{
"NDC": [
{
"NDCCode": "62902-0008-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0008-1) ",
"NDC11Code": "62902-0008-01",
"ProductNDC": "62902-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clean Sweep Formula 4",
"NonProprietaryName": "Carduus Marianus, Chelidonium Majus, Cinchona Officinalis, Lycopodium Clavatum, Taraxacum Officinale, Veratrum Album, Avena Sativa, Cynara Scolymus, Methylcobalamin, Menadione, Alpha-lipoicum Acidum, Hepar Suis, Colon (suis), Duodenum (suis), Gallbladder (suis), Intestine (suis), Lymph Node (suis), Pancreas Suis, Thymus, Alpha-ketoglutaricum Acidum, Cholesterinum, Formicum Acidum, Glyoxal Trimer Dihydrate, Histaminum Hydrochloricum, Malicum Acidum, Natrum Oxalaceticum, Sulphur, Calcarea Carbonica",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170511",
"EndMarketingDate": "20220601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; FORMIC ACID; GLYOXAL TRIMER DIHYDRATE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MALIC ACID; MENADIONE; METHYLCOBALAMIN; MILK THISTLE; OROTIC ACID; OXOGLURIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK INTESTINE; PORK LIVER; PROTEUS MORGANII; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; SUS SCROFA LYMPH; SUS SCROFA PANCREAS; SUS SCROFA THYMUS; TARAXACUM OFFICINALE; THIOCTIC ACID; VERATRUM ALBUM ROOT",
"StrengthNumber": "6; 4; 10; 4; 6; 10; 10; 10; 4; 10; 6; 6; 3; 7; 10; 28; 8; 8; 30; 30; 10; 13; 8; 8; 8; 8; 8; 8; 4; 8; 4",
"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_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170511",
"EndMarketingDatePackage": "20220601",
"SamplePackage": "N"
},
{
"NDCCode": "62902-0001-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0001-1)",
"NDC11Code": "62902-0001-01",
"ProductNDC": "62902-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lean Love",
"NonProprietaryName": "Asclepias Vincetoxicum, Echinacea (angustifolia), Hypothalamus (suis), Brain (suis), Hepar Suis, Methylcobalamin, Pancreas Suis, Kidney (suis), Stomach (suis), Aacg-a, Aacg-b, Calcarea Carbonica, Gambogia Gelsemium, Sempervirens Graphites, Nux Vomica, Phytolacca Decandra, 7-keto-dhea (dehydroepiandrosterone), Atp (adenosinum Triphosphoricum Dinatrum), Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (vulgaris)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140522",
"EndMarketingDate": "20190513",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": "CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; METHYLCOBALAMIN; SUS SCROFA PANCREAS; PORK KIDNEY; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN HUMAN; LACTIC ACID, L-; PROTEUS VULGARIS",
"StrengthNumber": "6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_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",
"Status": "Deprecated",
"LastUpdate": "2019-05-14",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "62902-0002-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0002-1) ",
"NDC11Code": "62902-0002-01",
"ProductNDC": "62902-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Craving And Appetite Ease",
"NonProprietaryName": "Acetyl Coenzyme A, Adenosinum Triphosphoricum Dinatrum, Adrenal Cortex (suis), Bacopa Speciosa, Dopamine Hydrochloride, Equol, Gambogia, Oxytocin Acetate, Rhodiola, Stomach (suis), Thyroidinum (suis), Chininum Sulphuricum, Cina, Iodium, Lycopodium Clavatum, Phosphorus, Serotonin (hydrochloride), Morgan Gaertner",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160824",
"EndMarketingDate": "20220602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": "ACETYL COENZYME A; ADENOSINE TRIPHOSPHATE DISODIUM; ARTEMISIA CINA PRE-FLOWERING TOP; BACOPA MONNIERI WHOLE; DOPAMINE HYDROCHLORIDE; EQUOL, (+/-)-; GAMBOGE; IODINE; LYCOPODIUM CLAVATUM SPORE; OXYTOCIN ACETATE; PHOSPHORUS; QUININE SULFATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEDUM ROSEUM WHOLE; SEROTONIN HYDROCHLORIDE; SUS SCROFA ADRENAL CORTEX; SUS SCROFA STOMACH; SUS SCROFA THYROID",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 30; 6; 6; 6; 6; 6",
"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_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160824",
"EndMarketingDatePackage": "20220602",
"SamplePackage": "N"
},
{
"NDCCode": "62902-0003-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0003-1) ",
"NDC11Code": "62902-0003-01",
"ProductNDC": "62902-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Metabolic Rewire Support",
"NonProprietaryName": "Asclepias Vincetoxicum, Echinacea (angustifolia), Hypothalamus (suis), Hepar Suis, Kidney (suis), Methylcobalamin, Gambogia, Graphites, Nux Vomica, Phytolacca Decandra, 7-keto (3-acetyl-7-oxo-dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (suis), Sarcolacticum Acidum, Proteus (vulgaris)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20151012",
"EndMarketingDate": "20220602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": "7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; GAMBOGE; GLUCAGON; GRAPHITE; INSULIN PORK; LACTIC ACID, L-; METHYLCOBALAMIN; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PORK LIVER; PROTEUS VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA HYPOTHALAMUS",
"StrengthNumber": "30; 30; 6; 6; 12; 30; 12; 30; 30; 8; 12; 8; 8; 30; 12; 6",
"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_C]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Antihypoglycemic Agent [EPC], Cell-mediated Immunity [PE], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151012",
"EndMarketingDatePackage": "20220602",
"SamplePackage": "N"
},
{
"NDCCode": "62902-0004-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0004-1) ",
