{
"NDC": [
{
"NDCCode": "73069-277-17",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-277-17) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-17",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-25",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (73069-277-25) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-25",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-27",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-277-27) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-27",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-37",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-277-37) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-37",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-47",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-277-47) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-47",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-57",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-277-57) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-57",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-67",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-277-67) > 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-67",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-77",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-277-77) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-77",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-87",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-277-87) > 100 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-87",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "31722-277-32",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-32) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-277-10) ",
"NDC11Code": "31722-0277-32",
"ProductNDC": "31722-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; RETROBULBAR",
"StartMarketingDate": "20240327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217821",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240327",
"SamplePackage": "N",
"IndicationAndUsage": "Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection is recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.5, 5.7, 5.9)].",
"Description": "Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection, USP is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Bupivacaine hydrochloride, USP is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white or almost white, crystalline powder or colorless crystals that is soluble in water, freely soluble in alcohol. It has the molecular formula C 18H 28N 2O.HCl.H 2O and it has the following structural formula:. Bupivacaine hydrochloride injection, USP is a clear and colorless sterile, isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection."
},
{
"NDCCode": "31722-277-34",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-34) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-277-30) ",
"NDC11Code": "31722-0277-34",
"ProductNDC": "31722-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; RETROBULBAR",
"StartMarketingDate": "20240327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217821",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240327",
"SamplePackage": "N",
"IndicationAndUsage": "Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection is recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.5, 5.7, 5.9)].",
"Description": "Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection, USP is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Bupivacaine hydrochloride, USP is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white or almost white, crystalline powder or colorless crystals that is soluble in water, freely soluble in alcohol. It has the molecular formula C 18H 28N 2O.HCl.H 2O and it has the following structural formula:. Bupivacaine hydrochloride injection, USP is a clear and colorless sterile, isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection."
},
{
"NDCCode": "43744-277-25",
"PackageDescription": "25 g in 1 DRUM (43744-277-25)",
"NDC11Code": "43744-0277-25",
"ProductNDC": "43744-277",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120808",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "47682-277-73",
"PackageDescription": "25 POUCH in 1 BOX (47682-277-73) > .9 g in 1 POUCH (47682-277-99) ",
"NDC11Code": "47682-0277-73",
"ProductNDC": "47682-277",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-first Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130415",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130415",
"SamplePackage": "N"
},
{
"NDCCode": "69039-277-00",
"PackageDescription": "4.25 g in 1 TUBE (69039-277-00) ",
"NDC11Code": "69039-0277-00",
"ProductNDC": "69039-277",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Bum Signature Spf 30 Sunscreen Lip Balm",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Sun Bum, LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180315",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "73069-277-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (73069-277-11) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-11",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-12",
"PackageDescription": "3 VIAL, MULTI-DOSE in 1 BOX (73069-277-12) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-12",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-13",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-277-13) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-13",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-14",
"PackageDescription": "6 VIAL, MULTI-DOSE in 1 BOX (73069-277-14) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-14",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-15",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (73069-277-15) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-15",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-16",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-277-16) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-16",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
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"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
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"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-18",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-277-18) > 1 mL in 1 VIAL, MULTI-DOSE",
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"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
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"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
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"LastUpdate": "2021-01-01",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-19",
"PackageDescription": "100 VIAL, MULTI-DOSE in 1 BOX (73069-277-19) > 1 mL in 1 VIAL, MULTI-DOSE",
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"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
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"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
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"Status": "Deprecated",
"LastUpdate": "2021-01-01",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-21",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (73069-277-21) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-21",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
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"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
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"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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-22",
"PackageDescription": "3 VIAL, MULTI-DOSE in 1 BOX (73069-277-22) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-22",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
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"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-23",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-277-23) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-23",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
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"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
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"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-24",
"PackageDescription": "6 VIAL, MULTI-DOSE in 1 BOX (73069-277-24) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-24",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
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"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-26",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-277-26) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0277-26",
"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-277-28",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-277-28) > 2 mL in 1 VIAL, MULTI-DOSE",
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"ProductNDC": "73069-277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ki-ub",
"NonProprietaryName": "Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE",
