{
"NDC": [
{
"NDCCode": "64232-046-17",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (64232-046-17) > 10 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "64232-0046-17",
"ProductNDC": "64232-046",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Notaquensan",
"NonProprietaryName": "Penicillium Chrysogenum Var. Chrysogenum And Penicillium Glabrum",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20170104",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM",
"StrengthNumber": "4; 4",
"StrengthUnit": "[hp_X]/10mL; [hp_X]/10mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170104",
"SamplePackage": "N"
},
{
"NDCCode": "16729-046-17",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (16729-046-17) ",
"NDC11Code": "16729-0046-17",
"ProductNDC": "16729-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207687",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180806",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.",
"Description": "Atorvastatin calcium tablets are an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets USP for oral administration contain 10, 20, 40, or 80 mg of atorvastatin and the following inactive ingredients: croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry-YS-1-7040 white (hypromellose, polyethylene glycol, talc, titanium dioxide), polysorbate 80, precipitated calcium carbonate."
},
{
"NDCCode": "35192-046-17",
"PackageDescription": "61 g in 1 PACKAGE (35192-046-17) ",
"NDC11Code": "35192-0046-17",
"ProductNDC": "35192-046",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Visage",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "CA-Botana International",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "12.81",
"StrengthUnit": "g/12.81g",
"Status": "Deprecated",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor."
},
{
"NDCCode": "64232-004-17",
"PackageDescription": "10 CAPSULE in 1 CAN (64232-004-17) ",
"NDC11Code": "64232-0004-17",
"ProductNDC": "64232-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cereussan",
"NonProprietaryName": "Bacillus Cereus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "BACILLUS CEREUS",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N"
},
{
"NDCCode": "64232-008-17",
"PackageDescription": "10 CAPSULE in 1 CAN (64232-008-17) ",
"NDC11Code": "64232-0008-17",
"ProductNDC": "64232-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Firmusan",
"NonProprietaryName": "Bacillus Firmus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "BACILLUS FIRMUS",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171201",
"SamplePackage": "N"
},
{
"NDCCode": "64232-021-17",
"PackageDescription": "2 BLISTER PACK in 1 BOX (64232-021-17) > 5 SUPPOSITORY in 1 BLISTER PACK",
"NDC11Code": "64232-0021-17",
"ProductNDC": "64232-021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quentasan",
"NonProprietaryName": "Penicillium Glabrum",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20170107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "PENICILLIUM GLABRUM",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170107",
"SamplePackage": "N"
},
{
"NDCCode": "64232-022-17",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (64232-022-17) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "64232-0022-17",
"ProductNDC": "64232-022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quentasan",
"NonProprietaryName": "Penicillium Glabrum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170104",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "PENICILLIUM GLABRUM",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/10mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170104",
"SamplePackage": "N"
},
{
"NDCCode": "64232-028-17",
"PackageDescription": "30 CAPSULE in 1 CAN (64232-028-17) ",
"NDC11Code": "64232-0028-17",
"ProductNDC": "64232-028",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candidasan",
"NonProprietaryName": "Candida Parapsilosis",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171120",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "CANDIDA PARAPSILOSIS",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171120",
"SamplePackage": "N"
},
{
"NDCCode": "64232-029-17",
"PackageDescription": "2 BLISTER PACK in 1 BOX (64232-029-17) > 5 SUPPOSITORY in 1 BLISTER PACK",
"NDC11Code": "64232-0029-17",
"ProductNDC": "64232-029",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspersan",
"NonProprietaryName": "Aspergillus Niger Var. Niger",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "ASPERGILLUS NIGER VAR. NIGER",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171201",
"SamplePackage": "N"
},
{
"NDCCode": "64232-030-17",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (64232-030-17) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "64232-0030-17",
"ProductNDC": "64232-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspersan",
"NonProprietaryName": "Aspergillus Niger Var. Niger",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170104",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "ASPERGILLUS NIGER VAR. NIGER",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/10mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170104",
"SamplePackage": "N"
},
{
"NDCCode": "64232-032-17",
"PackageDescription": "30 CAPSULE in 1 CAN (64232-032-17) ",
"NDC11Code": "64232-0032-17",
"ProductNDC": "64232-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspersan",