"NDC11Code": "62902-0004-01",
"ProductNDC": "62902-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hgh Vibrancy",
"NonProprietaryName": "Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-dopa, Melatonin, Testosterone, Alpha-lipoicum Acidum, Adenosinum Triphosphoricum Dinatrum, Coenzyme A, Ubidecarenonum, Nadidum, Sarcolacticum Acidum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (suis), Lymph Node(suis), Medulla Ossis Suis, Oophorinum (suis), Orchitinum (suis), Pancreas Suis, Spleen (suis)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20151012",
"EndMarketingDate": "20201026",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": "CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; .ALPHA.-LIPOIC ACID; COENZYME A; NADIDE; LACTIC ACID, L-; UBIDECARENONE; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151012",
"EndMarketingDatePackage": "20201026",
"SamplePackage": "N"
},
{
"NDCCode": "62902-0005-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0005-1) ",
"NDC11Code": "62902-0005-01",
"ProductNDC": "62902-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clean Sweep Formula 1",
"NonProprietaryName": "Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, Gaba, Norepinephrine, Octopamine (hydrochloride), Serotonin (hydrochloride), Taurine, Adenosinum Cyclophosphoricum, Cerebrum (suis), Diencephalon (suis), Pineal Gland (suis), Thalamus Opticus,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170509",
"EndMarketingDate": "20220602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": ".GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC PHOSPHATE; DOPAMINE HYDROCHLORIDE; EPINEPHRINE; NOREPINEPHRINE; OCTOPAMINE HYDROCHLORIDE; SEROTONIN HYDROCHLORIDE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE",
"StrengthNumber": "6; 6; 8; 6; 6; 6; 6; 6; 8; 8; 8; 8; 6",
"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": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamine [EPC], Catecholamine [EPC], Catecholamines [CS], Catecholamines [CS], Catecholamines [CS], Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170509",
"EndMarketingDatePackage": "20220602",
"SamplePackage": "N"
},
{
"NDCCode": "62902-0006-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0006-1) ",
"NDC11Code": "62902-0006-01",
"ProductNDC": "62902-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clean Sweep Formula 2",
"NonProprietaryName": "Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Cuprum Aceticum, Nadidum, Natrum Oxalaceticum, Nicotinamidum, Picricum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Alpha-lipoicum Acidum, Ammonium Muriaticum, Cartilago Suis, Discus Intervertebralis Suis, Silicea, Argentum Metallicum, Calcarea Phosphorica, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Gnaphalium Polycephalum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170510",
"EndMarketingDate": "20220602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": "AMMONIUM CHLORIDE; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; ENTEROBACTER CLOACAE; HORSE CHESTNUT; MERCURIC OXIDE; NADIDE; NIACINAMIDE; PANTOTHENIC ACID; PICRIC ACID; PROTEUS MORGANII; PROTEUS VULGARIS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; PYRIDOXINE HYDROCHLORIDE; RANUNCULUS BULBOSUS; RHODODENDRON TOMENTOSUM LEAFY TWIG; RIBOFLAVIN; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SILICON DIOXIDE; SILVER; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA UMBILICAL CORD; THIAMINE HYDROCHLORIDE; THIOCTIC ACID; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "8; 4; 4; 4; 4; 6; 30; 6; 10; 6; 6; 10; 6; 30; 30; 10; 6; 4; 4; 6; 30; 8; 10; 6; 28; 10; 10; 8; 8; 10; 6; 8; 10",
"StrengthUnit": "[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_C]/mL; [hp_C]/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_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170510",
"EndMarketingDatePackage": "20220602",
"SamplePackage": "N"
},
{
"NDCCode": "62902-0007-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0007-1) ",
"NDC11Code": "62902-0007-01",
"ProductNDC": "62902-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clean Sweep Formula 3",
"NonProprietaryName": "Ceanothus Americanus, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Hydrastis Canadensis, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (vulgaris), Bile Duct (suis), Colon (suis), Duodenum (suis), Esophagus (suis), Eye (suis), Gallbladder (suis), Ileum (suis), Intestine (suis), Ipecacuanha, Jejunum (suis), Kali Bichromicum, Lung (suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (suis), Pancreas Suis, Phosphorus, Rectal Mucosa (suis), Stomach (suis)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170510",
"EndMarketingDate": "20220602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": "ANEMONE PULSATILLA; ATROPA BELLADONNA; CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PHOSPHORUS; PORK INTESTINE; POTASSIUM DICHROMATE; SEMECARPUS ANACARDIUM JUICE; SHIGELLA DYSENTERIAE; SILVER NITRATE; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SUS SCROFA URINARY BLADDER; VERATRUM ALBUM ROOT; WOOD CREOSOTE; YEAST MANNAN",
"StrengthNumber": "6; 8; 4; 6; 8; 10; 10; 6; 6; 6; 8; 8; 8; 6; 30; 6; 8; 8; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 6; 4; 10; 8",
"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_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_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_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170510",
"EndMarketingDatePackage": "20220602",
"SamplePackage": "N"
},
{
"NDCCode": "62902-0009-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0009-1) ",
