{
"NDC": [
{
"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": "71742-0001-1",
"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": "71742-0009-1",
"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": "71742-0011-1",
"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": "0054-0010-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0054-0010-20) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00054-0010-20",
"ProductNDC": "0054-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0054-0010-21",
"PackageDescription": "60 TABLET in 1 BOTTLE (0054-0010-21) ",
"NDC11Code": "00054-0010-21",
"ProductNDC": "0054-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0054-0010-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-0010-25) ",
"NDC11Code": "00054-0010-25",
"ProductNDC": "0054-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0074-3575-01",
"PackageDescription": "1 KIT in 1 CARTON (0074-3575-01) * 1.5 mL in 1 SYRINGE (0074-3410-01) * 2 SWAB in 1 PACKET (0074-0010-01) ",
"NDC11Code": "00074-3575-01",
"ProductNDC": "0074-3575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "20230414",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230414",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0093-0010-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0093-0010-05) ",
"NDC11Code": "00093-0010-05",
"ProductNDC": "0093-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077006",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151101",
"SamplePackage": "N"
},
{
"NDCCode": "0093-0010-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0093-0010-06) ",
"NDC11Code": "00093-0010-06",
"ProductNDC": "0093-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077006",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151101",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.",
"Description": "This product contains tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). It has the following structural formula. C26H37NO7 M.W. 475.6. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Each tolterodine tartrate tablet, for oral administration, contains 1 mg or 2 mg of tolterodine tartrate. In addition, each tablet contains the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, and titanium dioxide."
},
{
"NDCCode": "0185-0010-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0185-0010-01) ",
"NDC11Code": "00185-0010-01",
"ProductNDC": "0185-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl",
"NonProprietaryName": "Labetalol Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980804",
"EndMarketingDate": "20230930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075113",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19980804",
"EndMarketingDatePackage": "20230930",
"SamplePackage": "N"
},
{
"NDCCode": "0185-0010-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0185-0010-05) ",
"NDC11Code": "00185-0010-05",
"ProductNDC": "0185-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl",
"NonProprietaryName": "Labetalol Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980804",
"EndMarketingDate": "20230930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075113",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19980804",
"EndMarketingDatePackage": "20230930",
"SamplePackage": "N"
},
{
"NDCCode": "0185-0010-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (0185-0010-10) ",
"NDC11Code": "00185-0010-10",
"ProductNDC": "0185-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl",
"NonProprietaryName": "Labetalol Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075113",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19980804",
"SamplePackage": "N"
},
{
"NDCCode": "0187-0010-50",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0187-0010-50) / 50 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00187-0010-50",
"ProductNDC": "0187-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ammonul",
"NonProprietaryName": "Sodium Phenylacetate And Sodium Benzoate",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050217",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020645",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "SODIUM BENZOATE; SODIUM PHENYLACETATE",
"StrengthNumber": "100; 100",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050217",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "AMMONUL is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see Warnings and Precautions (5)].",
"Description": "AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% (a nitrogen binding agent) is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 6 and 8. Sodium phenylacetate is a white to off-white powder. It is soluble in water. Sodium benzoate is a white to off-white powder that is readily soluble in water. Figure 1. Sodium phenylacetate has a molecular weight of 158.14 and the molecular formula C 8H 7NaO 2. Sodium benzoate has a molecular weight of 144.10 and the molecular formula C 7H 5NaO 2. Each mL of AMMONUL contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. AMMONUL injection is a sterile, concentrated solution intended for intravenous administration via a central venous catheter only after dilution [see Dosage and Administration (2)]."
},
{
"NDCCode": "0220-0010-41",
"PackageDescription": "5 [hp_C] in 1 TUBE (0220-0010-41) ",
"NDC11Code": "00220-0010-41",
"ProductNDC": "0220-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Abies Nigra",
"NonProprietaryName": "Picea Mariana Resin",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "PICEA MARIANA RESIN",
"StrengthNumber": "5",
"StrengthUnit": "[hp_C]/5[hp_C]",
"Status": "Active",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: See symptoms on front panel. Relieves acid indigestion, sour stomach, heartburn *."
