{
"NDC": [
{
"NDCCode": "60986-1040-6",
"PackageDescription": "15 mL in 1 BOTTLE, SPRAY (60986-1040-6) ",
"NDC11Code": "60986-1040-06",
"ProductNDC": "60986-1040",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acusine",
"NonProprietaryName": "Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20211224",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC",
"SubstanceName": "DAPHNE MEZEREUM BARK; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL; KEROSENE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "3; 3; 4; 8; 3; 3; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211224",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children."
},
{
"NDCCode": "60986-1040-5",
"PackageDescription": "20 mL in 1 BOTTLE, SPRAY (60986-1040-5) ",
"NDC11Code": "60986-1040-05",
"ProductNDC": "60986-1040",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acusine",
"NonProprietaryName": "Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20211224",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC",
"SubstanceName": "LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; DAPHNE MEZEREUM BARK; KEROSENE; THUJA OCCIDENTALIS LEAFY TWIG; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL",
"StrengthNumber": "3; 3; 3; 8; 10; 3; 4",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211224",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children."
},
{
"NDCCode": "24673-900-04",
"PackageDescription": "1040.6 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (24673-900-04) ",
"NDC11Code": "24673-0900-04",
"ProductNDC": "24673-900",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "C2020 Ipa Hand Senitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "RWM TECHNOLIGES",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200511",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "62991-1040-6",
"PackageDescription": "1000 g in 1 JAR (62991-1040-6) ",
"NDC11Code": "62991-1040-06",
"ProductNDC": "62991-1040",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110927",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "LETCO MEDICAL, LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-06-19",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "27-SEP-11"
},
{
"NDCCode": "66064-1040-6",
"PackageDescription": "500 TABLET in 1 BOTTLE (66064-1040-6) ",
"NDC11Code": "66064-1040-06",
"ProductNDC": "66064-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213320",
"LabelerName": "Harman Finochem Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220601",
"SamplePackage": "N"
},
{
"NDCCode": "60986-1003-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1003-3) ",
"NDC11Code": "60986-1003-03",
"ProductNDC": "60986-1003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allernest",
"NonProprietaryName": "Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111118",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "FORMIC ACID; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; KEROSENE; TOXICODENDRON PUBESCENS LEAF; ARALIA RACEMOSA ROOT; GALPHIMIA GLAUCA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; URTICA DIOICA; CARDIOSPERMUM HALICACABUM FLOWERING TOP",
"StrengthNumber": "12; 8; 6; 6; 6; 4; 4; 4; 4; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180227",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: in acute disorders, take 10 drops every 15 minutes on the tongue or with water until improvement if felt, then take 10 drops less frequently. To maintain balance, take 15 drops three times daily. Children receive 1/2 of the adult amount."
},
{
"NDCCode": "60986-1003-4",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (60986-1003-4) ",
"NDC11Code": "60986-1003-04",
"ProductNDC": "60986-1003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allernest",
"NonProprietaryName": "Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111118",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "FORMIC ACID; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; KEROSENE; TOXICODENDRON PUBESCENS LEAF; ARALIA RACEMOSA ROOT; GALPHIMIA GLAUCA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; URTICA DIOICA; CARDIOSPERMUM HALICACABUM FLOWERING TOP",
"StrengthNumber": "12; 8; 6; 6; 6; 4; 4; 4; 4; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180227",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: in acute disorders, take 10 drops every 15 minutes on the tongue or with water until improvement if felt, then take 10 drops less frequently. To maintain balance, take 15 drops three times daily. Children receive 1/2 of the adult amount."
},
{
"NDCCode": "60986-1004-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1004-3) ",
"NDC11Code": "60986-1004-03",
"ProductNDC": "60986-1004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lymphonest",
"NonProprietaryName": "Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; ARTEMISIA ABROTANUM FLOWERING TOP; KEROSENE; ALOE; MERCURIUS SOLUBILIS; CROTALUS HORRIDUS HORRIDUS VENOM; THUJA OCCIDENTALIS LEAFY TWIG; LACHESIS MUTA VENOM; ARISTOLOCHIA CLEMATITIS ROOT",
"StrengthNumber": "1; 1; 3; 3; 1; 12; 10; 10; 8; 6",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "30 drops in water 3 times daily. In acute stages, take 50 drops at once followed by 30 drops 4 times daily. Children receive one half or less of the adult amount."
},
{
"NDCCode": "60986-1004-4",
"PackageDescription": "100 mL in 1 PACKAGE (60986-1004-4) ",
"NDC11Code": "60986-1004-04",
"ProductNDC": "60986-1004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lymphonest",
"NonProprietaryName": "Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; ARTEMISIA ABROTANUM FLOWERING TOP; KEROSENE; ALOE; MERCURIUS SOLUBILIS; CROTALUS HORRIDUS HORRIDUS VENOM; THUJA OCCIDENTALIS LEAFY TWIG; LACHESIS MUTA VENOM; ARISTOLOCHIA CLEMATITIS ROOT",
"StrengthNumber": "1; 1; 3; 3; 1; 12; 10; 10; 8; 6",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "30 drops in water 3 times daily. In acute stages, take 50 drops at once followed by 30 drops 4 times daily. Children receive one half or less of the adult amount."
},
{
"NDCCode": "60986-1008-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1008-3) ",
"NDC11Code": "60986-1008-03",
"ProductNDC": "60986-1008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cholenest",
"NonProprietaryName": "Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "FRANGULA PURSHIANA BARK; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; MORELLA CERIFERA ROOT BARK; BERBERIS VULGARIS ROOT BARK; SODIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; COPPER",
"StrengthNumber": "1; 1; 1; 1; 2; 2; 2; 6; 8; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180227",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals."
},
{
"NDCCode": "60986-1008-4",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (60986-1008-4) ",
"NDC11Code": "60986-1008-04",
"ProductNDC": "60986-1008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cholenest",
"NonProprietaryName": "Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "FRANGULA PURSHIANA BARK; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; MORELLA CERIFERA ROOT BARK; BERBERIS VULGARIS ROOT BARK; SODIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; COPPER",
"StrengthNumber": "1; 1; 1; 1; 2; 2; 2; 6; 8; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180227",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals."