"NDC11Code": "62902-0009-01",
"ProductNDC": "62902-0009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clean Sweep Formula 5",
"NonProprietaryName": "Solidago Virgaurea, Baptisia Tinctoria, Berberis Vulgaris, Equisetum Hyemale, Argentum Nitricum, Cantharis, Capsicum Annuum, Cuprum Sulphuricum, Orthosiphon Stamineus, Pareira Brava, Sarsaparilla (smilax Regelii), Terebinthina, Apis Venenum Purum, Barosma (betulina), Mercurius Corrosivus, Pyelon (suis), Ureter (suis), Urethra (suis), Urinary Bladder (suis), Glyoxal Trimer Dihydrate, Hepar Sulphuris Calcareum, Natrum Pyruvicum, Quercetin, Colibacillinum Cum Natrum Muriaticum, Dysentery Bacillus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170512",
"EndMarketingDate": "20220601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": "AGATHOSMA BETULINA LEAF; APIS MELLIFERA VENOM; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CAPSICUM; CHONDRODENDRON TOMENTOSUM ROOT; CUPRIC SULFATE; EQUISETUM HYEMALE; ESCHERICHIA COLI; GLYOXAL TRIMER DIHYDRATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; QUERCETIN; SHIGELLA DYSENTERIAE; SILVER NITRATE; SMILAX ORNATA ROOT; SODIUM PYRUVATE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; TURPENTINE OIL",
"StrengthNumber": "8; 8; 4; 4; 10; 6; 6; 6; 4; 15; 8; 6; 8; 10; 30; 6; 6; 10; 3; 8; 8; 8; 8; 6",
"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_C]/mL; [hp_X]/mL; [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": "Deprecated",
"LastUpdate": "2022-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170512",
"EndMarketingDatePackage": "20220601",
"SamplePackage": "N"
},
{
"NDCCode": "62902-0010-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0010-1) ",
"NDC11Code": "62902-0010-01",
"ProductNDC": "62902-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clean Sweep Formula 6",
"NonProprietaryName": "Conium Maculatum, Dulcamara, Echinacea (angustifolia), Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Pulsatilla (vulgaris), Sarcolacticum Acidum, Lymph Node (suis), Sulphur, Glandula Suprarenalis Suis, L-phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (suis), Spleen (suis), Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Glyphosate, Funiculus Umbilicalis Suis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170512",
"EndMarketingDate": "20220601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; BARIUM CARBONATE; BISPHENOL A; BROMINE; CHLORINE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; FERRUM PHOSPHORICUM; GALIUM APARINE; GENTIANA LUTEA ROOT; GLYPHOSATE; HORSE CHESTNUT; HYDROFLUORIC ACID; IODINE; LACTIC ACID, L-; LIOTHYRONINE; MERCURIUS SOLUBILIS; PHENYLALANINE; PORK LIVER; PROTORTONIA CACTI; PULSATILLA VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA TONSIL; SUS SCROFA UMBILICAL CORD; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "6; 6; 28; 12; 12; 12; 4; 13; 4; 30; 10; 6; 6; 1000; 6; 12; 12; 6; 10; 13; 8; 10; 6; 6; 9; 4; 8; 8; 12; 10; 6; 10; 6; 6; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/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_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/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_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL",
"Pharm_Classes": "Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Increased Coagulation Factor Activity [PE], Triiodothyronine [CS], Vitamin C [EPC], l-Triiodothyronine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170512",
"EndMarketingDatePackage": "20220601",
"SamplePackage": "N"
},
{
"NDCCode": "62902-0011-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0011-1) ",
"NDC11Code": "62902-0011-01",
"ProductNDC": "62902-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lean Love",
"NonProprietaryName": "Asclepias Vincetoxicum, Echinacea (angustifolia), Hypothalamus (suis), Cerebrum Suis, Hepar Suis, Methylcobalamin, Pancreas Suis, Kidney (suis), Stomach (suis), Aacg-a, Aacg-b, Calcarea Carbonica, Gambogia Gelsemium, Sempervirens Graphites, Nux Vomica, Phytolacca Decandra, 7-keto (3-acetyl-7-oxo-dehyroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (suis), Sarcolacticum Acidum, Proteus (vulgaris)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170509",
"EndMarketingDate": "20220607",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": "7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; APC-356433; APC-356434; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GLUCAGON; GRAPHITE; INSULIN PORK; LACTIC ACID, L-; METHYLCOBALAMIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PORK LIVER; PROTEUS VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA CEREBRUM; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PANCREAS; SUS SCROFA STOMACH",
"StrengthNumber": "30; 30; 8; 8; 6; 6; 12; 12; 30; 12; 30; 30; 8; 12; 12; 8; 8; 30; 12; 8; 6; 8; 8",
"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_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Antihypoglycemic Agent [EPC], Cell-mediated Immunity [PE], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170509",
"EndMarketingDatePackage": "20220607",
"SamplePackage": "N"
},
{
"NDCCode": "62902-0012-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0012-1) ",
"NDC11Code": "62902-0012-01",
"ProductNDC": "62902-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hormone Harmony",
"NonProprietaryName": "Salsolinol (hydrochloride), Dhea (dehydroepiandrosterone), 7-oxo- Dehydroepiandrosterone-3b-acetate (7-keto), Cholesterinum, Folliculinum, Oophorinum (suis), Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181022",
