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"NDCCode": "70925-170-71",
"PackageDescription": "50 BLISTER PACK in 1 CARTON (70925-170-71) > 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "70925-0170-71",
"ProductNDC": "70925-170",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humana Pharmacy Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20161221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076789",
"LabelerName": "Humana Pharmacy, Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-22",
"ProductNdcExcludeFlag": "N",
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},
{
"NDCCode": "70925-029-71",
"PackageDescription": "50 BLISTER PACK in 1 CARTON (70925-029-71) > 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "70925-0029-71",
"ProductNDC": "70925-029",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humana Pharmacy Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20161221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076775",
"LabelerName": "Humana Pharmacy, Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
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"NDCCode": "70925-604-71",
"PackageDescription": "1 BOTTLE in 1 CARTON (70925-604-71) > 50 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "70925-0604-71",
"ProductNDC": "70925-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humana Pharmacy Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072096",
"LabelerName": "Humana Pharmacy, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20161221",
"SamplePackage": "N"
},
{
"NDCCode": "36800-170-71",
"PackageDescription": "50 BLISTER PACK in 1 CARTON (36800-170-71) > 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "36800-0170-71",
"ProductNDC": "36800-170",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20050419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076789",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20050419",
"SamplePackage": "N"
},
{
"NDCCode": "56062-170-71",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (56062-170-71) > 10 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "56062-0170-71",
"ProductNDC": "56062-170",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stop Smoking Aid",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20051206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076789",
"LabelerName": "Publix Super Markets Inc",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "58503-170-01",
"PackageDescription": "1 TUBE in 1 BOX (58503-170-01) / 71 g in 1 TUBE",
"NDC11Code": "58503-0170-01",
"ProductNDC": "58503-170",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diaper Rash Cream 2.5oz",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231204",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "China Ningbo Shangge Cosmetics Technology Corp.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": ".4",
"StrengthUnit": "g/g",
"Status": "Active",
"LastUpdate": "2023-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231204",
"SamplePackage": "N",
"IndicationAndUsage": "helps treat and prevent diaper rash. protects chafed skin due to diaper rash and helps seal out wetness."
},
{
"NDCCode": "59779-170-71",
"PackageDescription": "50 BLISTER PACK in 1 CARTON (59779-170-71) > 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "59779-0170-71",
"ProductNDC": "59779-170",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"ProprietaryNameSuffix": "Stop Smoking Aid",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20050707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076789",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-10-29",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "17772-085-21",
"PackageDescription": "21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-21) ",
"NDC11Code": "17772-0085-21",
"ProductNDC": "17772-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "68.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "Y",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "17772-085-60",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-60) ",
"NDC11Code": "17772-0085-60",
"ProductNDC": "17772-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "68.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "N",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "17772-170-21",
"PackageDescription": "21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-170-21) ",
"NDC11Code": "17772-0170-21",
"ProductNDC": "17772-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "137",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "Y",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "17772-170-60",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-170-60) ",
"NDC11Code": "17772-0170-60",
"ProductNDC": "17772-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "137",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "N",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "54860-170-01",
"PackageDescription": "59 g in 1 BOTTLE, PLASTIC (54860-170-01) ",
"NDC11Code": "54860-0170-01",
"ProductNDC": "54860-170",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mellow 59ml Hand Sanitizer Original",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200408",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Shenzhen Lantern Scicence Co Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "71",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200408",
"SamplePackage": "Y",
"IndicationAndUsage": "Wet hands thoroughly with product and rub until dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants."
