{
"NDC": [
{
"NDCCode": "42658-108-08",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (42658-108-08) ",
"NDC11Code": "42658-0108-08",
"ProductNDC": "42658-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206557",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):.",
"Description": "Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42658-108-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42658-108-01) ",
"NDC11Code": "42658-0108-01",
"ProductNDC": "42658-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206557",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):.",
"Description": "Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42658-108-04",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42658-108-04) ",
"NDC11Code": "42658-0108-04",
"ProductNDC": "42658-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206557",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):.",
"Description": "Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42658-102-08",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42658-102-08) ",
"NDC11Code": "42658-0102-08",
"ProductNDC": "42658-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204795",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets, USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide and macrogol. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "42658-103-08",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42658-103-08) ",
"NDC11Code": "42658-0103-08",
"ProductNDC": "42658-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204795",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets, USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide and macrogol. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "42658-104-08",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42658-104-08) ",
"NDC11Code": "42658-0104-08",
"ProductNDC": "42658-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204795",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets, USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide and macrogol. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "42658-105-08",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42658-105-08) ",
"NDC11Code": "42658-0105-08",
"ProductNDC": "42658-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206061",
"LabelerName": "Hisun Pharmaceuiticals USA, Inc",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Pravastatin sodium tablets USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S-[1α (β S*,δ S*),2α,6α,8β( R*),8aα]]-. Structural formula. C 23H 35NaO 7 MW 446.52. Pravastatin sodium is an odorless, white to yellowish-white powder or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: magnesium oxide, anhydrous dibasic calcium phosphate, lactose monohydrate, cellulose powder, yellow ferric oxide, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate."
},
{
"NDCCode": "42658-106-08",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42658-106-08) ",
"NDC11Code": "42658-0106-08",
"ProductNDC": "42658-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206061",
"LabelerName": "Hisun Pharmaceuiticals USA, Inc",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Pravastatin sodium tablets USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S-[1α (β S*,δ S*),2α,6α,8β( R*),8aα]]-. Structural formula. C 23H 35NaO 7 MW 446.52. Pravastatin sodium is an odorless, white to yellowish-white powder or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: magnesium oxide, anhydrous dibasic calcium phosphate, lactose monohydrate, cellulose powder, yellow ferric oxide, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate."
},
{
"NDCCode": "42658-107-08",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42658-107-08) ",
"NDC11Code": "42658-0107-08",
"ProductNDC": "42658-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206061",
"LabelerName": "Hisun Pharmaceuiticals USA, Inc",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Pravastatin sodium tablets USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S-[1α (β S*,δ S*),2α,6α,8β( R*),8aα]]-. Structural formula. C 23H 35NaO 7 MW 446.52. Pravastatin sodium is an odorless, white to yellowish-white powder or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: magnesium oxide, anhydrous dibasic calcium phosphate, lactose monohydrate, cellulose powder, yellow ferric oxide, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate."
},
{
"NDCCode": "42658-109-08",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (42658-109-08) ",
"NDC11Code": "42658-0109-08",
"ProductNDC": "42658-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206557",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):.",
"Description": "Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42658-110-08",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (42658-110-08) ",
"NDC11Code": "42658-0110-08",
"ProductNDC": "42658-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206557",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):.",
"Description": "Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42658-111-08",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (42658-111-08) ",
"NDC11Code": "42658-0111-08",
"ProductNDC": "42658-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206557",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):.",
"Description": "Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42658-119-08",
"PackageDescription": "1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-08) ",
"NDC11Code": "42658-0119-08",
"ProductNDC": "42658-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205269",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride orally disintegrating tablets, USP are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white to off-white powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride orally disintegrating tablets, USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablet, USP contains 5 mg or 10 mg of donepezil hydrochloride. Inactive ingredients are microcrystalline cellulose, mannitol, sucralose, sodium chloride, peppermint flavor, crospovidone, colloidal silicon dioxide, magnesium stearate. Additionally, the 10 mg tablet contains ferric oxide (yellow) as a coloring agent."
