{
"NDC": [
{
"NDCCode": "65862-443-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (65862-443-12) > 120 mL in 1 BOTTLE",
"NDC11Code": "65862-0443-12",
"ProductNDC": "65862-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Cetirizine Hydrochloride Hives Relief",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090750",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "65862-443-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (65862-443-24) > 240 mL in 1 BOTTLE",
"NDC11Code": "65862-0443-24",
"ProductNDC": "65862-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Cetirizine Hydrochloride Hives Relief",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090750",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "65862-443-48",
"PackageDescription": "480 mL in 1 BOTTLE (65862-443-48)",
"NDC11Code": "65862-0443-48",
"ProductNDC": "65862-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Cetirizine Hydrochloride Hives Relief",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090750",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "46122-443-62",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-443-62) / 12 TABLET in 1 BLISTER PACK",
"NDC11Code": "46122-0443-62",
"ProductNDC": "46122-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Pressure Pain",
"ProprietaryNameSuffix": "Maximum Strength, Non-drowsy",
"NonProprietaryName": "Acetaminophen, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050623",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050623",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:minor aches and painsnasal congestion headachesinus congestion and pressure . promotes sinus drainage. temporarily reduces fever ."
},
{
"NDCCode": "54340-135-12",
"PackageDescription": "6 BOTTLE, DISPENSING in 1 CARTON (54340-135-12) / 443 mL in 1 BOTTLE, DISPENSING (54340-135-11) ",
"NDC11Code": "54340-0135-12",
"ProductNDC": "54340-135",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dial Professional Original Gold Antibacterial",
"NonProprietaryName": "Dial Professional Original Gold Antibacterial Hand Soap",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Henkel Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "55315-443-12",
"PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (55315-443-12) ",
"NDC11Code": "55315-0443-12",
"ProductNDC": "55315-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu Relief",
"ProprietaryNameSuffix": "Nighttime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180331",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Freds Inc",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180331",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold/flu symptoms: ."
},
{
"NDCCode": "55319-443-12",
"PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (55319-443-12) ",
"NDC11Code": "55319-0443-12",
"ProductNDC": "55319-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu",
"ProprietaryNameSuffix": "Nighttime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171231",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Family Dollar (FAMILY WELLNESS)",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171231",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold/flu symptoms: : 1 minor aches and pains , 2 headache , 3 sore throat , 4 fever , 5 runny nose and sneezing , 6 cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "55910-443-12",
"PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (55910-443-12) ",
"NDC11Code": "55910-0443-12",
"ProductNDC": "55910-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu",
"ProprietaryNameSuffix": "Nighttime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180331",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180331",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold/flu symptoms: : 1 minor aches and pains , 2 headache , 3 sore throat , 4 fever , 5 runny nose and sneezing , 6 cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "57896-443-12",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (57896-443-12) / 6 SUPPOSITORY in 1 BLISTER PACK (57896-443-66) ",
"NDC11Code": "57896-0443-12",
"ProductNDC": "57896-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bisacodyl",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20191101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "GERI-CARE PHARMACEUTICAL CORP",
"SubstanceName": "BISACODYL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 relieves occasional constipation, 2 this product generally produces a bowel movement in 15 minutes to 1 hour."