},
{
"NDCCode": "0268-0010-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0010-10)",
"NDC11Code": "00268-0010-10",
"ProductNDC": "0268-0010",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "House Dust",
"NonProprietaryName": "House Dust",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "HOUSE DUST",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0295-0010-06",
"PackageDescription": "28.35 g in 1 TUBE (0295-0010-06) ",
"NDC11Code": "00295-0010-06",
"ProductNDC": "0295-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zapzyt Acne",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Denison Pharmaceuticals, Inc.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20171201",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment & prevention of acne pimples, blemishes, blackheads or whiteheads."
},
{
"NDCCode": "0360-0010-02",
"PackageDescription": "1 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0360-0010-02) ",
"NDC11Code": "00360-0010-02",
"ProductNDC": "0360-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Argentum Nitricum",
"NonProprietaryName": "Argentum Nitricum",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Standard Homeopathic Company",
"SubstanceName": "SILVER NITRATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "0363-0010-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (0363-0010-01) > 200 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "00363-0010-01",
"ProductNDC": "0363-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wal-zan",
"NonProprietaryName": "Ranitidine Hydrochloride Tablets 150mg",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078192",
"LabelerName": "Walgreens Company",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231"
},
{
"NDCCode": "0363-0010-23",
"PackageDescription": "1 BOTTLE in 1 CARTON (0363-0010-23) > 36 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "00363-0010-23",
"ProductNDC": "0363-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wal-zan",
"NonProprietaryName": "Ranitidine Hydrochloride Tablets 150mg",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078192",
"LabelerName": "Walgreens Company",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231"
}
]
}
{"NDC":[{"NDCCode":"71742-0010-1","ProprietaryName":"Respiro-pro","NonProprietaryName":"Ammonium Muriaticum, Antimonium Tartaricum, Arsenicum Album, Bryonia (alba), Calcarea Carbonica, Lobelia Inflata, Natrum Sulphuricum, Phosphorus, Spongia Tosta"},{"NDCCode":"71742-0001-1","ProprietaryName":"Neuro-pro","NonProprietaryName":"Gaba, L-dopa, Norepinephrine, Serotonin, Adrenocorticotrophin, Anacardium Orientale, Arsenicum Album, Baryta Carbonica, Calcarea Carbonica, Calcarea Phosphorica, Hyoscyamus Niger, Lycopodium Clavatum, Stramonium"},{"NDCCode":"71742-0002-1","ProprietaryName":"Arthri-joint","NonProprietaryName":"Apis Mellifica, Bryonia (alba), Causticum, Colchicum Autumnale, Kali Carbonicum, Kalmia Latifolia, Ledum Palustre, Pulsatilla (vulgaris), Rhododendron Chrysanthum, Rhus Tox"},{"NDCCode":"71742-0003-1","ProprietaryName":"Vascu-pro","NonProprietaryName":"Cactus Grandiflorus, Hamamelis Virginiana, Valeriana Officinalis, Arteria Suis, Heart (suis), Arnica Montana, Aurum 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Hepar Sulphuris Calcareum, Mercurius Cyanatus, Ferrum Iodatum, Aranea Diadema, Calcarea Phosphorica, Parathyroid Gland (bovine), Thymus (suis), Thyroidinum (suis)"},{"NDCCode":"71742-0008-1","ProprietaryName":"Heavy Metal Detox","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"},{"NDCCode":"71742-0009-1","ProprietaryName":"Glucose Control","NonProprietaryName":"Syzygium Jambolanum, Glandula Suprarenalis Suis, Hydrastis Canadensis, Hypophysis Suis, Pancreas Suis, Phaseolus, Aceticum Acidum, Lacticum Acidum, Phosphoricum 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Tartrate","NonProprietaryName":"Tolterodine Tartrate"},{"NDCCode":"0185-0010-01","ProprietaryName":"Labetalol Hcl","NonProprietaryName":"Labetalol Hcl"},{"NDCCode":"0185-0010-05","ProprietaryName":"Labetalol Hcl","NonProprietaryName":"Labetalol Hcl"},{"NDCCode":"0185-0010-10","ProprietaryName":"Labetalol Hcl","NonProprietaryName":"Labetalol Hcl"},{"NDCCode":"0187-0010-50","ProprietaryName":"Ammonul","NonProprietaryName":"Sodium Phenylacetate And Sodium Benzoate"},{"NDCCode":"0220-0010-41","ProprietaryName":"Abies Nigra","NonProprietaryName":"Picea Mariana Resin"},{"NDCCode":"0268-0010-10","ProprietaryName":"House Dust","NonProprietaryName":"House Dust"},{"NDCCode":"0295-0010-06","ProprietaryName":"Zapzyt Acne","NonProprietaryName":"Benzoyl Peroxide"},{"NDCCode":"0360-0010-02","ProprietaryName":"Argentum Nitricum","NonProprietaryName":"Argentum Nitricum"},{"NDCCode":"0363-0010-01","ProprietaryName":"Wal-zan","NonProprietaryName":"Ranitidine Hydrochloride Tablets 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<NDCList>
<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>
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<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>71742-0001-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0001-1)</PackageDescription>
