{
"NDC": [
{
"NDCCode": "73069-024-12",
"PackageDescription": "3 VIAL, MULTI-DOSE in 1 BOX (73069-024-12) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-12",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-16",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-024-16) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-16",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-26",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-024-26) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-26",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-36",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-024-36) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-36",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-46",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-024-46) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-46",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190505",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-56",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-024-56) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-56",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-66",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-024-66) > 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-66",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-76",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-024-76) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-76",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-86",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-024-86) > 100 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-86",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "11084-024-12",
"PackageDescription": "1200 mL in 1 BOTTLE, PLASTIC (11084-024-12) ",
"NDC11Code": "11084-0024-12",
"ProductNDC": "11084-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Agrobac Pure Foam",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "for hand washing to reduce bacteria on the skin."
},
{
"NDCCode": "16714-024-12",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16714-024-12)",
"NDC11Code": "16714-0024-12",
"ProductNDC": "16714-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078213",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "41520-024-62",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (41520-024-62) > 2 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "41520-0024-62",
"ProductNDC": "41520-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Careone Sinus Relief Severe",
"NonProprietaryName": "Acetaminophen, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160902",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "American Sales Company",
"SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160902",
"SamplePackage": "N"
},
{
"NDCCode": "42291-024-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (42291-024-12) ",
"NDC11Code": "42291-0024-12",
"ProductNDC": "42291-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208327",
"LabelerName": "AvKARE",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190114",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC) .",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. USP dissolution test pending."
},
{
"NDCCode": "45861-024-12",
"PackageDescription": ".012 kg in 1 BOTTLE (45861-024-12)",
"NDC11Code": "45861-0024-12",
"ProductNDC": "45861-024",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131122",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Pharmaceutica North America Inc",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49999-024-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE (49999-024-12)",
"NDC11Code": "49999-0024-12",
"ProductNDC": "49999-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040804",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "HYDROXYZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-02-03"
},
{
"NDCCode": "51523-024-01",
"PackageDescription": "12 g in 1 CARTON (51523-024-01)",
"NDC11Code": "51523-0024-01",
"ProductNDC": "51523-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "The Flower Uv Intense Pact",
"ProprietaryNameSuffix": "Spf50 Pa Nb23",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20070301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "THEFACESHOP CO., LTD.",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "1.65; 1.54",
"StrengthUnit": "g/12g; g/12g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Warnings:When using this productKeep out of eyes. Rinse with water to remove.Stop use and ask a doctor ifRash or irritation develops and lasts.Directions:Apply evenly before sun exposure and as needed."
},
{
"NDCCode": "52862-024-12",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (52862-024-12) ",
"NDC11Code": "52862-0024-12",
"ProductNDC": "52862-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Rubbing Alcohol 70%",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200618",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Home Smart Products",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200618",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 to decrease germs in minor cuts and scrapes, 2 helps relieve minor muscular aches due to exertion."
},
{
"NDCCode": "63486-024-12",
"PackageDescription": "12 BOTTLE, PUMP in 1 CASE (63486-024-12) > 50 g in 1 BOTTLE, PUMP",
"NDC11Code": "63486-0024-12",
"ProductNDC": "63486-024",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Clindamycin Phosphate And Benzoyl Peroxide",
"DosageFormName": "GEL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Contract Pharmaceuticals Limited Canada",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE",
"StrengthNumber": ".6; 1.875",
"StrengthUnit": "g/50g; g/50g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63691-024-12",
"PackageDescription": "591 mL in 1 BOTTLE (63691-024-12)",
"NDC11Code": "63691-0024-12",
"ProductNDC": "63691-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Exchange Select Ultra Citrus Scent",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Sun Products Corporation",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Use helps fight germs on hands when used as a hand soap."
},
{
"NDCCode": "68987-024-12",
"PackageDescription": "125 g in 1 BOTTLE, PUMP (68987-024-12)",
"NDC11Code": "68987-0024-12",
"ProductNDC": "68987-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Purelife Apf",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "DENTAL",
"StartMarketingDate": "20130327",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureLife Dental",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5375",
"StrengthUnit": "g/125g",
"Status": "Deprecated",
"LastUpdate": "2019-02-08",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "This is a prescription fluoride treatment foam used to help prevent dental decay."