},
{
"NDCCode": "60986-1011-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1011-3) ",
"NDC11Code": "60986-1011-03",
"ProductNDC": "60986-1011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rubus",
"NonProprietaryName": "Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "BLACKBERRY; IRIS X GERMANICA ROOT; BILBERRY; SYZYGIUM CUMINI SEED; OKOUBAKA AUBREVILLEI BARK",
"StrengthNumber": "2; 4; 3; 3; 6",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920301",
"SamplePackage": "N",
"IndicationAndUsage": "Dosage: For acute conditions take 25 drops in water 3-4 times daily. For long-term usage, take 20 drops in water morning and evening."
},
{
"NDCCode": "60986-1011-4",
"PackageDescription": "100 mL in 1 PACKAGE (60986-1011-4) ",
"NDC11Code": "60986-1011-04",
"ProductNDC": "60986-1011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rubus",
"NonProprietaryName": "Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "BLACKBERRY; IRIS X GERMANICA ROOT; BILBERRY; SYZYGIUM CUMINI SEED; OKOUBAKA AUBREVILLEI BARK",
"StrengthNumber": "2; 4; 3; 3; 6",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920301",
"SamplePackage": "N",
"IndicationAndUsage": "Dosage: For acute conditions take 25 drops in water 3-4 times daily. For long-term usage, take 20 drops in water morning and evening."
},
{
"NDCCode": "60986-1020-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1020-3) ",
"NDC11Code": "60986-1020-03",
"ProductNDC": "60986-1020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Solidago",
"NonProprietaryName": "Solidago Virgaurea, Uva-ursi, Pareira Brava, Sabal Serrulata, Populus Tremuloides, Staphysagria, Cantharis, Terebinthia, Borax",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SAW PALMETTO; POPULUS TREMULOIDES BARK; DELPHINIUM STAPHISAGRIA SEED; LYTTA VESICATORIA; LARIX DECIDUA RESIN; SODIUM BORATE",
"StrengthNumber": "1; 1; 3; 1; 2; 3; 4; 6; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: Take 40 drops in tepid water three times daily. For severe symptoms, take 40 drops four to five time daily. After improvement is felt, take 40 drops three times daily. Children receive 1/2 or less of the adult amount."
},
{
"NDCCode": "60986-1020-4",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (60986-1020-4) ",
"NDC11Code": "60986-1020-04",
"ProductNDC": "60986-1020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Solidago",
"NonProprietaryName": "Solidago Virgaurea, Uva-ursi, Pareira Brava, Sabal Serrulata, Populus Tremuloides, Staphysagria, Cantharis, Terebinthia, Borax",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SAW PALMETTO; POPULUS TREMULOIDES BARK; DELPHINIUM STAPHISAGRIA SEED; LYTTA VESICATORIA; LARIX DECIDUA RESIN; SODIUM BORATE",
"StrengthNumber": "1; 1; 3; 1; 2; 3; 4; 6; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: Take 40 drops in tepid water three times daily. For severe symptoms, take 40 drops four to five time daily. After improvement is felt, take 40 drops three times daily. Children receive 1/2 or less of the adult amount."
},
{
"NDCCode": "60986-1021-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1021-3)",
"NDC11Code": "60986-1021-03",
"ProductNDC": "60986-1021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cactus",
"NonProprietaryName": "Cactus Grandiflorus, Convallaria Majalis, Crataegus Laevigata, Camphora, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana,tabacum, Glonoinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; CRATAEGUS LAEVIGATA WHOLE; CAMPHOR (NATURAL); KALMIA LATIFOLIA LEAF; SPIGELIA ANTHELMIA; LACHESIS MUTA VENOM; ARNICA MONTANA; TOBACCO LEAF; NITROGLYCERIN",
"StrengthNumber": "2; 3; 1; 2; 4; 4; 8; 6; 8; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "60986-1021-4",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (60986-1021-4)",
"NDC11Code": "60986-1021-04",
"ProductNDC": "60986-1021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cactus",
"NonProprietaryName": "Cactus Grandiflorus, Convallaria Majalis, Crataegus Laevigata, Camphora, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana,tabacum, Glonoinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; CRATAEGUS LAEVIGATA WHOLE; CAMPHOR (NATURAL); KALMIA LATIFOLIA LEAF; SPIGELIA ANTHELMIA; LACHESIS MUTA VENOM; ARNICA MONTANA; TOBACCO LEAF; NITROGLYCERIN",
"StrengthNumber": "2; 3; 1; 2; 4; 4; 8; 6; 8; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "60986-1026-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1026-3)",
"NDC11Code": "60986-1026-03",
"ProductNDC": "60986-1026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lycopus",
"NonProprietaryName": "Lycopus Virginicus, Spongia Tosta, Lophophytum Leandrii, Chininum Arsenicosum, Calcarea Phosphorica, Magnesia Phosphorica",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "LYCOPUS VIRGINICUS; SPONGIA OFFICINALIS SKELETON, ROASTED; LOPHOPHYTUM LEANDRII; QUININE ARSENITE; TRIBASIC CALCIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
"StrengthNumber": "1; 1; 6; 6; 8; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ADULTS TAKE 5 DROPS IN 1 TABLESPOON TEPID WATER THREE TIME DAILY, INCREASING BY 1 DROP DAILY UNTIL REACTION LEVEL IS REACHED. MAXIMUM AMOUNT: 20 DROPS THREE TIMES DAILY. CHILDREN RECEIVE 1/2 OR LESS OF THE ADULT AMOUNT."