},
{
"NDCCode": "61919-547-71",
"PackageDescription": "100 TABLET in 1 BOTTLE (61919-547-71) ",
"NDC11Code": "61919-0547-71",
"ProductNDC": "61919-547",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075991",
"LabelerName": "Direct_Rx",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190821",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin is indicated to reduce the risk of. Myocardial infarction Unstable angina Coronary revascularization procedures. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Coronary Heart Disease. Lovastatin is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for artherosclerotic vascular disease due to hypercholesterolemia. Lovastatin is indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb 2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin is indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. LDL-C remains >189 mg/dL or LDL-C remains >160 mg/dL and:. there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the adolescent patient. General Recommendations. Prior to initiating therapy with lovastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-C, HDL-C, and TG. For patients with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = total-C - [0.2 × (TG) + HDL-C]. For TG levels >400 mg/dL (>4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated total-C. In such cases, lovastatin is not indicated. The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below. † CHD, coronary heart disease. †† Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of <100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. ††† Almost all people with 0-1 risk factor have a 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary. NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories Risk Category LDL Goal (mg/dL) LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL) LDL Level at Which to Consider Drug Therapy (mg/dL) CHD † or CHD risk equivalents (10-year risk >20%) <100 ≥100 ≥130 (100-129: drug optional) †† 2+ Risk factors (10 year risk ≤20%) <130 ≥130 10-year risk 10-20%: ≥130 10-year risk <10%: ≥160 0-1 Risk factor ††† <160 ≥160 ≥190 (160-189: LDL-lowering drug optional). 2 Classification of Hyperlipoproteinemias Lipid Elevations Type Lipoproteins elevated major minor I chylomicrons TG ↑→C IIa LDL C -- IIb LDL, VLDL C TG III (rare) IDL C/TG -- IV VLDL TG ↑→C V (rare) chylomicrons, VLDL TG ↑→C IDL = intermediate-density lipoprotein. After the LDL-C goal has been achieved, if the TG is still ≥200 mg/dL, non-HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category. At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C is ≥130 mg/dL (see NCEP Guidelines above). Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the total-C be used to monitor therapy. Although lovastatin may be useful to reduce elevated LDL-C levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (Type IIb hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL or IDL (i.e., hyperlipoproteinemia types I, III, IV, or V). ***. The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below. Category Total-C (mg/dL) LDL-C (mg/dL) Acceptable <170 <110 Borderline 170-199 110-129 High ≥200 ≥130. Children treated with lovastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C.",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S -[1α( R *), 3α, 7β, 8β(2 S *,4 S *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24 H 36 O 5 and its molecular weight is 404.55. Its structural formula is. [Structural Formula ]. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyanisole and talc. Butylated hydroxyanisole (BHA) is added as a preservative."
},
{
"NDCCode": "61919-676-71",
"PackageDescription": "100 TABLET in 1 BOTTLE (61919-676-71) ",
"NDC11Code": "61919-0676-71",
"ProductNDC": "61919-676",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075636",
"LabelerName": "DIRECT RX",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160303",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of. - Myocardial infarction. - Unstable angina. - Coronary revascularization procedures. (See CLINICAL PHARMACOLOGY, Clinical Studies). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. ____________________________________________________. 2Classification of Hyperlipoproteinemias. Lipid Elevations. Type. Lipoproteins Elevated. Major. Minor. I. chylomicrons. TG. ↑→C. IIa. LDL. C. −. IIb. LDL, VLDL. C. TG. III (rare). IDL. C/TG. −. IV. VLDL. TG. ↑→C. V (rare). chylomicrons, VLDL. TG. ↑→C. IDL = intermediate-density lipoprotein. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains >189 mg/dL or. 2. LDL-C remains >160 mg/dL and. there is a positive family history of premature cardiovascular disease or. two or more other CVD risk factors are present in the adolescent patients General Recommendations. Prior to initiating therapy with lovastatin tablets USP, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-C, HDL-C, and TG. For patients with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = total-C - [0.2 x (TG) + HDL-C]. For TG levels >400 mg/dL (>4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated total-C. In such cases, lovastatin tablets USP are not indicated. The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below. CHD, coronary heart disease Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of <100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. Almost all people with 0-1 risk factor have a 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary. NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories. Risk Category. LDL Goal (mg/dL). LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL). LDL Level at Which to Consider Drug Therapy (mg/dL). CHD*or CHD risk equivalents (10-year risk >20%). <100. ≥100. ≥130 (100-129: drug optional)†. 2+ Risk factors (10-year risk ≤20%). <130. ≥130. 10-year risk 10-20%: ≥130 10-year risk <10%: ≥160. 0-1 Risk factor. <160. ≥160. ≥190 (160-189: LDL-lowering drug optional). After the LDL-C goal has been achieved, if the TG is still >200 mg/dL, non HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category. At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C is >130 mg/dL (see NCEP Guidelines above). Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the total-C be used to monitor therapy. Although lovastatin tablets USP may be useful to reduce elevated LDL-C levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (Type IIb hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL or IDL (i.e., hyperlipoproteinemia types I, III, IV, or V).2. 2 Classification of Hyperlipoproteinemias. The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below. Category. Total-C (mg/dL). LDL-C (mg/dL). Acceptable. <170. <110. Borderline. 170 to 199. 110 to 129. High. ≥200. ≥130.",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding ß-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1 α(R*),3 α,7ß,8ß(2S*,4S*), 8aß]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H3605 and its molecular weight is 404.55. Its structural formula is. [Chemical Structure]. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin Tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and corn starch. Butylated hydroxyanisole (BHA) is added as a preservative. In addition the 10 mg tablets also contain red iron oxide and yellow iron oxide; the 20 mg tablets also contain FD&C blue No. 2; and the 40 mg tablets also contain D&C yellow No. 10 and FD&C blue No. 2."