"NonProprietaryName": "Aspergillus Niger Var. Niger",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171120",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "ASPERGILLUS NIGER VAR. NIGER",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171120",
"SamplePackage": "N"
},
{
"NDCCode": "64232-039-17",
"PackageDescription": "2 BLISTER PACK in 1 BOX (64232-039-17) > 5 SUPPOSITORY in 1 BLISTER PACK",
"NDC11Code": "64232-0039-17",
"ProductNDC": "64232-039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Notasan",
"NonProprietaryName": "Penicillium Chrysogenum Var. Chrysogenum",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170107",
"SamplePackage": "N"
},
{
"NDCCode": "64232-040-17",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (64232-040-17) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "64232-0040-17",
"ProductNDC": "64232-040",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Notasan",
"NonProprietaryName": "Penicillium Chrysogenum Var. Chrysogenum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170104",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/10mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170104",
"SamplePackage": "N"
},
{
"NDCCode": "64232-045-17",
"PackageDescription": "2 BLISTER PACK in 1 BOX (64232-045-17) > 5 SUPPOSITORY in 1 BLISTER PACK",
"NDC11Code": "64232-0045-17",
"ProductNDC": "64232-045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candiroqsan",
"NonProprietaryName": "Candida Parapsilosis And Penicillium Roqueforti",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20170107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "CANDIDA PARAPSILOSIS; PENICILLIUM ROQUEFORTI",
"StrengthNumber": "3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170107",
"SamplePackage": "N"
},
{
"NDCCode": "64232-102-17",
"PackageDescription": "150 mL in 1 BOTTLE, PUMP (64232-102-17) ",
"NDC11Code": "64232-0102-17",
"ProductNDC": "64232-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucorsan",
"NonProprietaryName": "Mucor Racemosus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "MUCOR RACEMOSUS",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/150mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170107",
"SamplePackage": "N"
},
{
"NDCCode": "64232-103-17",
"PackageDescription": "150 mL in 1 BOTTLE, PUMP (64232-103-17) ",
"NDC11Code": "64232-0103-17",
"ProductNDC": "64232-103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Notasan",
"NonProprietaryName": "Penicillium Chrysogenum Var. Chrysogenum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/150mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170107",
"SamplePackage": "N"
},
{
"NDCCode": "64232-105-17",
"PackageDescription": "2 BLISTER PACK in 1 BOX (64232-105-17) > 5 SUPPOSITORY in 1 BLISTER PACK",
"NDC11Code": "64232-0105-17",
"ProductNDC": "64232-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Firmusan",
"NonProprietaryName": "Bacillus Firmus",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20000101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "sanPharma GmbH",
"SubstanceName": "BACILLUS FIRMUS",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N"
},
{
"NDCCode": "0264-1915-00",
"PackageDescription": "6 CARTON in 1 CASE (0264-1915-00) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER",
"NDC11Code": "00264-1915-00",
"ProductNDC": "0264-1915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Procalamine",
"NonProprietaryName": "Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19820506",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018582",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE",
"StrengthNumber": ".21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "0264-1915-07",
"PackageDescription": "6 CARTON in 1 CASE (0264-1915-07) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER",
"NDC11Code": "00264-1915-07",
"ProductNDC": "0264-1915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Procalamine",
"NonProprietaryName": "Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19820506",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018582",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE",
"StrengthNumber": ".21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Allergens [CS], Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19820506",
"SamplePackage": "N"
},
{
"NDCCode": "10544-046-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (10544-046-20)",
"NDC11Code": "10544-0046-20",
"ProductNDC": "10544-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085162",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory diseases: symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous system: acute exacerbations of multiple sclerosis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C 21H 26O 5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone Tablets USP 20 mg also contain FD&C Yellow No. 6."
},
{
"NDCCode": "10544-046-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10544-046-30)",
"NDC11Code": "10544-0046-30",
"ProductNDC": "10544-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085162",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory diseases: symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous system: acute exacerbations of multiple sclerosis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C 21H 26O 5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone Tablets USP 20 mg also contain FD&C Yellow No. 6."
