{
"NDC": [
{
"NDCCode": "71742-0008-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0008-1)",
"NDC11Code": "71742-0008-01",
"ProductNDC": "71742-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heavy Metal Detox",
"ProprietaryNameSuffix": "T014",
"NonProprietaryName": "Allium Sativum, Avena Sativa, Berberis Vulgaris, Lappa Major, Phytolacca Decandra, Solidago Virgaurea, Lycopodium Clavatum, Nux Vomica, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171026",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "GARLIC; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; LANTHANUM; NIOBIUM; TANTALUM",
"StrengthNumber": "3; 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 14; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_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; [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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2017-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171026",
"SamplePackage": "N",
"IndicationAndUsage": "May temporarily relieve vomiting, exhaustion and metallic taste."
},
{
"NDCCode": "71742-0001-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0001-1)",
"NDC11Code": "71742-0001-01",
"ProductNDC": "71742-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neuro-pro",
"ProprietaryNameSuffix": "T007",
"NonProprietaryName": "Gaba, L-dopa, Norepinephrine, Serotonin, Adrenocorticotrophin, Anacardium Orientale, Arsenicum Album, Baryta Carbonica, Calcarea Carbonica, Calcarea Phosphorica, Hyoscyamus Niger, Lycopodium Clavatum, Stramonium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171018",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": ".GAMMA.-AMINOBUTYRIC ACID; LEVODOPA; NOREPINEPHRINE; SEROTONIN HYDROCHLORIDE; CORTICOTROPIN; ANACARDIUM OCCIDENTALE FRUIT; ARSENIC TRIOXIDE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; HYOSCYAMUS NIGER; LYCOPODIUM CLAVATUM SPORE; DATURA STRAMONIUM",
"StrengthNumber": "6; 6; 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Catecholamine [EPC], Catecholamines [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2017-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171018",
"SamplePackage": "N",
"IndicationAndUsage": "May temporarily relieve symptoms associated with attention disorders."
},
{
"NDCCode": "71742-0002-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0002-1)",
"NDC11Code": "71742-0002-01",
"ProductNDC": "71742-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthri-joint",
"ProprietaryNameSuffix": "T008",
"NonProprietaryName": "Apis Mellifica, Bryonia (alba), Causticum, Colchicum Autumnale, Kali Carbonicum, Kalmia Latifolia, Ledum Palustre, Pulsatilla (vulgaris), Rhododendron Chrysanthum, Rhus Tox",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171019",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "APIS MELLIFERA; BRYONIA ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2017-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171019",
"SamplePackage": "N",
"IndicationAndUsage": "May temporarily relieve symptoms due to minor joint inflammation and swelling."
},
{
"NDCCode": "71742-0003-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0003-1) ",
"NDC11Code": "71742-0003-01",
"ProductNDC": "71742-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vascu-pro",
"ProprietaryNameSuffix": "T009",
"NonProprietaryName": "Cactus Grandiflorus, Hamamelis Virginiana, Valeriana Officinalis, Arteria Suis, Heart (suis), Arnica Montana, Aurum Metallicum, Baryta Muriatica, Cholesterinum, Lecithin, Magnesia Muriatica, Oxalicum Acidum, Phosphorus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171019",
"EndMarketingDate": "20271111",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "SELENICEREUS GRANDIFLORUS STEM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; VALERIAN; SUS SCROFA ARTERY; PORK HEART; ARNICA MONTANA WHOLE; GOLD; BARIUM CHLORIDE DIHYDRATE; CHOLESTEROL; LECITHIN, SOYBEAN; MAGNESIUM CHLORIDE; OXALIC ACID; PHOSPHORUS",
"StrengthNumber": "3; 3; 3; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Chemical Allergen [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171019",
"EndMarketingDatePackage": "20271111",
"SamplePackage": "N"
},
{
"NDCCode": "71742-0004-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0004-1)",
"NDC11Code": "71742-0004-01",
"ProductNDC": "71742-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Female Vitality",
"ProprietaryNameSuffix": "T010",
"NonProprietaryName": "Cimicifuga Racemosa, Fucus Vesiculosus, Oophorinum (suis), Hypophysis Suis, Thyroidinum (suis), Graphites, Lachesis Mutus, Natrum Muriaticum, Pulsatilla (pratensis), Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171020",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "BLACK COHOSH; FUCUS VESICULOSUS; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; GRAPHITE; LACHESIS MUTA VENOM; SODIUM CHLORIDE; ANEMONE PRATENSIS; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "3; 3; 6; 6; 6; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2017-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171020",
"SamplePackage": "N",
"IndicationAndUsage": "May temporarily relieve menstrual pain and cramps, pain immediately prior to menses, sore breasts associated with menstruation."
