{
"NDC": [
{
"NDCCode": "63776-440-19",
"PackageDescription": "1000 mL in 1 BOTTLE (63776-440-19) ",
"NDC11Code": "63776-0440-19",
"ProductNDC": "63776-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pollens Early",
"NonProprietaryName": "Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN",
"StrengthNumber": "200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary 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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210325",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary support of symptoms related to seasonal spring sensitivities."
},
{
"NDCCode": "29300-440-19",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (29300-440-19) ",
"NDC11Code": "29300-0440-19",
"ProductNDC": "29300-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219593",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260803",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is sparingly soluble in water, very slightly soluble to practically insoluble in methanol, acetonitrile and practically insoluble in heptane. The log of the partition coefficient is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with hydroxypropyl cellulose, mannitol, pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 25 mg,50 mg and 300 mg capsule shells contains FD & C Yellow# 6.The 100 mg, 150 mg, 200 mg and 225 mg capsule shells contains FD & C Blue 1.The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "63776-081-19",
"PackageDescription": "1000 mL in 1 BOTTLE (63776-081-19) ",
"NDC11Code": "63776-0081-19",
"ProductNDC": "63776-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-cellulite",
"NonProprietaryName": "Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; ADENOSINE TRIPHOSPHATE; ANDROSTERONE; ARTICHOKE; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS LYMPH VESSEL; BOS TAURUS VEIN; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COBALT; ERSOFERMIN; ESTROGENS, ESTERIFIED; FERROUS FUMARATE; FUMARIC ACID; HAMAMELIS VIRGINIANA BARK; HEPTAMINOL; HYALURONIDASE; INTERLEUKIN-3; LACTIC ACID; LEVOCARNITINE; MANGANESE; MELILOTUS OFFICINALIS WHOLE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA LYMPH VESSEL; SUS SCROFA VEIN; VITAMIN A; ZINC",
"StrengthNumber": "30; 30; 30; 30; 200; 200; 200; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Carnitine Analog [EPC], Carnitine [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS], Vitamin A [CS], Vitamin A [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210224",
"SamplePackage": "N",
"IndicationAndUsage": "Cellulite drainage & tonification, metabolism and lipid balance, hormonal support, circulatory support and regeneration."
},
{
"NDCCode": "63776-175-19",
"PackageDescription": "1000 mL in 1 BOTTLE (63776-175-19) ",
"NDC11Code": "63776-0175-19",
"ProductNDC": "63776-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-f Gus",
"NonProprietaryName": "Berberis, Cochlerearia Armor, Echinacea, Ferrum, Hydrastis, Iridium, Lapacho, Lomatium, Lycopodium, Myrrh, Phosporicum Acidum, Propolis, Pulsatilla, Seleneium, Thymus, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANEMONE PULSATILLA; ARMORACIA RUSTICANA WHOLE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS THYMUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HANDROANTHUS IMPETIGINOSUS WHOLE; IRIDIUM; IRON; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHOSPHORIC ACID; PROPOLIS WAX; SELENIUM; SUS SCROFA THYMUS; ZINC",
"StrengthNumber": "12; 3; 3; 6; 3; 3; 3; 12; 12; 3; 12; 3; 12; 3; 12; 6; 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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210224",
"SamplePackage": "N",
"IndicationAndUsage": "nutritional support for fungal, mold, bacteria challenges.",
"Description": "Viatrexx-F gus is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
},
{
"NDCCode": "63776-410-19",
"PackageDescription": "1000 mL in 1 BOTTLE (63776-410-19) ",
"NDC11Code": "63776-0410-19",
"ProductNDC": "63776-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanine, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ASCORBIC ACID; AZELAIC ACID; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); NEPIDERMIN; PHENYLALANINE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SKIN; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ZINC",
"StrengthNumber": "30; 30; 30; 200; 30; 200; 30; 30; 200; 30; 200; 200; 200; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Cells, Epidermal [EXT], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Animal Skin Allergenic Extract [EPC], Non-Standardized Animal Skin Allergenic Extract [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "Skin Issues.",
"Description": "Viatrexx-Pigmentation is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system."