"EndMarketingDate": "20231212",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": "7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ALDOSTERONE; ANDROSTERONE; CHOLESTEROL; CORTISONE ACETATE; ESTRONE; FOLLITROPIN; PRASTERONE; PROGESTERONE; SALSOLINOL HYDROCHLORIDE, (+/-)-; SUS SCROFA OVARY; TESTOSTERONE",
"StrengthNumber": "8; 12; 12; 8; 12; 8; 12; 6; 8; 6; 8; 8",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_C]/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",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Gonadotropin [EPC], Gonadotropins [CS], Progesterone [CS], Progesterone [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2023-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181022",
"EndMarketingDatePackage": "20231212",
"SamplePackage": "N"
},
{
"NDCCode": "62902-0013-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62902-0013-1) ",
"NDC11Code": "62902-0013-01",
"ProductNDC": "62902-0013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hgh Vibrancy",
"NonProprietaryName": "Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-dopa, Melatonin, Testosterone, Alpha-lipoicum Acidum, Adenosinum Triphosphoricum Dinatrum, Ubidecarenonum, Nadidum, Sarcolacticum Acidum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (suis), Lymph Node(suis), Medulla Ossis Suis, Oophorinum (suis), Orchitinum (suis), Pancreas Suis, Spleen (suis), Human Growth Hormone, Proteus (morgani)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181105",
"EndMarketingDate": "20240111",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Intentional Nourishment",
"SubstanceName": ".ALPHA.-LIPOIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; AMBERGRIS; APIOLE (PARSLEY); BARIUM CARBONATE; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; ESTRADIOL; ESTRIOL; ESTRONE; LACTIC ACID, L-; LEVODOPA; MELATONIN; NADIDE; PANTOTHENIC ACID; PORK LIVER; PROTEUS MORGANII; SELENIUM; SOMATROPIN; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA TESTICLE; SUS SCROFA UMBILICAL CORD; TESTOSTERONE; UBIDECARENONE",
"StrengthNumber": "8; 8; 6; 6; 8; 6; 8; 6; 6; 8; 8; 6; 6; 8; 8; 30; 30; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [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": "Amino Acids, Aromatic [CS], Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Aromatic Amino Acid [EPC], Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2024-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181105",
"EndMarketingDatePackage": "20240111",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms related to aging including fatigue, minor joint pain and muscle soreness.**. **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "0008-0045-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-01) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0045-01",
"ProductNDC": "0008-0045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vinorelbine Tartrate",
"NonProprietaryName": "Vinorelbine Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA178408",
"LabelerName": "Wyeth Pharmaceuticals Company",
"SubstanceName": "VINORELBINE TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vinca Alkaloid [EPC],Vinca Alkaloids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0008-0045-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-02) > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0045-02",
"ProductNDC": "0008-0045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vinorelbine Tartrate",
"NonProprietaryName": "Vinorelbine Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA178408",
"LabelerName": "Wyeth Pharmaceuticals Company",
"SubstanceName": "VINORELBINE TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vinca Alkaloid [EPC],Vinca Alkaloids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0008-0100-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0100-01",
"ProductNDC": "0008-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Besponsa",
"NonProprietaryName": "Inotuzumab Ozogamicin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170818",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761040",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "INOTUZUMAB OZOGAMICIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170818",
"SamplePackage": "N",
"IndicationAndUsage": "BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.",
"Description": "Inotuzumab ozogamicin is a CD22-directed antibody and cytotoxic-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for human CD22, 2) N-acetyl-gamma-calicheamicin that causes double-stranded DNA breaks, and 3) an acid-cleavable linker composed of the condensation product of 4-(4'-acetylphenoxy)-butanoic acid (AcBut) and 3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that covalently attaches N-acetyl-gamma-calicheamicin to inotuzumab. Inotuzumab ozogamicin has an approximate molecular weight of 160 kDa. The average number of calicheamicin derivative molecules conjugated to each inotuzumab molecule is approximately 6 with a distribution from 2–8. Inotuzumab ozogamicin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the semisynthetic calicheamicin derivative is produced by microbial fermentation followed by synthetic modification. BESPONSA (inotuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous administration. Each single-dose vial delivers 0.9 mg inotuzumab ozogamicin. Inactive ingredients are polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). After reconstitution with 4 mL of Sterile Water for Injection, USP, the final concentration is 0.25 mg/mL of inotuzumab ozogamicin with a deliverable volume of 3.6 mL (0.9 mg) and a pH of approximately 8.0."