},
{
"NDCCode": "70377-024-12",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-024-12) ",
"NDC11Code": "70377-0024-12",
"ProductNDC": "70377-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211470",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "DAPAGLIFLOZIN 2,3-BUTANEDIOL MONOHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin tablets are indicated: 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Dapagliflozin, an inhibitor of SGLT2, is described chemically as (2S, 3R, 4R, 5S, 6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxyl methyl) tetrahydro-2H-pyran-3,4,5-triol compound with meso-butane 2,3-diol (1:1) hydrate. The empirical formula is C25H37ClO9 and the molecular weight is 517.01. The structural formula is. Dapagliflozin is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin butane-2,3-diol monohydrate or the equivalent of 10 mg dapagliflozin as dapagliflozin butane-2,3-diol monohydrate, and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Contains no ingredient made from a gluten containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "73212-024-12",
"PackageDescription": "100 g in 1 BOTTLE (73212-024-12) ",
"NDC11Code": "73212-0024-12",
"ProductNDC": "73212-024",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ll-37",
"DosageFormName": "POWDER",
"StartMarketingDate": "20220103",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Biopeptek Co., Ltd.",
"SubstanceName": "LL-37",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-01-12",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "03-JAN-22"
},
{
"NDCCode": "75448-024-12",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (75448-024-12) ",
"NDC11Code": "75448-0024-12",
"ProductNDC": "75448-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Egolan",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Sanrace Biotechnology Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "USE: Hand Sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "82953-024-08",
"PackageDescription": "12 g in 1 CYLINDER (82953-024-08) ",
"NDC11Code": "82953-0024-08",
"ProductNDC": "82953-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Spf15 Lip Balm",
"ProprietaryNameSuffix": "01",
"NonProprietaryName": "Octocrylene, Octisalate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Cosmuses Cosmetics (Ningbo) Co., Ltd.",
"SubstanceName": "OCTOCRYLENE; OCTISALATE",
"StrengthNumber": "8; 4",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection."
},
{
"NDCCode": "83511-024-12",
"PackageDescription": ".001 kg in 1 DRUM (83511-024-12) ",
"NDC11Code": "83511-0024-12",
"ProductNDC": "83511-024",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Inositol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250814",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "STHREE CHEMICALS PRIVATE LIMITED",
"SubstanceName": "INOSITOL",
"StrengthNumber": "35",
"StrengthUnit": "kg/35kg",
"Status": "Unfinished",
"LastUpdate": "2025-08-26",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "14-AUG-25"
},
{
"NDCCode": "73069-024-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (73069-024-11) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-11",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-13",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-024-13) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-13",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-14",
"PackageDescription": "6 VIAL, MULTI-DOSE in 1 BOX (73069-024-14) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-14",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-15",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (73069-024-15) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-15",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-024-17",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-024-17) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-17",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
}
]
}
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<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-024-46</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-024-46) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-46</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-024-56</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-024-56) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-56</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-024-66</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-024-66) > 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-66</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-024-76</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-024-76) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-76</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-024-86</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-024-86) > 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-86</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11084-024-12</NDCCode>
<PackageDescription>1200 mL in 1 BOTTLE, PLASTIC (11084-024-12) </PackageDescription>
<NDC11Code>11084-0024-12</NDC11Code>
<ProductNDC>11084-024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Agrobac Pure Foam</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for hand washing to reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-024-12</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (16714-024-12)</PackageDescription>
<NDC11Code>16714-0024-12</NDC11Code>
<ProductNDC>16714-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078213</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>41520-024-62</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (41520-024-62) > 2 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41520-0024-62</NDC11Code>
<ProductNDC>41520-024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Careone Sinus Relief Severe</ProprietaryName>
<NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160902</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-024-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (42291-024-12) </PackageDescription>
<NDC11Code>42291-0024-12</NDC11Code>
<ProductNDC>42291-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208327</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC) .</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>45861-024-12</NDCCode>
<PackageDescription>.012 kg in 1 BOTTLE (45861-024-12)</PackageDescription>
<NDC11Code>45861-0024-12</NDC11Code>
<ProductNDC>45861-024</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131122</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Pharmaceutica North America Inc</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49999-024-12</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE (49999-024-12)</PackageDescription>
<NDC11Code>49999-0024-12</NDC11Code>
<ProductNDC>49999-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040804</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>51523-024-01</NDCCode>
<PackageDescription>12 g in 1 CARTON (51523-024-01)</PackageDescription>
<NDC11Code>51523-0024-01</NDC11Code>
<ProductNDC>51523-024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>The Flower Uv Intense Pact</ProprietaryName>
<ProprietaryNameSuffix>Spf50 Pa Nb23</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20070301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>THEFACESHOP CO., LTD.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.65; 1.54</StrengthNumber>
<StrengthUnit>g/12g; g/12g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Warnings:When using this productKeep out of eyes. Rinse with water to remove.Stop use and ask a doctor ifRash or irritation develops and lasts.Directions:Apply evenly before sun exposure and as needed.</Description>
</NDC>
<NDC>
<NDCCode>52862-024-12</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (52862-024-12) </PackageDescription>
<NDC11Code>52862-0024-12</NDC11Code>