},
{
"NDCCode": "10544-046-42",
"PackageDescription": "42 TABLET in 1 BOTTLE (10544-046-42)",
"NDC11Code": "10544-0046-42",
"ProductNDC": "10544-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085162",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory diseases: symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous system: acute exacerbations of multiple sclerosis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C 21H 26O 5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone Tablets USP 20 mg also contain FD&C Yellow No. 6."
},
{
"NDCCode": "13107-046-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13107-046-01) ",
"NDC11Code": "13107-0046-01",
"ProductNDC": "13107-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201972",
"LabelerName": "Aurolife Pharma, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130715",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP …………….............. 325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "13107-046-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13107-046-05) ",
"NDC11Code": "13107-0046-05",
"ProductNDC": "13107-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201972",
"LabelerName": "Aurolife Pharma, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130715",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP …………….............. 325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "13107-046-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13107-046-30) ",
"NDC11Code": "13107-0046-30",
"ProductNDC": "13107-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201972",
"LabelerName": "Aurolife Pharma, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130715",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP …………….............. 325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "13107-046-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (13107-046-99) ",
"NDC11Code": "13107-0046-99",
"ProductNDC": "13107-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201972",
"LabelerName": "Aurolife Pharma, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130715",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP …………….............. 325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "13537-046-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-046-02) > 2 g in 1 TUBE (13537-046-01)",
"NDC11Code": "13537-0046-02",
"ProductNDC": "13537-046",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Perfect Skin Coverage Concealer Spf 17",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110923",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation (San Juan, P.R)",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".04",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "21922-046-41",
"PackageDescription": "1 APPLICATOR in 1 CARTON (21922-046-41) / 5 g in 1 APPLICATOR",
"NDC11Code": "21922-0046-41",
"ProductNDC": "21922-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole Vaginal Gel",
"NonProprietaryName": "Metronidazole Vaginal Gel, 1.3 %",
"DosageFormName": "GEL",
"RouteName": "VAGINAL",
"StartMarketingDate": "20240319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216795",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "65",
"StrengthUnit": "mg/5g",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240319",
"SamplePackage": "N",
"IndicationAndUsage": "Metronidazole vaginal gel is indicated for the treatment of bacterial vaginosis in females 12 years of age and older.",
"Description": "Metronidazole vaginal gel contains 1.3% metronidazole, USP in a single-dose prefilled disposable applicator. It is intended for intravaginal use. Metronidazole is a nitroimidazole antimicrobial. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. Its structural formula is. The molecular formula is C6H9N3O3 with a molecular weight of 171.16. Metronidazole vaginal gel is an aqueous gel containing metronidazole at a concentration of 13 mg/g (1.3%). The gel is formulated at pH 4.0. The gel also contains benzyl alcohol, methyl paraben, polycarbophil, polyethylene glycol 400, propylene glycol, propyl paraben, and purified water. Each applicator contains approximately 65 mg of metronidazole in 5 g of vaginal gel."
},
{
"NDCCode": "42291-046-12",
"PackageDescription": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-046-12) ",
"NDC11Code": "42291-0046-12",
"ProductNDC": "42291-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Icosapent Ethyl",
"NonProprietaryName": "Icosapent Ethyl",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209525",
"LabelerName": "AvKARE",
"SubstanceName": "ICOSAPENT ETHYL",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "Icosapent ethyl capsules are indicated: 1 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.",
"Description": "Icosapent ethyl, a lipid-regulating agent, is supplied as either a 500 milligram or a 1 gram, transparent, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains either 500 milligrams of icosapent ethyl (in a 500 milligram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The molecular formula of icosapent ethyl is C 22H 34O 2and the molecular weight is 330.5. The chemical name for icosapent ethyl is all-cis-5,8,11,14,17-eicosapentaenoic acid ethyl ester with the following chemical structure:. Icosapent ethyl capsules also contain the following inactive ingredients: dl-alpha-tocopherol, ethyl acetate, gelatin, glycerin anhydrous, iron oxide black, polyethylene glycol 400, polyvinyl acetate phthalate, propylene glycol, and purified water."