},
{
"NDCCode": "63776-523-19",
"PackageDescription": "1000 mL in 1 BOTTLE (63776-523-19) ",
"NDC11Code": "63776-0523-19",
"ProductNDC": "63776-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-tone",
"NonProprietaryName": "Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC",
"StrengthNumber": "200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"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], Depigmenting Activity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Meat Proteins [EXT], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210419",
"SamplePackage": "N",
"IndicationAndUsage": "Soft tissue regeneration.",
"Description": "Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system."
},
{
"NDCCode": "63776-440-11",
"PackageDescription": ".5 mL in 1 AMPULE (63776-440-11) ",
"NDC11Code": "63776-0440-11",
"ProductNDC": "63776-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pollens Early",
"NonProprietaryName": "Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN",
"StrengthNumber": "200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary 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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN",
"StrengthNumber": "200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary 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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210325",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary support of symptoms related to seasonal spring sensitivities."
},
{
"NDCCode": "63776-075-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-075-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0075-14",
"ProductNDC": "63776-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida I",
"NonProprietaryName": "Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Penicillin G, Vaccinium Vitis-idaea Leaf Spray",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "CAFFEIC ACID; CANDIDA ALBICANS; TANACETUM PARTHENIUM; CENTELLA ASIATICA; YEAST MANNAN; PENICILLIN G; VACCINIUM VITIS-IDAEA LEAF",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "16714-440-01",
"PackageDescription": "1 BLISTER PACK in 1 PACKET (16714-440-01) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0440-01",
"ProductNDC": "16714-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deblitane",
"NonProprietaryName": "Norethindrone",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202014",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130913",
"SamplePackage": "N",
"IndicationAndUsage": "1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.",
"Description": "Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive."
},
{
"NDCCode": "16714-440-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (16714-440-02) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0440-02",
"ProductNDC": "16714-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deblitane",
"NonProprietaryName": "Norethindrone",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202014",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.",
"Description": "Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive."
},
{
"NDCCode": "16714-440-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (16714-440-03) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0440-03",
"ProductNDC": "16714-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deblitane",
"NonProprietaryName": "Norethindrone",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202014",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.",
"Description": "Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive."
},
{
"NDCCode": "16714-440-04",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (16714-440-04) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0440-04",
"ProductNDC": "16714-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deblitane",
"NonProprietaryName": "Norethindrone",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202014",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130913",
"SamplePackage": "N",
"IndicationAndUsage": "1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.",
"Description": "Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive."
},
{
"NDCCode": "28595-710-40",
"PackageDescription": "40 TABLET in 1 BOTTLE (28595-710-40) ",
"NDC11Code": "28595-0710-40",
"ProductNDC": "28595-710",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mag 440",
"NonProprietaryName": "Megnesium Oxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250127",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Allegis Pharmaceuticals, LLC",
"SubstanceName": "MAGNESIUM OXIDE",
"StrengthNumber": "440",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250127",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves: Acid indigestion and upset stomach."
},
{
"NDCCode": "31722-440-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (31722-440-01) ",
"NDC11Code": "31722-0440-01",
"ProductNDC": "31722-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avanafil",
"NonProprietaryName": "Avanafil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209266",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "AVANAFIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240614",
"SamplePackage": "N",
"IndicationAndUsage": "Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.",
"Description": "Avanafil is a selective inhibitor of cGMP-specific PDE5. Avanafil is designated chemically as (S)-4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]- N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide and has the following structural formula:. Avanafil occurs as an off-white to white powder, molecular formula C 23H 26ClN 7O 3and molecular weight of 483.95 and is slightly soluble in methanol, ethanol and insoluble in water. Avanafil tablets, for oral administration, is supplied as oval, white to off-white tablets containing 50 mg, 100 mg, or 200 mg avanafil. In addition to the active ingredient, avanafil, each tablet contains the following inactive ingredients: fumaric acid, hydroxyl propyl cellulose, low- substituted hydroxyl propyl cellulose, magnesium stearate, mannitol and sodium bicarbonate."
},
{
"NDCCode": "31722-440-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (31722-440-30) ",
"NDC11Code": "31722-0440-30",
"ProductNDC": "31722-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avanafil",
"NonProprietaryName": "Avanafil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209266",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "AVANAFIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240614",
"SamplePackage": "N",
"IndicationAndUsage": "Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.",
"Description": "Avanafil is a selective inhibitor of cGMP-specific PDE5. Avanafil is designated chemically as (S)-4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]- N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide and has the following structural formula:. Avanafil occurs as an off-white to white powder, molecular formula C 23H 26ClN 7O 3and molecular weight of 483.95 and is slightly soluble in methanol, ethanol and insoluble in water. Avanafil tablets, for oral administration, is supplied as oval, white to off-white tablets containing 50 mg, 100 mg, or 200 mg avanafil. In addition to the active ingredient, avanafil, each tablet contains the following inactive ingredients: fumaric acid, hydroxyl propyl cellulose, low- substituted hydroxyl propyl cellulose, magnesium stearate, mannitol and sodium bicarbonate."
