{
"NDC": [
{
"NDCCode": "64547-7040-3",
"PackageDescription": "25 kg in 1 BOX (64547-7040-3) ",
"NDC11Code": "64547-7040-03",
"ProductNDC": "64547-7040",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Avobenzone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190523",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Merck, S.L.",
"SubstanceName": "AVOBENZONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "23-MAY-19"
},
{
"NDCCode": "14639-7040-3",
"PackageDescription": "25 kg in 1 BOX (14639-7040-3)",
"NDC11Code": "14639-7040-03",
"ProductNDC": "14639-7040",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Avobenzone",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20181025",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Merck KGaA",
"SubstanceName": "AVOBENZONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "50114-7040-3",
"PackageDescription": "3 AMPULE in 1 CARTON (50114-7040-3) > 1.1 mL in 1 AMPULE",
"NDC11Code": "50114-7040-03",
"ProductNDC": "50114-7040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spascupreel",
"NonProprietaryName": "Aconitum Napellus, Ammonium Bromide, Citrullus Colocynthis Fruit Pulp, Atropine Sulfate, Gelsemium Sempervirens Root, Magnesium Phosphate, Dibasic Trihydrate, Veratrum Album Root, Passiflora Incarnata Flowering Top, Matricaria Recutita, Amanita Muscaria Fruiting Body And Cupric Sulfate",
"DosageFormName": "INJECTION",
"RouteName": "INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20110120",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; AMMONIUM BROMIDE; ATROPINE SULFATE; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC SULFATE; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VERATRUM ALBUM ROOT",
"StrengthNumber": "6; 4; 4; 6; 4; 6; 6; 6; 3; 2; 6",
"StrengthUnit": "[hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-12-19"
},
{
"NDCCode": "53002-7040-3",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (53002-7040-3) ",
"NDC11Code": "53002-7040-03",
"ProductNDC": "53002-7040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin Monohydrate/ Macrocrystalline",
"NonProprietaryName": "Nitrofurantoin Monohydrate/macrocrystalline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110525",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020064",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin is an antibacterial agent specific for urinary tract infections. The nitrofurantoin monohydrate/macrocrystals capsules brand of nitrofurantoin is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 934P, corn starch, compressible sugar, D&C Yellow No. 10, edible gray ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 8."
},
{
"NDCCode": "64547-6023-3",
"PackageDescription": "15 kg in 1 BAG (64547-6023-3)",
"NDC11Code": "64547-6023-03",
"ProductNDC": "64547-6023",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110722",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck,S.L.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".73",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64547-6024-3",
"PackageDescription": "15 kg in 1 BAG (64547-6024-3)",
"NDC11Code": "64547-6024-03",
"ProductNDC": "64547-6024",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110722",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck, S.L",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".8",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64547-6025-3",
"PackageDescription": "15 kg in 1 BAG (64547-6025-3)",
"NDC11Code": "64547-6025-03",
"ProductNDC": "64547-6025",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110722",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck, S.L.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".83",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64547-6026-3",
"PackageDescription": "15 kg in 1 BAG (64547-6026-3)",
"NDC11Code": "64547-6026-03",
"ProductNDC": "64547-6026",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110725",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck, S.L.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".82",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64547-6027-3",
"PackageDescription": "15 kg in 1 BAG (64547-6027-3)",
"NDC11Code": "64547-6027-03",
"ProductNDC": "64547-6027",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110722",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck, S.L.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".93",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64547-6028-3",
"PackageDescription": "15 kg in 1 BAG (64547-6028-3)",
"NDC11Code": "64547-6028-03",
"ProductNDC": "64547-6028",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110725",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck, S.L.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".81",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64547-6029-3",
"PackageDescription": "15 kg in 1 BAG (64547-6029-3)",
"NDC11Code": "64547-6029-03",
"ProductNDC": "64547-6029",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110725",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck, S.L.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".92",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64547-6030-3",
"PackageDescription": "15 kg in 1 BAG (64547-6030-3)",
"NDC11Code": "64547-6030-03",
"ProductNDC": "64547-6030",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110725",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck, S.L.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".85",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64547-6031-3",
"PackageDescription": "15 kg in 1 BAG (64547-6031-3)",
"NDC11Code": "64547-6031-03",
"ProductNDC": "64547-6031",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110725",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck, S.L.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".88",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64547-7001-3",
"PackageDescription": "23.9 L in 1 DRUM (64547-7001-3) ",
"NDC11Code": "64547-7001-03",
"ProductNDC": "64547-7001",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Octocrylene",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20180822",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck, S.L.",
"SubstanceName": "OCTOCRYLENE",
"StrengthNumber": "1",
"StrengthUnit": "kg/L",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "22-AUG-18"
},
{
"NDCCode": "0071-0155-23",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0071-0155-23) ",
"NDC11Code": "00071-0155-23",
"ProductNDC": "0071-0155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipitor",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19961217",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020702",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961217",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.",
"Description": "LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion."