},
{
"NDCCode": "62742-4109-1",
"PackageDescription": "71 g in 1 TUBE (62742-4109-1) ",
"NDC11Code": "62742-4109-01",
"ProductNDC": "62742-4109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clear Clear Zinc Solar Protection Spf 30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171204",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Allure Labs, LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "170",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171204",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Help prevent sunburn."
},
{
"NDCCode": "62742-4110-1",
"PackageDescription": "71 g in 1 TUBE (62742-4110-1) ",
"NDC11Code": "62742-4110-01",
"ProductNDC": "62742-4110",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Light Tint Clear Zinc Solar Protection Spf 30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171204",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Allure Labs, Inc",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "170",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2017-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171204",
"SamplePackage": "N"
},
{
"NDCCode": "63323-714-14",
"PackageDescription": "1440 mL in 1 BAG (63323-714-14) ",
"NDC11Code": "63323-0714-14",
"ProductNDC": "63323-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perikabiven",
"NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140825",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200656",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "7.5; 3.5; 170; 124; 105; 68; 20; 187; 164; 164; 152; 141; 116; 116; 116; 40; 333; 235; 164; 141; 116; 94; 71; 4.8",
"StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140825",
"SamplePackage": "N",
"IndicationAndUsage": "PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.",
"Description": "PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "63323-714-19",
"PackageDescription": "1920 mL in 1 BAG (63323-714-19) ",
"NDC11Code": "63323-0714-19",
"ProductNDC": "63323-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perikabiven",
"NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140825",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200656",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "7.5; 3.5; 170; 124; 105; 68; 20; 187; 164; 164; 152; 141; 116; 116; 116; 40; 333; 235; 164; 141; 116; 94; 71; 4.8",
"StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140825",
"SamplePackage": "N",
"IndicationAndUsage": "PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.",
"Description": "PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "63323-714-24",
"PackageDescription": "2400 mL in 1 BAG (63323-714-24) ",
"NDC11Code": "63323-0714-24",
"ProductNDC": "63323-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perikabiven",
"NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140825",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200656",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
"StrengthNumber": "333; 235; 71; 20; 6.8; 116; 164; 141; 116; 164; 187; 68; 116; 164; 174; 141; 94; 170; 105; 3.5; 116; 40; 4.8; 152",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-02-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140825",
"SamplePackage": "N"
},
{
"NDCCode": "65219-042-71",
"PackageDescription": "24 BAG in 1 CARTON (65219-042-71) / 100 mL in 1 BAG (65219-042-21) ",
"NDC11Code": "65219-0042-71",
"ProductNDC": "65219-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208619",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥ 16 years of age) with the following seizure types when oral administration is temporarily not feasible: : 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures (1.3) .",
"Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate."
},
{
"NDCCode": "65219-044-71",
"PackageDescription": "24 BAG in 1 CARTON (65219-044-71) / 100 mL in 1 BAG (65219-044-21) ",
"NDC11Code": "65219-0044-71",
"ProductNDC": "65219-044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208619",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥ 16 years of age) with the following seizure types when oral administration is temporarily not feasible: : 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures (1.3) .",
"Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate."
