{
"NDC": [
{
"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": "71742-0001-1",
"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": "71742-0008-1",
"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": "71742-0010-1",
"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": "0009-0003-02",
"PackageDescription": "1 VIAL in 1 CARTON (0009-0003-02) / 4 mL in 1 VIAL",
"NDC11Code": "00009-0003-02",
"ProductNDC": "0009-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-medrol",
"NonProprietaryName": "Methylprednisolone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19590402",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011856",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19590402",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8."
},
{
"NDCCode": "0009-0005-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0005-01) / 8 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00009-0005-01",
"ProductNDC": "0009-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-cortef",
"NonProprietaryName": "Hydrocortisone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19550427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009866",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE SODIUM SUCCINATE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/8mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19550427",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0009-0011-04",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0009-0011-04) / 2 mL in 1 VIAL, SINGLE-DOSE (0009-0011-03) ",
"NDC11Code": "00009-0011-04",
"ProductNDC": "0009-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-cortef",
"NonProprietaryName": "Hydrocortisone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19550427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009866",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE SODIUM SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19550427",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0009-0012-01",
"PackageDescription": "50 TABLET in 1 BOTTLE (0009-0012-01) ",
"NDC11Code": "00009-0012-01",
"ProductNDC": "0009-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cortef",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19521215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA008697",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19521215",
"SamplePackage": "N",
"IndicationAndUsage": "CORTEF Tablets are indicated in the following conditions.",
"Description": "CORTEF Tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. CORTEF Tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose."
},
{
"NDCCode": "0009-0013-05",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0013-05) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00009-0013-05",
"ProductNDC": "0009-0013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-cortef",
"NonProprietaryName": "Hydrocortisone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19550427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009866",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE SODIUM SUCCINATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19550427",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0009-0013-06",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-0013-06) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00009-0013-06",
"ProductNDC": "0009-0013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-cortef",
"NonProprietaryName": "Hydrocortisone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19550427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009866",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE SODIUM SUCCINATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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},
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{
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"LastUpdate": "2016-12-02"
},
{
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"LabelerName": "Pharmacia & Upjohn Company LLC",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8."
},
{
"NDCCode": "0009-0020-01",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medrol",
"NonProprietaryName": "Methylprednisolone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011153",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "METHYLPREDNISOLONE",
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"StrengthUnit": "mg/1",
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"IndicationAndUsage": "MEDROL Tablets are indicated in the following conditions.",
"Description": "MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below. Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. Inactive ingredients."
},
{
"NDCCode": "0009-0022-01",
"PackageDescription": "25 TABLET in 1 BOTTLE (0009-0022-01) ",
"NDC11Code": "00009-0022-01",
"ProductNDC": "0009-0022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medrol",
"NonProprietaryName": "Methylprednisolone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"MarketingCategoryName": "NDA",
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"LabelerName": "Pharmacia & Upjohn Company LLC",
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"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
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"IndicationAndUsage": "MEDROL Tablets are indicated in the following conditions.",
"Description": "MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below. Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. Inactive ingredients."
},
{
"NDCCode": "0009-0024-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0009-0024-01)",
"NDC11Code": "00009-0024-01",
"ProductNDC": "0009-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Didrex",
"NonProprietaryName": "Benzphetamine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19601026",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012427",
"LabelerName": "Pharmacia and Upjohn Company",
"SubstanceName": "BENZPHETAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "0009-0024-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (0009-0024-02)",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Pharmacia and Upjohn Company",
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"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
}
]
}
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<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>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ProprietaryName>Neuro-pro</ProprietaryName>
<ProprietaryNameSuffix>T007</ProprietaryNameSuffix>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<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</SubstanceName>
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<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May temporarily relieve symptoms associated with attention disorders.</IndicationAndUsage>
</NDC>
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<ProductNDC>71742-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthri-joint</ProprietaryName>
<ProprietaryNameSuffix>T008</ProprietaryNameSuffix>
<NonProprietaryName>Apis Mellifica, Bryonia (alba), Causticum, Colchicum Autumnale, Kali Carbonicum, Kalmia Latifolia, Ledum Palustre, Pulsatilla (vulgaris), Rhododendron Chrysanthum, Rhus Tox</NonProprietaryName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<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>71742-0008-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0008-1)</PackageDescription>
<NDC11Code>71742-0008-01</NDC11Code>
<ProductNDC>71742-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heavy Metal Detox</ProprietaryName>
<ProprietaryNameSuffix>T014</ProprietaryNameSuffix>
<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</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171026</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<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</SubstanceName>
<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</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; [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</StrengthUnit>
<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]</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>May temporarily relieve vomiting, exhaustion and metallic taste.</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>0009-0003-02</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0009-0003-02) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>00009-0003-02</NDC11Code>