},
{
"NDCCode": "0071-0156-23",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0071-0156-23) ",
"NDC11Code": "00071-0156-23",
"ProductNDC": "0071-0156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipitor",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19961217",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020702",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961217",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.",
"Description": "LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion."
},
{
"NDCCode": "0071-0157-23",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0071-0157-23) ",
"NDC11Code": "00071-0157-23",
"ProductNDC": "0071-0157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipitor",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19961217",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020702",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961217",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.",
"Description": "LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion."
},
{
"NDCCode": "0071-0158-23",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0071-0158-23) ",
"NDC11Code": "00071-0158-23",
"ProductNDC": "0071-0158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipitor",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000407",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020702",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000407",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.",
"Description": "LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion."
},
{
"NDCCode": "0074-7040-02",
"PackageDescription": "2 CARTON in 1 CARTON (0074-7040-02) / 1 KIT in 1 CARTON * 1 mL in 1 SYRINGE, GLASS (0074-7032-01) ",
"NDC11Code": "00074-7040-02",
"ProductNDC": "0074-7040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skyrizi",
"NonProprietaryName": "Risankizumab-rzaa",
"DosageFormName": "KIT",
"StartMarketingDate": "20240304",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761105",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240304",
"SamplePackage": "N",
"IndicationAndUsage": "SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).",
"Description": "Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7."
},
{
"NDCCode": "0574-7040-04",
"PackageDescription": "4 PACKET in 1 BOX (0574-7040-04) / 1 SUPPOSITORY in 1 PACKET",
"NDC11Code": "00574-7040-04",
"ProductNDC": "0574-7040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belladonna And Opium",
"NonProprietaryName": "Atropa Belladonna And Opium",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "19970422",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Padagis US LLC",
"SubstanceName": "ATROPA BELLADONNA; OPIUM",
"StrengthNumber": "16.2; 60",
"StrengthUnit": "mg/1; mg/1",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180822",
"SamplePackage": "N",
"IndicationAndUsage": "Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Each belladonna and opium suppository contains (in a water-soluble base consisting of polyethylene glycol 400, 1450, 8000 and polysorbate 60). Belladonna (16.2 mg) and Opium (30 mg). Powdered belladonna extract 16.2 mg and powdered opium 30 mg. Belladonna (16.2 mg) and Opium (60 mg). Powdered belladonna extract 16.2 mg and powdered opium 60 mg. This drug falls into the pharmacological/therapeutic class of narcotic analgesic/antispasmotic agents. The pharmacologically active principles present in the belladonna extract component of belladonna and opium suppositories are. Established Name: Atropine. Chemical Name: dl Tropyl Tropate. Established Name: Scopolamine. Chemical Name: dl Scopolamine. Opium contains more than twenty alkaloids, the principle ones being morphine (10%), narcotine (6%), papaverine (1%) and codeine (0.5%). The major pharmacologically active principle of the powdered opium component of belladonna and opium suppositories, however, is. Name: Morphine. Chemical Name: 7, 8-Didehydro-4, 5-epoxy-17-Methyl-morphinan-3, 6-diol."