},
{
"NDCCode": "71742-0006-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0006-1)",
"NDC11Code": "71742-0006-01",
"ProductNDC": "71742-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Well",
"ProprietaryNameSuffix": "T012",
"NonProprietaryName": "Arsenicum Album, Avena Sativa, Coffea Cruda, Kali Carbonicum, Magnesia Carbonica, Nux Vomica, Passiflora Incarnata, Sepia, Valeriana Officinalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171024",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; SEPIA OFFICINALIS JUICE; VALERIAN",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2017-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171024",
"SamplePackage": "N",
"IndicationAndUsage": "May temporarily relieve symptoms due to fatigue and restlessness from inability to sleep."
},
{
"NDCCode": "71742-0007-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0007-1) ",
"NDC11Code": "71742-0007-01",
"ProductNDC": "71742-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lymph Detox",
"ProprietaryNameSuffix": "T013",
"NonProprietaryName": "Geranium Robertianum, Nasturtium Aquaticum, Aloe, Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Apis Mellifica, Equisetum Hyemale, Fumaria Officinalis, Natrum Sulphuricum, Phytolacca Decandra, Pinus Sylvestris, Veronica Officinalis, Gentiana Lutea, Juglans Regia, Sarsaparilla (smilax Regelii) Baryta Carbonica, Hepar Sulphuris Calcareum, Mercurius Cyanatus, Ferrum Iodatum, Aranea Diadema, Calcarea Phosphorica, Parathyroid Gland (bovine), Thymus (suis), Thyroidinum (suis)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171024",
"EndMarketingDate": "20221106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; BOS TAURUS PARATHYROID GLAND; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SCROPHULARIA NODOSA; SMILAX ORNATA ROOT; SODIUM SULFATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "3; 4; 12; 8; 12; 8; 4; 8; 4; 5; 3; 5; 5; 8; 3; 3; 4; 4; 3; 6; 4; 12; 12; 4; 12; 5",
"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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171024",
"EndMarketingDatePackage": "20221106",
"SamplePackage": "N"
},
{
"NDCCode": "71742-0009-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0009-1)",
"NDC11Code": "71742-0009-01",
"ProductNDC": "71742-0009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glucose Control",
"ProprietaryNameSuffix": "T015",
"NonProprietaryName": "Syzygium Jambolanum, Glandula Suprarenalis Suis, Hydrastis Canadensis, Hypophysis Suis, Pancreas Suis, Phaseolus, Aceticum Acidum, Lacticum Acidum, Phosphoricum Acidum, Phosphorus, Uranium Nitricum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171026",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "SYZYGIUM CUMINI SEED; SUS SCROFA ADRENAL GLAND; GOLDENSEAL; SUS SCROFA PITUITARY GLAND; SUS SCROFA PANCREAS; KIDNEY BEAN; ACETIC ACID; LACTIC ACID; PHOSPHORIC ACID; PHOSPHORUS; URANYL NITRATE HEXAHYDRATE",
"StrengthNumber": "3; 6; 6; 6; 6; 9; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2017-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171026",
"SamplePackage": "N",
"IndicationAndUsage": "Pancreas support, blood sugar regulation."
},
{
"NDCCode": "71742-0010-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0010-1)",
"NDC11Code": "71742-0010-01",
"ProductNDC": "71742-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Respiro-pro",
"ProprietaryNameSuffix": "T016",
"NonProprietaryName": "Ammonium Muriaticum, Antimonium Tartaricum, Arsenicum Album, Bryonia (alba), Calcarea Carbonica, Lobelia Inflata, Natrum Sulphuricum, Phosphorus, Spongia Tosta",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171026",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "AMMONIUM CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LOBELIA INFLATA; SODIUM SULFATE; PHOSPHORUS; SPONGIA OFFICINALIS SKELETON, ROASTED",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2017-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171026",
"SamplePackage": "N",
"IndicationAndUsage": "May temporarily relieve symptoms due to chronic lung disorders, lung inflammation."