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<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-27</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-277-27) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-27</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-37</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-277-37) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-37</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-47</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-277-47) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-47</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-57</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-277-57) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-57</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-67</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-277-67) > 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-67</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-77</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-277-77) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-77</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-87</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-277-87) > 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-87</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>31722-277-32</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-32) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-277-10) </PackageDescription>
<NDC11Code>31722-0277-32</NDC11Code>
<ProductNDC>31722-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; RETROBULBAR</RouteName>
<StartMarketingDate>20240327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217821</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection is recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.5, 5.7, 5.9)].</IndicationAndUsage>
<Description>Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection, USP is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Bupivacaine hydrochloride, USP is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white or almost white, crystalline powder or colorless crystals that is soluble in water, freely soluble in alcohol. It has the molecular formula C 18H 28N 2O.HCl.H 2O and it has the following structural formula:. Bupivacaine hydrochloride injection, USP is a clear and colorless sterile, isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection.</Description>
</NDC>
<NDC>
<NDCCode>31722-277-34</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-34) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-277-30) </PackageDescription>
<NDC11Code>31722-0277-34</NDC11Code>
<ProductNDC>31722-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; RETROBULBAR</RouteName>
<StartMarketingDate>20240327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217821</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection is recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.5, 5.7, 5.9)].</IndicationAndUsage>
<Description>Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection, USP is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Bupivacaine hydrochloride, USP is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white or almost white, crystalline powder or colorless crystals that is soluble in water, freely soluble in alcohol. It has the molecular formula C 18H 28N 2O.HCl.H 2O and it has the following structural formula:. Bupivacaine hydrochloride injection, USP is a clear and colorless sterile, isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection.</Description>
</NDC>
<NDC>
<NDCCode>43744-277-25</NDCCode>
<PackageDescription>25 g in 1 DRUM (43744-277-25)</PackageDescription>
<NDC11Code>43744-0277-25</NDC11Code>
<ProductNDC>43744-277</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120808</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47682-277-73</NDCCode>
<PackageDescription>25 POUCH in 1 BOX (47682-277-73) > .9 g in 1 POUCH (47682-277-99) </PackageDescription>
<NDC11Code>47682-0277-73</NDC11Code>
<ProductNDC>47682-277</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-first Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130415</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69039-277-00</NDCCode>
<PackageDescription>4.25 g in 1 TUBE (69039-277-00) </PackageDescription>
<NDC11Code>69039-0277-00</NDC11Code>
<ProductNDC>69039-277</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sun Bum Signature Spf 30 Sunscreen Lip Balm</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Sun Bum, LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73069-277-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (73069-277-11) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-11</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-12</NDCCode>
<PackageDescription>3 VIAL, MULTI-DOSE in 1 BOX (73069-277-12) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-12</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-13</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-277-13) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-13</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-14</NDCCode>
<PackageDescription>6 VIAL, MULTI-DOSE in 1 BOX (73069-277-14) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-14</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-15</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 BOX (73069-277-15) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-15</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-16</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-277-16) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-16</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
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<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
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<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-18</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-277-18) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-18</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-19</NDCCode>
<PackageDescription>100 VIAL, MULTI-DOSE in 1 BOX (73069-277-19) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-19</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
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<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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<NDCCode>73069-277-21</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (73069-277-21) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-21</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
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<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-22</NDCCode>
<PackageDescription>3 VIAL, MULTI-DOSE in 1 BOX (73069-277-22) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-22</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-23</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-277-23) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-23</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
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<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-24</NDCCode>
<PackageDescription>6 VIAL, MULTI-DOSE in 1 BOX (73069-277-24) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-24</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-277-26</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-277-26) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0277-26</NDC11Code>
<ProductNDC>73069-277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
<NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>NITRIC ACID; SUCCINIC ACID; ESCHERICHIA COLI; BERBERIS VULGARIS ROOT; EQUISETUM HYEMALE; POTASSIUM NITRATE; BEEF KIDNEY; PORK KIDNEY; METHYL BLUE; ONONIS SPINOSA WHOLE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS URETER; SUS SCROFA URETER; BOS TAURUS URINARY BLADDER; SUS SCROFA URINARY BLADDER; PROTEUS INCONSTANS; HIERACIUM PILOSELLA WHOLE; QUINHYDRONE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
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<StartMarketingDate>20190329</StartMarketingDate>
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<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
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<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<ProprietaryName>Viatrexx-ki-ub</ProprietaryName>
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<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
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<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName></NDC><NDC><NDCCode>73069-277-24</NDCCode><ProprietaryName>Viatrexx-ki-ub</ProprietaryName><NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And 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Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName></NDC><NDC><NDCCode>73069-277-29</NDCCode><ProprietaryName>Viatrexx-ki-ub</ProprietaryName><NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName></NDC><NDC><NDCCode>73069-277-31</NDCCode><ProprietaryName>Viatrexx-ki-ub</ProprietaryName><NonProprietaryName>Nitric Acid , Succinic Acid , Escherichia Coli , Berberis Vulgaris Root , Equisetum Hyemale , Potassium Nitrate , Beef Kidney , Pork Kidney , Methyl Blue , Ononis Spinosa Whole , Clerodendranthus Spicatus Leaf , Chondrodendron Tomentosum Root , Plantago Major , Smilax Regelii Root , Solidago Virgaurea Flowering Top , Bos Taurus Ureter , Sus Scrofa Ureter , Bos Taurus Urinary Bladder , Sus Scrofa Urinary Bladder , Proteus Inconstans , Hieracium Pilosella Whole And Quinhydrone</NonProprietaryName></NDC></NDCList>