NDC>
<NDCCode>43598-283-35</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 PACKAGE (43598-283-35) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>43598-0283-35</NDC11Code>
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<ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName>
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<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208657</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, USP an anthracycline topoisomerase inhibitor, that is encapsulated in PEGYLATED liposomes for intravenous use. The chemical name of doxorubicin hydrochloride, USP is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxohexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27H29NO11HCl; its molecular weight is 579.99. The structure formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each vial contains 20 mg or 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The PEGYLATED liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH adjustment; and sucrose 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the PEGYLATED liposomes. MPEG-DSPE has the following structural formula. n=ca. 45. HSPC has the following structural formula. m,n=14 or 16. Representation of a PEGYLATED liposome.</Description>
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<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, USP an anthracycline topoisomerase inhibitor, that is encapsulated in PEGYLATED liposomes for intravenous use. The chemical name of doxorubicin hydrochloride, USP is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxohexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27H29NO11HCl; its molecular weight is 579.99. The structure formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each vial contains 20 mg or 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The PEGYLATED liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH adjustment; and sucrose 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the PEGYLATED liposomes. MPEG-DSPE has the following structural formula. n=ca. 45. HSPC has the following structural formula. m,n=14 or 16. Representation of a PEGYLATED liposome.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2025-11-27</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<Description>Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in PEGYLATED liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxohexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-nap hthacenedione hydrochloride. The molecular formula is C27H29NO11HCl; its molecular weight is 579.99. The structure formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The PEGYLATED liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH adjustment; and sucrose 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the PEGYLATED liposomes. MPEG-DSPE has the following structural formula. n=ca. 45. HSPC has the following structural formula. m,n=14 or 16. Representation of a PEGYLATED liposome.</Description>
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<ApplicationNumber>ANDA208657</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in PEGYLATED liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxohexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-nap hthacenedione hydrochloride. The molecular formula is C27H29NO11HCl; its molecular weight is 579.99. The structure formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The PEGYLATED liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH adjustment; and sucrose 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the PEGYLATED liposomes. MPEG-DSPE has the following structural formula. n=ca. 45. HSPC has the following structural formula. m,n=14 or 16. Representation of a PEGYLATED liposome.</Description>
</NDC>
<NDC>
<NDCCode>43598-164-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (43598-164-01) </PackageDescription>
<NDC11Code>43598-0164-01</NDC11Code>
<ProductNDC>43598-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-164-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-164-05) </PackageDescription>
<NDC11Code>43598-0164-05</NDC11Code>
<ProductNDC>43598-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-164-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (43598-164-10) </PackageDescription>
<NDC11Code>43598-0164-10</NDC11Code>
<ProductNDC>43598-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-164-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (43598-164-30) </PackageDescription>
<NDC11Code>43598-0164-30</NDC11Code>
<ProductNDC>43598-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-164-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (43598-164-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-164-79) </PackageDescription>
<NDC11Code>43598-0164-78</NDC11Code>
<ProductNDC>43598-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-165-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (43598-165-01) </PackageDescription>
<NDC11Code>43598-0165-01</NDC11Code>
<ProductNDC>43598-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-165-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-165-05) </PackageDescription>
<NDC11Code>43598-0165-05</NDC11Code>
<ProductNDC>43598-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-165-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (43598-165-30) </PackageDescription>
<NDC11Code>43598-0165-30</NDC11Code>
<ProductNDC>43598-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-165-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (43598-165-60) </PackageDescription>
<NDC11Code>43598-0165-60</NDC11Code>
<ProductNDC>43598-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-165-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (43598-165-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-165-79) </PackageDescription>
<NDC11Code>43598-0165-78</NDC11Code>
<ProductNDC>43598-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-166-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (43598-166-01) </PackageDescription>
<NDC11Code>43598-0166-01</NDC11Code>
<ProductNDC>43598-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
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<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
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<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
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<NDCCode>43598-166-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (43598-166-30) </PackageDescription>
<NDC11Code>43598-0166-30</NDC11Code>
<ProductNDC>43598-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
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<NDCCode>43598-166-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (43598-166-60) </PackageDescription>
<NDC11Code>43598-0166-60</NDC11Code>
<ProductNDC>43598-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
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<NDC>
<NDCCode>43598-166-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (43598-166-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-166-79) </PackageDescription>
<NDC11Code>43598-0166-78</NDC11Code>
<ProductNDC>43598-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
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<NDC>
<NDCCode>0338-9051-12</NDCCode>
<PackageDescription>12 CARTON in 1 CARTON (0338-9051-12) / 1 BAG in 1 CARTON (0338-9051-01) / 50 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-9051-12</NDC11Code>
<ProductNDC>0338-9051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Micafungin In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Micafungin In Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216142</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>MICAFUNGIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Micafungin in Sodium Chloride Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved [see Use in Specific Populations (8.4)]., 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.3)].</IndicationAndUsage>
<Description>Micafungin in Sodium Chloride Injection is a premixed, iso-osmotic, sterile, nonpyrogenic solution for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin in Sodium Chloride Injection is supplied as a refrigerated 50 mL, 100 mL, or 150 mL single-dose GALAXY container in the following presentations. 50 mg/50 mL (1 mg/mL): containing 50 mg of micafungin (equivalent to 50.87 mg of micafungin sodium); 36 mg citric acid, anhydrous; 450 mg sodium chloride; 92 mg sodium citrate dihydrate;. 100 mg/100 mL (1 mg/mL): containing 100 mg of micafungin (equivalent to 101.73 mg of micafungin sodium); 72 mg citric acid, anhydrous; 900 mg sodium chloride; 184 mg sodium citrate dihydrate;. 150 mg/150 mL (1 mg/mL): containing 150 mg of micafungin (equivalent to 152.60 mg of micafungin sodium); 108 mg citric acid, anhydrous; 1350 mg sodium chloride; 276 mg sodium citrate dihydrate. : 1 Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium., 2 Each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium., 3 Each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium.</Description>
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<NDCCode>0338-9053-12</NDCCode>
<PackageDescription>12 CARTON in 1 CARTON (0338-9053-12) / 1 BAG in 1 CARTON (0338-9053-01) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-9053-12</NDC11Code>
<ProductNDC>0338-9053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Micafungin In Sodium Chloride</ProprietaryName>
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<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216142</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>MICAFUNGIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Micafungin in Sodium Chloride Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved [see Use in Specific Populations (8.4)]., 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.3)].</IndicationAndUsage>
<Description>Micafungin in Sodium Chloride Injection is a premixed, iso-osmotic, sterile, nonpyrogenic solution for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin in Sodium Chloride Injection is supplied as a refrigerated 50 mL, 100 mL, or 150 mL single-dose GALAXY container in the following presentations. 50 mg/50 mL (1 mg/mL): containing 50 mg of micafungin (equivalent to 50.87 mg of micafungin sodium); 36 mg citric acid, anhydrous; 450 mg sodium chloride; 92 mg sodium citrate dihydrate;. 100 mg/100 mL (1 mg/mL): containing 100 mg of micafungin (equivalent to 101.73 mg of micafungin sodium); 72 mg citric acid, anhydrous; 900 mg sodium chloride; 184 mg sodium citrate dihydrate;. 150 mg/150 mL (1 mg/mL): containing 150 mg of micafungin (equivalent to 152.60 mg of micafungin sodium); 108 mg citric acid, anhydrous; 1350 mg sodium chloride; 276 mg sodium citrate dihydrate. : 1 Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium., 2 Each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium., 3 Each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium.</Description>
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