},
{
"NDCCode": "60986-1028-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1028-3) ",
"NDC11Code": "60986-1028-03",
"ProductNDC": "60986-1028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cactus",
"NonProprietaryName": "Crataegus Laevigata, Cactus Grandiflorus, Convallaria Majalis, Camphor, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana, Tabacum, Glonoinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "ARNICA MONTANA; CAMPHOR (NATURAL); CONVALLARIA MAJALIS; CRATAEGUS LAEVIGATA WHOLE; KALMIA LATIFOLIA LEAF; LACHESIS MUTA VENOM; NITROGLYCERIN; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; TOBACCO LEAF",
"StrengthNumber": "6; 2; 3; 1; 4; 8; 8; 2; 4; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N"
},
{
"NDCCode": "60986-1028-4",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (60986-1028-4) ",
"NDC11Code": "60986-1028-04",
"ProductNDC": "60986-1028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cactus",
"NonProprietaryName": "Crataegus Laevigata, Cactus Grandiflorus, Convallaria Majalis, Camphor, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana, Tabacum, Glonoinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "ARNICA MONTANA; CAMPHOR (NATURAL); CONVALLARIA MAJALIS; CRATAEGUS LAEVIGATA WHOLE; KALMIA LATIFOLIA LEAF; LACHESIS MUTA VENOM; NITROGLYCERIN; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; TOBACCO LEAF",
"StrengthNumber": "6; 2; 3; 1; 4; 8; 8; 2; 4; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Adults take 30 drops in 1 oz water three times daily. For acute symptoms, take 40 drops four to five times daily. Children receive 10 drops in 1 oz tepid water three time daily."
},
{
"NDCCode": "60986-1030-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1030-3) ",
"NDC11Code": "60986-1030-03",
"ProductNDC": "60986-1030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lycopus",
"NonProprietaryName": "Lycopus Virginicus, Spongia Tosta, Lophophytum Leandrii, Chininum Arsenicosum, Calcarea Phosphorica, Magnesia Phosphorica",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "LOPHOPHYTUM LEANDRII; LYCOPUS VIRGINICUS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; QUININE ARSENITE; SPONGIA OFFICINALIS SKELETON, ROASTED; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "6; 1; 8; 6; 1; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Adults take 5 drops on the tongue or in 1 tablespoon water 3 times daily, increasing by one drop daily until reaction level is reached. Maxixum amount: 20 drops three times daily. Children receive 1/2 or less of the adult amount."
},
{
"NDCCode": "60986-1030-4",
"PackageDescription": "100 mL in 1 PACKAGE (60986-1030-4) ",
"NDC11Code": "60986-1030-04",
"ProductNDC": "60986-1030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lycopus",
"NonProprietaryName": "Lycopus Virginicus, Spongia Tosta, Lophophytum Leandrii, Chininum Arsenicosum, Calcarea Phosphorica, Magnesia Phosphorica",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "LYCOPUS VIRGINICUS; SPONGIA OFFICINALIS SKELETON, ROASTED; LOPHOPHYTUM LEANDRII; QUININE ARSENITE; TRIBASIC CALCIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
"StrengthNumber": "1; 1; 6; 6; 8; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Adults take 5 drops on the tongue or in 1 tablespoon water 3 times daily, increasing by one drop daily until reaction level is reached. Maxixum amount: 20 drops three times daily. Children receive 1/2 or less of the adult amount."
},
{
"NDCCode": "60986-1032-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1032-3) ",
"NDC11Code": "60986-1032-03",
"ProductNDC": "60986-1032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Polygonum",
"NonProprietaryName": "Polygonum Aviculare, Acorus Calamus, Rhus Toxicodendron, Gnaphalium Polycephalum, Rhododendron Chrysanthum, Colocynthis, Colchicum Autumnale, Kali Iodatum, Ichthyolum, Symphytum Officinale",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220614",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "POLYGONUM AVICULARE TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; COLCHICUM AUTUMNALE BULB; POTASSIUM IODIDE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; PSEUDOGNAPHALIUM OBTUSIFOLIUM; ACORUS CALAMUS WHOLE; ICHTHAMMOL",
"StrengthNumber": "1; 3; 6; 3; 4; 3; 4; 2; 1; 3",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220614",
"SamplePackage": "N",
"IndicationAndUsage": "Indications: For temporary relief of pain in joints and muscles."
},
{
"NDCCode": "60986-1032-4",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (60986-1032-4) ",
"NDC11Code": "60986-1032-04",
"ProductNDC": "60986-1032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Polygonum",
"NonProprietaryName": "Polygonum Aviculare, Acorus Calamus, Rhus Toxicodendron, Gnaphalium Polycephalum, Rhododendron Chrysanthum, Colocynthis, Colchicum Autumnale, Kali Iodatum, Ichthyolum, Symphytum Officinale",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220614",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "POLYGONUM AVICULARE TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; COLCHICUM AUTUMNALE BULB; POTASSIUM IODIDE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; PSEUDOGNAPHALIUM OBTUSIFOLIUM; ACORUS CALAMUS WHOLE; ICHTHAMMOL",
"StrengthNumber": "1; 3; 6; 3; 4; 3; 4; 2; 1; 3",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220614",
"SamplePackage": "N",
"IndicationAndUsage": "Indications: For temporary relief of pain in joints and muscles."
},
{
"NDCCode": "60986-2025-2",
"PackageDescription": "60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (60986-2025-2) ",
"NDC11Code": "60986-2025-02",
"ProductNDC": "60986-2025",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Luffa",
"NonProprietaryName": "Luffa, Hydrastis Canadensis, Mercurius Sulph. Rub, Allium Cepa, Natrum Muriticum, Phosphorus, Eupatorium Perf, Sticta",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "LUFFA ACUTANGULA FRUIT; GOLDENSEAL; MERCURIC SULFIDE; ONION; SODIUM CHLORIDE; PHOSPHORUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; LOBARIA PULMONARIA",
"StrengthNumber": "6; 4; 4; 6; 6; 6; 5; 2",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Adults take 1 tablet three times daily, dissolving on the tongue. For severe symptoms, take 1 tablet every hour until improvement is felt. Children receive 1/2 or less the adult amount."