},
{
"NDCCode": "66902-443-12",
"PackageDescription": "3785 mL in 1 JUG (66902-443-12) ",
"NDC11Code": "66902-0443-12",
"ProductNDC": "66902-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Germ Attack Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200327",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Natural Essentials, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200327",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "68428-443-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-443-12) ",
"NDC11Code": "68428-0443-12",
"ProductNDC": "68428-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iris Versicolor",
"NonProprietaryName": "Iris Versicolor Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "IRIS VERSICOLOR ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "68599-5306-3",
"PackageDescription": "12 BOTTLE, PLASTIC in 1 CASE (68599-5306-3) > 443 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "68599-5306-03",
"ProductNDC": "68599-5306",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-pak Performance Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "McKesson Medical-Surgical Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "64.5",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "68599-5309-3",
"PackageDescription": "12 BOTTLE, PLASTIC in 1 CASE (68599-5309-3) > 443 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "68599-5309-03",
"ProductNDC": "68599-5309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-pak Performance Instant Hand Sanitizer With Aloe",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "McKesson Medical-Surgical Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "64.5",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "73069-443-12",
"PackageDescription": "3 VIAL, MULTI-DOSE in 1 BOX (73069-443-12) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-12",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-16",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-443-16) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-16",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-26",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-443-26) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-26",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-36",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-443-36) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-36",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-46",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-443-46) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-46",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190505",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-56",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-443-56) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-56",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-66",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-443-66) > 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-66",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-76",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-443-76) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-76",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-86",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-443-86) > 100 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-86",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "65862-060-11",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (65862-060-11) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "65862-0060-11",
"ProductNDC": "65862-060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077731",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081007",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline.Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "65862-066-12",
"PackageDescription": "1200 TABLET, FOR SUSPENSION in 1 BAG (65862-066-12)",
"NDC11Code": "65862-0066-12",
"ProductNDC": "65862-066",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "TABLET, FOR SUSPENSION",
"StartMarketingDate": "20131212",
"EndMarketingDate": "20171221",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171221"
},
{
"NDCCode": "65862-085-12",
"PackageDescription": "1200 CAPSULE in 1 BAG (65862-085-12) ",
"NDC11Code": "65862-0085-12",
"ProductNDC": "65862-085",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cefadroxil",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20070125",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CEFADROXIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-01-31",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "25-JAN-07"
},
{
"NDCCode": "65862-306-12",
"PackageDescription": "120 mL in 1 BOTTLE, GLASS (65862-306-12) ",
"NDC11Code": "65862-0306-12",
"ProductNDC": "65862-306",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079209",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090319",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine oral solution is indicated for the treatment of:. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.",
"Description": "Fluoxetine oral solution, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 mL (64.7 μmol) of fluoxetine. It also contains alcohol 0.23%, sucrose, glycerin, benzoic acid, natural peppermint flavor, and purified water."
},
{
"NDCCode": "65862-420-12",
"PackageDescription": "12500 TABLET in 1 BAG (65862-420-12) ",
"NDC11Code": "65862-0420-12",
"ProductNDC": "65862-420",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-03-29",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "24-JUL-19"
},
{
"NDCCode": "65862-422-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (65862-422-12) > 120 mL in 1 BOTTLE",
"NDC11Code": "65862-0422-12",
"ProductNDC": "65862-422",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Cetirizine Hydrochloride Allergy",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090750",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "65862-450-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (65862-450-12) > 120 mL in 1 BOTTLE",
"NDC11Code": "65862-0450-12",
"ProductNDC": "65862-450",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20091216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090751",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-09-26"
},
{
"NDCCode": "65862-550-12",
"PackageDescription": "1200 TABLET, FILM COATED in 1 BAG (65862-550-12) ",
"NDC11Code": "65862-0550-12",
"ProductNDC": "65862-550",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20130321",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "HYDROCHLOROTHIAZIDE; VALSARTAN",
"StrengthNumber": "12.5; 320",
"StrengthUnit": "mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-06-20",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "21-MAR-13"
}
]
}