},
{
"NDCCode": "71742-0011-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0011-1) ",
"NDC11Code": "71742-0011-01",
"ProductNDC": "71742-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kidney-pro",
"ProprietaryNameSuffix": "T017",
"NonProprietaryName": "Berberis Vulgaris, Petroselinum Sativum, Sabal Serrulata, Uva Ursi, Cantharis, Lithium Carbonicum, Mercurius Corrosivus, Pareira Brava, Sarsaparilla (smilax Regelii), Solidago Virgaurea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171026",
"EndMarketingDate": "20240229",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CHONDRODENDRON TOMENTOSUM ROOT; LITHIUM CARBONATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; PETROSELINUM CRISPUM WHOLE; SAW PALMETTO; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "3; 3; 12; 12; 12; 12; 3; 3; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171026",
"EndMarketingDatePackage": "20240229",
"SamplePackage": "N",
"IndicationAndUsage": "Detoxification of the kidneys."
},
{
"NDCCode": "71742-0012-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0012-1)",
"NDC11Code": "71742-0012-01",
"ProductNDC": "71742-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Spleen-pro",
"ProprietaryNameSuffix": "T018",
"NonProprietaryName": "Spleen (suis), Arsenicum Album, Carbo Vegetabilis, Ceanothus Americanus, Chininum Sulphuricum, Ignatia Amara, Iodium, Natrum Muriaticum, Nitricum Acidum, Phosphoricum Acidum, Phosphorus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171026",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "SUS SCROFA SPLEEN; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; CEANOTHUS AMERICANUS LEAF; QUININE SULFATE; STRYCHNOS IGNATII SEED; IODINE; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORIC ACID; PHOSPHORUS",
"StrengthNumber": "6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Active",
"LastUpdate": "2017-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171026",
"SamplePackage": "N",
"IndicationAndUsage": "Spleen support, immune system support."
},
{
"NDCCode": "71742-0013-1",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (71742-0013-1)",
"NDC11Code": "71742-0013-01",
"ProductNDC": "71742-0013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thyro-pro",
"ProprietaryNameSuffix": "T019",
"NonProprietaryName": "Fucus Vesiculosus, Spongia Tosta, Glandula Suprarenalis Suis, Hypophysis Suis, Thyroidinum (suis), Bromium, Calcarea Carbonica, Iodium, Lachesis Mutus, Pulsatilla (vulgaris)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171026",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; LACHESIS MUTA VENOM; PULSATILLA VULGARIS",
"StrengthNumber": "3; 3; 6; 6; 6; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2017-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171026",
"SamplePackage": "N",
"IndicationAndUsage": "Thymus support, immune system booster."
},
{
"NDCCode": "71742-0014-1",
"PackageDescription": "59 mL in 1 PACKAGE (71742-0014-1)",
"NDC11Code": "71742-0014-01",
"ProductNDC": "71742-0014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hgh-pro",
"ProprietaryNameSuffix": "T020",
"NonProprietaryName": "Human Growth Hormone, Hypophysis Suis, Hepar Suis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "SOMATROPIN; SUS SCROFA PITUITARY GLAND; PORK LIVER",
"StrengthNumber": "30; 30; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2017-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171031",
"SamplePackage": "N",
"IndicationAndUsage": "May temporarily relieve some of the symptoms of aging and/or run-down condition, which may include: low energy, lack of vigor and sleeplessness."