},
{
"NDCCode": "0574-7040-12",
"PackageDescription": "12 PACKET in 1 BOX (0574-7040-12) / 1 SUPPOSITORY in 1 PACKET",
"NDC11Code": "00574-7040-12",
"ProductNDC": "0574-7040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belladonna And Opium",
"NonProprietaryName": "Atropa Belladonna And Opium",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "19970422",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Padagis US LLC",
"SubstanceName": "ATROPA BELLADONNA; OPIUM",
"StrengthNumber": "16.2; 60",
"StrengthUnit": "mg/1; mg/1",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19970422",
"SamplePackage": "N",
"IndicationAndUsage": "Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Each belladonna and opium suppository contains (in a water-soluble base consisting of polyethylene glycol 400, 1450, 8000 and polysorbate 60). Belladonna (16.2 mg) and Opium (30 mg). Powdered belladonna extract 16.2 mg and powdered opium 30 mg. Belladonna (16.2 mg) and Opium (60 mg). Powdered belladonna extract 16.2 mg and powdered opium 60 mg. This drug falls into the pharmacological/therapeutic class of narcotic analgesic/antispasmotic agents. The pharmacologically active principles present in the belladonna extract component of belladonna and opium suppositories are. Established Name: Atropine. Chemical Name: dl Tropyl Tropate. Established Name: Scopolamine. Chemical Name: dl Scopolamine. Opium contains more than twenty alkaloids, the principle ones being morphine (10%), narcotine (6%), papaverine (1%) and codeine (0.5%). The major pharmacologically active principle of the powdered opium component of belladonna and opium suppositories, however, is. Name: Morphine. Chemical Name: 7, 8-Didehydro-4, 5-epoxy-17-Methyl-morphinan-3, 6-diol."
},
{
"NDCCode": "16571-136-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (16571-136-09) ",
"NDC11Code": "16571-0136-09",
"ProductNDC": "16571-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.",
"Description": "Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "16571-136-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16571-136-10) ",
"NDC11Code": "16571-0136-10",
"ProductNDC": "16571-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.",
"Description": "Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "16571-136-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-136-50) ",
"NDC11Code": "16571-0136-50",
"ProductNDC": "16571-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.",
"Description": "Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "16571-137-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (16571-137-09) ",
"NDC11Code": "16571-0137-09",
"ProductNDC": "16571-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.",
"Description": "Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "16571-137-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16571-137-10) ",
"NDC11Code": "16571-0137-10",
"ProductNDC": "16571-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.",
"Description": "Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "16571-137-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-137-50) ",
"NDC11Code": "16571-0137-50",
"ProductNDC": "16571-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.",
"Description": "Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "16571-138-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (16571-138-09) ",
"NDC11Code": "16571-0138-09",
"ProductNDC": "16571-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.",
"Description": "Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "16571-138-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16571-138-10) ",
"NDC11Code": "16571-0138-10",
"ProductNDC": "16571-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.",
"Description": "Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "16571-138-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-138-50) ",
"NDC11Code": "16571-0138-50",
"ProductNDC": "16571-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.",
"Description": "Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
}
]
}
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<NDCList>
<NDC>
<NDCCode>64547-7040-3</NDCCode>
<PackageDescription>25 kg in 1 BOX (64547-7040-3) </PackageDescription>
<NDC11Code>64547-7040-03</NDC11Code>
<ProductNDC>64547-7040</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Avobenzone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190523</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Merck, S.L.</LabelerName>
<SubstanceName>AVOBENZONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-MAY-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14639-7040-3</NDCCode>
<PackageDescription>25 kg in 1 BOX (14639-7040-3)</PackageDescription>
<NDC11Code>14639-7040-03</NDC11Code>
<ProductNDC>14639-7040</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Avobenzone</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20181025</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Merck KGaA</LabelerName>
<SubstanceName>AVOBENZONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50114-7040-3</NDCCode>
<PackageDescription>3 AMPULE in 1 CARTON (50114-7040-3) > 1.1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>50114-7040-03</NDC11Code>
<ProductNDC>50114-7040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spascupreel</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Ammonium Bromide, Citrullus Colocynthis Fruit Pulp, Atropine Sulfate, Gelsemium Sempervirens Root, Magnesium Phosphate, Dibasic Trihydrate, Veratrum Album Root, Passiflora Incarnata Flowering Top, Matricaria Recutita, Amanita Muscaria Fruiting Body And Cupric Sulfate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20110120</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; AMMONIUM BROMIDE; ATROPINE SULFATE; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC SULFATE; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>6; 4; 4; 6; 4; 6; 6; 6; 3; 2; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>53002-7040-3</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (53002-7040-3) </PackageDescription>
<NDC11Code>53002-7040-03</NDC11Code>