},
{
"NDCCode": "42658-120-08",
"PackageDescription": "1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-120-08) ",
"NDC11Code": "42658-0120-08",
"ProductNDC": "42658-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205269",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride orally disintegrating tablets, USP are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white to off-white powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride orally disintegrating tablets, USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablet, USP contains 5 mg or 10 mg of donepezil hydrochloride. Inactive ingredients are microcrystalline cellulose, mannitol, sucralose, sodium chloride, peppermint flavor, crospovidone, colloidal silicon dioxide, magnesium stearate. Additionally, the 10 mg tablet contains ferric oxide (yellow) as a coloring agent."
},
{
"NDCCode": "14789-108-05",
"PackageDescription": "24 BAG in 1 BOX (14789-108-05) / 50 mL in 1 BAG (14789-108-08) ",
"NDC11Code": "14789-0108-05",
"ProductNDC": "14789-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214727",
"LabelerName": "Nexus Pharamaceuticals Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "14.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2023-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210228",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K+ LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.",
"Description": "This Potassium Chloride Injection, is a sterile, nonpyrogenic, highly concentrated, readyto-use, solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents."
},
{
"NDCCode": "17511-108-08",
"PackageDescription": "1 mg in 1 DRUM (17511-108-08) ",
"NDC11Code": "17511-0108-08",
"ProductNDC": "17511-108",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20200210",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "COHANCE LIFESCIENCES LIMITED",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mg",
"Status": "Unfinished",
"LastUpdate": "2025-12-30",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "10-FEB-20"
},
{
"NDCCode": "25000-108-08",
"PackageDescription": "1 BOTTLE in 1 CARTON (25000-108-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "25000-0108-08",
"ProductNDC": "25000-108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen Extended-release Tablets, 650 Mg",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215486",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221014",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain: 1 temporarily relieves minor aches and pains due to: ."
},
{
"NDCCode": "36800-108-08",
"PackageDescription": "222 mL in 1 BOTTLE, PLASTIC (36800-108-08)",
"NDC11Code": "36800-0108-08",
"ProductNDC": "36800-108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare",
"ProprietaryNameSuffix": "Antibacterial Foaming Hand Berry Blast",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140727",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "TOPCO ASSOCIATES LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "HELPS ELIMINATE BACTERIA ON HANDS."
},
{
"NDCCode": "53113-108-08",
"PackageDescription": "228 g in 1 JAR (53113-108-08)",
"NDC11Code": "53113-0108-08",
"ProductNDC": "53113-108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ice Quake",
"ProprietaryNameSuffix": "Muscle Rub",
"NonProprietaryName": "Menthol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Gadal Laboratories Inc",
"SubstanceName": "MENTHOL",
"StrengthNumber": "2",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses. For the temporary relief of minor aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains, 6 sport injuries."
},
{
"NDCCode": "54157-108-08",
"PackageDescription": "200 g in 1 TUBE (54157-108-08)",
"NDC11Code": "54157-0108-08",
"ProductNDC": "54157-108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Upc 801803 00203 Megafresh Fluoride Tooth",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20170603",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "American Amenities, Inc.",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Aids in the prevention of dental cavities."
},
{
"NDCCode": "55550-108-08",
"PackageDescription": "1.5 mL in 1 POUCH (55550-108-08) ",
"NDC11Code": "55550-0108-08",
"ProductNDC": "55550-108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "08",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990505",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Total Resources International Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "66.5",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19990505",
"SamplePackage": "N",
"IndicationAndUsage": "Directions wet hands and wrists thoroughly with product and allow to dry without wiping supervise children while using this product."
},
{
"NDCCode": "57664-108-08",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-108-08) ",
"NDC11Code": "57664-0108-08",
"ProductNDC": "57664-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040863",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20101203",
"SamplePackage": "N"
},
{
"NDCCode": "59779-700-08",
"PackageDescription": "1 BOTTLE in 1 CARTON (59779-700-08) > 108 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "59779-0700-08",
"ProductNDC": "59779-700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120221",
"SamplePackage": "N"
},
{
"NDCCode": "63148-108-08",
"PackageDescription": "222 mL in 1 BOTTLE, PLASTIC (63148-108-08)",
"NDC11Code": "63148-0108-08",
"ProductNDC": "63148-108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Giant Eagle Red Berry Foaming",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170509",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Apollo Health and Beauty Care Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "helps eliminate bacteria on hands."