},
{
"NDCCode": "0008-1040-05",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1040-05) ",
"NDC11Code": "00008-1040-05",
"ProductNDC": "0008-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100301",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100301",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0008-1040-10",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-1040-10) / 1 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "00008-1040-10",
"ProductNDC": "0008-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100301",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100301",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0074-1040-04",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0074-1040-04) / 4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00074-1040-04",
"ProductNDC": "0074-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Survanta",
"NonProprietaryName": "Beractant",
"DosageFormName": "SUSPENSION",
"RouteName": "ENDOTRACHEAL",
"StartMarketingDate": "19910701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020032",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "BERACTANT",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19910701",
"SamplePackage": "N",
"IndicationAndUsage": "SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.",
"Description": "SURVANTA® contains beractant, a pulmonary surfactant, which is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins (SP) to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL of phospholipids (including 11.0-15.5 mg/mL of disaturated phosphatidylcholine), 0.5-1.75 mg/mL of triglycerides, 1.4-3.5 mg/mL of free fatty acids, and less than 1 mg/mL of SP (including SP-B, a 79-amino acid protein, and SP-C, a 35-amino acid peptide). SURVANTA (beractant) intratracheal suspension is a sterile, preservative-free, non-pyrogenic off-white to light brown liquid supplied in single-dose glass vials for intratracheal use only. Each vial contains 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids). Each mL of SURVANTA contains 25 mg of phospholipids. It is suspended in 0.9% sodium chloride solution and heat-sterilized. SURVANTA contains no preservatives. Sodium hydroxide or hydrochloric acid may be added to adjust the pH. The pH is approximately 6.2 to 7.6."
},
{
"NDCCode": "0074-1040-08",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0074-1040-08) / 8 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00074-1040-08",
"ProductNDC": "0074-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Survanta",
"NonProprietaryName": "Beractant",
"DosageFormName": "SUSPENSION",
"RouteName": "ENDOTRACHEAL",
"StartMarketingDate": "19910701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020032",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "BERACTANT",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19910701",
"SamplePackage": "N",
"IndicationAndUsage": "SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.",
"Description": "SURVANTA® contains beractant, a pulmonary surfactant, which is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins (SP) to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL of phospholipids (including 11.0-15.5 mg/mL of disaturated phosphatidylcholine), 0.5-1.75 mg/mL of triglycerides, 1.4-3.5 mg/mL of free fatty acids, and less than 1 mg/mL of SP (including SP-B, a 79-amino acid protein, and SP-C, a 35-amino acid peptide). SURVANTA (beractant) intratracheal suspension is a sterile, preservative-free, non-pyrogenic off-white to light brown liquid supplied in single-dose glass vials for intratracheal use only. Each vial contains 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids). Each mL of SURVANTA contains 25 mg of phospholipids. It is suspended in 0.9% sodium chloride solution and heat-sterilized. SURVANTA contains no preservatives. Sodium hydroxide or hydrochloric acid may be added to adjust the pH. The pH is approximately 6.2 to 7.6."
},
{
"NDCCode": "0615-7976-39",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7976-39) ",
"NDC11Code": "00615-7976-39",
"ProductNDC": "0615-7976",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120109",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160504",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablet is indicated for adjunctive therapy in the treatment of: 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) .",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow ( iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
}
]
}
{"NDC":[{"NDCCode":"60986-1040-6","ProprietaryName":"Acusine","NonProprietaryName":"Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis"},{"NDCCode":"60986-1040-5","ProprietaryName":"Acusine","NonProprietaryName":"Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis"},{"NDCCode":"24673-900-04","ProprietaryName":"C2020 Ipa Hand Senitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"62991-1040-6","NonProprietaryName":"Cyclobenzaprine Hydrochloride"},{"NDCCode":"66064-1040-6","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"},{"NDCCode":"60986-1003-3","ProprietaryName":"Allernest","NonProprietaryName":"Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum"},{"NDCCode":"60986-1003-4","ProprietaryName":"Allernest","NonProprietaryName":"Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum"},{"NDCCode":"60986-1004-3","ProprietaryName":"Lymphonest","NonProprietaryName":"Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis"},{"NDCCode":"60986-1004-4","ProprietaryName":"Lymphonest","NonProprietaryName":"Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis"},{"NDCCode":"60986-1008-3","ProprietaryName":"Cholenest","NonProprietaryName":"Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum"},{"NDCCode":"60986-1008-4","ProprietaryName":"Cholenest","NonProprietaryName":"Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum"},{"NDCCode":"60986-1011-3","ProprietaryName":"Rubus","NonProprietaryName":"Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei"},{"NDCCode":"60986-1011-4","ProprietaryName":"Rubus","NonProprietaryName":"Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei"},{"NDCCode":"60986-1020-3","ProprietaryName":"Solidago","NonProprietaryName":"Solidago Virgaurea, Uva-ursi, Pareira Brava, Sabal Serrulata, Populus Tremuloides, Staphysagria, Cantharis, Terebinthia, Borax"},{"NDCCode":"60986-1020-4","ProprietaryName":"Solidago","NonProprietaryName":"Solidago Virgaurea, Uva-ursi, Pareira Brava, Sabal Serrulata, Populus Tremuloides, Staphysagria, Cantharis, Terebinthia, Borax"},{"NDCCode":"60986-1021-3","ProprietaryName":"Cactus","NonProprietaryName":"Cactus Grandiflorus, Convallaria Majalis, Crataegus