<ProductNDC>53002-7040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin Monohydrate/ Macrocrystalline</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystalline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110525</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020064</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin is an antibacterial agent specific for urinary tract infections. The nitrofurantoin monohydrate/macrocrystals capsules brand of nitrofurantoin is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 934P, corn starch, compressible sugar, D&C Yellow No. 10, edible gray ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 8.</Description>
</NDC>
<NDC>
<NDCCode>64547-6023-3</NDCCode>
<PackageDescription>15 kg in 1 BAG (64547-6023-3)</PackageDescription>
<NDC11Code>64547-6023-03</NDC11Code>
<ProductNDC>64547-6023</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110722</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck,S.L.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.73</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64547-6024-3</NDCCode>
<PackageDescription>15 kg in 1 BAG (64547-6024-3)</PackageDescription>
<NDC11Code>64547-6024-03</NDC11Code>
<ProductNDC>64547-6024</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110722</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck, S.L</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.8</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64547-6025-3</NDCCode>
<PackageDescription>15 kg in 1 BAG (64547-6025-3)</PackageDescription>
<NDC11Code>64547-6025-03</NDC11Code>
<ProductNDC>64547-6025</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110722</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck, S.L.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.83</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64547-6026-3</NDCCode>
<PackageDescription>15 kg in 1 BAG (64547-6026-3)</PackageDescription>
<NDC11Code>64547-6026-03</NDC11Code>
<ProductNDC>64547-6026</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110725</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck, S.L.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.82</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64547-6027-3</NDCCode>
<PackageDescription>15 kg in 1 BAG (64547-6027-3)</PackageDescription>
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<LabelerName>Merck, S.L.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.93</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64547-6028-3</NDCCode>
<PackageDescription>15 kg in 1 BAG (64547-6028-3)</PackageDescription>
<NDC11Code>64547-6028-03</NDC11Code>
<ProductNDC>64547-6028</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110725</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck, S.L.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.81</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64547-6029-3</NDCCode>
<PackageDescription>15 kg in 1 BAG (64547-6029-3)</PackageDescription>
<NDC11Code>64547-6029-03</NDC11Code>
<ProductNDC>64547-6029</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110725</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck, S.L.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.92</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64547-6030-3</NDCCode>
<PackageDescription>15 kg in 1 BAG (64547-6030-3)</PackageDescription>
<NDC11Code>64547-6030-03</NDC11Code>
<ProductNDC>64547-6030</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110725</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck, S.L.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.85</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64547-6031-3</NDCCode>
<PackageDescription>15 kg in 1 BAG (64547-6031-3)</PackageDescription>
<NDC11Code>64547-6031-03</NDC11Code>
<ProductNDC>64547-6031</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110725</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck, S.L.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.88</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64547-7001-3</NDCCode>
<PackageDescription>23.9 L in 1 DRUM (64547-7001-3) </PackageDescription>
<NDC11Code>64547-7001-03</NDC11Code>
<ProductNDC>64547-7001</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Octocrylene</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20180822</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck, S.L.</LabelerName>
<SubstanceName>OCTOCRYLENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-AUG-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0071-0155-23</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0071-0155-23) </PackageDescription>
<NDC11Code>00071-0155-23</NDC11Code>
<ProductNDC>0071-0155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipitor</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961217</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961217</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
</NDC>
<NDC>
<NDCCode>0071-0156-23</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0071-0156-23) </PackageDescription>
<NDC11Code>00071-0156-23</NDC11Code>
<ProductNDC>0071-0156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipitor</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961217</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961217</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
</NDC>
<NDC>
<NDCCode>0071-0157-23</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0071-0157-23) </PackageDescription>
<NDC11Code>00071-0157-23</NDC11Code>
<ProductNDC>0071-0157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipitor</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961217</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</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>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961217</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
</NDC>
<NDC>
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<ProductNDC>0071-0158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000407</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000407</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
</NDC>
<NDC>
<NDCCode>0074-7040-02</NDCCode>
<PackageDescription>2 CARTON in 1 CARTON (0074-7040-02) / 1 KIT in 1 CARTON * 1 mL in 1 SYRINGE, GLASS (0074-7032-01) </PackageDescription>