<NDC11Code>71742-0001-01</NDC11Code>
<ProductNDC>71742-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neuro-pro</ProprietaryName>
<ProprietaryNameSuffix>T007</ProprietaryNameSuffix>
<NonProprietaryName>Gaba, L-dopa, Norepinephrine, Serotonin, Adrenocorticotrophin, Anacardium Orientale, Arsenicum Album, Baryta Carbonica, Calcarea Carbonica, Calcarea Phosphorica, Hyoscyamus Niger, Lycopodium Clavatum, Stramonium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171018</StartMarketingDate>
<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>
<StrengthNumber>6; 6; 6; 6; 8; 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_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>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>
<NDC>
<NDCCode>71742-0002-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0002-1)</PackageDescription>
<NDC11Code>71742-0002-01</NDC11Code>
<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>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171019</StartMarketingDate>
<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>71742-0009-1</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (71742-0009-1)</PackageDescription>
<NDC11Code>71742-0009-01</NDC11Code>
<ProductNDC>71742-0009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glucose Control</ProprietaryName>
<ProprietaryNameSuffix>T015</ProprietaryNameSuffix>
<NonProprietaryName>Syzygium Jambolanum, Glandula Suprarenalis Suis, Hydrastis Canadensis, Hypophysis Suis, Pancreas Suis, Phaseolus, Aceticum Acidum, Lacticum Acidum, Phosphoricum Acidum, Phosphorus, Uranium Nitricum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171026</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guangzhou Renuma Medical Systems Co., Ltd</LabelerName>
<SubstanceName>SYZYGIUM CUMINI SEED; SUS SCROFA ADRENAL GLAND; GOLDENSEAL; SUS SCROFA PITUITARY GLAND; SUS SCROFA PANCREAS; KIDNEY BEAN; ACETIC ACID; LACTIC ACID; PHOSPHORIC ACID; PHOSPHORUS; URANYL NITRATE HEXAHYDRATE</SubstanceName>
<StrengthNumber>3; 6; 6; 6; 6; 9; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pancreas support, blood sugar regulation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71742-0011-1</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>0054-0010-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0054-0010-20) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00054-0010-20</NDC11Code>
<ProductNDC>0054-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0054-0010-21</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0054-0010-21) </PackageDescription>
<NDC11Code>00054-0010-21</NDC11Code>
<ProductNDC>0054-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0054-0010-25</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0054-0010-25) </PackageDescription>
<NDC11Code>00054-0010-25</NDC11Code>
<ProductNDC>0054-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0074-3575-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3575-01) * 1.5 mL in 1 SYRINGE (0074-3410-01) * 2 SWAB in 1 PACKET (0074-0010-01) </PackageDescription>
<NDC11Code>00074-3575-01</NDC11Code>
<ProductNDC>0074-3575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230414</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0093-0010-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0093-0010-05) </PackageDescription>
<NDC11Code>00093-0010-05</NDC11Code>
<ProductNDC>0093-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077006</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-0010-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0093-0010-06) </PackageDescription>
<NDC11Code>00093-0010-06</NDC11Code>
<ProductNDC>0093-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077006</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
<Description>This product contains tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). It has the following structural formula. C26H37NO7 M.W. 475.6. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Each tolterodine tartrate tablet, for oral administration, contains 1 mg or 2 mg of tolterodine tartrate. In addition, each tablet contains the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0185-0010-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0185-0010-01) </PackageDescription>
<NDC11Code>00185-0010-01</NDC11Code>
<ProductNDC>0185-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hcl</ProprietaryName>
<NonProprietaryName>Labetalol Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980804</StartMarketingDate>
<EndMarketingDate>20230930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075113</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19980804</StartMarketingDatePackage>
<EndMarketingDatePackage>20230930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0185-0010-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0185-0010-05) </PackageDescription>
<NDC11Code>00185-0010-05</NDC11Code>
<ProductNDC>0185-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hcl</ProprietaryName>
