{
"NDC": [
{
"NDCCode": "81825-0004-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0004-1) ",
"NDC11Code": "81825-0004-01",
"ProductNDC": "81825-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida",
"NonProprietaryName": "Baptisia Tinctoria, Echinacea Purp, Glycyrrhiza Glabra, Astragalus, Candida Alb, Borax, Calc Carb, Kreosotum, Lycopodium, Nux Vom, Phosphoricum Ac, Pulsatilla, Sepia, Thuja Occ, Nat Phos, Nitricum Ac",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20211222",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "BAPTISIA TINCTORIA WHOLE; ECHINACEA PURPUREA WHOLE; GLYCYRRHIZA GLABRA; ASTRAGALUS NUTTALLII LEAF; CANDIDA ALBICANS; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID",
"StrengthNumber": "4; 4; 4; 6; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms associated with vaginal yeast.**."
},
{
"NDCCode": "81825-0001-2",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (81825-0001-2) ",
"NDC11Code": "81825-0001-02",
"ProductNDC": "81825-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrate Ii",
"NonProprietaryName": "Berber Aqui, Beta Vulg, Boldo, Carduus Mar, Chelidonium Maj, Hordeum Vulgare, Iris Vers, Rosmarinus, Taraxacum, Avena, Eleutherococcus Senticosus, Xanthoxylum, Equisetum Hyem, Hypericum, Ulmus Fulv, Gettysburg Aqua, Glycyrrhiza, Wildbad Aqua, Carlsbad Aqua, Atp, Hydrogen, Nat Mur, Oxygen, Silicea, Wiesbaden Aqua",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220216",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS WHOLE; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; HORDEUM VULGARE WHOLE; IRIS VERSICOLOR ROOT; SALVIA ROSMARINUS FLOWERING TOP; TARAXACUM OFFICINALE; AVENA SATIVA FLOWERING TOP; ELEUTHEROCOCCUS SENTICOSUS WHOLE; ZANTHOXYLUM AMERICANUM BARK; EQUISETUM HYEMALE WHOLE; HYPERICUM PERFORATUM WHOLE; ULMUS RUBRA BARK; GLYCYRRHIZA GLABRA; ADENOSINE TRIPHOSPHATE; HYDROGEN; SODIUM CHLORIDE; OXYGEN; SILICON DIOXIDE",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 30; 34; 30; 30; 30",
"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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220216",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves low energy, circulatory disorders, digestive upset, &/or symptoms related to poor cellular hydration.**."
},
{
"NDCCode": "81825-0002-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0002-1) ",
"NDC11Code": "81825-0002-01",
"ProductNDC": "81825-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mold Antigen",
"NonProprietaryName": "Alternaria Alternata, Aspergillus Fumigatus, Aspergillus Niger, Boletus Sat, Botrytis Cinerea, Cladosporium Metanigrum, Fusarium Oxysporum, Helminthosporium, Mucor Muecedo, Pullularia Pullulans, Rhizopus Nigricans, Ustilago Maydis, Arsenicum Alb, Candida Alb, Carbo An, Lachesis, Lycopodium, Merc Solub, Nitricum Ac, Phosphorus, Pulsatilla, Sepia, Silicea, Thuja Occ",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20211201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; RHIZOPUS STOLONIFER; USTILAGO MAYDIS; ARSENIC TRIOXIDE; CANDIDA ALBICANS; CARBO ANIMALIS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"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; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211201",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms associated with allergies from mold.**."
},
{
"NDCCode": "81825-0003-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0003-1) ",
"NDC11Code": "81825-0003-01",
"ProductNDC": "81825-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "E.n.v.",
"NonProprietaryName": "Belladonna, Berberis Vulg, Carduus Mar, Chelidonium Maj, Colocynthis, Dioscorea, Hydrastis, Lycopodium, Nat Sulphuricum, Nux Vom, Phos, Pulsatilla, Veratrum Alb",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20211208",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; VERATRUM ALBUM ROOT",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211208",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves flatulence, constipation, and belching.**."
},
{
"NDCCode": "81825-0005-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0005-1) ",
"NDC11Code": "81825-0005-01",
"ProductNDC": "81825-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "H.m.d.",
"NonProprietaryName": "Allium Sat, Avena, Berber Vulg, Lappa, Phytolacca, Solidago, Alumina, Arg Nit, Baryta Carb, Beryllium, Cadmium Met, Curprum Met, Fluoricum Acidum, Indium, Iodium, Lithium Carb, Merc Solub, Niccolum Carb, Nitrogenum Oxygenatum, Plumb Met, Selenium, Strontium Carb, Titanium, Arsenicum Alb, Nat Mur, Nux Vom",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20211222",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "GARLIC; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; ALUMINUM OXIDE; SILVER NITRATE; BARIUM CARBONATE; BERYLLIUM; CADMIUM; COPPER; HYDROFLUORIC ACID; INDIUM; IODINE; LITHIUM CARBONATE; MERCURIUS SOLUBILIS; NICKEL CARBONATE HYDROXIDE TETRAHYDRATE; NITROUS OXIDE; LEAD; SELENIUM; STRONTIUM CARBONATE; TITANIUM; ARSENIC TRIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves weakness and fatigue.**."