{"NDC":[{"NDCCode":"65862-443-12","ProprietaryName":"Childrens Cetirizine Hydrochloride Hives Relief","NonProprietaryName":"Cetirizine Hydrochloride"},{"NDCCode":"65862-443-24","ProprietaryName":"Childrens Cetirizine Hydrochloride Hives Relief","NonProprietaryName":"Cetirizine Hydrochloride"},{"NDCCode":"65862-443-48","ProprietaryName":"Childrens Cetirizine Hydrochloride Hives Relief","NonProprietaryName":"Cetirizine Hydrochloride"},{"NDCCode":"46122-443-62","ProprietaryName":"Sinus Pressure Pain","NonProprietaryName":"Acetaminophen, Phenylephrine Hcl"},{"NDCCode":"54340-135-12","ProprietaryName":"Dial Professional Original Gold Antibacterial","NonProprietaryName":"Dial Professional Original Gold Antibacterial Hand Soap"},{"NDCCode":"55315-443-12","ProprietaryName":"Cold And Flu Relief","NonProprietaryName":"Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate"},{"NDCCode":"55319-443-12","ProprietaryName":"Cold And Flu","NonProprietaryName":"Acetaminophen, 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<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
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<Status>Deprecated</Status>
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<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<ProductNDC>46122-443</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Pressure Pain</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength, Non-drowsy</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050623</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:minor aches and painsnasal congestion headachesinus congestion and pressure . promotes sinus drainage. temporarily reduces fever .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54340-135-12</NDCCode>
<PackageDescription>6 BOTTLE, DISPENSING in 1 CARTON (54340-135-12) / 443 mL in 1 BOTTLE, DISPENSING (54340-135-11) </PackageDescription>
<NDC11Code>54340-0135-12</NDC11Code>
<ProductNDC>54340-135</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dial Professional Original Gold Antibacterial</ProprietaryName>
<NonProprietaryName>Dial Professional Original Gold Antibacterial Hand Soap</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Henkel Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55315-443-12</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE, PLASTIC (55315-443-12) </PackageDescription>
<NDC11Code>55315-0443-12</NDC11Code>
<ProductNDC>55315-443</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu Relief</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180331</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Freds Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
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<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180331</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>55319-443-12</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE, PLASTIC (55319-443-12) </PackageDescription>
<NDC11Code>55319-0443-12</NDC11Code>
<ProductNDC>55319-443</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
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<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171231</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
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<ApplicationNumber>part341</ApplicationNumber>
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<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171231</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold/flu symptoms: : 1 minor aches and pains , 2 headache , 3 sore throat , 4 fever , 5 runny nose and sneezing , 6 cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-443-12</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE, PLASTIC (55910-443-12) </PackageDescription>
<NDC11Code>55910-0443-12</NDC11Code>
<ProductNDC>55910-443</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
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<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold/flu symptoms: : 1 minor aches and pains , 2 headache , 3 sore throat , 4 fever , 5 runny nose and sneezing , 6 cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57896-443-12</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (57896-443-12) / 6 SUPPOSITORY in 1 BLISTER PACK (57896-443-66) </PackageDescription>
<NDC11Code>57896-0443-12</NDC11Code>
<ProductNDC>57896-443</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bisacodyl</ProprietaryName>
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<RouteName>RECTAL</RouteName>
<StartMarketingDate>20191101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>GERI-CARE PHARMACEUTICAL CORP</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 relieves occasional constipation, 2 this product generally produces a bowel movement in 15 minutes to 1 hour.</IndicationAndUsage>
</NDC>
<NDC>
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<ProductNDC>66902-443</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Germ Attack Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200327</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Natural Essentials, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-443-12</NDCCode>
<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-443-12) </PackageDescription>
<NDC11Code>68428-0443-12</NDC11Code>
<ProductNDC>68428-443</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iris Versicolor</ProprietaryName>
<NonProprietaryName>Iris Versicolor Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>IRIS VERSICOLOR ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68599-5306-3</NDCCode>
<PackageDescription>12 BOTTLE, PLASTIC in 1 CASE (68599-5306-3) > 443 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>68599-5306-03</NDC11Code>
<ProductNDC>68599-5306</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-pak Performance Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>McKesson Medical-Surgical Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>64.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>68599-5309-3</NDCCode>
<PackageDescription>12 BOTTLE, PLASTIC in 1 CASE (68599-5309-3) > 443 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>68599-5309-03</NDC11Code>
<ProductNDC>68599-5309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-pak Performance Instant Hand Sanitizer With Aloe</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>McKesson Medical-Surgical Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>64.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>73069-443-12</NDCCode>