<NDC11Code>00074-7040-02</NDC11Code>
<ProductNDC>0074-7040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Skyrizi</ProprietaryName>
<NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240304</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761105</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
<Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
</NDC>
<NDC>
<NDCCode>0574-7040-04</NDCCode>
<PackageDescription>4 PACKET in 1 BOX (0574-7040-04) / 1 SUPPOSITORY in 1 PACKET</PackageDescription>
<NDC11Code>00574-7040-04</NDC11Code>
<ProductNDC>0574-7040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belladonna And Opium</ProprietaryName>
<NonProprietaryName>Atropa Belladonna And Opium</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>19970422</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Padagis US LLC</LabelerName>
<SubstanceName>ATROPA BELLADONNA; OPIUM</SubstanceName>
<StrengthNumber>16.2; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-04-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Each belladonna and opium suppository contains (in a water-soluble base consisting of polyethylene glycol 400, 1450, 8000 and polysorbate 60). Belladonna (16.2 mg) and Opium (30 mg). Powdered belladonna extract 16.2 mg and powdered opium 30 mg. Belladonna (16.2 mg) and Opium (60 mg). Powdered belladonna extract 16.2 mg and powdered opium 60 mg. This drug falls into the pharmacological/therapeutic class of narcotic analgesic/antispasmotic agents. The pharmacologically active principles present in the belladonna extract component of belladonna and opium suppositories are. Established Name: Atropine. Chemical Name: dl Tropyl Tropate. Established Name: Scopolamine. Chemical Name: dl Scopolamine. Opium contains more than twenty alkaloids, the principle ones being morphine (10%), narcotine (6%), papaverine (1%) and codeine (0.5%). The major pharmacologically active principle of the powdered opium component of belladonna and opium suppositories, however, is. Name: Morphine. Chemical Name: 7, 8-Didehydro-4, 5-epoxy-17-Methyl-morphinan-3, 6-diol.</Description>
</NDC>
<NDC>
<NDCCode>0574-7040-12</NDCCode>
<PackageDescription>12 PACKET in 1 BOX (0574-7040-12) / 1 SUPPOSITORY in 1 PACKET</PackageDescription>
<NDC11Code>00574-7040-12</NDC11Code>
<ProductNDC>0574-7040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belladonna And Opium</ProprietaryName>
<NonProprietaryName>Atropa Belladonna And Opium</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>19970422</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Padagis US LLC</LabelerName>
<SubstanceName>ATROPA BELLADONNA; OPIUM</SubstanceName>
<StrengthNumber>16.2; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-04-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Each belladonna and opium suppository contains (in a water-soluble base consisting of polyethylene glycol 400, 1450, 8000 and polysorbate 60). Belladonna (16.2 mg) and Opium (30 mg). Powdered belladonna extract 16.2 mg and powdered opium 30 mg. Belladonna (16.2 mg) and Opium (60 mg). Powdered belladonna extract 16.2 mg and powdered opium 60 mg. This drug falls into the pharmacological/therapeutic class of narcotic analgesic/antispasmotic agents. The pharmacologically active principles present in the belladonna extract component of belladonna and opium suppositories are. Established Name: Atropine. Chemical Name: dl Tropyl Tropate. Established Name: Scopolamine. Chemical Name: dl Scopolamine. Opium contains more than twenty alkaloids, the principle ones being morphine (10%), narcotine (6%), papaverine (1%) and codeine (0.5%). The major pharmacologically active principle of the powdered opium component of belladonna and opium suppositories, however, is. Name: Morphine. Chemical Name: 7, 8-Didehydro-4, 5-epoxy-17-Methyl-morphinan-3, 6-diol.</Description>
</NDC>
<NDC>
<NDCCode>16571-136-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16571-136-09) </PackageDescription>
<NDC11Code>16571-0136-09</NDC11Code>
<ProductNDC>16571-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>16571-136-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (16571-136-10) </PackageDescription>
<NDC11Code>16571-0136-10</NDC11Code>
<ProductNDC>16571-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>16571-136-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16571-136-50) </PackageDescription>
<NDC11Code>16571-0136-50</NDC11Code>
<ProductNDC>16571-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>16571-137-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16571-137-09) </PackageDescription>
<NDC11Code>16571-0137-09</NDC11Code>
<ProductNDC>16571-137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>16571-137-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (16571-137-10) </PackageDescription>
<NDC11Code>16571-0137-10</NDC11Code>
<ProductNDC>16571-137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
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<NDCCode>16571-137-50</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
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<NDCCode>16571-138-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16571-138-09) </PackageDescription>
<NDC11Code>16571-0138-09</NDC11Code>
<ProductNDC>16571-138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
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<StartMarketingDate>20231020</StartMarketingDate>
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<LabelerName>Rising Pharma Holdings, Inc.</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>
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<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
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<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
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<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 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. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin 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 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 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, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
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