},
{
"NDCCode": "81825-0006-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0006-1) ",
"NDC11Code": "81825-0006-01",
"ProductNDC": "81825-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Psoriasis",
"NonProprietaryName": "Arsenicum Album, Arsenicum Iodatum, Borax, Calcarea Carbonica, Graphites, Mezereum, Proteus, Natrum Muriaticum, Phytolacca Decandra, Sepia, Silicea, Sulphur, Thyroidinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20211201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ARSENIC TRIOXIDE; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; DAPHNE MEZEREUM BARK; PROTEUS MORGANII; SODIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; SULFUR; THYROID, UNSPECIFIED; ARSENIC TRIIODIDE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211201",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves rough skin, dry skin eruptions, rose-colored blotches, itchy skin, &/or other symptoms related to psoriasis.**."
},
{
"NDCCode": "81825-0007-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0007-1) ",
"NDC11Code": "81825-0007-01",
"ProductNDC": "81825-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy",
"NonProprietaryName": "Allium Cepa, Ambrosia, Arsenicum Alb, Carbo Veg, Euphrasia, Nux Vom, Phosphorus, Pulsatilla, Sulphur, Solidago",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220216",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ONION; AMBROSIA ARTEMISIIFOLIA WHOLE; ACTIVATED CHARCOAL; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SULFUR; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220216",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves hay fever, coryza, itching and burning eyes, coughing and/or other symptoms associated with hay fever and allergies.**."
},
{
"NDCCode": "81825-0008-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0008-1) ",
"NDC11Code": "81825-0008-01",
"ProductNDC": "81825-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viral Hp",
"NonProprietaryName": "Arsenic Trioxide, Atropa Belladonna, Echinacea Angustifolia, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Lycopodium Clavatum Spore, Phosphoric Acid, Phosphorus, Rancid Beef, Toxicodendron Pubescens Leaf",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220406",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; ARSENIC TRIOXIDE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"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": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220406",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves aches, fevers, restlessness.**."
},
{
"NDCCode": "81825-0009-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0009-1) ",
"NDC11Code": "81825-0009-01",
"ProductNDC": "81825-0009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu",
"NonProprietaryName": "Aconitum Napellus, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Ferrum Phosphoricum, Gelsemium Sempervirens Root",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20221003",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30",
"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": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221003",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves flu-like symptoms.**."
},
{
"NDCCode": "81825-0010-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0010-1) ",
"NDC11Code": "81825-0010-01",
"ProductNDC": "81825-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stress",
"NonProprietaryName": "Aralia Quin, Passiflora, Scutellaria, Valeriana, Arsenicum Alb, Aur Met, Calc Carb, Coffea Cruda, Ignatia, Kali Phos, Lycopus, Phosphorus, Staphysagria",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220922",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "AMERICAN GINSENG; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA WHOLE; VALERIAN; ARSENIC TRIOXIDE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; DIBASIC POTASSIUM PHOSPHATE; LYCOPUS VIRGINICUS WHOLE; PHOSPHORUS; DELPHINIUM STAPHISAGRIA SEED",
"StrengthNumber": "6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220922",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms of simple nervous tension.**."
},
{
"NDCCode": "81825-0011-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0011-1) ",
"NDC11Code": "81825-0011-01",
"ProductNDC": "81825-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stress Ii",
"NonProprietaryName": "Epinephrine, Thyroid, Unspecified, Bos Taurus Pituitary Gland, Posterior, Arsenic Trioxide, Oyster Shell Calcium Carbonate, Crude, Conium Maculatum Flowering Top, Cortisone Acetate, Crotalus Horridus Horridus Venom, Iron, Strychnos Nux-vomica Seed, Phosphoric Acid, Phosphorus, Selenium, Sepia Officinalis Juice, And Zanthoxylum Americanum Bark",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20250616",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex",
"SubstanceName": "EPINEPHRINE; THYROID, UNSPECIFIED; BOS TAURUS PITUITARY GLAND, POSTERIOR; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; CROTALUS HORRIDUS HORRIDUS VENOM; IRON; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; ZANTHOXYLUM AMERICANUM BARK",
"StrengthNumber": "9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30",
"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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250616",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves symptoms of stress, fatigue and simple nervous tension.Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated."
},
{
"NDCCode": "81825-0012-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0012-1) ",
"NDC11Code": "81825-0012-01",
"ProductNDC": "81825-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Parasode",
"NonProprietaryName": "Artemisia Vulgaris Root, Chelidonium Majus Whole, Punica Granatum Root Bark, Spigelia Anthelmia Whole, Krameria Lappacea Root, Arsenic Trioxide, Iron, Oyster Shell Calcium Carbonate, Crude, Artemisia Cina Pre-flowering Top, Salmonella Enterica Enterica Serovar Enteritidis, Graphite, Calomel, Sodium Chloride, And Sodium Phosphate, Dibasic, Heptahydrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20250627",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex",
"SubstanceName": "ARTEMISIA VULGARIS ROOT; CHELIDONIUM MAJUS WHOLE; PUNICA GRANATUM ROOT BARK; SPIGELIA ANTHELMIA WHOLE; KRAMERIA LAPPACEA ROOT; ARSENIC TRIOXIDE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARTEMISIA CINA PRE-FLOWERING TOP; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; GRAPHITE; CALOMEL; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "4; 4; 4; 4; 4; 6; 9; 12; 12; 12; 12; 12; 12; 12",
"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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250627",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves symptoms caused by pinworm infestation.Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated."
},
{
"NDCCode": "81825-0013-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0013-1) ",
"NDC11Code": "81825-0013-01",
"ProductNDC": "81825-0013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bac",
"NonProprietaryName": "Apis Mellifera, Arsenic Trioxide, Atropa Belladonna, Matricaria Chamomilla Flowering Top Oil, Lachesis Muta Venom, Mercurius Solubilis, Pulsatilla Vulgaris Whole, Toxicodendron Pubescens Leaf, And Silicon Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20250626",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex",
"SubstanceName": "APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS WHOLE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30",
"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",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250626",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves fever, chilliness with fever, headache.Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated."