},
{
"NDCCode": "0008-0407-03",
"PackageDescription": "1 mL in 1 VIAL (0008-0407-03)",
"NDC11Code": "00008-0407-03",
"ProductNDC": "0008-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Antivenin (micrurus Fulvius)",
"NonProprietaryName": "Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19670601",
"EndMarketingDate": "20170331",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101099",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)",
"StrengthNumber": "1",
"StrengthUnit": "g/10mL",
"Status": "Deprecated",
"LastUpdate": "2017-04-04"
},
{
"NDCCode": "0008-0423-03",
"PackageDescription": "1 VIAL in 1 CARTON (0008-0423-03) > 10 mL in 1 VIAL (0008-0423-01) ",
"NDC11Code": "00008-0423-03",
"ProductNDC": "0008-0423",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "North American Coral Snake Antivenin (equine)",
"NonProprietaryName": "Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20161012",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101099",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)",
"StrengthNumber": "250",
"StrengthUnit": "[arb'U]/10mL",
"Status": "Active",
"LastUpdate": "2022-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161012",
"SamplePackage": "N",
"IndicationAndUsage": "North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties).",
"Description": "North American Coral Snake Antivenin (Equine) is a sterile lyophilized powder for solution for injection containing serum globulins obtained by fractionating blood from healthy horses that have been immunized with eastern coral snake (Micrurus fulvius fulvius) venom. Prior to lyophilization, the product contains 0.25% phenol."
},
{
"NDCCode": "0008-0606-01",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0606-01)",
"NDC11Code": "00008-0606-01",
"ProductNDC": "0008-0606",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20170930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "0008-0607-01",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0607-01)",
"NDC11Code": "00008-0607-01",
"ProductNDC": "0008-0607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20171031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "0008-0607-04",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-0607-04) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "00008-0607-04",
"ProductNDC": "0008-0607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
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{
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{
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"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-21) ",
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"ProductNDC": "0008-0833",
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{
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"ProductNDC": "0008-0833",
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"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
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{
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{
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{
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"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<ProprietaryName>Lean Love</ProprietaryName>
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<EndMarketingDate>20190513</EndMarketingDate>
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<LabelerName>Intentional Nourishment</LabelerName>
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<LastUpdate>2019-05-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>62902-0002-1</NDCCode>
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<NDC11Code>62902-0002-01</NDC11Code>
<ProductNDC>62902-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Craving And Appetite Ease</ProprietaryName>
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<EndMarketingDate>20220602</EndMarketingDate>
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<LabelerName>Intentional Nourishment</LabelerName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160824</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>62902-0003-1</NDCCode>
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<NDC11Code>62902-0003-01</NDC11Code>
<ProductNDC>62902-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Metabolic Rewire Support</ProprietaryName>
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<StartMarketingDate>20151012</StartMarketingDate>
<EndMarketingDate>20220602</EndMarketingDate>
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<LabelerName>Intentional Nourishment</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151012</StartMarketingDatePackage>
<EndMarketingDatePackage>20220602</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62902-0004-1</NDCCode>
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<NDC11Code>62902-0004-01</NDC11Code>
<ProductNDC>62902-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hgh Vibrancy</ProprietaryName>
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<DosageFormName>LIQUID</DosageFormName>
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<StartMarketingDate>20151012</StartMarketingDate>
<EndMarketingDate>20201026</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Intentional Nourishment</LabelerName>
<SubstanceName>CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; .ALPHA.-LIPOIC ACID; COENZYME A; NADIDE; LACTIC ACID, L-; UBIDECARENONE; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2020-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151012</StartMarketingDatePackage>
<EndMarketingDatePackage>20201026</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62902-0005-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62902-0005-1) </PackageDescription>
<NDC11Code>62902-0005-01</NDC11Code>
<ProductNDC>62902-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clean Sweep Formula 1</ProprietaryName>