<ProductNDC>52862-024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Rubbing Alcohol 70%</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200618</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Home Smart Products</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 to decrease germs in minor cuts and scrapes, 2 helps relieve minor muscular aches due to exertion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63486-024-12</NDCCode>
<PackageDescription>12 BOTTLE, PUMP in 1 CASE (63486-024-12) > 50 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>63486-0024-12</NDC11Code>
<ProductNDC>63486-024</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Clindamycin Phosphate And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Contract Pharmaceuticals Limited Canada</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>.6; 1.875</StrengthNumber>
<StrengthUnit>g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63691-024-12</NDCCode>
<PackageDescription>591 mL in 1 BOTTLE (63691-024-12)</PackageDescription>
<NDC11Code>63691-0024-12</NDC11Code>
<ProductNDC>63691-024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Exchange Select Ultra Citrus Scent</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Sun Products Corporation</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Use helps fight germs on hands when used as a hand soap.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68987-024-12</NDCCode>
<PackageDescription>125 g in 1 BOTTLE, PUMP (68987-024-12)</PackageDescription>
<NDC11Code>68987-0024-12</NDC11Code>
<ProductNDC>68987-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Purelife Apf</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20130327</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureLife Dental</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5375</StrengthNumber>
<StrengthUnit>g/125g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-08</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>This is a prescription fluoride treatment foam used to help prevent dental decay.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70377-024-12</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-024-12) </PackageDescription>
<NDC11Code>70377-0024-12</NDC11Code>
<ProductNDC>70377-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211470</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>DAPAGLIFLOZIN 2,3-BUTANEDIOL MONOHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin tablets are indicated: 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Dapagliflozin, an inhibitor of SGLT2, is described chemically as (2S, 3R, 4R, 5S, 6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxyl methyl) tetrahydro-2H-pyran-3,4,5-triol compound with meso-butane 2,3-diol (1:1) hydrate. The empirical formula is C25H37ClO9 and the molecular weight is 517.01. The structural formula is. Dapagliflozin is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin butane-2,3-diol monohydrate or the equivalent of 10 mg dapagliflozin as dapagliflozin butane-2,3-diol monohydrate, and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Contains no ingredient made from a gluten containing grain (wheat, barley, or rye).</Description>
</NDC>
<NDC>
<NDCCode>73212-024-12</NDCCode>
<PackageDescription>100 g in 1 BOTTLE (73212-024-12) </PackageDescription>
<NDC11Code>73212-0024-12</NDC11Code>
<ProductNDC>73212-024</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ll-37</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20220103</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Biopeptek Co., Ltd.</LabelerName>
<SubstanceName>LL-37</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-01-12</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-JAN-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>75448-024-12</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (75448-024-12) </PackageDescription>
<NDC11Code>75448-0024-12</NDC11Code>
<ProductNDC>75448-024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Egolan</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Sanrace Biotechnology Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USE: Hand Sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82953-024-08</NDCCode>
<PackageDescription>12 g in 1 CYLINDER (82953-024-08) </PackageDescription>
<NDC11Code>82953-0024-08</NDC11Code>
<ProductNDC>82953-024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Spf15 Lip Balm</ProprietaryName>
<ProprietaryNameSuffix>01</ProprietaryNameSuffix>
<NonProprietaryName>Octocrylene, Octisalate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Cosmuses Cosmetics (Ningbo) Co., Ltd.</LabelerName>
<SubstanceName>OCTOCRYLENE; OCTISALATE</SubstanceName>
<StrengthNumber>8; 4</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83511-024-12</NDCCode>
<PackageDescription>.001 kg in 1 DRUM (83511-024-12) </PackageDescription>
<NDC11Code>83511-0024-12</NDC11Code>
<ProductNDC>83511-024</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Inositol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250814</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>STHREE CHEMICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>INOSITOL</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>kg/35kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-08-26</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-AUG-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>73069-024-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (73069-024-11) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-11</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-024-13</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-024-13) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-13</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
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<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-024-14</NDCCode>
<PackageDescription>6 VIAL, MULTI-DOSE in 1 BOX (73069-024-14) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-14</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-024-15</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 BOX (73069-024-15) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-15</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-024-17</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-024-17) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-17</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>
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Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName></NDC><NDC><NDCCode>73069-024-26</NDCCode><ProprietaryName>Viatrexx-adipose</ProprietaryName><NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName></NDC><NDC><NDCCode>73069-024-36</NDCCode><ProprietaryName>Viatrexx-adipose</ProprietaryName><NonProprietaryName>Epinephrine , Artery , 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Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName></NDC><NDC><NDCCode>73069-024-56</NDCCode><ProprietaryName>Viatrexx-adipose</ProprietaryName><NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName></NDC><NDC><NDCCode>73069-024-66</NDCCode><ProprietaryName>Viatrexx-adipose</ProprietaryName><NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName></NDC><NDC><NDCCode>73069-024-76</NDCCode><ProprietaryName>Viatrexx-adipose</ProprietaryName><NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina 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Octisalate</NonProprietaryName></NDC><NDC><NDCCode>83511-024-12</NDCCode><NonProprietaryName>Inositol</NonProprietaryName></NDC><NDC><NDCCode>73069-024-11</NDCCode><ProprietaryName>Viatrexx-adipose</ProprietaryName><NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName></NDC><NDC><NDCCode>73069-024-13</NDCCode><ProprietaryName>Viatrexx-adipose</ProprietaryName><NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , 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Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName></NDC></NDCList>