},
{
"NDCCode": "0004-0028-28",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0004-0028-28)",
"NDC11Code": "00004-0028-28",
"ProductNDC": "0004-0028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naprosyn",
"NonProprietaryName": "Naproxen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19870323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018965",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0004-0038-22",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0038-22) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "00004-0038-22",
"ProductNDC": "0004-0038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valcyte",
"NonProprietaryName": "Valganciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010329",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021304",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "VALGANCICLOVIR HYDROCHLORIDE",
"StrengthNumber": "450",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20010329",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.",
"Description": "VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir."
},
{
"NDCCode": "0004-0038-86",
"PackageDescription": "1 BOTTLE in 1 CARTON (0004-0038-86) > 60 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00004-0038-86",
"ProductNDC": "0004-0038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valcyte",
"NonProprietaryName": "Valganciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021304",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "VALGANCICLOVIR HYDROCHLORIDE",
"StrengthNumber": "450",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150309",
"SamplePackage": "N"
},
{
"NDCCode": "0004-0039-09",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0004-0039-09) / 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00004-0039-09",
"ProductNDC": "0004-0039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valcyte",
"NonProprietaryName": "Valganciclovir Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090828",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022257",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "VALGANCICLOVIR HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090828",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.",
"Description": "VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir."
},
{
"NDCCode": "0004-0058-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0004-0058-01) ",
"NDC11Code": "00004-0058-01",
"ProductNDC": "0004-0058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klonopin",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19750602",
"EndMarketingDate": "20240228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017533",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100904",
"EndMarketingDatePackage": "20240228",
"SamplePackage": "N",
"IndicationAndUsage": "Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).",
"Description": "Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula."
},
{
"NDCCode": "0004-0058-32",
"PackageDescription": "10000 TABLET in 1 DRUM (0004-0058-32) ",
"NDC11Code": "00004-0058-32",
"ProductNDC": "0004-0058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klonopin",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19750602",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017533",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19750602",
"SamplePackage": "N"
},
{
"NDCCode": "0004-0068-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0004-0068-01) ",
"NDC11Code": "00004-0068-01",
"ProductNDC": "0004-0068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klonopin",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19750602",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017533",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100826",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).",
"Description": "Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula."
},
{
"NDCCode": "0004-0068-32",
"PackageDescription": "10000 TABLET in 1 DRUM (0004-0068-32) ",
"NDC11Code": "00004-0068-32",
"ProductNDC": "0004-0068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klonopin",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19750602",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017533",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19750602",
"SamplePackage": "N"
},
{
"NDCCode": "0004-0086-94",
"PackageDescription": "168 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-0086-94) ",
"NDC11Code": "00004-0086-94",
"ProductNDC": "0004-0086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Copegus",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20021203",
"EndMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021511",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0004-0098-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0004-0098-01) ",
"NDC11Code": "00004-0098-01",
"ProductNDC": "0004-0098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klonopin",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19750602",
"EndMarketingDate": "20230630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017533",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100826",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N"
},
{
"NDCCode": "0004-0186-82",
"PackageDescription": "3 BLISTER PACK in 1 BOX (0004-0186-82) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00004-0186-82",
"ProductNDC": "0004-0186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Boniva",
"NonProprietaryName": "Ibandronate Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050324",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021455",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "IBANDRONATE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20050324",
"EndMarketingDatePackage": "20190131",
"SamplePackage": "N"
},
{
"NDCCode": "0004-0186-83",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0004-0186-83) > 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00004-0186-83",
"ProductNDC": "0004-0186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Boniva",
"NonProprietaryName": "Ibandronate Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050324",
"EndMarketingDate": "20230731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021455",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "IBANDRONATE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141217",
"EndMarketingDatePackage": "20230731",
"SamplePackage": "N"
},
{
"NDCCode": "0004-0186-98",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0004-0186-98) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00004-0186-98",
"ProductNDC": "0004-0186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Boniva",
"NonProprietaryName": "Ibandronate Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021455",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "IBANDRONATE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-01-16"
},
{
"NDCCode": "0004-0191-09",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0004-0191-09) > 3 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00004-0191-09",
"ProductNDC": "0004-0191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Boniva",
"NonProprietaryName": "Ibandronate Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20060106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021858",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "IBANDRONATE SODIUM",
"StrengthNumber": "3",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20060106",
"EndMarketingDatePackage": "20210630",
"SamplePackage": "N"
},
{
"NDCCode": "0004-0244-51",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-0244-51) ",
"NDC11Code": "00004-0244-51",
"ProductNDC": "0004-0244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invirase",
"NonProprietaryName": "Saquinavir Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041217",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021785",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SAQUINAVIR MESYLATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20041217",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults (over the age of 16 years). The following points should be considered when initiating therapy with INVIRASE/ritonavir: 1 – The twice daily administration of INVIRASE in combination with ritonavir is supported by safety data from the MaxCmin 1 trial [see Adverse Reactions (6.1)] and pharmacokinetic data [see Clinical Pharmacology (12.3)]., 2 – The efficacy of INVIRASE with ritonavir has not been compared against the efficacy of antiretroviral regimens currently considered standard of care., 3 – The number of baseline primary protease inhibitor mutations affects the virologic response to INVIRASE/ritonavir.",
"Description": "INVIRASE brand of saquinavir mesylate is an inhibitor of the human immunodeficiency virus type 1 (HIV-1) protease. The chemical name for saquinavir mesylate is N-tert-butyl-decahydro-2-[2(R)-hydroxy-4-phenyl-3(S)-[[N-(2-quinolylcarbonyl)-L-asparaginyl]amino]butyl]-(4aS,8aS)-isoquinoline-3(S)-carboxamide methanesulfonate with a molecular formula C38H50N6O5∙CH4O3S and a molecular weight of 766.96. The molecular weight of the free base is 670.86. Saquinavir mesylate has the following structural formula. Saquinavir mesylate is a white to off-white, very fine powder with an aqueous solubility of 2.22 mg per mL at 25°C. INVIRASE tablets are available as light orange to greyish- or brownish-orange, oval cylindrical, biconvex film-coated tablet for oral administration in 500-mg strength (as saquinavir free base). Each tablet also contains the inactive ingredients lactose, microcrystalline cellulose, povidone K30, croscarmellose sodium, and magnesium stearate. Each film coat contains hypromellose, titanium dioxide, talc, iron oxide yellow, iron oxide red, and triacetin."
