{
"NDC": [
{
"NDCCode": "62217-317-82",
"PackageDescription": "100 mL in 1 BOTTLE (62217-317-82) ",
"NDC11Code": "62217-0317-82",
"ProductNDC": "62217-317",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Sun Town City",
"NonProprietaryName": "Spf 30 Lotion Sunscreen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200213",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 80; 45; 60",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200213",
"SamplePackage": "N"
},
{
"NDCCode": "62217-317-11",
"PackageDescription": "237 mL in 1 BOTTLE (62217-317-11) ",
"NDC11Code": "62217-0317-11",
"ProductNDC": "62217-317",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Sun Town City",
"NonProprietaryName": "Spf 30 Lotion Sunscreen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200213",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 80; 45; 60",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200213",
"SamplePackage": "N"
},
{
"NDCCode": "62217-317-83",
"PackageDescription": "44 mL in 1 TUBE (62217-317-83) ",
"NDC11Code": "62217-0317-83",
"ProductNDC": "62217-317",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Sun Town City",
"NonProprietaryName": "Spf 30 Lotion Sunscreen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200213",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 80; 45; 60",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200213",
"SamplePackage": "N"
},
{
"NDCCode": "62217-069-82",
"PackageDescription": "100 mL in 1 BOTTLE (62217-069-82) ",
"NDC11Code": "62217-0069-82",
"ProductNDC": "62217-069",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth Sun Town City Spf 50 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191210",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 45; 80",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191210",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protectino measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "62217-074-82",
"PackageDescription": "100 mL in 1 BOTTLE (62217-074-82) ",
"NDC11Code": "62217-0074-82",
"ProductNDC": "62217-074",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth Sun Town City Baby Spf 50 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191210",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 45; 80",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191210",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "62217-079-82",
"PackageDescription": "100 mL in 1 BOTTLE (62217-079-82) ",
"NDC11Code": "62217-0079-82",
"ProductNDC": "62217-079",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth Sun Town City Spf 30 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 80; 45; 60",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191209",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging casued by the sun."
},
{
"NDCCode": "62217-305-82",
"PackageDescription": "100 mL in 1 BOTTLE (62217-305-82) ",
"NDC11Code": "62217-0305-82",
"ProductNDC": "62217-305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Sun Town City",
"NonProprietaryName": "Spf 50 Lotion Sunscreen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200210",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 45; 80",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200210",
"SamplePackage": "N"
},
{
"NDCCode": "62217-306-82",
"PackageDescription": "100 mL in 1 BOTTLE (62217-306-82) ",
"NDC11Code": "62217-0306-82",
"ProductNDC": "62217-306",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Sun Town City",
"NonProprietaryName": "Sport Spf 50 Lotion Sunscreen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200210",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 45; 80",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200210",
"SamplePackage": "N"
},
{
"NDCCode": "62217-307-82",
"PackageDescription": "100 mL in 1 BOTTLE (62217-307-82) ",
"NDC11Code": "62217-0307-82",
"ProductNDC": "62217-307",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Sun Town City",
"NonProprietaryName": "Kids Spf 50 Lotion Sunscreen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200210",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 45; 80",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200210",
"SamplePackage": "N"
},
{
"NDCCode": "62217-312-82",
"PackageDescription": "100 mL in 1 BOTTLE (62217-312-82) ",
"NDC11Code": "62217-0312-82",
"ProductNDC": "62217-312",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Sun Town City",
"NonProprietaryName": "Baby Spf 50 Lotion Sunscreen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200211",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 45; 80",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200211",
"SamplePackage": "N"
},
{
"NDCCode": "16590-317-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (16590-317-15)",
"NDC11Code": "16590-0317-15",
"ProductNDC": "16590-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19940527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074217",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.",
"Description": "Metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available as 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. (C15H25NO3)2C4H606. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients: Tablets contain lactose anhydrous, microcrystalline cellulose, sodium starch glycolate, talc, povidone, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and polysorbate 80. The 50 mg dosage strength also contains D&C Red No. 30 aluminum lake and the 100 mg dosage strength also contains FD&C Blue No. 2 aluminum lake."
},
{
"NDCCode": "16590-317-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16590-317-30)",
"NDC11Code": "16590-0317-30",
"ProductNDC": "16590-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19940527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074217",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.",
"Description": "Metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available as 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. (C15H25NO3)2C4H606. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients: Tablets contain lactose anhydrous, microcrystalline cellulose, sodium starch glycolate, talc, povidone, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and polysorbate 80. The 50 mg dosage strength also contains D&C Red No. 30 aluminum lake and the 100 mg dosage strength also contains FD&C Blue No. 2 aluminum lake."