<NonProprietaryName>Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, Gaba, Norepinephrine, Octopamine (hydrochloride), Serotonin (hydrochloride), Taurine, Adenosinum Cyclophosphoricum, Cerebrum (suis), Diencephalon (suis), Pineal Gland (suis), Thalamus Opticus,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170509</StartMarketingDate>
<EndMarketingDate>20220602</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Intentional Nourishment</LabelerName>
<SubstanceName>.GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC PHOSPHATE; DOPAMINE HYDROCHLORIDE; EPINEPHRINE; NOREPINEPHRINE; OCTOPAMINE HYDROCHLORIDE; SEROTONIN HYDROCHLORIDE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE</SubstanceName>
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<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>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamine [EPC], Catecholamine [EPC], Catecholamines [CS], Catecholamines [CS], Catecholamines [CS], Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170509</StartMarketingDatePackage>
<EndMarketingDatePackage>20220602</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62902-0006-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62902-0006-1) </PackageDescription>
<NDC11Code>62902-0006-01</NDC11Code>
<ProductNDC>62902-0006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clean Sweep Formula 2</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Cuprum Aceticum, Nadidum, Natrum Oxalaceticum, Nicotinamidum, Picricum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Alpha-lipoicum Acidum, Ammonium Muriaticum, Cartilago Suis, Discus Intervertebralis Suis, Silicea, Argentum Metallicum, Calcarea Phosphorica, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Gnaphalium Polycephalum</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20170510</StartMarketingDate>
<EndMarketingDate>20220602</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Intentional Nourishment</LabelerName>
<SubstanceName>AMMONIUM CHLORIDE; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; ENTEROBACTER CLOACAE; HORSE CHESTNUT; MERCURIC OXIDE; NADIDE; NIACINAMIDE; PANTOTHENIC ACID; PICRIC ACID; PROTEUS MORGANII; PROTEUS VULGARIS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; PYRIDOXINE HYDROCHLORIDE; RANUNCULUS BULBOSUS; RHODODENDRON TOMENTOSUM LEAFY TWIG; RIBOFLAVIN; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SILICON DIOXIDE; SILVER; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA UMBILICAL CORD; THIAMINE HYDROCHLORIDE; THIOCTIC ACID; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>8; 4; 4; 4; 4; 6; 30; 6; 10; 6; 6; 10; 6; 30; 30; 10; 6; 4; 4; 6; 30; 8; 10; 6; 28; 10; 10; 8; 8; 10; 6; 8; 10</StrengthNumber>
<StrengthUnit>[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_C]/mL; [hp_C]/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_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170510</StartMarketingDatePackage>
<EndMarketingDatePackage>20220602</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62902-0007-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62902-0007-1) </PackageDescription>
<NDC11Code>62902-0007-01</NDC11Code>
<ProductNDC>62902-0007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clean Sweep Formula 3</ProprietaryName>
<NonProprietaryName>Ceanothus Americanus, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Hydrastis Canadensis, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (vulgaris), Bile Duct (suis), Colon (suis), Duodenum (suis), Esophagus (suis), Eye (suis), Gallbladder (suis), Ileum (suis), Intestine (suis), Ipecacuanha, Jejunum (suis), Kali Bichromicum, Lung (suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (suis), Pancreas Suis, Phosphorus, Rectal Mucosa (suis), Stomach (suis)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170510</StartMarketingDate>
<EndMarketingDate>20220602</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Intentional Nourishment</LabelerName>
<SubstanceName>ANEMONE PULSATILLA; ATROPA BELLADONNA; CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PHOSPHORUS; PORK INTESTINE; POTASSIUM DICHROMATE; SEMECARPUS ANACARDIUM JUICE; SHIGELLA DYSENTERIAE; SILVER NITRATE; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SUS SCROFA URINARY BLADDER; VERATRUM ALBUM ROOT; WOOD CREOSOTE; YEAST MANNAN</SubstanceName>
<StrengthNumber>6; 8; 4; 6; 8; 10; 10; 6; 6; 6; 8; 8; 8; 6; 30; 6; 8; 8; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 6; 4; 10; 8</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_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_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_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170510</StartMarketingDatePackage>
<EndMarketingDatePackage>20220602</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62902-0009-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62902-0009-1) </PackageDescription>
<NDC11Code>62902-0009-01</NDC11Code>
<ProductNDC>62902-0009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clean Sweep Formula 5</ProprietaryName>
<NonProprietaryName>Solidago Virgaurea, Baptisia Tinctoria, Berberis Vulgaris, Equisetum Hyemale, Argentum Nitricum, Cantharis, Capsicum Annuum, Cuprum Sulphuricum, Orthosiphon Stamineus, Pareira Brava, Sarsaparilla (smilax Regelii), Terebinthina, Apis Venenum Purum, Barosma (betulina), Mercurius Corrosivus, Pyelon (suis), Ureter (suis), Urethra (suis), Urinary Bladder (suis), Glyoxal Trimer Dihydrate, Hepar Sulphuris Calcareum, Natrum Pyruvicum, Quercetin, Colibacillinum Cum Natrum Muriaticum, Dysentery Bacillus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170512</StartMarketingDate>
<EndMarketingDate>20220601</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Intentional Nourishment</LabelerName>
<SubstanceName>AGATHOSMA BETULINA LEAF; APIS MELLIFERA VENOM; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CAPSICUM; CHONDRODENDRON TOMENTOSUM ROOT; CUPRIC SULFATE; EQUISETUM HYEMALE; ESCHERICHIA COLI; GLYOXAL TRIMER DIHYDRATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; QUERCETIN; SHIGELLA DYSENTERIAE; SILVER NITRATE; SMILAX ORNATA ROOT; SODIUM PYRUVATE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; TURPENTINE OIL</SubstanceName>