},
{
"NDCCode": "0004-0245-15",
"PackageDescription": "270 CAPSULE in 1 BOTTLE, PLASTIC (0004-0245-15) ",
"NDC11Code": "00004-0245-15",
"ProductNDC": "0004-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invirase",
"NonProprietaryName": "Saquinavir Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19951206",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020628",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SAQUINAVIR MESYLATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19951206",
"SamplePackage": "N"
},
{
"NDCCode": "0004-0257-52",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (0004-0257-52) ",
"NDC11Code": "00004-0257-52",
"ProductNDC": "0004-0257",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xenical",
"NonProprietaryName": "Orlistat",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101217",
"EndMarketingDate": "20200229",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020766",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "ORLISTAT",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Intestinal Lipase Inhibitor [EPC],Lipase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101217",
"EndMarketingDatePackage": "20200229",
"SamplePackage": "N"
}
]
}
{"NDC":[{"NDCCode":"81825-0004-1","ProprietaryName":"Candida","NonProprietaryName":"Baptisia Tinctoria, Echinacea Purp, Glycyrrhiza Glabra, Astragalus, Candida Alb, Borax, Calc Carb, Kreosotum, Lycopodium, Nux Vom, Phosphoricum Ac, Pulsatilla, Sepia, Thuja Occ, Nat Phos, Nitricum Ac"},{"NDCCode":"81825-0001-2","ProprietaryName":"Hydrate Ii","NonProprietaryName":"Berber Aqui, Beta Vulg, Boldo, Carduus Mar, Chelidonium Maj, Hordeum Vulgare, Iris Vers, Rosmarinus, Taraxacum, Avena, Eleutherococcus Senticosus, Xanthoxylum, Equisetum Hyem, Hypericum, Ulmus Fulv, Gettysburg Aqua, Glycyrrhiza, Wildbad Aqua, Carlsbad Aqua, Atp, Hydrogen, Nat Mur, Oxygen, Silicea, Wiesbaden Aqua"},{"NDCCode":"81825-0002-1","ProprietaryName":"Mold Antigen","NonProprietaryName":"Alternaria Alternata, Aspergillus Fumigatus, Aspergillus Niger, Boletus Sat, Botrytis Cinerea, Cladosporium Metanigrum, Fusarium Oxysporum, Helminthosporium, Mucor Muecedo, Pullularia Pullulans, Rhizopus Nigricans, Ustilago Maydis, Arsenicum Alb, Candida Alb, Carbo An, Lachesis, Lycopodium, Merc Solub, Nitricum Ac, Phosphorus, Pulsatilla, Sepia, Silicea, Thuja Occ"},{"NDCCode":"81825-0003-1","ProprietaryName":"E.n.v.","NonProprietaryName":"Belladonna, Berberis Vulg, Carduus Mar, Chelidonium Maj, Colocynthis, Dioscorea, Hydrastis, Lycopodium, Nat Sulphuricum, Nux Vom, Phos, Pulsatilla, Veratrum Alb"},{"NDCCode":"81825-0005-1","ProprietaryName":"H.m.d.","NonProprietaryName":"Allium Sat, Avena, Berber Vulg, Lappa, Phytolacca, Solidago, Alumina, Arg Nit, Baryta Carb, Beryllium, Cadmium Met, Curprum Met, Fluoricum Acidum, Indium, Iodium, Lithium Carb, Merc Solub, Niccolum Carb, Nitrogenum Oxygenatum, Plumb Met, Selenium, Strontium Carb, Titanium, Arsenicum Alb, Nat Mur, Nux Vom"},{"NDCCode":"81825-0006-1","ProprietaryName":"Psoriasis","NonProprietaryName":"Arsenicum Album, Arsenicum Iodatum, Borax, Calcarea Carbonica, Graphites, Mezereum, Proteus, Natrum Muriaticum, Phytolacca Decandra, Sepia, Silicea, Sulphur, Thyroidinum"},{"NDCCode":"81825-0007-1","ProprietaryName":"Allergy","NonProprietaryName":"Allium Cepa, Ambrosia, Arsenicum Alb, Carbo Veg, Euphrasia, Nux Vom, Phosphorus, Pulsatilla, Sulphur, Solidago"},{"NDCCode":"81825-0008-1","ProprietaryName":"Viral Hp","NonProprietaryName":"Arsenic Trioxide, Atropa Belladonna, Echinacea Angustifolia, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Lycopodium Clavatum Spore, Phosphoric Acid, Phosphorus, Rancid Beef, Toxicodendron Pubescens Leaf"},{"NDCCode":"81825-0009-1","ProprietaryName":"Flu","NonProprietaryName":"Aconitum Napellus, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Ferrum Phosphoricum, Gelsemium Sempervirens Root"},{"NDCCode":"81825-0010-1","ProprietaryName":"Stress","NonProprietaryName":"Aralia Quin, Passiflora, Scutellaria, Valeriana, Arsenicum Alb, Aur Met, Calc Carb, Coffea Cruda, Ignatia, Kali Phos, Lycopus, Phosphorus, Staphysagria"},{"NDCCode":"81825-0011-1","ProprietaryName":"Stress Ii","NonProprietaryName":"Epinephrine, Thyroid, Unspecified, Bos Taurus Pituitary Gland, Posterior, Arsenic Trioxide, Oyster Shell Calcium Carbonate, Crude, Conium Maculatum Flowering Top, Cortisone Acetate, Crotalus Horridus Horridus Venom, Iron, Strychnos Nux-vomica Seed, Phosphoric Acid, Phosphorus, Selenium, Sepia Officinalis Juice, And Zanthoxylum Americanum Bark"},{"NDCCode":"81825-0012-1","ProprietaryName":"Parasode","NonProprietaryName":"Artemisia Vulgaris Root, Chelidonium Majus Whole, Punica Granatum Root Bark, Spigelia Anthelmia Whole, Krameria Lappacea Root, Arsenic Trioxide, Iron, Oyster Shell Calcium Carbonate, Crude, Artemisia Cina Pre-flowering Top, Salmonella Enterica Enterica Serovar Enteritidis, Graphite, Calomel, Sodium Chloride, And Sodium Phosphate, Dibasic, Heptahydrate"},{"NDCCode":"81825-0013-1","ProprietaryName":"Bac","NonProprietaryName":"Apis Mellifera, Arsenic Trioxide, Atropa Belladonna, Matricaria Chamomilla Flowering Top Oil, Lachesis Muta Venom, Mercurius Solubilis, Pulsatilla Vulgaris Whole, Toxicodendron Pubescens Leaf, And Silicon Dioxide"},{"NDCCode":"0004-0028-28","ProprietaryName":"Naprosyn","NonProprietaryName":"Naproxen"},{"NDCCode":"0004-0038-22","ProprietaryName":"Valcyte","NonProprietaryName":"Valganciclovir"},{"NDCCode":"0004-0038-86","ProprietaryName":"Valcyte","NonProprietaryName":"Valganciclovir"},{"NDCCode":"0004-0039-09","ProprietaryName":"Valcyte","NonProprietaryName":"Valganciclovir Hydrochloride"},{"NDCCode":"0004-0058-01","ProprietaryName":"Klonopin","NonProprietaryName":"Clonazepam"},{"NDCCode":"0004-0058-32","ProprietaryName":"Klonopin","NonProprietaryName":"Clonazepam"},{"NDCCode":"0004-0068-01","ProprietaryName":"Klonopin","NonProprietaryName":"Clonazepam"},{"NDCCode":"0004-0068-32","ProprietaryName":"Klonopin","NonProprietaryName":"Clonazepam"},{"NDCCode":"0004-0086-94","ProprietaryName":"Copegus","NonProprietaryName":"Ribavirin"},{"NDCCode":"0004-0098-01","ProprietaryName":"Klonopin","NonProprietaryName":"Clonazepam"},{"NDCCode":"0004-0186-82","ProprietaryName":"Boniva","NonProprietaryName":"Ibandronate Sodium"},{"NDCCode":"0004-0186-83","ProprietaryName":"Boniva","NonProprietaryName":"Ibandronate Sodium"},{"NDCCode":"0004-0186-98","ProprietaryName":"Boniva","NonProprietaryName":"Ibandronate Sodium"},{"NDCCode":"0004-0191-09","ProprietaryName":"Boniva","NonProprietaryName":"Ibandronate Sodium"},{"NDCCode":"0004-0244-51","ProprietaryName":"Invirase","NonProprietaryName":"Saquinavir Mesylate"},{"NDCCode":"0004-0245-15","ProprietaryName":"Invirase","NonProprietaryName":"Saquinavir Mesylate"},{"NDCCode":"0004-0257-52","ProprietaryName":"Xenical","NonProprietaryName":"Orlistat"}]}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>81825-0004-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0004-1) </PackageDescription>