Laevigata, Camphora, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana,tabacum, Glonoinum"},{"NDCCode":"60986-1021-4","ProprietaryName":"Cactus","NonProprietaryName":"Cactus Grandiflorus, Convallaria Majalis, Crataegus Laevigata, Camphora, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana,tabacum, Glonoinum"},{"NDCCode":"60986-1026-3","ProprietaryName":"Lycopus","NonProprietaryName":"Lycopus Virginicus, Spongia Tosta, Lophophytum Leandrii, Chininum Arsenicosum, Calcarea Phosphorica, Magnesia Phosphorica"},{"NDCCode":"60986-1028-3","ProprietaryName":"Cactus","NonProprietaryName":"Crataegus Laevigata, Cactus Grandiflorus, Convallaria Majalis, Camphor, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana, Tabacum, Glonoinum"},{"NDCCode":"60986-1028-4","ProprietaryName":"Cactus","NonProprietaryName":"Crataegus Laevigata, Cactus Grandiflorus, Convallaria Majalis, Camphor, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana, Tabacum, Glonoinum"},{"NDCCode":"60986-1030-3","ProprietaryName":"Lycopus","NonProprietaryName":"Lycopus Virginicus, Spongia Tosta, Lophophytum Leandrii, Chininum Arsenicosum, Calcarea Phosphorica, Magnesia Phosphorica"},{"NDCCode":"60986-1030-4","ProprietaryName":"Lycopus","NonProprietaryName":"Lycopus Virginicus, Spongia Tosta, Lophophytum Leandrii, Chininum Arsenicosum, Calcarea Phosphorica, Magnesia Phosphorica"},{"NDCCode":"60986-1032-3","ProprietaryName":"Polygonum","NonProprietaryName":"Polygonum Aviculare, Acorus Calamus, Rhus Toxicodendron, Gnaphalium Polycephalum, Rhododendron Chrysanthum, Colocynthis, Colchicum Autumnale, Kali Iodatum, Ichthyolum, Symphytum Officinale"},{"NDCCode":"60986-1032-4","ProprietaryName":"Polygonum","NonProprietaryName":"Polygonum Aviculare, Acorus Calamus, Rhus Toxicodendron, Gnaphalium Polycephalum, Rhododendron Chrysanthum, Colocynthis, Colchicum Autumnale, Kali Iodatum, Ichthyolum, Symphytum Officinale"},{"NDCCode":"60986-2025-2","ProprietaryName":"Luffa","NonProprietaryName":"Luffa, Hydrastis Canadensis, Mercurius Sulph. Rub, Allium Cepa, Natrum Muriticum, Phosphorus, Eupatorium Perf, Sticta"},{"NDCCode":"0008-1040-05","ProprietaryName":"Rapamune","NonProprietaryName":"Sirolimus"},{"NDCCode":"0008-1040-10","ProprietaryName":"Rapamune","NonProprietaryName":"Sirolimus"},{"NDCCode":"0074-1040-04","ProprietaryName":"Survanta","NonProprietaryName":"Beractant"},{"NDCCode":"0074-1040-08","ProprietaryName":"Survanta","NonProprietaryName":"Beractant"},{"NDCCode":"0615-7976-39","ProprietaryName":"Levetiracetam","NonProprietaryName":"Levetiracetam"}]}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>60986-1040-6</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, SPRAY (60986-1040-6) </PackageDescription>
<NDC11Code>60986-1040-06</NDC11Code>
<ProductNDC>60986-1040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acusine</ProprietaryName>
<NonProprietaryName>Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20211224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC</LabelerName>
<SubstanceName>DAPHNE MEZEREUM BARK; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL; KEROSENE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>3; 3; 4; 8; 3; 3; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1040-5</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE, SPRAY (60986-1040-5) </PackageDescription>
<NDC11Code>60986-1040-05</NDC11Code>
<ProductNDC>60986-1040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acusine</ProprietaryName>
<NonProprietaryName>Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20211224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC</LabelerName>
<SubstanceName>LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; DAPHNE MEZEREUM BARK; KEROSENE; THUJA OCCIDENTALIS LEAFY TWIG; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL</SubstanceName>
<StrengthNumber>3; 3; 3; 8; 10; 3; 4</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24673-900-04</NDCCode>
<PackageDescription>1040.6 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (24673-900-04) </PackageDescription>
<NDC11Code>24673-0900-04</NDC11Code>
<ProductNDC>24673-900</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>C2020 Ipa Hand Senitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>RWM TECHNOLIGES</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62991-1040-6</NDCCode>
<PackageDescription>1000 g in 1 JAR (62991-1040-6) </PackageDescription>
<NDC11Code>62991-1040-06</NDC11Code>
<ProductNDC>62991-1040</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110927</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>LETCO MEDICAL, LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-06-19</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-SEP-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>66064-1040-6</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (66064-1040-6) </PackageDescription>
<NDC11Code>66064-1040-06</NDC11Code>
<ProductNDC>66064-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213320</ApplicationNumber>
<LabelerName>Harman Finochem Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60986-1003-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1003-3) </PackageDescription>
<NDC11Code>60986-1003-03</NDC11Code>
<ProductNDC>60986-1003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allernest</ProprietaryName>
<NonProprietaryName>Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>FORMIC ACID; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; KEROSENE; TOXICODENDRON PUBESCENS LEAF; ARALIA RACEMOSA ROOT; GALPHIMIA GLAUCA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; URTICA DIOICA; CARDIOSPERMUM HALICACABUM FLOWERING TOP</SubstanceName>
<StrengthNumber>12; 8; 6; 6; 6; 4; 4; 4; 4; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: in acute disorders, take 10 drops every 15 minutes on the tongue or with water until improvement if felt, then take 10 drops less frequently. To maintain balance, take 15 drops three times daily. Children receive 1/2 of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1003-4</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (60986-1003-4) </PackageDescription>
<NDC11Code>60986-1003-04</NDC11Code>
<ProductNDC>60986-1003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allernest</ProprietaryName>
<NonProprietaryName>Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>FORMIC ACID; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; KEROSENE; TOXICODENDRON PUBESCENS LEAF; ARALIA RACEMOSA ROOT; GALPHIMIA GLAUCA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; URTICA DIOICA; CARDIOSPERMUM HALICACABUM FLOWERING TOP</SubstanceName>