},
{
"NDCCode": "65219-046-71",
"PackageDescription": "10 BAG in 1 CARTON (65219-046-71) / 100 mL in 1 BAG (65219-046-21) ",
"NDC11Code": "65219-0046-71",
"ProductNDC": "65219-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208619",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥ 16 years of age) with the following seizure types when oral administration is temporarily not feasible: : 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures (1.3) .",
"Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate."
},
{
"NDCCode": "70482-085-21",
"PackageDescription": "21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-21) ",
"NDC11Code": "70482-0085-21",
"ProductNDC": "70482-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "68.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "Y",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "70482-085-60",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-60) ",
"NDC11Code": "70482-0085-60",
"ProductNDC": "70482-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "68.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "N",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "70482-085-61",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-61) ",
"NDC11Code": "70482-0085-61",
"ProductNDC": "70482-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "68.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "Y",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "70482-170-21",
"PackageDescription": "21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-21) ",
"NDC11Code": "70482-0170-21",
"ProductNDC": "70482-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "137",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "Y",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "70482-170-60",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-60) ",
"NDC11Code": "70482-0170-60",
"ProductNDC": "70482-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "137",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "70482-170-61",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-61) ",
"NDC11Code": "70482-0170-61",
"ProductNDC": "70482-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "137",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "77720-012-09",
"PackageDescription": "170 mL in 1 BOTTLE (77720-012-09) ",
"NDC11Code": "77720-0012-09",
"ProductNDC": "77720-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201115",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Skaffles Group Limited Liability Company",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "71",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201115",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizing to help reduce bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "78336-170-01",
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"NDC11Code": "78336-0170-01",
"ProductNDC": "78336-170",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Charles and Associates, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "71",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria on the skin that potentially can cause sickness, recommended for repeated use."
}
]
}
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
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<LastUpdate>2021-11-16</LastUpdate>
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>5 BLISTER PACK in 1 CARTON (56062-170-71) > 10 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stop Smoking Aid</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Publix Super Markets Inc</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2017-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<PackageDescription>1 TUBE in 1 BOX (58503-170-01) / 71 g in 1 TUBE</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diaper Rash Cream 2.5oz</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231204</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>China Ningbo Shangge Cosmetics Technology Corp.</LabelerName>
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<StrengthNumber>.4</StrengthNumber>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>helps treat and prevent diaper rash. protects chafed skin due to diaper rash and helps seal out wetness.</IndicationAndUsage>
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<PackageDescription>50 BLISTER PACK in 1 CARTON (59779-170-71) > 1 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<Status>Deprecated</Status>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<PackageDescription>21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-21) </PackageDescription>
<NDC11Code>17772-0085-21</NDC11Code>
<ProductNDC>17772-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gocovri</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208944</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMANTADINE</SubstanceName>
<StrengthNumber>68.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<PackageDescription>60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-60) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gocovri</ProprietaryName>
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<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208944</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMANTADINE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<NDC>
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<PackageDescription>21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-170-21) </PackageDescription>
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<ProductNDC>17772-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gocovri</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208944</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMANTADINE</SubstanceName>
<StrengthNumber>137</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170824</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<NDC>
<NDCCode>17772-170-60</NDCCode>
<PackageDescription>60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-170-60) </PackageDescription>
<NDC11Code>17772-0170-60</NDC11Code>
<ProductNDC>17772-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gocovri</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208944</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMANTADINE</SubstanceName>
<StrengthNumber>137</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<NDCCode>54860-170-01</NDCCode>
<PackageDescription>59 g in 1 BOTTLE, PLASTIC (54860-170-01) </PackageDescription>
<NDC11Code>54860-0170-01</NDC11Code>