<NDC11Code>81825-0004-01</NDC11Code>
<ProductNDC>81825-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida</ProprietaryName>
<NonProprietaryName>Baptisia Tinctoria, Echinacea Purp, Glycyrrhiza Glabra, Astragalus, Candida Alb, Borax, Calc Carb, Kreosotum, Lycopodium, Nux Vom, Phosphoricum Ac, Pulsatilla, Sepia, Thuja Occ, Nat Phos, Nitricum Ac</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211222</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA WHOLE; ECHINACEA PURPUREA WHOLE; GLYCYRRHIZA GLABRA; ASTRAGALUS NUTTALLII LEAF; CANDIDA ALBICANS; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID</SubstanceName>
<StrengthNumber>4; 4; 4; 6; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms associated with vaginal yeast.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0001-2</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (81825-0001-2) </PackageDescription>
<NDC11Code>81825-0001-02</NDC11Code>
<ProductNDC>81825-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrate Ii</ProprietaryName>
<NonProprietaryName>Berber Aqui, Beta Vulg, Boldo, Carduus Mar, Chelidonium Maj, Hordeum Vulgare, Iris Vers, Rosmarinus, Taraxacum, Avena, Eleutherococcus Senticosus, Xanthoxylum, Equisetum Hyem, Hypericum, Ulmus Fulv, Gettysburg Aqua, Glycyrrhiza, Wildbad Aqua, Carlsbad Aqua, Atp, Hydrogen, Nat Mur, Oxygen, Silicea, Wiesbaden Aqua</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220216</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS WHOLE; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; HORDEUM VULGARE WHOLE; IRIS VERSICOLOR ROOT; SALVIA ROSMARINUS FLOWERING TOP; TARAXACUM OFFICINALE; AVENA SATIVA FLOWERING TOP; ELEUTHEROCOCCUS SENTICOSUS WHOLE; ZANTHOXYLUM AMERICANUM BARK; EQUISETUM HYEMALE WHOLE; HYPERICUM PERFORATUM WHOLE; ULMUS RUBRA BARK; GLYCYRRHIZA GLABRA; ADENOSINE TRIPHOSPHATE; HYDROGEN; SODIUM CHLORIDE; OXYGEN; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 30; 34; 30; 30; 30</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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves low energy, circulatory disorders, digestive upset, &/or symptoms related to poor cellular hydration.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0002-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0002-1) </PackageDescription>
<NDC11Code>81825-0002-01</NDC11Code>
<ProductNDC>81825-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mold Antigen</ProprietaryName>
<NonProprietaryName>Alternaria Alternata, Aspergillus Fumigatus, Aspergillus Niger, Boletus Sat, Botrytis Cinerea, Cladosporium Metanigrum, Fusarium Oxysporum, Helminthosporium, Mucor Muecedo, Pullularia Pullulans, Rhizopus Nigricans, Ustilago Maydis, Arsenicum Alb, Candida Alb, Carbo An, Lachesis, Lycopodium, Merc Solub, Nitricum Ac, Phosphorus, Pulsatilla, Sepia, Silicea, Thuja Occ</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; RHIZOPUS STOLONIFER; USTILAGO MAYDIS; ARSENIC TRIOXIDE; CANDIDA ALBICANS; CARBO ANIMALIS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</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; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms associated with allergies from mold.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0003-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0003-1) </PackageDescription>
<NDC11Code>81825-0003-01</NDC11Code>
<ProductNDC>81825-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>E.n.v.</ProprietaryName>
<NonProprietaryName>Belladonna, Berberis Vulg, Carduus Mar, Chelidonium Maj, Colocynthis, Dioscorea, Hydrastis, Lycopodium, Nat Sulphuricum, Nux Vom, Phos, Pulsatilla, Veratrum Alb</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211208</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves flatulence, constipation, and belching.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0005-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0005-1) </PackageDescription>
<NDC11Code>81825-0005-01</NDC11Code>
<ProductNDC>81825-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>H.m.d.</ProprietaryName>
<NonProprietaryName>Allium Sat, Avena, Berber Vulg, Lappa, Phytolacca, Solidago, Alumina, Arg Nit, Baryta Carb, Beryllium, Cadmium Met, Curprum Met, Fluoricum Acidum, Indium, Iodium, Lithium Carb, Merc Solub, Niccolum Carb, Nitrogenum Oxygenatum, Plumb Met, Selenium, Strontium Carb, Titanium, Arsenicum Alb, Nat Mur, Nux Vom</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211222</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>GARLIC; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; ALUMINUM OXIDE; SILVER NITRATE; BARIUM CARBONATE; BERYLLIUM; CADMIUM; COPPER; HYDROFLUORIC ACID; INDIUM; IODINE; LITHIUM CARBONATE; MERCURIUS SOLUBILIS; NICKEL CARBONATE HYDROXIDE TETRAHYDRATE; NITROUS OXIDE; LEAD; SELENIUM; STRONTIUM CARBONATE; TITANIUM; ARSENIC TRIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves weakness and fatigue.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0006-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0006-1) </PackageDescription>
<NDC11Code>81825-0006-01</NDC11Code>
<ProductNDC>81825-0006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Psoriasis</ProprietaryName>