},
{
"NDCCode": "16590-317-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (16590-317-60)",
"NDC11Code": "16590-0317-60",
"ProductNDC": "16590-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19940527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074217",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.",
"Description": "Metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available as 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. (C15H25NO3)2C4H606. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients: Tablets contain lactose anhydrous, microcrystalline cellulose, sodium starch glycolate, talc, povidone, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and polysorbate 80. The 50 mg dosage strength also contains D&C Red No. 30 aluminum lake and the 100 mg dosage strength also contains FD&C Blue No. 2 aluminum lake."
},
{
"NDCCode": "16590-317-71",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16590-317-71)",
"NDC11Code": "16590-0317-71",
"ProductNDC": "16590-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19940527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074217",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.",
"Description": "Metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available as 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. (C15H25NO3)2C4H606. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients: Tablets contain lactose anhydrous, microcrystalline cellulose, sodium starch glycolate, talc, povidone, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and polysorbate 80. The 50 mg dosage strength also contains D&C Red No. 30 aluminum lake and the 100 mg dosage strength also contains FD&C Blue No. 2 aluminum lake."
},
{
"NDCCode": "33342-317-10",
"PackageDescription": "90 TABLET in 1 BOTTLE (33342-317-10) ",
"NDC11Code": "33342-0317-10",
"ProductNDC": "33342-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208480",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240603",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
},
{
"NDCCode": "33342-317-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (33342-317-11) ",
"NDC11Code": "33342-0317-11",
"ProductNDC": "33342-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208480",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260521",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
},
{
"NDCCode": "33342-317-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-317-12) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "33342-0317-12",
"ProductNDC": "33342-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208480",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240603",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
},
{
"NDCCode": "33342-317-15",
"PackageDescription": "500 TABLET in 1 BOTTLE (33342-317-15) ",
"NDC11Code": "33342-0317-15",
"ProductNDC": "33342-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208480",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240603",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
},
{
"NDCCode": "33342-317-44",
"PackageDescription": "1000 TABLET in 1 BOTTLE (33342-317-44) ",
"NDC11Code": "33342-0317-44",
"ProductNDC": "33342-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208480",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260527",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
},
{
"NDCCode": "43598-317-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-317-05) ",
"NDC11Code": "43598-0317-05",
"ProductNDC": "43598-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "2.5; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-317-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43598-317-30) ",
"NDC11Code": "43598-0317-30",
"ProductNDC": "43598-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "2.5; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-317-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-317-60) ",
"NDC11Code": "43598-0317-60",
"ProductNDC": "43598-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "2.5; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-317-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (43598-317-90) ",
"NDC11Code": "43598-0317-90",
"ProductNDC": "43598-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "2.5; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "61919-317-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (61919-317-30) ",
"NDC11Code": "61919-0317-30",
"ProductNDC": "61919-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074644",
"LabelerName": "Direct_Rx",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190918",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).",
"Description": "Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. (C15H25NO3)2 C4H6O6. Metoprolol tartare, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients. Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "61919-317-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (61919-317-60) ",
"NDC11Code": "61919-0317-60",
"ProductNDC": "61919-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074644",
"LabelerName": "Direct_Rx",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190918",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).",
"Description": "Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. (C15H25NO3)2 C4H6O6. Metoprolol tartare, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients. Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "62217-001-13",
"PackageDescription": "100 mL in 1 TUBE (62217-001-13) ",
"NDC11Code": "62217-0001-13",
"ProductNDC": "62217-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth, Inc.",
"ProprietaryNameSuffix": "Luv That Sun Spf 30 Natural Mineral Sunscreen",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "31.16; 40.4625",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180206",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection."
},
{
"NDCCode": "62217-002-15",
"PackageDescription": "177 mL in 1 TUBE (62217-002-15) ",
"NDC11Code": "62217-0002-15",
"ProductNDC": "62217-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth, Inc.",
"ProprietaryNameSuffix": "Luv That Sun Spf 30 Natural Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180207",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTOCRYLENE",
"StrengthNumber": "18; 70; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180207",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection."
},
{
"NDCCode": "62217-003-15",
"PackageDescription": "177 mL in 1 TUBE (62217-003-15) ",
"NDC11Code": "62217-0003-15",
"ProductNDC": "62217-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth, Inc.",
"ProprietaryNameSuffix": "Luv That Sun Kids Spf 50 Natural Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 60",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180206",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection."