},
{
"NDCCode": "64092-108-08",
"PackageDescription": "237 mL in 1 BOTTLE (64092-108-08)",
"NDC11Code": "64092-0108-08",
"ProductNDC": "64092-108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Healthcare Instant Hand Sanitizer Vanilla Scent",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110810",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "USE: : 1 for handwashing to decrease bacteria on the skin, 2 recommended for repeated use."
},
{
"NDCCode": "64220-108-08",
"PackageDescription": "25 kg in 1 DRUM (64220-108-08)",
"NDC11Code": "64220-0108-08",
"ProductNDC": "64220-108",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Eprosartan Mesylate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110209",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "EPROSARTAN MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2019-02-23",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "70120-108-08",
"PackageDescription": "1500 CAPSULE in 1 BAG (70120-108-08)",
"NDC11Code": "70120-0108-08",
"ProductNDC": "70120-108",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20191225",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "APL HEALTHCARE LIMITED",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2020-10-29",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "70156-108-08",
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"StrengthUnit": "mg/g; mg/g",
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{
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"PackageDescription": "113.4 g in 1 JAR (70994-108-08) ",
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"ProductTypeName": "HUMAN OTC DRUG",
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"IndicationAndUsage": "■ temporarily protects minor ■ burns ■ sun overexposed skin ■ helps prevent and temporarily protects and helps relieve ■ chapped skin ■ helps protect from the drying effects of wind and cold weather ■ temporarily protects and helps relieve minor skin irritation and itching due to ■ sunburns ■ scars ■ puffy eyes."
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{
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"ProprietaryName": "Balsamum Peruvianum",
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"LabelerName": "Washington Homeopathic Products",
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"PackageNdcExcludeFlag": "N",
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<NDCList>
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<Description>Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP.</Description>
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<Description>Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP.</Description>
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<NDCCode>42658-108-04</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42658-108-04) </PackageDescription>
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<Status>Deprecated</Status>
<LastUpdate>2024-05-07</LastUpdate>
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<Description>Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC>
<NDCCode>42658-102-08</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42658-102-08) </PackageDescription>
<NDC11Code>42658-0102-08</NDC11Code>
<ProductNDC>42658-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204795</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets, USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide and macrogol. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>42658-103-08</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42658-103-08) </PackageDescription>
<NDC11Code>42658-0103-08</NDC11Code>
<ProductNDC>42658-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets, USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide and macrogol. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>42658-104-08</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42658-104-08) </PackageDescription>
<NDC11Code>42658-0104-08</NDC11Code>
<ProductNDC>42658-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<ApplicationNumber>ANDA204795</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets, USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide and macrogol. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>42658-105-08</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42658-105-08) </PackageDescription>
<NDC11Code>42658-0105-08</NDC11Code>
<ProductNDC>42658-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206061</ApplicationNumber>
<LabelerName>Hisun Pharmaceuiticals USA, Inc</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Pravastatin sodium tablets USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S-[1α (β S*,δ S*),2α,6α,8β( R*),8aα]]-. Structural formula. C 23H 35NaO 7 MW 446.52. Pravastatin sodium is an odorless, white to yellowish-white powder or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: magnesium oxide, anhydrous dibasic calcium phosphate, lactose monohydrate, cellulose powder, yellow ferric oxide, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>42658-106-08</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42658-106-08) </PackageDescription>
<NDC11Code>42658-0106-08</NDC11Code>
<ProductNDC>42658-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206061</ApplicationNumber>
<LabelerName>Hisun Pharmaceuiticals USA, Inc</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Pravastatin sodium tablets USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S-[1α (β S*,δ S*),2α,6α,8β( R*),8aα]]-. Structural formula. C 23H 35NaO 7 MW 446.52. Pravastatin sodium is an odorless, white to yellowish-white powder or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: magnesium oxide, anhydrous dibasic calcium phosphate, lactose monohydrate, cellulose powder, yellow ferric oxide, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>42658-107-08</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42658-107-08) </PackageDescription>
<NDC11Code>42658-0107-08</NDC11Code>