<NonProprietaryName>Arsenicum Album, Arsenicum Iodatum, Borax, Calcarea Carbonica, Graphites, Mezereum, Proteus, Natrum Muriaticum, Phytolacca Decandra, Sepia, Silicea, Sulphur, Thyroidinum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; DAPHNE MEZEREUM BARK; PROTEUS MORGANII; SODIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; SULFUR; THYROID, UNSPECIFIED; ARSENIC TRIIODIDE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves rough skin, dry skin eruptions, rose-colored blotches, itchy skin, &/or other symptoms related to psoriasis.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0007-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0007-1) </PackageDescription>
<NDC11Code>81825-0007-01</NDC11Code>
<ProductNDC>81825-0007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy</ProprietaryName>
<NonProprietaryName>Allium Cepa, Ambrosia, Arsenicum Alb, Carbo Veg, Euphrasia, Nux Vom, Phosphorus, Pulsatilla, Sulphur, Solidago</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220216</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>ONION; AMBROSIA ARTEMISIIFOLIA WHOLE; ACTIVATED CHARCOAL; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SULFUR; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves hay fever, coryza, itching and burning eyes, coughing and/or other symptoms associated with hay fever and allergies.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0008-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0008-1) </PackageDescription>
<NDC11Code>81825-0008-01</NDC11Code>
<ProductNDC>81825-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viral Hp</ProprietaryName>
<NonProprietaryName>Arsenic Trioxide, Atropa Belladonna, Echinacea Angustifolia, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Lycopodium Clavatum Spore, Phosphoric Acid, Phosphorus, Rancid Beef, Toxicodendron Pubescens Leaf</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220406</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30</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>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves aches, fevers, restlessness.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0009-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0009-1) </PackageDescription>
<NDC11Code>81825-0009-01</NDC11Code>
<ProductNDC>81825-0009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Ferrum Phosphoricum, Gelsemium Sempervirens Root</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221003</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30</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>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves flu-like symptoms.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0010-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0010-1) </PackageDescription>
<NDC11Code>81825-0010-01</NDC11Code>
<ProductNDC>81825-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stress</ProprietaryName>
<NonProprietaryName>Aralia Quin, Passiflora, Scutellaria, Valeriana, Arsenicum Alb, Aur Met, Calc Carb, Coffea Cruda, Ignatia, Kali Phos, Lycopus, Phosphorus, Staphysagria</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220922</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>AMERICAN GINSENG; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA WHOLE; VALERIAN; ARSENIC TRIOXIDE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; DIBASIC POTASSIUM PHOSPHATE; LYCOPUS VIRGINICUS WHOLE; PHOSPHORUS; DELPHINIUM STAPHISAGRIA SEED</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12</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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms of simple nervous tension.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0011-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0011-1) </PackageDescription>
<NDC11Code>81825-0011-01</NDC11Code>
<ProductNDC>81825-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stress Ii</ProprietaryName>
<NonProprietaryName>Epinephrine, Thyroid, Unspecified, Bos Taurus Pituitary Gland, Posterior, Arsenic Trioxide, Oyster Shell Calcium Carbonate, Crude, Conium Maculatum Flowering Top, Cortisone Acetate, Crotalus Horridus Horridus Venom, Iron, Strychnos Nux-vomica Seed, Phosphoric Acid, Phosphorus, Selenium, Sepia Officinalis Juice, And Zanthoxylum Americanum Bark</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250616</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex</LabelerName>
<SubstanceName>EPINEPHRINE; THYROID, UNSPECIFIED; BOS TAURUS PITUITARY GLAND, POSTERIOR; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; CROTALUS HORRIDUS HORRIDUS VENOM; IRON; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; ZANTHOXYLUM AMERICANUM BARK</SubstanceName>
<StrengthNumber>9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30</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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves symptoms of stress, fatigue and simple nervous tension.Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0012-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0012-1) </PackageDescription>
<NDC11Code>81825-0012-01</NDC11Code>
<ProductNDC>81825-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Parasode</ProprietaryName>
<NonProprietaryName>Artemisia Vulgaris Root, Chelidonium Majus Whole, Punica Granatum Root Bark, Spigelia Anthelmia Whole, Krameria Lappacea Root, Arsenic Trioxide, Iron, Oyster Shell Calcium Carbonate, Crude, Artemisia Cina Pre-flowering Top, Salmonella Enterica Enterica Serovar Enteritidis, Graphite, Calomel, Sodium Chloride, And Sodium Phosphate, Dibasic, Heptahydrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250627</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex</LabelerName>
<SubstanceName>ARTEMISIA VULGARIS ROOT; CHELIDONIUM MAJUS WHOLE; PUNICA GRANATUM ROOT BARK; SPIGELIA ANTHELMIA WHOLE; KRAMERIA LAPPACEA ROOT; ARSENIC TRIOXIDE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARTEMISIA CINA PRE-FLOWERING TOP; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; GRAPHITE; CALOMEL; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 6; 9; 12; 12; 12; 12; 12; 12; 12</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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves symptoms caused by pinworm infestation.Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0013-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0013-1) </PackageDescription>