},
{
"NDCCode": "43063-046-03",
"PackageDescription": "3 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-03) ",
"NDC11Code": "43063-0046-03",
"ProductNDC": "43063-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlordiazepoxide Hydrochloride",
"NonProprietaryName": "Chlordiazepoxide Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19760701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084769",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101206",
"SamplePackage": "N",
"IndicationAndUsage": "Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride, USP is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide hydrochloride, USP is 7-chloro-2-(methylamino)-5-phenyl-3 H-1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is:. C 16H 14ClN 3O HCl M.W. 336.22. Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains FD&C red no. 40, povidone, propylene glycol, and sodium hydroxide. The 5 mg and 25 mg may also contain propylene glycol."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>64232-046-17</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (64232-046-17) > 10 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>64232-0046-17</NDC11Code>
<ProductNDC>64232-046</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Notaquensan</ProprietaryName>
<NonProprietaryName>Penicillium Chrysogenum Var. Chrysogenum And Penicillium Glabrum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20170104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM</SubstanceName>
<StrengthNumber>4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/10mL; [hp_X]/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16729-046-17</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (16729-046-17) </PackageDescription>
<NDC11Code>16729-0046-17</NDC11Code>
<ProductNDC>16729-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207687</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin calcium tablets are an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets USP for oral administration contain 10, 20, 40, or 80 mg of atorvastatin and the following inactive ingredients: croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry-YS-1-7040 white (hypromellose, polyethylene glycol, talc, titanium dioxide), polysorbate 80, precipitated calcium carbonate.</Description>
</NDC>
<NDC>
<NDCCode>35192-046-17</NDCCode>
<PackageDescription>61 g in 1 PACKAGE (35192-046-17) </PackageDescription>
<NDC11Code>35192-0046-17</NDC11Code>
<ProductNDC>35192-046</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Visage</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>CA-Botana International</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>12.81</StrengthNumber>
<StrengthUnit>g/12.81g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64232-004-17</NDCCode>
<PackageDescription>10 CAPSULE in 1 CAN (64232-004-17) </PackageDescription>
<NDC11Code>64232-0004-17</NDC11Code>
<ProductNDC>64232-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cereussan</ProprietaryName>
<NonProprietaryName>Bacillus Cereus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>BACILLUS CEREUS</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-008-17</NDCCode>
<PackageDescription>10 CAPSULE in 1 CAN (64232-008-17) </PackageDescription>
<NDC11Code>64232-0008-17</NDC11Code>
<ProductNDC>64232-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Firmusan</ProprietaryName>
<NonProprietaryName>Bacillus Firmus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>BACILLUS FIRMUS</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-021-17</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 BOX (64232-021-17) > 5 SUPPOSITORY in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64232-0021-17</NDC11Code>
<ProductNDC>64232-021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quentasan</ProprietaryName>
<NonProprietaryName>Penicillium Glabrum</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20170107</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>PENICILLIUM GLABRUM</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-022-17</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (64232-022-17) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>64232-0022-17</NDC11Code>
<ProductNDC>64232-022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quentasan</ProprietaryName>
<NonProprietaryName>Penicillium Glabrum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>PENICILLIUM GLABRUM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-028-17</NDCCode>
<PackageDescription>30 CAPSULE in 1 CAN (64232-028-17) </PackageDescription>
<NDC11Code>64232-0028-17</NDC11Code>
<ProductNDC>64232-028</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candidasan</ProprietaryName>
<NonProprietaryName>Candida Parapsilosis</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171120</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>CANDIDA PARAPSILOSIS</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-029-17</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 BOX (64232-029-17) > 5 SUPPOSITORY in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64232-0029-17</NDC11Code>
<ProductNDC>64232-029</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspersan</ProprietaryName>
<NonProprietaryName>Aspergillus Niger Var. Niger</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>ASPERGILLUS NIGER VAR. NIGER</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-030-17</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (64232-030-17) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>64232-0030-17</NDC11Code>
<ProductNDC>64232-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspersan</ProprietaryName>
<NonProprietaryName>Aspergillus Niger Var. Niger</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>ASPERGILLUS NIGER VAR. NIGER</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-032-17</NDCCode>
<PackageDescription>30 CAPSULE in 1 CAN (64232-032-17) </PackageDescription>
<NDC11Code>64232-0032-17</NDC11Code>
<ProductNDC>64232-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspersan</ProprietaryName>