<ProductNDC>54860-170</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mellow 59ml Hand Sanitizer Original</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200408</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Shenzhen Lantern Scicence Co Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>71</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200408</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Wet hands thoroughly with product and rub until dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.</IndicationAndUsage>
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<NDC>
<NDCCode>61919-547-71</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (61919-547-71) </PackageDescription>
<NDC11Code>61919-0547-71</NDC11Code>
<ProductNDC>61919-547</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075991</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>LOVASTATIN</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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin is indicated to reduce the risk of. Myocardial infarction Unstable angina Coronary revascularization procedures. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Coronary Heart Disease. Lovastatin is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for artherosclerotic vascular disease due to hypercholesterolemia. Lovastatin is indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb 2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin is indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. LDL-C remains >189 mg/dL or LDL-C remains >160 mg/dL and:. there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the adolescent patient. General Recommendations. Prior to initiating therapy with lovastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-C, HDL-C, and TG. For patients with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = total-C - [0.2 × (TG) + HDL-C]. For TG levels >400 mg/dL (>4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated total-C. In such cases, lovastatin is not indicated. The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below. † CHD, coronary heart disease. †† Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of <100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. ††† Almost all people with 0-1 risk factor have a 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary. NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories Risk Category LDL Goal (mg/dL) LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL) LDL Level at Which to Consider Drug Therapy (mg/dL) CHD † or CHD risk equivalents (10-year risk >20%) <100 ≥100 ≥130 (100-129: drug optional) †† 2+ Risk factors (10 year risk ≤20%) <130 ≥130 10-year risk 10-20%: ≥130 10-year risk <10%: ≥160 0-1 Risk factor ††† <160 ≥160 ≥190 (160-189: LDL-lowering drug optional). 2 Classification of Hyperlipoproteinemias Lipid Elevations Type Lipoproteins elevated major minor I chylomicrons TG ↑→C IIa LDL C -- IIb LDL, VLDL C TG III (rare) IDL C/TG -- IV VLDL TG ↑→C V (rare) chylomicrons, VLDL TG ↑→C IDL = intermediate-density lipoprotein. After the LDL-C goal has been achieved, if the TG is still ≥200 mg/dL, non-HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category. At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C is ≥130 mg/dL (see NCEP Guidelines above). Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the total-C be used to monitor therapy. Although lovastatin may be useful to reduce elevated LDL-C levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (Type IIb hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL or IDL (i.e., hyperlipoproteinemia types I, III, IV, or V). ***. The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below. Category Total-C (mg/dL) LDL-C (mg/dL) Acceptable <170 <110 Borderline 170-199 110-129 High ≥200 ≥130. Children treated with lovastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C.</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S -[1α( R *), 3α, 7β, 8β(2 S *,4 S *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24 H 36 O 5 and its molecular weight is 404.55. Its structural formula is. [Structural Formula ]. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyanisole and talc. Butylated hydroxyanisole (BHA) is added as a preservative.</Description>
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<NDCCode>61919-676-71</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (61919-676-71) </PackageDescription>
<NDC11Code>61919-0676-71</NDC11Code>
<ProductNDC>61919-676</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075636</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>LOVASTATIN</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>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of. - Myocardial infarction. - Unstable angina. - Coronary revascularization procedures. (See CLINICAL PHARMACOLOGY, Clinical Studies). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. ____________________________________________________. 2Classification of Hyperlipoproteinemias. Lipid Elevations. Type. Lipoproteins Elevated. Major. Minor. I. chylomicrons. TG. ↑→C. IIa. LDL. C. −. IIb. LDL, VLDL. C. TG. III (rare). IDL. C/TG. −. IV. VLDL. TG. ↑→C. V (rare). chylomicrons, VLDL. TG. ↑→C. IDL = intermediate-density lipoprotein. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains >189 mg/dL or. 2. LDL-C remains >160 mg/dL and. there is a positive family history of premature cardiovascular disease or. two or more other CVD risk factors are present in the adolescent patients General Recommendations. Prior to initiating therapy with lovastatin tablets USP, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-C, HDL-C, and TG. For patients with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = total-C - [0.2 x (TG) + HDL-C]. For TG levels >400 mg/dL (>4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated total-C. In such cases, lovastatin tablets USP are not indicated. The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below. CHD, coronary heart disease Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of <100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. Almost all people with 0-1 risk factor have a 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary. NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories. Risk Category. LDL Goal (mg/dL). LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL). LDL Level at Which to Consider Drug Therapy (mg/dL). CHD*or CHD risk equivalents (10-year risk >20%). <100. ≥100. ≥130 (100-129: drug optional)†. 2+ Risk factors (10-year risk ≤20%). <130. ≥130. 10-year risk 10-20%: ≥130 10-year risk <10%: ≥160. 