<NDC11Code>81825-0013-01</NDC11Code>
<ProductNDC>81825-0013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bac</ProprietaryName>
<NonProprietaryName>Apis Mellifera, Arsenic Trioxide, Atropa Belladonna, Matricaria Chamomilla Flowering Top Oil, Lachesis Muta Venom, Mercurius Solubilis, Pulsatilla Vulgaris Whole, Toxicodendron Pubescens Leaf, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250626</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex</LabelerName>
<SubstanceName>APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS WHOLE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30</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>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves fever, chilliness with fever, headache.Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0004-0028-28</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0004-0028-28)</PackageDescription>
<NDC11Code>00004-0028-28</NDC11Code>
<ProductNDC>0004-0028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naprosyn</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018965</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0004-0038-22</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0004-0038-22) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00004-0038-22</NDC11Code>
<ProductNDC>0004-0038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valcyte</ProprietaryName>
<NonProprietaryName>Valganciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010329</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021304</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20010329</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
<Description>VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir.</Description>
</NDC>
<NDC>
<NDCCode>0004-0038-86</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0004-0038-86) > 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00004-0038-86</NDC11Code>
<ProductNDC>0004-0038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valcyte</ProprietaryName>
<NonProprietaryName>Valganciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010329</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021304</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0004-0039-09</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0004-0039-09) / 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00004-0039-09</NDC11Code>
<ProductNDC>0004-0039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valcyte</ProprietaryName>
<NonProprietaryName>Valganciclovir Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090828</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022257</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090828</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
<Description>VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir.</Description>
</NDC>
<NDC>
<NDCCode>0004-0058-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0004-0058-01) </PackageDescription>
<NDC11Code>00004-0058-01</NDC11Code>
<ProductNDC>0004-0058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klonopin</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750602</StartMarketingDate>
<EndMarketingDate>20240228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017533</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100904</StartMarketingDatePackage>
<EndMarketingDatePackage>20240228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).</IndicationAndUsage>
<Description>Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0004-0058-32</NDCCode>
<PackageDescription>10000 TABLET in 1 DRUM (0004-0058-32) </PackageDescription>
<NDC11Code>00004-0058-32</NDC11Code>
<ProductNDC>0004-0058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klonopin</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750602</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017533</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0004-0068-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0004-0068-01) </PackageDescription>
<NDC11Code>00004-0068-01</NDC11Code>
<ProductNDC>0004-0068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klonopin</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750602</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017533</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100826</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).</IndicationAndUsage>
<Description>Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0004-0068-32</NDCCode>
<PackageDescription>10000 TABLET in 1 DRUM (0004-0068-32) </PackageDescription>
<NDC11Code>00004-0068-32</NDC11Code>
<ProductNDC>0004-0068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klonopin</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750602</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017533</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0004-0086-94</NDCCode>
<PackageDescription>168 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-0086-94) </PackageDescription>
<NDC11Code>00004-0086-94</NDC11Code>
<ProductNDC>0004-0086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Copegus</ProprietaryName>
<NonProprietaryName>Ribavirin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021203</StartMarketingDate>
<EndMarketingDate>20180131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021511</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>RIBAVIRIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0004-0098-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0004-0098-01) </PackageDescription>
<NDC11Code>00004-0098-01</NDC11Code>
<ProductNDC>0004-0098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klonopin</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750602</StartMarketingDate>
<EndMarketingDate>20230630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017533</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100826</StartMarketingDatePackage>