},
{
"NDCCode": "62217-004-03",
"PackageDescription": "88 mL in 1 TUBE (62217-004-03) ",
"NDC11Code": "62217-0004-03",
"ProductNDC": "62217-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Block Up Spf 50 Full Spectrum Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE",
"StrengthNumber": "75; 15; 50; 90; 20; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170515",
"SamplePackage": "N"
},
{
"NDCCode": "62217-004-16",
"PackageDescription": "30 mL in 1 TUBE (62217-004-16) ",
"NDC11Code": "62217-0004-16",
"ProductNDC": "62217-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Block Up Spf 50 Full Spectrum Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE",
"StrengthNumber": "75; 15; 50; 90; 20; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170515",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62217-317-82</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (62217-317-82) </PackageDescription>
<NDC11Code>62217-0317-82</NDC11Code>
<ProductNDC>62217-317</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Sun Town City</ProprietaryNameSuffix>
<NonProprietaryName>Spf 30 Lotion Sunscreen</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 80; 45; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62217-317-11</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (62217-317-11) </PackageDescription>
<NDC11Code>62217-0317-11</NDC11Code>
<ProductNDC>62217-317</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Sun Town City</ProprietaryNameSuffix>
<NonProprietaryName>Spf 30 Lotion Sunscreen</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 80; 45; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62217-317-83</NDCCode>
<PackageDescription>44 mL in 1 TUBE (62217-317-83) </PackageDescription>
<NDC11Code>62217-0317-83</NDC11Code>
<ProductNDC>62217-317</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Sun Town City</ProprietaryNameSuffix>
<NonProprietaryName>Spf 30 Lotion Sunscreen</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 80; 45; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62217-069-82</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (62217-069-82) </PackageDescription>
<NDC11Code>62217-0069-82</NDC11Code>
<ProductNDC>62217-069</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth Sun Town City Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 45; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protectino measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62217-074-82</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (62217-074-82) </PackageDescription>
<NDC11Code>62217-0074-82</NDC11Code>
<ProductNDC>62217-074</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth Sun Town City Baby Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 45; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62217-079-82</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (62217-079-82) </PackageDescription>
<NDC11Code>62217-0079-82</NDC11Code>
<ProductNDC>62217-079</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth Sun Town City Spf 30 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 80; 45; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging casued by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62217-305-82</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (62217-305-82) </PackageDescription>
<NDC11Code>62217-0305-82</NDC11Code>
<ProductNDC>62217-305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Sun Town City</ProprietaryNameSuffix>
<NonProprietaryName>Spf 50 Lotion Sunscreen</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 45; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62217-306-82</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (62217-306-82) </PackageDescription>
<NDC11Code>62217-0306-82</NDC11Code>
<ProductNDC>62217-306</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Sun Town City</ProprietaryNameSuffix>
<NonProprietaryName>Sport Spf 50 Lotion Sunscreen</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 45; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62217-307-82</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (62217-307-82) </PackageDescription>
<NDC11Code>62217-0307-82</NDC11Code>
<ProductNDC>62217-307</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Sun Town City</ProprietaryNameSuffix>
<NonProprietaryName>Kids Spf 50 Lotion Sunscreen</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 45; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62217-312-82</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (62217-312-82) </PackageDescription>
<NDC11Code>62217-0312-82</NDC11Code>
<ProductNDC>62217-312</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Sun Town City</ProprietaryNameSuffix>
<NonProprietaryName>Baby Spf 50 Lotion Sunscreen</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200211</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 45; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16590-317-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (16590-317-15)</PackageDescription>
<NDC11Code>16590-0317-15</NDC11Code>
<ProductNDC>16590-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074217</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available as 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. (C15H25NO3)2C4H606. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients: Tablets contain lactose anhydrous, microcrystalline cellulose, sodium starch glycolate, talc, povidone, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and polysorbate 80. The 50 mg dosage strength also contains D&C Red No. 30 aluminum lake and the 100 mg dosage strength also contains FD&C Blue No. 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>16590-317-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16590-317-30)</PackageDescription>
<NDC11Code>16590-0317-30</NDC11Code>
<ProductNDC>16590-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074217</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available as 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. (C15H25NO3)2C4H606. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients: Tablets contain lactose anhydrous, microcrystalline cellulose, sodium starch glycolate, talc, povidone, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and polysorbate 80. The 50 mg dosage strength also contains D&C Red No. 30 aluminum lake and the 100 mg dosage strength also contains FD&C Blue No. 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>16590-317-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16590-317-60)</PackageDescription>
<NDC11Code>16590-0317-60</NDC11Code>