<NonProprietaryName>Aspergillus Niger Var. Niger</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171120</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>ASPERGILLUS NIGER VAR. NIGER</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-039-17</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 BOX (64232-039-17) > 5 SUPPOSITORY in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64232-0039-17</NDC11Code>
<ProductNDC>64232-039</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Notasan</ProprietaryName>
<NonProprietaryName>Penicillium Chrysogenum Var. Chrysogenum</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-040-17</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (64232-040-17) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>64232-0040-17</NDC11Code>
<ProductNDC>64232-040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Notasan</ProprietaryName>
<NonProprietaryName>Penicillium Chrysogenum Var. Chrysogenum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-045-17</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 BOX (64232-045-17) > 5 SUPPOSITORY in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64232-0045-17</NDC11Code>
<ProductNDC>64232-045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candiroqsan</ProprietaryName>
<NonProprietaryName>Candida Parapsilosis And Penicillium Roqueforti</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20170107</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>CANDIDA PARAPSILOSIS; PENICILLIUM ROQUEFORTI</SubstanceName>
<StrengthNumber>3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-102-17</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE, PUMP (64232-102-17) </PackageDescription>
<NDC11Code>64232-0102-17</NDC11Code>
<ProductNDC>64232-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucorsan</ProprietaryName>
<NonProprietaryName>Mucor Racemosus</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170107</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>MUCOR RACEMOSUS</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/150mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-103-17</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE, PUMP (64232-103-17) </PackageDescription>
<NDC11Code>64232-0103-17</NDC11Code>
<ProductNDC>64232-103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Notasan</ProprietaryName>
<NonProprietaryName>Penicillium Chrysogenum Var. Chrysogenum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170107</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/150mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64232-105-17</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 BOX (64232-105-17) > 5 SUPPOSITORY in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64232-0105-17</NDC11Code>
<ProductNDC>64232-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Firmusan</ProprietaryName>
<NonProprietaryName>Bacillus Firmus</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20000101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>sanPharma GmbH</LabelerName>
<SubstanceName>BACILLUS FIRMUS</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0264-1915-00</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0264-1915-00) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-1915-00</NDC11Code>
<ProductNDC>0264-1915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Procalamine</ProprietaryName>
<NonProprietaryName>Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19820506</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018582</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE</SubstanceName>
<StrengthNumber>.21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>0264-1915-07</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0264-1915-07) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-1915-07</NDC11Code>
<ProductNDC>0264-1915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Procalamine</ProprietaryName>
<NonProprietaryName>Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19820506</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018582</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE</SubstanceName>
<StrengthNumber>.21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], 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>2023-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10544-046-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (10544-046-20)</PackageDescription>
<NDC11Code>10544-0046-20</NDC11Code>
<ProductNDC>10544-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085162</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory diseases: symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous system: acute exacerbations of multiple sclerosis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C 21H 26O 5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone Tablets USP 20 mg also contain FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>10544-046-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10544-046-30)</PackageDescription>
<NDC11Code>10544-0046-30</NDC11Code>
<ProductNDC>10544-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085162</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory diseases: symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous system: acute exacerbations of multiple sclerosis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C 21H 26O 5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone Tablets USP 20 mg also contain FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>10544-046-42</NDCCode>
<PackageDescription>42 TABLET in 1 BOTTLE (10544-046-42)</PackageDescription>
<NDC11Code>10544-0046-42</NDC11Code>
<ProductNDC>10544-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085162</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory diseases: symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous system: acute exacerbations of multiple sclerosis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C 21H 26O 5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone Tablets USP 20 mg also contain FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>13107-046-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13107-046-01) </PackageDescription>