},
{
"NDCCode": "42627-440-01",
"PackageDescription": "1 TUBE in 1 CARTON (42627-440-01) / 50 mL in 1 TUBE",
"NDC11Code": "42627-0440-01",
"ProductNDC": "42627-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla",
"ProprietaryNameSuffix": "Spf 15",
"NonProprietaryName": "Octonoxate, Octisalate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210630",
"EndMarketingDate": "20230818",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Kingdon Animalia, LLC DBA Hourglass Cosmetics",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "7; 4; 4",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210630",
"EndMarketingDatePackage": "20230818",
"SamplePackage": "N"
},
{
"NDCCode": "46123-440-01",
"PackageDescription": "1 L in 1 TANK (46123-440-01) ",
"NDC11Code": "46123-0440-01",
"ProductNDC": "46123-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20020701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205850",
"LabelerName": "Roberts Oxygen Company, Inc.",
"SubstanceName": "NITROGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020701",
"SamplePackage": "N"
},
{
"NDCCode": "55150-440-10",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (55150-440-10) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "55150-0440-10",
"ProductNDC": "55150-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketamine Hydrochloride",
"NonProprietaryName": "Ketamine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20210315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076092",
"LabelerName": "Eugia US LLC",
"SubstanceName": "KETAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210315",
"SamplePackage": "N",
"IndicationAndUsage": "Ketamine hydrochloride injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.",
"Description": "Ketamine hydrochloride injection, USP for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is dl-2-(o-Chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride."
},
{
"NDCCode": "63545-440-01",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (63545-440-01) ",
"NDC11Code": "63545-0440-01",
"ProductNDC": "63545-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Berberis Vulgaris",
"NonProprietaryName": "Berberis Vulgaris",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220415",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220415",
"SamplePackage": "N"
},
{
"NDCCode": "63545-440-02",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (63545-440-02) ",
"NDC11Code": "63545-0440-02",
"ProductNDC": "63545-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Berberis Vulgaris",
"NonProprietaryName": "Berberis Vulgaris",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220415",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220415",
"SamplePackage": "N"
},
{
"NDCCode": "63545-440-03",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (63545-440-03) ",
"NDC11Code": "63545-0440-03",
"ProductNDC": "63545-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Berberis Vulgaris",
"NonProprietaryName": "Berberis Vulgaris",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220415",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-04-19",
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},
{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Berberis Vulgaris",
"NonProprietaryName": "Berberis Vulgaris",
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"RouteName": "ORAL",
"StartMarketingDate": "20220415",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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},
{
"NDCCode": "65084-440-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (65084-440-10)",
"NDC11Code": "65084-0440-10",
"ProductNDC": "65084-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dilaudid",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19560101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019892",
"LabelerName": "Mckesson Rxpak Inc",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "84515-440-01",
"PackageDescription": "50 g in 1 BOX (84515-440-01) ",
"NDC11Code": "84515-0440-01",
"ProductNDC": "84515-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "For All Skin Types",
"NonProprietaryName": "For All Skin Types",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241016",
"EndMarketingDate": "20311231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241016",
"EndMarketingDatePackage": "20311231",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "85347-001-01",
"PackageDescription": "50 mL in 1 VIAL, GLASS (85347-001-01) ",
"NDC11Code": "85347-0001-01",
"ProductNDC": "85347-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pylarify Truvu",
"NonProprietaryName": "Piflufolastat F-18",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220089",
"LabelerName": "Aphelion LLC",
"SubstanceName": "PIFLUFOLASTAT F-18",
"StrengthNumber": "120",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "PYLARIFY TRUVU is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: 1 with suspected metastasis who are candidates for initial definitive therapy, 2 with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.",
"Description": "PYLARIFY TRUVU (piflufolastat F 18) injection is a radioactive diagnostic drug for intravenous use. The chemical name of piflufolastat F 18 is 2-(3-{1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}ureido)-pentanedioic acid. The molecular weight is 441.4 and the structural formula is. PYLARIFY TRUVU is a sterile, clear, colorless to pale yellow solution. Each mL contains 37 MBq to 4,440 MBq (1 mCi to 120 mCi) piflufolastat F 18 at end of synthesis, ≤8 μg of piflufolastat, 5 mg to 15 mg of ascorbic acid, and ≤7.89% (w/v) of ethanol in 0.9% sodium chloride injection. The pH of the solution is 5.0 to 7.0. The specific activity is at least 1,000 mCi/µmol at the time of administration."