<StrengthNumber>12; 8; 6; 6; 6; 4; 4; 4; 4; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: in acute disorders, take 10 drops every 15 minutes on the tongue or with water until improvement if felt, then take 10 drops less frequently. To maintain balance, take 15 drops three times daily. Children receive 1/2 of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1004-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1004-3) </PackageDescription>
<NDC11Code>60986-1004-03</NDC11Code>
<ProductNDC>60986-1004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lymphonest</ProprietaryName>
<NonProprietaryName>Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; ARTEMISIA ABROTANUM FLOWERING TOP; KEROSENE; ALOE; MERCURIUS SOLUBILIS; CROTALUS HORRIDUS HORRIDUS VENOM; THUJA OCCIDENTALIS LEAFY TWIG; LACHESIS MUTA VENOM; ARISTOLOCHIA CLEMATITIS ROOT</SubstanceName>
<StrengthNumber>1; 1; 3; 3; 1; 12; 10; 10; 8; 6</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>30 drops in water 3 times daily. In acute stages, take 50 drops at once followed by 30 drops 4 times daily. Children receive one half or less of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1004-4</NDCCode>
<PackageDescription>100 mL in 1 PACKAGE (60986-1004-4) </PackageDescription>
<NDC11Code>60986-1004-04</NDC11Code>
<ProductNDC>60986-1004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lymphonest</ProprietaryName>
<NonProprietaryName>Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; ARTEMISIA ABROTANUM FLOWERING TOP; KEROSENE; ALOE; MERCURIUS SOLUBILIS; CROTALUS HORRIDUS HORRIDUS VENOM; THUJA OCCIDENTALIS LEAFY TWIG; LACHESIS MUTA VENOM; ARISTOLOCHIA CLEMATITIS ROOT</SubstanceName>
<StrengthNumber>1; 1; 3; 3; 1; 12; 10; 10; 8; 6</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>30 drops in water 3 times daily. In acute stages, take 50 drops at once followed by 30 drops 4 times daily. Children receive one half or less of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1008-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1008-3) </PackageDescription>
<NDC11Code>60986-1008-03</NDC11Code>
<ProductNDC>60986-1008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cholenest</ProprietaryName>
<NonProprietaryName>Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>FRANGULA PURSHIANA BARK; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; MORELLA CERIFERA ROOT BARK; BERBERIS VULGARIS ROOT BARK; SODIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; COPPER</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 2; 2; 2; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1008-4</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (60986-1008-4) </PackageDescription>
<NDC11Code>60986-1008-04</NDC11Code>
<ProductNDC>60986-1008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cholenest</ProprietaryName>
<NonProprietaryName>Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>FRANGULA PURSHIANA BARK; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; MORELLA CERIFERA ROOT BARK; BERBERIS VULGARIS ROOT BARK; SODIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; COPPER</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 2; 2; 2; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1011-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1011-3) </PackageDescription>
<NDC11Code>60986-1011-03</NDC11Code>
<ProductNDC>60986-1011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rubus</ProprietaryName>
<NonProprietaryName>Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>BLACKBERRY; IRIS X GERMANICA ROOT; BILBERRY; SYZYGIUM CUMINI SEED; OKOUBAKA AUBREVILLEI BARK</SubstanceName>
<StrengthNumber>2; 4; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dosage: For acute conditions take 25 drops in water 3-4 times daily. For long-term usage, take 20 drops in water morning and evening.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1011-4</NDCCode>
<PackageDescription>100 mL in 1 PACKAGE (60986-1011-4) </PackageDescription>
<NDC11Code>60986-1011-04</NDC11Code>
<ProductNDC>60986-1011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rubus</ProprietaryName>
<NonProprietaryName>Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>BLACKBERRY; IRIS X GERMANICA ROOT; BILBERRY; SYZYGIUM CUMINI SEED; OKOUBAKA AUBREVILLEI BARK</SubstanceName>
<StrengthNumber>2; 4; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dosage: For acute conditions take 25 drops in water 3-4 times daily. For long-term usage, take 20 drops in water morning and evening.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1020-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1020-3) </PackageDescription>
<NDC11Code>60986-1020-03</NDC11Code>
<ProductNDC>60986-1020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Solidago</ProprietaryName>
<NonProprietaryName>Solidago Virgaurea, Uva-ursi, Pareira Brava, Sabal Serrulata, Populus Tremuloides, Staphysagria, Cantharis, Terebinthia, Borax</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SAW PALMETTO; POPULUS TREMULOIDES BARK; DELPHINIUM STAPHISAGRIA SEED; LYTTA VESICATORIA; LARIX DECIDUA RESIN; SODIUM BORATE</SubstanceName>
<StrengthNumber>1; 1; 3; 1; 2; 3; 4; 6; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: Take 40 drops in tepid water three times daily. For severe symptoms, take 40 drops four to five time daily. After improvement is felt, take 40 drops three times daily. Children receive 1/2 or less of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1020-4</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (60986-1020-4) </PackageDescription>
<NDC11Code>60986-1020-04</NDC11Code>
<ProductNDC>60986-1020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Solidago</ProprietaryName>
<NonProprietaryName>Solidago Virgaurea, Uva-ursi, Pareira Brava, Sabal Serrulata, Populus Tremuloides, Staphysagria, Cantharis, Terebinthia, Borax</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SAW PALMETTO; POPULUS TREMULOIDES BARK; DELPHINIUM STAPHISAGRIA SEED; LYTTA VESICATORIA; LARIX DECIDUA RESIN; SODIUM BORATE</SubstanceName>
<StrengthNumber>1; 1; 3; 1; 2; 3; 4; 6; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: Take 40 drops in tepid water three times daily. For severe symptoms, take 40 drops four to five time daily. After improvement is felt, take 40 drops three times daily. Children receive 1/2 or less of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1021-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1021-3)</PackageDescription>
<NDC11Code>60986-1021-03</NDC11Code>
<ProductNDC>60986-1021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cactus</ProprietaryName>