<NDC11Code>13107-0046-01</NDC11Code>
<ProductNDC>13107-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201972</ApplicationNumber>
<LabelerName>Aurolife Pharma, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP …………….............. 325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>13107-046-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13107-046-05) </PackageDescription>
<NDC11Code>13107-0046-05</NDC11Code>
<ProductNDC>13107-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201972</ApplicationNumber>
<LabelerName>Aurolife Pharma, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP …………….............. 325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>13107-046-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13107-046-30) </PackageDescription>
<NDC11Code>13107-0046-30</NDC11Code>
<ProductNDC>13107-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201972</ApplicationNumber>
<LabelerName>Aurolife Pharma, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP …………….............. 325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>13107-046-99</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (13107-046-99) </PackageDescription>
<NDC11Code>13107-0046-99</NDC11Code>
<ProductNDC>13107-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201972</ApplicationNumber>
<LabelerName>Aurolife Pharma, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP …………….............. 325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>13537-046-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-046-02) > 2 g in 1 TUBE (13537-046-01)</PackageDescription>
<NDC11Code>13537-0046-02</NDC11Code>
<ProductNDC>13537-046</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Perfect Skin Coverage Concealer Spf 17</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110923</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation (San Juan, P.R)</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.04</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21922-046-41</NDCCode>
<PackageDescription>1 APPLICATOR in 1 CARTON (21922-046-41) / 5 g in 1 APPLICATOR</PackageDescription>
<NDC11Code>21922-0046-41</NDC11Code>
<ProductNDC>21922-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole Vaginal Gel</ProprietaryName>
<NonProprietaryName>Metronidazole Vaginal Gel, 1.3 %</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20240319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216795</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>65</StrengthNumber>
<StrengthUnit>mg/5g</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metronidazole vaginal gel is indicated for the treatment of bacterial vaginosis in females 12 years of age and older.</IndicationAndUsage>
<Description>Metronidazole vaginal gel contains 1.3% metronidazole, USP in a single-dose prefilled disposable applicator. It is intended for intravaginal use. Metronidazole is a nitroimidazole antimicrobial. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. Its structural formula is. The molecular formula is C6H9N3O3 with a molecular weight of 171.16. Metronidazole vaginal gel is an aqueous gel containing metronidazole at a concentration of 13 mg/g (1.3%). The gel is formulated at pH 4.0. The gel also contains benzyl alcohol, methyl paraben, polycarbophil, polyethylene glycol 400, propylene glycol, propyl paraben, and purified water. Each applicator contains approximately 65 mg of metronidazole in 5 g of vaginal gel.</Description>
</NDC>
<NDC>
<NDCCode>42291-046-12</NDCCode>
<PackageDescription>120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-046-12) </PackageDescription>
<NDC11Code>42291-0046-12</NDC11Code>
<ProductNDC>42291-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Icosapent Ethyl</ProprietaryName>
<NonProprietaryName>Icosapent Ethyl</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209525</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ICOSAPENT ETHYL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Icosapent ethyl capsules are indicated: 1 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.</IndicationAndUsage>
<Description>Icosapent ethyl, a lipid-regulating agent, is supplied as either a 500 milligram or a 1 gram, transparent, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains either 500 milligrams of icosapent ethyl (in a 500 milligram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The molecular formula of icosapent ethyl is C 22H 34O 2and the molecular weight is 330.5. The chemical name for icosapent ethyl is all-cis-5,8,11,14,17-eicosapentaenoic acid ethyl ester with the following chemical structure:. Icosapent ethyl capsules also contain the following inactive ingredients: dl-alpha-tocopherol, ethyl acetate, gelatin, glycerin anhydrous, iron oxide black, polyethylene glycol 400, polyvinyl acetate phthalate, propylene glycol, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>43063-046-03</NDCCode>
<PackageDescription>3 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-03) </PackageDescription>
<NDC11Code>43063-0046-03</NDC11Code>
<ProductNDC>43063-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlordiazepoxide Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlordiazepoxide Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084769</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLORDIAZEPOXIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride, USP is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide hydrochloride, USP is 7-chloro-2-(methylamino)-5-phenyl-3 H-1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is:. C 16H 14ClN 3O HCl M.W. 336.22. Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains FD&C red no. 40, povidone, propylene glycol, and sodium hydroxide. The 5 mg and 25 mg may also contain propylene glycol.</Description>
</NDC>
</NDCList>