}
]
}
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<NDCList>
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<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary 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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>29300-440-19</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (29300-440-19) </PackageDescription>
<NDC11Code>29300-0440-19</NDC11Code>
<ProductNDC>29300-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219593</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is sparingly soluble in water, very slightly soluble to practically insoluble in methanol, acetonitrile and practically insoluble in heptane. The log of the partition coefficient is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with hydroxypropyl cellulose, mannitol, pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 25 mg,50 mg and 300 mg capsule shells contains FD & C Yellow# 6.The 100 mg, 150 mg, 200 mg and 225 mg capsule shells contains FD & C Blue 1.The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>63776-081-19</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (63776-081-19) </PackageDescription>
<NDC11Code>63776-0081-19</NDC11Code>
<ProductNDC>63776-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-cellulite</ProprietaryName>
<NonProprietaryName>Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; ADENOSINE TRIPHOSPHATE; ANDROSTERONE; ARTICHOKE; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS LYMPH VESSEL; BOS TAURUS VEIN; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COBALT; ERSOFERMIN; ESTROGENS, ESTERIFIED; FERROUS FUMARATE; FUMARIC ACID; HAMAMELIS VIRGINIANA BARK; HEPTAMINOL; HYALURONIDASE; INTERLEUKIN-3; LACTIC ACID; LEVOCARNITINE; MANGANESE; MELILOTUS OFFICINALIS WHOLE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA LYMPH VESSEL; SUS SCROFA VEIN; VITAMIN A; ZINC</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 200; 200; 200; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Carnitine Analog [EPC], Carnitine [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS], Vitamin A [CS], Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cellulite drainage & tonification, metabolism and lipid balance, hormonal support, circulatory support and regeneration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-175-19</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (63776-175-19) </PackageDescription>
<NDC11Code>63776-0175-19</NDC11Code>
<ProductNDC>63776-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-f Gus</ProprietaryName>
<NonProprietaryName>Berberis, Cochlerearia Armor, Echinacea, Ferrum, Hydrastis, Iridium, Lapacho, Lomatium, Lycopodium, Myrrh, Phosporicum Acidum, Propolis, Pulsatilla, Seleneium, Thymus, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANEMONE PULSATILLA; ARMORACIA RUSTICANA WHOLE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS THYMUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HANDROANTHUS IMPETIGINOSUS WHOLE; IRIDIUM; IRON; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHOSPHORIC ACID; PROPOLIS WAX; SELENIUM; SUS SCROFA THYMUS; ZINC</SubstanceName>
<StrengthNumber>12; 3; 3; 6; 3; 3; 3; 12; 12; 3; 12; 3; 12; 3; 12; 6; 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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>nutritional support for fungal, mold, bacteria challenges.</IndicationAndUsage>
<Description>Viatrexx-F gus is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-410-19</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (63776-410-19) </PackageDescription>
<NDC11Code>63776-0410-19</NDC11Code>
<ProductNDC>63776-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanine, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ASCORBIC ACID; AZELAIC ACID; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); NEPIDERMIN; PHENYLALANINE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SKIN; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ZINC</SubstanceName>
<StrengthNumber>30; 30; 30; 200; 30; 200; 30; 30; 200; 30; 200; 200; 200; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Cells, Epidermal [EXT], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Animal Skin Allergenic Extract [EPC], Non-Standardized Animal Skin Allergenic Extract [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Skin Issues.</IndicationAndUsage>
<Description>Viatrexx-Pigmentation is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-523-19</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (63776-523-19) </PackageDescription>
<NDC11Code>63776-0523-19</NDC11Code>
<ProductNDC>63776-523</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-tone</ProprietaryName>
<NonProprietaryName>Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</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], Depigmenting Activity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Meat Proteins [EXT], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Soft tissue regeneration.</IndicationAndUsage>
<Description>Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-440-11</NDCCode>
<PackageDescription>.5 mL in 1 AMPULE (63776-440-11) </PackageDescription>
<NDC11Code>63776-0440-11</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary 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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-440-14</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63776-440-14) </PackageDescription>
<NDC11Code>63776-0440-14</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary 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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-440-15</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (63776-440-15) </PackageDescription>
<NDC11Code>63776-0440-15</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary 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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-440-16</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (63776-440-16) </PackageDescription>