<ProductNDC>42658-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206061</ApplicationNumber>
<LabelerName>Hisun Pharmaceuiticals USA, Inc</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Pravastatin sodium tablets USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S-[1α (β S*,δ S*),2α,6α,8β( R*),8aα]]-. Structural formula. C 23H 35NaO 7 MW 446.52. Pravastatin sodium is an odorless, white to yellowish-white powder or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: magnesium oxide, anhydrous dibasic calcium phosphate, lactose monohydrate, cellulose powder, yellow ferric oxide, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>42658-109-08</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42658-109-08) </PackageDescription>
<NDC11Code>42658-0109-08</NDC11Code>
<ProductNDC>42658-109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206557</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):.</IndicationAndUsage>
<Description>Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42658-110-08</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42658-110-08) </PackageDescription>
<NDC11Code>42658-0110-08</NDC11Code>
<ProductNDC>42658-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206557</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):.</IndicationAndUsage>
<Description>Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42658-111-08</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42658-111-08) </PackageDescription>
<NDC11Code>42658-0111-08</NDC11Code>
<ProductNDC>42658-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206557</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):.</IndicationAndUsage>
<Description>Simvastatin, USP is a prodrug of 3-hydoroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 10 mg, 20 mg, 40 mg, or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, butylated hydroxyanisole, anhydrous citric acid, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide and iron oxide red. Additionally the 10 mg, 40 mg, and 80 mg strengths contain talc; the 10 mg and 20 mg strengths contain iron oxide yellow; and the 20 mg strength contains iron oxide black. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42658-119-08</NDCCode>
<PackageDescription>1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-08) </PackageDescription>
<NDC11Code>42658-0119-08</NDC11Code>
<ProductNDC>42658-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205269</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride orally disintegrating tablets, USP are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white to off-white powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride orally disintegrating tablets, USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablet, USP contains 5 mg or 10 mg of donepezil hydrochloride. Inactive ingredients are microcrystalline cellulose, mannitol, sucralose, sodium chloride, peppermint flavor, crospovidone, colloidal silicon dioxide, magnesium stearate. Additionally, the 10 mg tablet contains ferric oxide (yellow) as a coloring agent.</Description>
</NDC>
<NDC>
<NDCCode>42658-120-08</NDCCode>
<PackageDescription>1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-120-08) </PackageDescription>
<NDC11Code>42658-0120-08</NDC11Code>
<ProductNDC>42658-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205269</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride orally disintegrating tablets, USP are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white to off-white powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride orally disintegrating tablets, USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablet, USP contains 5 mg or 10 mg of donepezil hydrochloride. Inactive ingredients are microcrystalline cellulose, mannitol, sucralose, sodium chloride, peppermint flavor, crospovidone, colloidal silicon dioxide, magnesium stearate. Additionally, the 10 mg tablet contains ferric oxide (yellow) as a coloring agent.</Description>
</NDC>
<NDC>
<NDCCode>14789-108-05</NDCCode>
<PackageDescription>24 BAG in 1 BOX (14789-108-05) / 50 mL in 1 BAG (14789-108-08) </PackageDescription>
<NDC11Code>14789-0108-05</NDC11Code>
<ProductNDC>14789-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214727</ApplicationNumber>
<LabelerName>Nexus Pharamaceuticals Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>14.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K+ LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.</IndicationAndUsage>
<Description>This Potassium Chloride Injection, is a sterile, nonpyrogenic, highly concentrated, readyto-use, solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents.</Description>
</NDC>
<NDC>
<NDCCode>17511-108-08</NDCCode>
<PackageDescription>1 mg in 1 DRUM (17511-108-08) </PackageDescription>
<NDC11Code>17511-0108-08</NDC11Code>
<ProductNDC>17511-108</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20200210</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>COHANCE LIFESCIENCES LIMITED</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-30</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-FEB-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>25000-108-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (25000-108-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>25000-0108-08</NDC11Code>
<ProductNDC>25000-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen Extended-release Tablets, 650 Mg</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215486</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain: 1 temporarily relieves minor aches and pains due to: .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-108-08</NDCCode>
<PackageDescription>222 mL in 1 BOTTLE, PLASTIC (36800-108-08)</PackageDescription>
<NDC11Code>36800-0108-08</NDC11Code>
<ProductNDC>36800-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare</ProprietaryName>