<NonProprietaryName>Cactus Grandiflorus, Convallaria Majalis, Crataegus Laevigata, Camphora, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana,tabacum, Glonoinum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; CRATAEGUS LAEVIGATA WHOLE; CAMPHOR (NATURAL); KALMIA LATIFOLIA LEAF; SPIGELIA ANTHELMIA; LACHESIS MUTA VENOM; ARNICA MONTANA; TOBACCO LEAF; NITROGLYCERIN</SubstanceName>
<StrengthNumber>2; 3; 1; 2; 4; 4; 8; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60986-1021-4</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (60986-1021-4)</PackageDescription>
<NDC11Code>60986-1021-04</NDC11Code>
<ProductNDC>60986-1021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cactus</ProprietaryName>
<NonProprietaryName>Cactus Grandiflorus, Convallaria Majalis, Crataegus Laevigata, Camphora, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana,tabacum, Glonoinum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; CRATAEGUS LAEVIGATA WHOLE; CAMPHOR (NATURAL); KALMIA LATIFOLIA LEAF; SPIGELIA ANTHELMIA; LACHESIS MUTA VENOM; ARNICA MONTANA; TOBACCO LEAF; NITROGLYCERIN</SubstanceName>
<StrengthNumber>2; 3; 1; 2; 4; 4; 8; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60986-1026-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1026-3)</PackageDescription>
<NDC11Code>60986-1026-03</NDC11Code>
<ProductNDC>60986-1026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lycopus</ProprietaryName>
<NonProprietaryName>Lycopus Virginicus, Spongia Tosta, Lophophytum Leandrii, Chininum Arsenicosum, Calcarea Phosphorica, Magnesia Phosphorica</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>LYCOPUS VIRGINICUS; SPONGIA OFFICINALIS SKELETON, ROASTED; LOPHOPHYTUM LEANDRII; QUININE ARSENITE; TRIBASIC CALCIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE</SubstanceName>
<StrengthNumber>1; 1; 6; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ADULTS TAKE 5 DROPS IN 1 TABLESPOON TEPID WATER THREE TIME DAILY, INCREASING BY 1 DROP DAILY UNTIL REACTION LEVEL IS REACHED. MAXIMUM AMOUNT: 20 DROPS THREE TIMES DAILY. CHILDREN RECEIVE 1/2 OR LESS OF THE ADULT AMOUNT.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1028-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1028-3) </PackageDescription>
<NDC11Code>60986-1028-03</NDC11Code>
<ProductNDC>60986-1028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cactus</ProprietaryName>
<NonProprietaryName>Crataegus Laevigata, Cactus Grandiflorus, Convallaria Majalis, Camphor, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana, Tabacum, Glonoinum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>ARNICA MONTANA; CAMPHOR (NATURAL); CONVALLARIA MAJALIS; CRATAEGUS LAEVIGATA WHOLE; KALMIA LATIFOLIA LEAF; LACHESIS MUTA VENOM; NITROGLYCERIN; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; TOBACCO LEAF</SubstanceName>
<StrengthNumber>6; 2; 3; 1; 4; 8; 8; 2; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60986-1028-4</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (60986-1028-4) </PackageDescription>
<NDC11Code>60986-1028-04</NDC11Code>
<ProductNDC>60986-1028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cactus</ProprietaryName>
<NonProprietaryName>Crataegus Laevigata, Cactus Grandiflorus, Convallaria Majalis, Camphor, Kalmia Latifolia, Spigelia Anthelmia, Lachesis Mutus, Arnica Montana, Tabacum, Glonoinum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>ARNICA MONTANA; CAMPHOR (NATURAL); CONVALLARIA MAJALIS; CRATAEGUS LAEVIGATA WHOLE; KALMIA LATIFOLIA LEAF; LACHESIS MUTA VENOM; NITROGLYCERIN; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; TOBACCO LEAF</SubstanceName>
<StrengthNumber>6; 2; 3; 1; 4; 8; 8; 2; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults take 30 drops in 1 oz water three times daily. For acute symptoms, take 40 drops four to five times daily. Children receive 10 drops in 1 oz tepid water three time daily.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1030-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1030-3) </PackageDescription>
<NDC11Code>60986-1030-03</NDC11Code>
<ProductNDC>60986-1030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lycopus</ProprietaryName>
<NonProprietaryName>Lycopus Virginicus, Spongia Tosta, Lophophytum Leandrii, Chininum Arsenicosum, Calcarea Phosphorica, Magnesia Phosphorica</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>LOPHOPHYTUM LEANDRII; LYCOPUS VIRGINICUS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; QUININE ARSENITE; SPONGIA OFFICINALIS SKELETON, ROASTED; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>6; 1; 8; 6; 1; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults take 5 drops on the tongue or in 1 tablespoon water 3 times daily, increasing by one drop daily until reaction level is reached. Maxixum amount: 20 drops three times daily. Children receive 1/2 or less of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1030-4</NDCCode>
<PackageDescription>100 mL in 1 PACKAGE (60986-1030-4) </PackageDescription>
<NDC11Code>60986-1030-04</NDC11Code>
<ProductNDC>60986-1030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lycopus</ProprietaryName>
<NonProprietaryName>Lycopus Virginicus, Spongia Tosta, Lophophytum Leandrii, Chininum Arsenicosum, Calcarea Phosphorica, Magnesia Phosphorica</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>LYCOPUS VIRGINICUS; SPONGIA OFFICINALIS SKELETON, ROASTED; LOPHOPHYTUM LEANDRII; QUININE ARSENITE; TRIBASIC CALCIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE</SubstanceName>
<StrengthNumber>1; 1; 6; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults take 5 drops on the tongue or in 1 tablespoon water 3 times daily, increasing by one drop daily until reaction level is reached. Maxixum amount: 20 drops three times daily. Children receive 1/2 or less of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1032-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1032-3) </PackageDescription>
<NDC11Code>60986-1032-03</NDC11Code>
<ProductNDC>60986-1032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Polygonum</ProprietaryName>
<NonProprietaryName>Polygonum Aviculare, Acorus Calamus, Rhus Toxicodendron, Gnaphalium Polycephalum, Rhododendron Chrysanthum, Colocynthis, Colchicum Autumnale, Kali Iodatum, Ichthyolum, Symphytum Officinale</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220614</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>POLYGONUM AVICULARE TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; COLCHICUM AUTUMNALE BULB; POTASSIUM IODIDE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; PSEUDOGNAPHALIUM OBTUSIFOLIUM; ACORUS CALAMUS WHOLE; ICHTHAMMOL</SubstanceName>
<StrengthNumber>1; 3; 6; 3; 4; 3; 4; 2; 1; 3</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications: For temporary relief of pain in joints and muscles.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1032-4</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (60986-1032-4) </PackageDescription>