<NDC11Code>63776-0440-16</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary 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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-440-17</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (63776-440-17) </PackageDescription>
<NDC11Code>63776-0440-17</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary 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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-440-18</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (63776-440-18) </PackageDescription>
<NDC11Code>63776-0440-18</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary 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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-075-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-075-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0075-14</NDC11Code>
<ProductNDC>63776-075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida I</ProprietaryName>
<NonProprietaryName>Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Penicillin G, Vaccinium Vitis-idaea Leaf Spray</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>CAFFEIC ACID; CANDIDA ALBICANS; TANACETUM PARTHENIUM; CENTELLA ASIATICA; YEAST MANNAN; PENICILLIN G; VACCINIUM VITIS-IDAEA LEAF</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16714-440-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKET (16714-440-01) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0440-01</NDC11Code>
<ProductNDC>16714-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deblitane</ProprietaryName>
<NonProprietaryName>Norethindrone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202014</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.</IndicationAndUsage>
<Description>Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>16714-440-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (16714-440-02) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0440-02</NDC11Code>
<ProductNDC>16714-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deblitane</ProprietaryName>
<NonProprietaryName>Norethindrone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202014</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.</IndicationAndUsage>
<Description>Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>16714-440-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (16714-440-03) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0440-03</NDC11Code>
<ProductNDC>16714-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deblitane</ProprietaryName>
<NonProprietaryName>Norethindrone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202014</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.</IndicationAndUsage>
<Description>Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>16714-440-04</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (16714-440-04) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0440-04</NDC11Code>
<ProductNDC>16714-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deblitane</ProprietaryName>
<NonProprietaryName>Norethindrone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202014</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.</IndicationAndUsage>
<Description>Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>28595-710-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (28595-710-40) </PackageDescription>
<NDC11Code>28595-0710-40</NDC11Code>
<ProductNDC>28595-710</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mag 440</ProprietaryName>
<NonProprietaryName>Megnesium Oxide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250127</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Allegis Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MAGNESIUM OXIDE</SubstanceName>
<StrengthNumber>440</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves: Acid indigestion and upset stomach.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>31722-440-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (31722-440-01) </PackageDescription>
<NDC11Code>31722-0440-01</NDC11Code>
<ProductNDC>31722-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avanafil</ProprietaryName>
<NonProprietaryName>Avanafil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209266</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AVANAFIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.</IndicationAndUsage>
<Description>Avanafil is a selective inhibitor of cGMP-specific PDE5. Avanafil is designated chemically as (S)-4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]- N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide and has the following structural formula:. Avanafil occurs as an off-white to white powder, molecular formula C 23H 26ClN 7O 3and molecular weight of 483.95 and is slightly soluble in methanol, ethanol and insoluble in water. Avanafil tablets, for oral administration, is supplied as oval, white to off-white tablets containing 50 mg, 100 mg, or 200 mg avanafil. In addition to the active ingredient, avanafil, each tablet contains the following inactive ingredients: fumaric acid, hydroxyl propyl cellulose, low- substituted hydroxyl propyl cellulose, magnesium stearate, mannitol and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>31722-440-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (31722-440-30) </PackageDescription>
<NDC11Code>31722-0440-30</NDC11Code>
<ProductNDC>31722-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avanafil</ProprietaryName>
<NonProprietaryName>Avanafil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209266</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AVANAFIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.</IndicationAndUsage>