<EndMarketingDatePackage>20230630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0004-0186-82</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX (0004-0186-82) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00004-0186-82</NDC11Code>
<ProductNDC>0004-0186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Boniva</ProprietaryName>
<NonProprietaryName>Ibandronate Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050324</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021455</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>IBANDRONATE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050324</StartMarketingDatePackage>
<EndMarketingDatePackage>20190131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0004-0186-83</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (0004-0186-83) > 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00004-0186-83</NDC11Code>
<ProductNDC>0004-0186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Boniva</ProprietaryName>
<NonProprietaryName>Ibandronate Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050324</StartMarketingDate>
<EndMarketingDate>20230731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021455</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>IBANDRONATE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141217</StartMarketingDatePackage>
<EndMarketingDatePackage>20230731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0004-0186-98</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (0004-0186-98) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00004-0186-98</NDC11Code>
<ProductNDC>0004-0186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Boniva</ProprietaryName>
<NonProprietaryName>Ibandronate Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021455</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>IBANDRONATE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-01-16</LastUpdate>
</NDC>
<NDC>
<NDCCode>0004-0191-09</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0004-0191-09) > 3 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00004-0191-09</NDC11Code>
<ProductNDC>0004-0191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Boniva</ProprietaryName>
<NonProprietaryName>Ibandronate Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20060106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021858</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>IBANDRONATE SODIUM</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060106</StartMarketingDatePackage>
<EndMarketingDatePackage>20210630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0004-0244-51</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-0244-51) </PackageDescription>
<NDC11Code>00004-0244-51</NDC11Code>
<ProductNDC>0004-0244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invirase</ProprietaryName>
<NonProprietaryName>Saquinavir Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041217</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021785</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>SAQUINAVIR MESYLATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20041217</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults (over the age of 16 years). The following points should be considered when initiating therapy with INVIRASE/ritonavir: 1 – The twice daily administration of INVIRASE in combination with ritonavir is supported by safety data from the MaxCmin 1 trial [see Adverse Reactions (6.1)] and pharmacokinetic data [see Clinical Pharmacology (12.3)]., 2 – The efficacy of INVIRASE with ritonavir has not been compared against the efficacy of antiretroviral regimens currently considered standard of care., 3 – The number of baseline primary protease inhibitor mutations affects the virologic response to INVIRASE/ritonavir.</IndicationAndUsage>
<Description>INVIRASE brand of saquinavir mesylate is an inhibitor of the human immunodeficiency virus type 1 (HIV-1) protease. The chemical name for saquinavir mesylate is N-tert-butyl-decahydro-2-[2(R)-hydroxy-4-phenyl-3(S)-[[N-(2-quinolylcarbonyl)-L-asparaginyl]amino]butyl]-(4aS,8aS)-isoquinoline-3(S)-carboxamide methanesulfonate with a molecular formula C38H50N6O5∙CH4O3S and a molecular weight of 766.96. The molecular weight of the free base is 670.86. Saquinavir mesylate has the following structural formula. Saquinavir mesylate is a white to off-white, very fine powder with an aqueous solubility of 2.22 mg per mL at 25°C. INVIRASE tablets are available as light orange to greyish- or brownish-orange, oval cylindrical, biconvex film-coated tablet for oral administration in 500-mg strength (as saquinavir free base). Each tablet also contains the inactive ingredients lactose, microcrystalline cellulose, povidone K30, croscarmellose sodium, and magnesium stearate. Each film coat contains hypromellose, titanium dioxide, talc, iron oxide yellow, iron oxide red, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0004-0245-15</NDCCode>
<PackageDescription>270 CAPSULE in 1 BOTTLE, PLASTIC (0004-0245-15) </PackageDescription>
<NDC11Code>00004-0245-15</NDC11Code>
<ProductNDC>0004-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invirase</ProprietaryName>
<NonProprietaryName>Saquinavir Mesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951206</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020628</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>SAQUINAVIR MESYLATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0004-0257-52</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (0004-0257-52) </PackageDescription>
<NDC11Code>00004-0257-52</NDC11Code>
<ProductNDC>0004-0257</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xenical</ProprietaryName>
<NonProprietaryName>Orlistat</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101217</StartMarketingDate>
<EndMarketingDate>20200229</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020766</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>ORLISTAT</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Intestinal Lipase Inhibitor [EPC],Lipase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20101217</StartMarketingDatePackage>
<EndMarketingDatePackage>20200229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>