<NDC11Code>60986-1032-04</NDC11Code>
<ProductNDC>60986-1032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Polygonum</ProprietaryName>
<NonProprietaryName>Polygonum Aviculare, Acorus Calamus, Rhus Toxicodendron, Gnaphalium Polycephalum, Rhododendron Chrysanthum, Colocynthis, Colchicum Autumnale, Kali Iodatum, Ichthyolum, Symphytum Officinale</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220614</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>POLYGONUM AVICULARE TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; COLCHICUM AUTUMNALE BULB; POTASSIUM IODIDE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; PSEUDOGNAPHALIUM OBTUSIFOLIUM; ACORUS CALAMUS WHOLE; ICHTHAMMOL</SubstanceName>
<StrengthNumber>1; 3; 6; 3; 4; 3; 4; 2; 1; 3</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications: For temporary relief of pain in joints and muscles.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-2025-2</NDCCode>
<PackageDescription>60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (60986-2025-2) </PackageDescription>
<NDC11Code>60986-2025-02</NDC11Code>
<ProductNDC>60986-2025</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Luffa</ProprietaryName>
<NonProprietaryName>Luffa, Hydrastis Canadensis, Mercurius Sulph. Rub, Allium Cepa, Natrum Muriticum, Phosphorus, Eupatorium Perf, Sticta</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>LUFFA ACUTANGULA FRUIT; GOLDENSEAL; MERCURIC SULFIDE; ONION; SODIUM CHLORIDE; PHOSPHORUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; LOBARIA PULMONARIA</SubstanceName>
<StrengthNumber>6; 4; 4; 6; 6; 6; 5; 2</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults take 1 tablet three times daily, dissolving on the tongue. For severe symptoms, take 1 tablet every hour until improvement is felt. Children receive 1/2 or less the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0008-1040-05</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1040-05) </PackageDescription>
<NDC11Code>00008-1040-05</NDC11Code>
<ProductNDC>0008-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapamune</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100301</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021110</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100301</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-1040-10</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-1040-10) / 1 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00008-1040-10</NDC11Code>
<ProductNDC>0008-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapamune</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100301</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021110</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100301</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
</NDC>
<NDC>
<NDCCode>0074-1040-04</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0074-1040-04) / 4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00074-1040-04</NDC11Code>
<ProductNDC>0074-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Survanta</ProprietaryName>
<NonProprietaryName>Beractant</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ENDOTRACHEAL</RouteName>
<StartMarketingDate>19910701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020032</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>BERACTANT</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.</IndicationAndUsage>
<Description>SURVANTA® contains beractant, a pulmonary surfactant, which is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins (SP) to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL of phospholipids (including 11.0-15.5 mg/mL of disaturated phosphatidylcholine), 0.5-1.75 mg/mL of triglycerides, 1.4-3.5 mg/mL of free fatty acids, and less than 1 mg/mL of SP (including SP-B, a 79-amino acid protein, and SP-C, a 35-amino acid peptide). SURVANTA (beractant) intratracheal suspension is a sterile, preservative-free, non-pyrogenic off-white to light brown liquid supplied in single-dose glass vials for intratracheal use only. Each vial contains 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids). Each mL of SURVANTA contains 25 mg of phospholipids. It is suspended in 0.9% sodium chloride solution and heat-sterilized. SURVANTA contains no preservatives. Sodium hydroxide or hydrochloric acid may be added to adjust the pH. The pH is approximately 6.2 to 7.6.</Description>
</NDC>
<NDC>
<NDCCode>0074-1040-08</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0074-1040-08) / 8 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00074-1040-08</NDC11Code>
<ProductNDC>0074-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Survanta</ProprietaryName>
<NonProprietaryName>Beractant</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ENDOTRACHEAL</RouteName>
<StartMarketingDate>19910701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020032</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>BERACTANT</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.</IndicationAndUsage>
<Description>SURVANTA® contains beractant, a pulmonary surfactant, which is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins (SP) to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL of phospholipids (including 11.0-15.5 mg/mL of disaturated phosphatidylcholine), 0.5-1.75 mg/mL of triglycerides, 1.4-3.5 mg/mL of free fatty acids, and less than 1 mg/mL of SP (including SP-B, a 79-amino acid protein, and SP-C, a 35-amino acid peptide). SURVANTA (beractant) intratracheal suspension is a sterile, preservative-free, non-pyrogenic off-white to light brown liquid supplied in single-dose glass vials for intratracheal use only. Each vial contains 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids). Each mL of SURVANTA contains 25 mg of phospholipids. It is suspended in 0.9% sodium chloride solution and heat-sterilized. SURVANTA contains no preservatives. Sodium hydroxide or hydrochloric acid may be added to adjust the pH. The pH is approximately 6.2 to 7.6.</Description>
</NDC>
<NDC>
<NDCCode>0615-7976-39</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7976-39) </PackageDescription>
<NDC11Code>00615-7976-39</NDC11Code>
<ProductNDC>0615-7976</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120109</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160504</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablet is indicated for adjunctive therapy in the treatment of: 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) .</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow ( iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
</NDCList>