<Description>Avanafil is a selective inhibitor of cGMP-specific PDE5. Avanafil is designated chemically as (S)-4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]- N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide and has the following structural formula:. Avanafil occurs as an off-white to white powder, molecular formula C 23H 26ClN 7O 3and molecular weight of 483.95 and is slightly soluble in methanol, ethanol and insoluble in water. Avanafil tablets, for oral administration, is supplied as oval, white to off-white tablets containing 50 mg, 100 mg, or 200 mg avanafil. In addition to the active ingredient, avanafil, each tablet contains the following inactive ingredients: fumaric acid, hydroxyl propyl cellulose, low- substituted hydroxyl propyl cellulose, magnesium stearate, mannitol and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>42627-440-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42627-440-01) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>42627-0440-01</NDC11Code>
<ProductNDC>42627-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla</ProprietaryName>
<ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octonoxate, Octisalate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210630</StartMarketingDate>
<EndMarketingDate>20230818</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Kingdon Animalia, LLC DBA Hourglass Cosmetics</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>7; 4; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<EndMarketingDatePackage>20230818</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46123-440-01</NDCCode>
<PackageDescription>1 L in 1 TANK (46123-440-01) </PackageDescription>
<NDC11Code>46123-0440-01</NDC11Code>
<ProductNDC>46123-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205850</ApplicationNumber>
<LabelerName>Roberts Oxygen Company, Inc.</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55150-440-10</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (55150-440-10) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>55150-0440-10</NDC11Code>
<ProductNDC>55150-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20210315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076092</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketamine hydrochloride injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.</IndicationAndUsage>
<Description>Ketamine hydrochloride injection, USP for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is dl-2-(o-Chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride.</Description>
</NDC>
<NDC>
<NDCCode>63545-440-01</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (63545-440-01) </PackageDescription>
<NDC11Code>63545-0440-01</NDC11Code>
<ProductNDC>63545-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Berberis Vulgaris</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63545-440-02</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (63545-440-02) </PackageDescription>
<NDC11Code>63545-0440-02</NDC11Code>
<ProductNDC>63545-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Berberis Vulgaris</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63545-440-03</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (63545-440-03) </PackageDescription>
<NDC11Code>63545-0440-03</NDC11Code>
<ProductNDC>63545-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Berberis Vulgaris</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63545-440-04</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (63545-440-04) </PackageDescription>
<NDC11Code>63545-0440-04</NDC11Code>
<ProductNDC>63545-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Berberis Vulgaris</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65084-440-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (65084-440-10)</PackageDescription>
<NDC11Code>65084-0440-10</NDC11Code>
<ProductNDC>65084-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dilaudid</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19560101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019892</ApplicationNumber>
<LabelerName>Mckesson Rxpak Inc</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>84515-440-01</NDCCode>
<PackageDescription>50 g in 1 BOX (84515-440-01) </PackageDescription>
<NDC11Code>84515-0440-01</NDC11Code>
<ProductNDC>84515-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>For All Skin Types</ProprietaryName>
<NonProprietaryName>For All Skin Types</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241016</StartMarketingDate>
<EndMarketingDate>20311231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241016</StartMarketingDatePackage>
<EndMarketingDatePackage>20311231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85347-001-01</NDCCode>
<PackageDescription>50 mL in 1 VIAL, GLASS (85347-001-01) </PackageDescription>
<NDC11Code>85347-0001-01</NDC11Code>
<ProductNDC>85347-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pylarify Truvu</ProprietaryName>
<NonProprietaryName>Piflufolastat F-18</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220089</ApplicationNumber>
<LabelerName>Aphelion LLC</LabelerName>
<SubstanceName>PIFLUFOLASTAT F-18</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PYLARIFY TRUVU is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: 1 with suspected metastasis who are candidates for initial definitive therapy, 2 with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.</IndicationAndUsage>
<Description>PYLARIFY TRUVU (piflufolastat F 18) injection is a radioactive diagnostic drug for intravenous use. The chemical name of piflufolastat F 18 is 2-(3-{1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}ureido)-pentanedioic acid. The molecular weight is 441.4 and the structural formula is. PYLARIFY TRUVU is a sterile, clear, colorless to pale yellow solution. Each mL contains 37 MBq to 4,440 MBq (1 mCi to 120 mCi) piflufolastat F 18 at end of synthesis, ≤8 μg of piflufolastat, 5 mg to 15 mg of ascorbic acid, and ≤7.89% (w/v) of ethanol in 0.9% sodium chloride injection. The pH of the solution is 5.0 to 7.0. The specific activity is at least 1,000 mCi/µmol at the time of administration.</Description>
</NDC>
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