},
{
"NDCCode": "71742-0015-1",
"PackageDescription": "59 mL in 1 PACKAGE (71742-0015-1) ",
"NDC11Code": "71742-0015-01",
"ProductNDC": "71742-0015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Male Vitality",
"ProprietaryNameSuffix": "T021",
"NonProprietaryName": "Damiana, Korean Ginseng, Populus Tremuloides, Nuphar Luteum, Arnica Montana, Carduus Marianus, Galium Aparine, Lactuca Virosa, Caladium Seguinum, Hepar Suis, Orchitinum (suis), Thymus (suis), Glandula Suprarenalis Suis, Hypophysis Suis, Thyroidinum (suis), Testosterone, Phosphoricum Acidum, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171031",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guangzhou Renuma Medical Systems Co., Ltd",
"SubstanceName": "ARNICA MONTANA WHOLE; ASIAN GINSENG; DIEFFENBACHIA SEGUINE WHOLE; GALIUM APARINE WHOLE; LACTUCA VIROSA WHOLE; MILK THISTLE; NUPHAR LUTEA ROOT; PHOSPHORIC ACID; POPULUS TREMULOIDES BARK; PORK LIVER; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA TESTICLE; SUS SCROFA THYMUS; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID; TURNERA DIFFUSA LEAFY TWIG",
"StrengthNumber": "3; 1; 6; 3; 3; 3; 2; 200; 1; 6; 12; 12; 6; 6; 30; 200; 12; 1",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171031",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "May temporarily relieve symptoms of occasional low male sexual energy, which may include decrease in sexual desire, performance and enjoyment, as well as feelings of fatigue."
},
{
"NDCCode": "0008-0045-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-01) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0045-01",
"ProductNDC": "0008-0045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vinorelbine Tartrate",
"NonProprietaryName": "Vinorelbine Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA178408",
"LabelerName": "Wyeth Pharmaceuticals Company",
"SubstanceName": "VINORELBINE TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vinca Alkaloid [EPC],Vinca Alkaloids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0008-0045-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-02) > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0045-02",
"ProductNDC": "0008-0045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vinorelbine Tartrate",
"NonProprietaryName": "Vinorelbine Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA178408",
"LabelerName": "Wyeth Pharmaceuticals Company",
"SubstanceName": "VINORELBINE TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vinca Alkaloid [EPC],Vinca Alkaloids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0008-0100-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0100-01",
"ProductNDC": "0008-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Besponsa",
"NonProprietaryName": "Inotuzumab Ozogamicin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170818",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761040",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "INOTUZUMAB OZOGAMICIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170818",
"SamplePackage": "N",
"IndicationAndUsage": "BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.",
"Description": "Inotuzumab ozogamicin is a CD22-directed antibody and cytotoxic-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for human CD22, 2) N-acetyl-gamma-calicheamicin that causes double-stranded DNA breaks, and 3) an acid-cleavable linker composed of the condensation product of 4-(4'-acetylphenoxy)-butanoic acid (AcBut) and 3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that covalently attaches N-acetyl-gamma-calicheamicin to inotuzumab. Inotuzumab ozogamicin has an approximate molecular weight of 160 kDa. The average number of calicheamicin derivative molecules conjugated to each inotuzumab molecule is approximately 6 with a distribution from 2–8. Inotuzumab ozogamicin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the semisynthetic calicheamicin derivative is produced by microbial fermentation followed by synthetic modification. BESPONSA (inotuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous administration. Each single-dose vial delivers 0.9 mg inotuzumab ozogamicin. Inactive ingredients are polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). After reconstitution with 4 mL of Sterile Water for Injection, USP, the final concentration is 0.25 mg/mL of inotuzumab ozogamicin with a deliverable volume of 3.6 mL (0.9 mg) and a pH of approximately 8.0."
},
{
"NDCCode": "0008-0407-03",
"PackageDescription": "1 mL in 1 VIAL (0008-0407-03)",
"NDC11Code": "00008-0407-03",
"ProductNDC": "0008-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Antivenin (micrurus Fulvius)",
"NonProprietaryName": "Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19670601",
"EndMarketingDate": "20170331",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101099",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)",
"StrengthNumber": "1",
"StrengthUnit": "g/10mL",
"Status": "Deprecated",
"LastUpdate": "2017-04-04"
},
{
"NDCCode": "0008-0423-03",
"PackageDescription": "1 VIAL in 1 CARTON (0008-0423-03) > 10 mL in 1 VIAL (0008-0423-01) ",
"NDC11Code": "00008-0423-03",
"ProductNDC": "0008-0423",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "North American Coral Snake Antivenin (equine)",
"NonProprietaryName": "Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20161012",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101099",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)",
"StrengthNumber": "250",
"StrengthUnit": "[arb'U]/10mL",
"Status": "Active",
"LastUpdate": "2022-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161012",
"SamplePackage": "N",
"IndicationAndUsage": "North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties).",
"Description": "North American Coral Snake Antivenin (Equine) is a sterile lyophilized powder for solution for injection containing serum globulins obtained by fractionating blood from healthy horses that have been immunized with eastern coral snake (Micrurus fulvius fulvius) venom. Prior to lyophilization, the product contains 0.25% phenol."