0-1 Risk factor. <160. ≥160. ≥190 (160-189: LDL-lowering drug optional). After the LDL-C goal has been achieved, if the TG is still >200 mg/dL, non HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category. At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C is >130 mg/dL (see NCEP Guidelines above). Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the total-C be used to monitor therapy. Although lovastatin tablets USP may be useful to reduce elevated LDL-C levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (Type IIb hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL or IDL (i.e., hyperlipoproteinemia types I, III, IV, or V).2. 2 Classification of Hyperlipoproteinemias. The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below. Category. Total-C (mg/dL). LDL-C (mg/dL). Acceptable. <170. <110. Borderline. 170 to 199. 110 to 129. High. ≥200. ≥130.</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding ß-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1 α(R*),3 α,7ß,8ß(2S*,4S*), 8aß]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H3605 and its molecular weight is 404.55. Its structural formula is. [Chemical Structure]. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin Tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and corn starch. Butylated hydroxyanisole (BHA) is added as a preservative. In addition the 10 mg tablets also contain red iron oxide and yellow iron oxide; the 20 mg tablets also contain FD&C blue No. 2; and the 40 mg tablets also contain D&C yellow No. 10 and FD&C blue No. 2.</Description>
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<PackageDescription>71 g in 1 TUBE (62742-4109-1) </PackageDescription>
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<IndicationAndUsage>Uses: Help prevent sunburn.</IndicationAndUsage>
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<PackageDescription>71 g in 1 TUBE (62742-4110-1) </PackageDescription>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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<LabelerName>Allure Labs, Inc</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
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<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
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<PackageDescription>1440 mL in 1 BAG (63323-714-14) </PackageDescription>
<NDC11Code>63323-0714-14</NDC11Code>
<ProductNDC>63323-714</ProductNDC>
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<ProprietaryName>Perikabiven</ProprietaryName>
<NonProprietaryName>Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName>
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<StartMarketingDate>20140825</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200656</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
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<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
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<IndicationAndUsage>PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.</IndicationAndUsage>
<Description>PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum.</Description>
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<PackageDescription>1920 mL in 1 BAG (63323-714-19) </PackageDescription>
<NDC11Code>63323-0714-19</NDC11Code>
<ProductNDC>63323-714</ProductNDC>
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<NonProprietaryName>Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName>
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<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140825</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200656</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
<StrengthNumber>7.5; 3.5; 170; 124; 105; 68; 20; 187; 164; 164; 152; 141; 116; 116; 116; 40; 333; 235; 164; 141; 116; 94; 71; 4.8</StrengthNumber>
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<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
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<IndicationAndUsage>PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.</IndicationAndUsage>
<Description>PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum.</Description>
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<PackageDescription>2400 mL in 1 BAG (63323-714-24) </PackageDescription>
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<SubstanceName>ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE</SubstanceName>
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<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-21</LastUpdate>
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<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65219-042-71</NDCCode>
<PackageDescription>24 BAG in 1 CARTON (65219-042-71) / 100 mL in 1 BAG (65219-042-21) </PackageDescription>
<NDC11Code>65219-0042-71</NDC11Code>
<ProductNDC>65219-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208619</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥ 16 years of age) with the following seizure types when oral administration is temporarily not feasible: : 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures (1.3) .</IndicationAndUsage>
<Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate.</Description>
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<IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥ 16 years of age) with the following seizure types when oral administration is temporarily not feasible: : 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures (1.3) .</IndicationAndUsage>
<Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate.</Description>
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<IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥ 16 years of age) with the following seizure types when oral administration is temporarily not feasible: : 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures (1.3) .</IndicationAndUsage>
<Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate.</Description>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208944</ApplicationNumber>
<LabelerName>Adamas Pharma, LLC</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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<LabelerName>Skaffles Group Limited Liability Company</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizing to help reduce bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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<LabelerName>Charles and Associates, LLC</LabelerName>
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<StrengthNumber>71</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria on the skin that potentially can cause sickness, recommended for repeated use.</IndicationAndUsage>
</NDC>
</NDCList>