<ProprietaryNameSuffix>Antibacterial Foaming Hand Berry Blast</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140727</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>HELPS ELIMINATE BACTERIA ON HANDS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53113-108-08</NDCCode>
<PackageDescription>228 g in 1 JAR (53113-108-08)</PackageDescription>
<NDC11Code>53113-0108-08</NDC11Code>
<ProductNDC>53113-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ice Quake</ProprietaryName>
<ProprietaryNameSuffix>Muscle Rub</ProprietaryNameSuffix>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Gadal Laboratories Inc</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses. For the temporary relief of minor aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains, 6 sport injuries.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54157-108-08</NDCCode>
<PackageDescription>200 g in 1 TUBE (54157-108-08)</PackageDescription>
<NDC11Code>54157-0108-08</NDC11Code>
<ProductNDC>54157-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Upc 801803 00203 Megafresh Fluoride Tooth</ProprietaryName>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20170603</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>American Amenities, Inc.</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55550-108-08</NDCCode>
<PackageDescription>1.5 mL in 1 POUCH (55550-108-08) </PackageDescription>
<NDC11Code>55550-0108-08</NDC11Code>
<ProductNDC>55550-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>08</ProprietaryNameSuffix>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Total Resources International Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>66.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions wet hands and wrists thoroughly with product and allow to dry without wiping supervise children while using this product.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57664-108-08</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-108-08) </PackageDescription>
<NDC11Code>57664-0108-08</NDC11Code>
<ProductNDC>57664-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040863</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59779-700-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59779-700-08) > 108 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>59779-0700-08</NDC11Code>
<ProductNDC>59779-700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63148-108-08</NDCCode>
<PackageDescription>222 mL in 1 BOTTLE, PLASTIC (63148-108-08)</PackageDescription>
<NDC11Code>63148-0108-08</NDC11Code>
<ProductNDC>63148-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Giant Eagle Red Berry Foaming</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170509</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Apollo Health and Beauty Care Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps eliminate bacteria on hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64092-108-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (64092-108-08)</PackageDescription>
<NDC11Code>64092-0108-08</NDC11Code>
<ProductNDC>64092-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Healthcare Instant Hand Sanitizer Vanilla Scent</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110810</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USE: : 1 for handwashing to decrease bacteria on the skin, 2 recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64220-108-08</NDCCode>
<PackageDescription>25 kg in 1 DRUM (64220-108-08)</PackageDescription>
<NDC11Code>64220-0108-08</NDC11Code>
<ProductNDC>64220-108</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Eprosartan Mesylate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110209</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>EPROSARTAN MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2019-02-23</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70120-108-08</NDCCode>
<PackageDescription>1500 CAPSULE in 1 BAG (70120-108-08)</PackageDescription>
<NDC11Code>70120-0108-08</NDC11Code>
<ProductNDC>70120-108</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20191225</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>APL HEALTHCARE LIMITED</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-10-29</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70156-108-08</NDCCode>
<PackageDescription>227 g in 1 BOTTLE (70156-108-08) </PackageDescription>
<NDC11Code>70156-0108-08</NDC11Code>
<ProductNDC>70156-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide 10%, Sulfur 2%</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide, Sulfur</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180206</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Noble Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70994-108-08</NDCCode>
<PackageDescription>113.4 g in 1 JAR (70994-108-08) </PackageDescription>
<NDC11Code>70994-0108-08</NDC11Code>
<ProductNDC>70994-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin Repair</ProprietaryName>
<NonProprietaryName>Rosa Canina, Matricaria Recutita, Archillea Millefolium</NonProprietaryName>
<DosageFormName>SALVE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Spry Life LLC</LabelerName>
<SubstanceName>ROSA MOSCHATA OIL; MATRICARIA RECUTITA; ACHILLEA MILLEFOLIUM</SubstanceName>
<StrengthNumber>3.06; .19; .19</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily protects minor ■ burns ■ sun overexposed skin ■ helps prevent and temporarily protects and helps relieve ■ chapped skin ■ helps protect from the drying effects of wind and cold weather ■ temporarily protects and helps relieve minor skin irritation and itching due to ■ sunburns ■ scars ■ puffy eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-108-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-108-08) </PackageDescription>
<NDC11Code>71919-0108-08</NDC11Code>
<ProductNDC>71919-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Balsamum Peruvianum</ProprietaryName>
<NonProprietaryName>Balsam Peru</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110421</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>BALSAM PERU</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>