},
{
"NDCCode": "0008-0606-01",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0606-01)",
"NDC11Code": "00008-0606-01",
"ProductNDC": "0008-0606",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20170930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "0008-0607-01",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0607-01)",
"NDC11Code": "00008-0607-01",
"ProductNDC": "0008-0607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20171031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "0008-0607-04",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-0607-04) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "00008-0607-04",
"ProductNDC": "0008-0607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-08-23"
},
{
"NDCCode": "0008-0833-03",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-0833-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0833-02) ",
"NDC11Code": "00008-0833-03",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19971101",
"SamplePackage": "N"
},
{
"NDCCode": "0008-0833-20",
"PackageDescription": "15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-20) ",
"NDC11Code": "00008-0833-20",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19971101",
"SamplePackage": "N"
},
{
"NDCCode": "0008-0833-21",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-21) ",
"NDC11Code": "00008-0833-21",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0833-22",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-22) ",
"NDC11Code": "00008-0833-22",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
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<SubstanceName>APIS MELLIFERA; BRYONIA ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May temporarily relieve symptoms due to minor joint inflammation and swelling.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71742-0003-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0003-1) </PackageDescription>
<NDC11Code>71742-0003-01</NDC11Code>
<ProductNDC>71742-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vascu-pro</ProprietaryName>
<ProprietaryNameSuffix>T009</ProprietaryNameSuffix>
<NonProprietaryName>Cactus Grandiflorus, Hamamelis Virginiana, Valeriana Officinalis, Arteria Suis, Heart (suis), Arnica Montana, Aurum Metallicum, Baryta Muriatica, Cholesterinum, Lecithin, Magnesia Muriatica, Oxalicum Acidum, Phosphorus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171019</StartMarketingDate>
<EndMarketingDate>20271111</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>SELENICEREUS GRANDIFLORUS STEM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; VALERIAN; SUS SCROFA ARTERY; PORK HEART; ARNICA MONTANA WHOLE; GOLD; BARIUM CHLORIDE DIHYDRATE; CHOLESTEROL; LECITHIN, SOYBEAN; MAGNESIUM CHLORIDE; OXALIC ACID; PHOSPHORUS</SubstanceName>
<StrengthNumber>3; 3; 3; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Chemical Allergen [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171019</StartMarketingDatePackage>
<EndMarketingDatePackage>20271111</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71742-0004-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0004-1)</PackageDescription>
<NDC11Code>71742-0004-01</NDC11Code>
<ProductNDC>71742-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Female Vitality</ProprietaryName>
<ProprietaryNameSuffix>T010</ProprietaryNameSuffix>
<NonProprietaryName>Cimicifuga Racemosa, Fucus Vesiculosus, Oophorinum (suis), Hypophysis Suis, Thyroidinum (suis), Graphites, Lachesis Mutus, Natrum Muriaticum, Pulsatilla (pratensis), Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171020</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>BLACK COHOSH; FUCUS VESICULOSUS; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; GRAPHITE; LACHESIS MUTA VENOM; SODIUM CHLORIDE; ANEMONE PRATENSIS; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>3; 3; 6; 6; 6; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2017-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May temporarily relieve menstrual pain and cramps, pain immediately prior to menses, sore breasts associated with menstruation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71742-0006-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0006-1)</PackageDescription>
<NDC11Code>71742-0006-01</NDC11Code>
<ProductNDC>71742-0006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Well</ProprietaryName>
<ProprietaryNameSuffix>T012</ProprietaryNameSuffix>
<NonProprietaryName>Arsenicum Album, Avena Sativa, Coffea Cruda, Kali Carbonicum, Magnesia Carbonica, Nux Vomica, Passiflora Incarnata, Sepia, Valeriana Officinalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171024</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; SEPIA OFFICINALIS JUICE; VALERIAN</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May temporarily relieve symptoms due to fatigue and restlessness from inability to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71742-0007-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0007-1) </PackageDescription>
<NDC11Code>71742-0007-01</NDC11Code>
<ProductNDC>71742-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lymph Detox</ProprietaryName>