<PackageDescription>3 VIAL, MULTI-DOSE in 1 BOX (73069-443-12) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-12</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</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>73069-443-16</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-443-16) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-16</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</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>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</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>73069-443-26</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-443-26) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-26</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</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>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</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>73069-443-36</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-443-36) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-36</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</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>
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<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-443-46) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-46</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</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>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-56</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-443-56) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-56</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</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>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</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>73069-443-66</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-443-66) > 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-66</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</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>73069-443-76</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-443-76) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-76</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</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>73069-443-86</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-443-86) > 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-86</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</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>65862-060-11</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (65862-060-11) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65862-0060-11</NDC11Code>
<ProductNDC>65862-060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077731</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline.Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>65862-066-12</NDCCode>
<PackageDescription>1200 TABLET, FOR SUSPENSION in 1 BAG (65862-066-12)</PackageDescription>
<NDC11Code>65862-0066-12</NDC11Code>
<ProductNDC>65862-066</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<StartMarketingDate>20131212</StartMarketingDate>
<EndMarketingDate>20171221</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171221</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65862-085-12</NDCCode>
<PackageDescription>1200 CAPSULE in 1 BAG (65862-085-12) </PackageDescription>
<NDC11Code>65862-0085-12</NDC11Code>
<ProductNDC>65862-085</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Cefadroxil</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20070125</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CEFADROXIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-01-31</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-JAN-07</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65862-306-12</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, GLASS (65862-306-12) </PackageDescription>
<NDC11Code>65862-0306-12</NDC11Code>
<ProductNDC>65862-306</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079209</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine oral solution is indicated for the treatment of:. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.</IndicationAndUsage>
<Description>Fluoxetine oral solution, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 mL (64.7 μmol) of fluoxetine. It also contains alcohol 0.23%, sucrose, glycerin, benzoic acid, natural peppermint flavor, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>65862-420-12</NDCCode>
<PackageDescription>12500 TABLET in 1 BAG (65862-420-12) </PackageDescription>
<NDC11Code>65862-0420-12</NDC11Code>
<ProductNDC>65862-420</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20100216</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-03-29</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>24-JUL-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65862-422-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65862-422-12) > 120 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65862-0422-12</NDC11Code>
<ProductNDC>65862-422</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Cetirizine Hydrochloride Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090750</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65862-450-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65862-450-12) > 120 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65862-0450-12</NDC11Code>
<ProductNDC>65862-450</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090751</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>65862-550-12</NDCCode>
<PackageDescription>1200 TABLET, FILM COATED in 1 BAG (65862-550-12) </PackageDescription>
<NDC11Code>65862-0550-12</NDC11Code>
<ProductNDC>65862-550</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20130321</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
<StrengthNumber>12.5; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-06-20</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-MAR-13</StartMarketingDatePackage>
</NDC>
</NDCList>
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E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-16</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-26</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-36</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-46</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-56</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-66</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-76</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-86</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>65862-060-11</NDCCode><ProprietaryName>Fluconazole</ProprietaryName><NonProprietaryName>Fluconazole</NonProprietaryName></NDC><NDC><NDCCode>65862-066-12</NDCCode><NonProprietaryName>Amoxicillin</NonProprietaryName></NDC><NDC><NDCCode>65862-085-12</NDCCode><NonProprietaryName>Cefadroxil</NonProprietaryName></NDC><NDC><NDCCode>65862-306-12</NDCCode><ProprietaryName>Fluoxetine</ProprietaryName><NonProprietaryName>Fluoxetine</NonProprietaryName></NDC><NDC><NDCCode>65862-420-12</NDCCode><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>65862-422-12</NDCCode><ProprietaryName>Childrens Cetirizine Hydrochloride Allergy</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>65862-450-12</NDCCode><ProprietaryName>Cetirizine Hydrochloride</ProprietaryName><NonProprietaryName>Cetirizine 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