<NonProprietaryName>Labetalol Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980804</StartMarketingDate>
<EndMarketingDate>20230930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075113</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19980804</StartMarketingDatePackage>
<EndMarketingDatePackage>20230930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0185-0010-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (0185-0010-10) </PackageDescription>
<NDC11Code>00185-0010-10</NDC11Code>
<ProductNDC>0185-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hcl</ProprietaryName>
<NonProprietaryName>Labetalol Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075113</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0187-0010-50</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0187-0010-50) / 50 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00187-0010-50</NDC11Code>
<ProductNDC>0187-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ammonul</ProprietaryName>
<NonProprietaryName>Sodium Phenylacetate And Sodium Benzoate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050217</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020645</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>SODIUM BENZOATE; SODIUM PHENYLACETATE</SubstanceName>
<StrengthNumber>100; 100</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050217</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AMMONUL is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% (a nitrogen binding agent) is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 6 and 8. Sodium phenylacetate is a white to off-white powder. It is soluble in water. Sodium benzoate is a white to off-white powder that is readily soluble in water. Figure 1. Sodium phenylacetate has a molecular weight of 158.14 and the molecular formula C 8H 7NaO 2. Sodium benzoate has a molecular weight of 144.10 and the molecular formula C 7H 5NaO 2. Each mL of AMMONUL contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. AMMONUL injection is a sterile, concentrated solution intended for intravenous administration via a central venous catheter only after dilution [see Dosage and Administration (2)].</Description>
</NDC>
<NDC>
<NDCCode>0220-0010-41</NDCCode>
<PackageDescription>5 [hp_C] in 1 TUBE (0220-0010-41) </PackageDescription>
<NDC11Code>00220-0010-41</NDC11Code>
<ProductNDC>0220-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Abies Nigra</ProprietaryName>
<NonProprietaryName>Picea Mariana Resin</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>PICEA MARIANA RESIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>[hp_C]/5[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: See symptoms on front panel. Relieves acid indigestion, sour stomach, heartburn *.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0268-0010-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0010-10)</PackageDescription>
<NDC11Code>00268-0010-10</NDC11Code>
<ProductNDC>0268-0010</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>House Dust</ProprietaryName>
<NonProprietaryName>House Dust</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>HOUSE DUST</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0295-0010-06</NDCCode>
<PackageDescription>28.35 g in 1 TUBE (0295-0010-06) </PackageDescription>
<NDC11Code>00295-0010-06</NDC11Code>
<ProductNDC>0295-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zapzyt Acne</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Denison Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment & prevention of acne pimples, blemishes, blackheads or whiteheads.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0360-0010-02</NDCCode>
<PackageDescription>1 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0360-0010-02) </PackageDescription>
<NDC11Code>00360-0010-02</NDC11Code>
<ProductNDC>0360-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Argentum Nitricum</ProprietaryName>
<NonProprietaryName>Argentum Nitricum</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Standard Homeopathic Company</LabelerName>
<SubstanceName>SILVER NITRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0363-0010-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0363-0010-01) > 200 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00363-0010-01</NDC11Code>
<ProductNDC>0363-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wal-zan</ProprietaryName>
<NonProprietaryName>Ranitidine Hydrochloride Tablets 150mg</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078192</ApplicationNumber>
<LabelerName>Walgreens Company</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0363-0010-23</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0363-0010-23) > 36 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00363-0010-23</NDC11Code>
<ProductNDC>0363-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wal-zan</ProprietaryName>
<NonProprietaryName>Ranitidine Hydrochloride Tablets 150mg</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078192</ApplicationNumber>
<LabelerName>Walgreens Company</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>