<ProductNDC>0009-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19590402</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011856</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19590402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
</NDC>
<NDC>
<NDCCode>0009-0005-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0005-01) / 8 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00009-0005-01</NDC11Code>
<ProductNDC>0009-0005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-cortef</ProprietaryName>
<NonProprietaryName>Hydrocortisone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19550427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009866</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>HYDROCORTISONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/8mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
</NDC>
<NDC>
<NDCCode>0009-0011-04</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0009-0011-04) / 2 mL in 1 VIAL, SINGLE-DOSE (0009-0011-03) </PackageDescription>
<NDC11Code>00009-0011-04</NDC11Code>
<ProductNDC>0009-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-cortef</ProprietaryName>
<NonProprietaryName>Hydrocortisone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19550427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009866</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>HYDROCORTISONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
</NDC>
<NDC>
<NDCCode>0009-0012-01</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (0009-0012-01) </PackageDescription>
<NDC11Code>00009-0012-01</NDC11Code>
<ProductNDC>0009-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cortef</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19521215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA008697</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19521215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CORTEF Tablets are indicated in the following conditions.</IndicationAndUsage>
<Description>CORTEF Tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. CORTEF Tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose.</Description>
</NDC>
<NDC>
<NDCCode>0009-0013-05</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0013-05) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00009-0013-05</NDC11Code>
<ProductNDC>0009-0013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-cortef</ProprietaryName>
<NonProprietaryName>Hydrocortisone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19550427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009866</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>HYDROCORTISONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
</NDC>
<NDC>
<NDCCode>0009-0013-06</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-0013-06) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00009-0013-06</NDC11Code>
<ProductNDC>0009-0013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-cortef</ProprietaryName>
<NonProprietaryName>Hydrocortisone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19550427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009866</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>HYDROCORTISONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
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<ApplicationNumber>NDA009866</ApplicationNumber>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>19550427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
</NDC>
<NDC>
<NDCCode>0009-0017-02</NDCCode>
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<ProductNDC>0009-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Halcion</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19821115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017892</ApplicationNumber>
<LabelerName>Pharmacia and Upjohn Company LLC</LabelerName>
<SubstanceName>TRIAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19821115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0009-0017-55</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0009-0017-55) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00009-0017-55</NDC11Code>
<ProductNDC>0009-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Halcion</ProprietaryName>
<NonProprietaryName>Triazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19821115</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017892</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>TRIAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19821115</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0009-0017-58</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (0009-0017-58) </PackageDescription>
<NDC11Code>00009-0017-58</NDC11Code>
<ProductNDC>0009-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Halcion</ProprietaryName>
<NonProprietaryName>Triazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19821115</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017892</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>TRIAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19821115</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0009-0017-59</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (0009-0017-59) > 10 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00009-0017-59</NDC11Code>
<ProductNDC>0009-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Halcion</ProprietaryName>
<NonProprietaryName>Triazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19821115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017892</ApplicationNumber>
<LabelerName>Pharmacia and Upjohn Company</LabelerName>
<SubstanceName>TRIAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0009-0018-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0009-0018-20) / 8 mL in 1 VIAL</PackageDescription>
<NDC11Code>00009-0018-20</NDC11Code>
<ProductNDC>0009-0018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19590402</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011856</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/8mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19590402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
</NDC>
<NDC>
<NDCCode>0009-0020-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0009-0020-01) </PackageDescription>
<NDC11Code>00009-0020-01</NDC11Code>
<ProductNDC>0009-0020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011153</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MEDROL Tablets are indicated in the following conditions.</IndicationAndUsage>
<Description>MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below. Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. Inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0009-0022-01</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (0009-0022-01) </PackageDescription>
<NDC11Code>00009-0022-01</NDC11Code>
<ProductNDC>0009-0022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19571024</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011153</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19571024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MEDROL Tablets are indicated in the following conditions.</IndicationAndUsage>
<Description>MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below. Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. Inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0009-0024-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0009-0024-01)</PackageDescription>
<NDC11Code>00009-0024-01</NDC11Code>
<ProductNDC>0009-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Didrex</ProprietaryName>
<NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19601026</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012427</ApplicationNumber>
<LabelerName>Pharmacia and Upjohn Company</LabelerName>
<SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0009-0024-02</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0009-0024-02)</PackageDescription>
<NDC11Code>00009-0024-02</NDC11Code>
<ProductNDC>0009-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Didrex</ProprietaryName>
<NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19601026</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012427</ApplicationNumber>
<LabelerName>Pharmacia and Upjohn Company</LabelerName>
<SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
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