<ProprietaryNameSuffix>T013</ProprietaryNameSuffix>
<NonProprietaryName>Geranium Robertianum, Nasturtium Aquaticum, Aloe, Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Apis Mellifica, Equisetum Hyemale, Fumaria Officinalis, Natrum Sulphuricum, Phytolacca Decandra, Pinus Sylvestris, Veronica Officinalis, Gentiana Lutea, Juglans Regia, Sarsaparilla (smilax Regelii) Baryta Carbonica, Hepar Sulphuris Calcareum, Mercurius Cyanatus, Ferrum Iodatum, Aranea Diadema, Calcarea Phosphorica, Parathyroid Gland (bovine), Thymus (suis), Thyroidinum (suis)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171024</StartMarketingDate>
<EndMarketingDate>20221106</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; BOS TAURUS PARATHYROID GLAND; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SCROPHULARIA NODOSA; SMILAX ORNATA ROOT; SODIUM SULFATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>3; 4; 12; 8; 12; 8; 4; 8; 4; 5; 3; 5; 5; 8; 3; 3; 4; 4; 3; 6; 4; 12; 12; 4; 12; 5</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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171024</StartMarketingDatePackage>
<EndMarketingDatePackage>20221106</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71742-0009-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0009-1)</PackageDescription>
<NDC11Code>71742-0009-01</NDC11Code>
<ProductNDC>71742-0009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glucose Control</ProprietaryName>
<ProprietaryNameSuffix>T015</ProprietaryNameSuffix>
<NonProprietaryName>Syzygium Jambolanum, Glandula Suprarenalis Suis, Hydrastis Canadensis, Hypophysis Suis, Pancreas Suis, Phaseolus, Aceticum Acidum, Lacticum Acidum, Phosphoricum Acidum, Phosphorus, Uranium Nitricum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171026</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>SYZYGIUM CUMINI SEED; SUS SCROFA ADRENAL GLAND; GOLDENSEAL; SUS SCROFA PITUITARY GLAND; SUS SCROFA PANCREAS; KIDNEY BEAN; ACETIC ACID; LACTIC ACID; PHOSPHORIC ACID; PHOSPHORUS; URANYL NITRATE HEXAHYDRATE</SubstanceName>
<StrengthNumber>3; 6; 6; 6; 6; 9; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pancreas support, blood sugar regulation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71742-0010-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0010-1)</PackageDescription>
<NDC11Code>71742-0010-01</NDC11Code>
<ProductNDC>71742-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Respiro-pro</ProprietaryName>
<ProprietaryNameSuffix>T016</ProprietaryNameSuffix>
<NonProprietaryName>Ammonium Muriaticum, Antimonium Tartaricum, Arsenicum Album, Bryonia (alba), Calcarea Carbonica, Lobelia Inflata, Natrum Sulphuricum, Phosphorus, Spongia Tosta</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171026</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>AMMONIUM CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LOBELIA INFLATA; SODIUM SULFATE; PHOSPHORUS; SPONGIA OFFICINALIS SKELETON, ROASTED</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2017-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May temporarily relieve symptoms due to chronic lung disorders, lung inflammation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71742-0011-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0011-1) </PackageDescription>
<NDC11Code>71742-0011-01</NDC11Code>
<ProductNDC>71742-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kidney-pro</ProprietaryName>
<ProprietaryNameSuffix>T017</ProprietaryNameSuffix>
<NonProprietaryName>Berberis Vulgaris, Petroselinum Sativum, Sabal Serrulata, Uva Ursi, Cantharis, Lithium Carbonicum, Mercurius Corrosivus, Pareira Brava, Sarsaparilla (smilax Regelii), Solidago Virgaurea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171026</StartMarketingDate>
<EndMarketingDate>20240229</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CHONDRODENDRON TOMENTOSUM ROOT; LITHIUM CARBONATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; PETROSELINUM CRISPUM WHOLE; SAW PALMETTO; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>3; 3; 12; 12; 12; 12; 3; 3; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171026</StartMarketingDatePackage>
<EndMarketingDatePackage>20240229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Detoxification of the kidneys.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71742-0012-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0012-1)</PackageDescription>
<NDC11Code>71742-0012-01</NDC11Code>
<ProductNDC>71742-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Spleen-pro</ProprietaryName>
<ProprietaryNameSuffix>T018</ProprietaryNameSuffix>
<NonProprietaryName>Spleen (suis), Arsenicum Album, Carbo Vegetabilis, Ceanothus Americanus, Chininum Sulphuricum, Ignatia Amara, Iodium, Natrum Muriaticum, Nitricum Acidum, Phosphoricum Acidum, Phosphorus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171026</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>SUS SCROFA SPLEEN; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; CEANOTHUS AMERICANUS LEAF; QUININE SULFATE; STRYCHNOS IGNATII SEED; IODINE; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORIC ACID; PHOSPHORUS</SubstanceName>