<StrengthNumber>8; 8; 4; 4; 10; 6; 6; 6; 4; 15; 8; 6; 8; 10; 30; 6; 6; 10; 3; 8; 8; 8; 8; 6</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_C]/mL; [hp_X]/mL; [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>Deprecated</Status>
<LastUpdate>2022-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170512</StartMarketingDatePackage>
<EndMarketingDatePackage>20220601</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62902-0010-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62902-0010-1) </PackageDescription>
<NDC11Code>62902-0010-01</NDC11Code>
<ProductNDC>62902-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clean Sweep Formula 6</ProprietaryName>
<NonProprietaryName>Conium Maculatum, Dulcamara, Echinacea (angustifolia), Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Pulsatilla (vulgaris), Sarcolacticum Acidum, Lymph Node (suis), Sulphur, Glandula Suprarenalis Suis, L-phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (suis), Spleen (suis), Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Glyphosate, Funiculus Umbilicalis Suis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170512</StartMarketingDate>
<EndMarketingDate>20220601</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Intentional Nourishment</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; BARIUM CARBONATE; BISPHENOL A; BROMINE; CHLORINE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; FERRUM PHOSPHORICUM; GALIUM APARINE; GENTIANA LUTEA ROOT; GLYPHOSATE; HORSE CHESTNUT; HYDROFLUORIC ACID; IODINE; LACTIC ACID, L-; LIOTHYRONINE; MERCURIUS SOLUBILIS; PHENYLALANINE; PORK LIVER; PROTORTONIA CACTI; PULSATILLA VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA TONSIL; SUS SCROFA UMBILICAL CORD; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>6; 6; 28; 12; 12; 12; 4; 13; 4; 30; 10; 6; 6; 1000; 6; 12; 12; 6; 10; 13; 8; 10; 6; 6; 9; 4; 8; 8; 12; 10; 6; 10; 6; 6; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/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_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/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_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Increased Coagulation Factor Activity [PE], Triiodothyronine [CS], Vitamin C [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170512</StartMarketingDatePackage>
<EndMarketingDatePackage>20220601</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62902-0011-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62902-0011-1) </PackageDescription>
<NDC11Code>62902-0011-01</NDC11Code>
<ProductNDC>62902-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lean Love</ProprietaryName>
<NonProprietaryName>Asclepias Vincetoxicum, Echinacea (angustifolia), Hypothalamus (suis), Cerebrum Suis, Hepar Suis, Methylcobalamin, Pancreas Suis, Kidney (suis), Stomach (suis), Aacg-a, Aacg-b, Calcarea Carbonica, Gambogia Gelsemium, Sempervirens Graphites, Nux Vomica, Phytolacca Decandra, 7-keto (3-acetyl-7-oxo-dehyroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (suis), Sarcolacticum Acidum, Proteus (vulgaris)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170509</StartMarketingDate>
<EndMarketingDate>20220607</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Intentional Nourishment</LabelerName>
<SubstanceName>7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; APC-356433; APC-356434; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GLUCAGON; GRAPHITE; INSULIN PORK; LACTIC ACID, L-; METHYLCOBALAMIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PORK LIVER; PROTEUS VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA CEREBRUM; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PANCREAS; SUS SCROFA STOMACH</SubstanceName>
<StrengthNumber>30; 30; 8; 8; 6; 6; 12; 12; 30; 12; 30; 30; 8; 12; 12; 8; 8; 30; 12; 8; 6; 8; 8</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_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antihypoglycemic Agent [EPC], Cell-mediated Immunity [PE], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170509</StartMarketingDatePackage>
<EndMarketingDatePackage>20220607</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62902-0012-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62902-0012-1) </PackageDescription>
<NDC11Code>62902-0012-01</NDC11Code>
<ProductNDC>62902-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hormone Harmony</ProprietaryName>
<NonProprietaryName>Salsolinol (hydrochloride), Dhea (dehydroepiandrosterone), 7-oxo- Dehydroepiandrosterone-3b-acetate (7-keto), Cholesterinum, Folliculinum, Oophorinum (suis), Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181022</StartMarketingDate>
<EndMarketingDate>20231212</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Intentional Nourishment</LabelerName>
<SubstanceName>7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ALDOSTERONE; ANDROSTERONE; CHOLESTEROL; CORTISONE ACETATE; ESTRONE; FOLLITROPIN; PRASTERONE; PROGESTERONE; SALSOLINOL HYDROCHLORIDE, (+/-)-; SUS SCROFA OVARY; TESTOSTERONE</SubstanceName>
<StrengthNumber>8; 12; 12; 8; 12; 8; 12; 6; 8; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_C]/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</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Gonadotropin [EPC], Gonadotropins [CS], Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181022</StartMarketingDatePackage>
<EndMarketingDatePackage>20231212</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62902-0013-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62902-0013-1) </PackageDescription>
<NDC11Code>62902-0013-01</NDC11Code>
<ProductNDC>62902-0013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hgh Vibrancy</ProprietaryName>