<ProductNDC>16590-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074217</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available as 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. (C15H25NO3)2C4H606. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients: Tablets contain lactose anhydrous, microcrystalline cellulose, sodium starch glycolate, talc, povidone, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and polysorbate 80. The 50 mg dosage strength also contains D&C Red No. 30 aluminum lake and the 100 mg dosage strength also contains FD&C Blue No. 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>16590-317-71</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16590-317-71)</PackageDescription>
<NDC11Code>16590-0317-71</NDC11Code>
<ProductNDC>16590-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074217</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available as 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. (C15H25NO3)2C4H606. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients: Tablets contain lactose anhydrous, microcrystalline cellulose, sodium starch glycolate, talc, povidone, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and polysorbate 80. The 50 mg dosage strength also contains D&C Red No. 30 aluminum lake and the 100 mg dosage strength also contains FD&C Blue No. 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>33342-317-10</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (33342-317-10) </PackageDescription>
<NDC11Code>33342-0317-10</NDC11Code>
<ProductNDC>33342-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208480</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>33342-317-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (33342-317-11) </PackageDescription>
<NDC11Code>33342-0317-11</NDC11Code>
<ProductNDC>33342-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208480</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>33342-317-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-317-12) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0317-12</NDC11Code>
<ProductNDC>33342-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208480</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>33342-317-15</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (33342-317-15) </PackageDescription>
<NDC11Code>33342-0317-15</NDC11Code>
<ProductNDC>33342-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208480</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>33342-317-44</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (33342-317-44) </PackageDescription>
<NDC11Code>33342-0317-44</NDC11Code>
<ProductNDC>33342-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208480</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>43598-317-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-317-05) </PackageDescription>
<NDC11Code>43598-0317-05</NDC11Code>
<ProductNDC>43598-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>2.5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
<NDC>
<NDCCode>43598-317-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (43598-317-30) </PackageDescription>
<NDC11Code>43598-0317-30</NDC11Code>
<ProductNDC>43598-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>2.5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
<NDC>
<NDCCode>43598-317-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (43598-317-60) </PackageDescription>
<NDC11Code>43598-0317-60</NDC11Code>
<ProductNDC>43598-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>2.5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
<NDC>
<NDCCode>43598-317-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (43598-317-90) </PackageDescription>
<NDC11Code>43598-0317-90</NDC11Code>
<ProductNDC>43598-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>2.5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
<NDC>
<NDCCode>61919-317-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (61919-317-30) </PackageDescription>
<NDC11Code>61919-0317-30</NDC11Code>
<ProductNDC>61919-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074644</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. (C15H25NO3)2 C4H6O6. Metoprolol tartare, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients. Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>61919-317-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (61919-317-60) </PackageDescription>
<NDC11Code>61919-0317-60</NDC11Code>
<ProductNDC>61919-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074644</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. (C15H25NO3)2 C4H6O6. Metoprolol tartare, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients. Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62217-001-13</NDCCode>
<PackageDescription>100 mL in 1 TUBE (62217-001-13) </PackageDescription>
<NDC11Code>62217-0001-13</NDC11Code>
<ProductNDC>62217-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth, Inc.</ProprietaryName>
<ProprietaryNameSuffix>Luv That Sun Spf 30 Natural Mineral Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>31.16; 40.4625</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62217-002-15</NDCCode>
<PackageDescription>177 mL in 1 TUBE (62217-002-15) </PackageDescription>
<NDC11Code>62217-0002-15</NDC11Code>
<ProductNDC>62217-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth, Inc.</ProprietaryName>
<ProprietaryNameSuffix>Luv That Sun Spf 30 Natural Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180207</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>18; 70; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62217-003-15</NDCCode>
<PackageDescription>177 mL in 1 TUBE (62217-003-15) </PackageDescription>
<NDC11Code>62217-0003-15</NDC11Code>
<ProductNDC>62217-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth, Inc.</ProprietaryName>
<ProprietaryNameSuffix>Luv That Sun Kids Spf 50 Natural Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62217-004-03</NDCCode>
<PackageDescription>88 mL in 1 TUBE (62217-004-03) </PackageDescription>
<NDC11Code>62217-0004-03</NDC11Code>
<ProductNDC>62217-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Block Up Spf 50 Full Spectrum Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE</SubstanceName>
<StrengthNumber>75; 15; 50; 90; 20; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62217-004-16</NDCCode>
<PackageDescription>30 mL in 1 TUBE (62217-004-16) </PackageDescription>
<NDC11Code>62217-0004-16</NDC11Code>
<ProductNDC>62217-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Block Up Spf 50 Full Spectrum Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE</SubstanceName>
<StrengthNumber>75; 15; 50; 90; 20; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>