<StrengthNumber>6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spleen support, immune system support.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71742-0013-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0013-1)</PackageDescription>
<NDC11Code>71742-0013-01</NDC11Code>
<ProductNDC>71742-0013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thyro-pro</ProprietaryName>
<ProprietaryNameSuffix>T019</ProprietaryNameSuffix>
<NonProprietaryName>Fucus Vesiculosus, Spongia Tosta, Glandula Suprarenalis Suis, Hypophysis Suis, Thyroidinum (suis), Bromium, Calcarea Carbonica, Iodium, Lachesis Mutus, Pulsatilla (vulgaris)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171026</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; LACHESIS MUTA VENOM; PULSATILLA VULGARIS</SubstanceName>
<StrengthNumber>3; 3; 6; 6; 6; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2017-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thymus support, immune system booster.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71742-0014-1</NDCCode>
<PackageDescription>59 mL in 1 PACKAGE (71742-0014-1)</PackageDescription>
<NDC11Code>71742-0014-01</NDC11Code>
<ProductNDC>71742-0014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hgh-pro</ProprietaryName>
<ProprietaryNameSuffix>T020</ProprietaryNameSuffix>
<NonProprietaryName>Human Growth Hormone, Hypophysis Suis, Hepar Suis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>SOMATROPIN; SUS SCROFA PITUITARY GLAND; PORK LIVER</SubstanceName>
<StrengthNumber>30; 30; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May temporarily relieve some of the symptoms of aging and/or run-down condition, which may include: low energy, lack of vigor and sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71742-0015-1</NDCCode>
<PackageDescription>59 mL in 1 PACKAGE (71742-0015-1) </PackageDescription>
<NDC11Code>71742-0015-01</NDC11Code>
<ProductNDC>71742-0015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Male Vitality</ProprietaryName>
<ProprietaryNameSuffix>T021</ProprietaryNameSuffix>
<NonProprietaryName>Damiana, Korean Ginseng, Populus Tremuloides, Nuphar Luteum, Arnica Montana, Carduus Marianus, Galium Aparine, Lactuca Virosa, Caladium Seguinum, Hepar Suis, Orchitinum (suis), Thymus (suis), Glandula Suprarenalis Suis, Hypophysis Suis, Thyroidinum (suis), Testosterone, Phosphoricum Acidum, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171031</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>ARNICA MONTANA WHOLE; ASIAN GINSENG; DIEFFENBACHIA SEGUINE WHOLE; GALIUM APARINE WHOLE; LACTUCA VIROSA WHOLE; MILK THISTLE; NUPHAR LUTEA ROOT; PHOSPHORIC ACID; POPULUS TREMULOIDES BARK; PORK LIVER; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA TESTICLE; SUS SCROFA THYMUS; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID; TURNERA DIFFUSA LEAFY TWIG</SubstanceName>
<StrengthNumber>3; 1; 6; 3; 3; 3; 2; 200; 1; 6; 12; 12; 6; 6; 30; 200; 12; 1</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171031</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May temporarily relieve symptoms of occasional low male sexual energy, which may include decrease in sexual desire, performance and enjoyment, as well as feelings of fatigue.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0008-0045-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-01) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0045-01</NDC11Code>
<ProductNDC>0008-0045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vinorelbine Tartrate</ProprietaryName>
<NonProprietaryName>Vinorelbine Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA178408</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Company</LabelerName>
<SubstanceName>VINORELBINE TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vinca Alkaloid [EPC],Vinca Alkaloids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0008-0045-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-02) > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0045-02</NDC11Code>
<ProductNDC>0008-0045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vinorelbine Tartrate</ProprietaryName>
<NonProprietaryName>Vinorelbine Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA178408</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Company</LabelerName>
<SubstanceName>VINORELBINE TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vinca Alkaloid [EPC],Vinca Alkaloids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0008-0100-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0100-01</NDC11Code>
<ProductNDC>0008-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Besponsa</ProprietaryName>
<NonProprietaryName>Inotuzumab Ozogamicin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170818</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761040</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>INOTUZUMAB OZOGAMICIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.</IndicationAndUsage>
<Description>Inotuzumab ozogamicin is a CD22-directed antibody and cytotoxic-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for human CD22, 2) N-acetyl-gamma-calicheamicin that causes double-stranded DNA breaks, and 3) an acid-cleavable linker composed of the condensation product of 4-(4'-acetylphenoxy)-butanoic acid (AcBut) and 3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that covalently attaches N-acetyl-gamma-calicheamicin to inotuzumab. Inotuzumab ozogamicin has an approximate molecular weight of 160 kDa. The average number of calicheamicin derivative molecules conjugated to each inotuzumab molecule is approximately 6 with a distribution from 2–8. Inotuzumab ozogamicin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the semisynthetic calicheamicin derivative is produced by microbial fermentation followed by synthetic modification. BESPONSA (inotuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous administration. Each single-dose vial delivers 0.9 mg inotuzumab ozogamicin. Inactive ingredients are polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). After reconstitution with 4 mL of Sterile Water for Injection, USP, the final concentration is 0.25 mg/mL of inotuzumab ozogamicin with a deliverable volume of 3.6 mL (0.9 mg) and a pH of approximately 8.0.</Description>
</NDC>
<NDC>
<NDCCode>0008-0407-03</NDCCode>
<PackageDescription>1 mL in 1 VIAL (0008-0407-03)</PackageDescription>
<NDC11Code>00008-0407-03</NDC11Code>
<ProductNDC>0008-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Antivenin (micrurus Fulvius)</ProprietaryName>
<NonProprietaryName>Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19670601</StartMarketingDate>
<EndMarketingDate>20170331</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101099</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-04-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0423-03</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0008-0423-03) > 10 mL in 1 VIAL (0008-0423-01) </PackageDescription>
<NDC11Code>00008-0423-03</NDC11Code>
<ProductNDC>0008-0423</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>North American Coral Snake Antivenin (equine)</ProprietaryName>
<NonProprietaryName>Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20161012</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101099</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>[arb'U]/10mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties).</IndicationAndUsage>
<Description>North American Coral Snake Antivenin (Equine) is a sterile lyophilized powder for solution for injection containing serum globulins obtained by fractionating blood from healthy horses that have been immunized with eastern coral snake (Micrurus fulvius fulvius) venom. Prior to lyophilization, the product contains 0.25% phenol.</Description>
</NDC>
<NDC>
<NDCCode>0008-0606-01</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0606-01)</PackageDescription>
<NDC11Code>00008-0606-01</NDC11Code>
<ProductNDC>0008-0606</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20170930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0607-01</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0607-01)</PackageDescription>
<NDC11Code>00008-0607-01</NDC11Code>
<ProductNDC>0008-0607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20171031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0607-04</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0607-04) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00008-0607-04</NDC11Code>
<ProductNDC>0008-0607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0833-03</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0833-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0833-02) </PackageDescription>
<NDC11Code>00008-0833-03</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0833-20</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-20) </PackageDescription>
<NDC11Code>00008-0833-20</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0833-21</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-21) </PackageDescription>
<NDC11Code>00008-0833-21</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0833-22</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-22) </PackageDescription>
<NDC11Code>00008-0833-22</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0836-03</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0836-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0836-02) </PackageDescription>
<NDC11Code>00008-0836-03</NDC11Code>
<ProductNDC>0008-0836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-20) </PackageDescription>
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<ProprietaryName>Effexor</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0836-21</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-21) </PackageDescription>
<NDC11Code>00008-0836-21</NDC11Code>
<ProductNDC>0008-0836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
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<ProductNDC>0008-0836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
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<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
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