<NonProprietaryName>Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-dopa, Melatonin, Testosterone, Alpha-lipoicum Acidum, Adenosinum Triphosphoricum Dinatrum, Ubidecarenonum, Nadidum, Sarcolacticum Acidum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (suis), Lymph Node(suis), Medulla Ossis Suis, Oophorinum (suis), Orchitinum (suis), Pancreas Suis, Spleen (suis), Human Growth Hormone, Proteus (morgani)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181105</StartMarketingDate>
<EndMarketingDate>20240111</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Intentional Nourishment</LabelerName>
<SubstanceName>.ALPHA.-LIPOIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; AMBERGRIS; APIOLE (PARSLEY); BARIUM CARBONATE; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; ESTRADIOL; ESTRIOL; ESTRONE; LACTIC ACID, L-; LEVODOPA; MELATONIN; NADIDE; PANTOTHENIC ACID; PORK LIVER; PROTEUS MORGANII; SELENIUM; SOMATROPIN; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA TESTICLE; SUS SCROFA UMBILICAL CORD; TESTOSTERONE; UBIDECARENONE</SubstanceName>
<StrengthNumber>8; 8; 6; 6; 8; 6; 8; 6; 6; 8; 8; 6; 6; 8; 8; 30; 30; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [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>Amino Acids, Aromatic [CS], Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Aromatic Amino Acid [EPC], Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181105</StartMarketingDatePackage>
<EndMarketingDatePackage>20240111</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms related to aging including fatigue, minor joint pain and muscle soreness.**. **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0008-0045-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-01) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0045-01</NDC11Code>
<ProductNDC>0008-0045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vinorelbine Tartrate</ProprietaryName>
<NonProprietaryName>Vinorelbine Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA178408</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Company</LabelerName>
<SubstanceName>VINORELBINE TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vinca Alkaloid [EPC],Vinca Alkaloids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0008-0045-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-02) > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0045-02</NDC11Code>
<ProductNDC>0008-0045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vinorelbine Tartrate</ProprietaryName>
<NonProprietaryName>Vinorelbine Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA178408</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Company</LabelerName>
<SubstanceName>VINORELBINE TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vinca Alkaloid [EPC],Vinca Alkaloids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0008-0100-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0100-01</NDC11Code>
<ProductNDC>0008-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Besponsa</ProprietaryName>
<NonProprietaryName>Inotuzumab Ozogamicin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170818</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761040</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>INOTUZUMAB OZOGAMICIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.</IndicationAndUsage>
<Description>Inotuzumab ozogamicin is a CD22-directed antibody and cytotoxic-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for human CD22, 2) N-acetyl-gamma-calicheamicin that causes double-stranded DNA breaks, and 3) an acid-cleavable linker composed of the condensation product of 4-(4'-acetylphenoxy)-butanoic acid (AcBut) and 3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that covalently attaches N-acetyl-gamma-calicheamicin to inotuzumab. Inotuzumab ozogamicin has an approximate molecular weight of 160 kDa. The average number of calicheamicin derivative molecules conjugated to each inotuzumab molecule is approximately 6 with a distribution from 2–8. Inotuzumab ozogamicin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the semisynthetic calicheamicin derivative is produced by microbial fermentation followed by synthetic modification. BESPONSA (inotuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous administration. Each single-dose vial delivers 0.9 mg inotuzumab ozogamicin. Inactive ingredients are polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). After reconstitution with 4 mL of Sterile Water for Injection, USP, the final concentration is 0.25 mg/mL of inotuzumab ozogamicin with a deliverable volume of 3.6 mL (0.9 mg) and a pH of approximately 8.0.</Description>
</NDC>
<NDC>
<NDCCode>0008-0407-03</NDCCode>
<PackageDescription>1 mL in 1 VIAL (0008-0407-03)</PackageDescription>
<NDC11Code>00008-0407-03</NDC11Code>
<ProductNDC>0008-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Antivenin (micrurus Fulvius)</ProprietaryName>
<NonProprietaryName>Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19670601</StartMarketingDate>
<EndMarketingDate>20170331</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101099</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-04-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0423-03</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0008-0423-03) > 10 mL in 1 VIAL (0008-0423-01) </PackageDescription>
<NDC11Code>00008-0423-03</NDC11Code>
<ProductNDC>0008-0423</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>North American Coral Snake Antivenin (equine)</ProprietaryName>
<NonProprietaryName>Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20161012</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101099</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>[arb'U]/10mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties).</IndicationAndUsage>
<Description>North American Coral Snake Antivenin (Equine) is a sterile lyophilized powder for solution for injection containing serum globulins obtained by fractionating blood from healthy horses that have been immunized with eastern coral snake (Micrurus fulvius fulvius) venom. Prior to lyophilization, the product contains 0.25% phenol.</Description>
</NDC>
<NDC>
<NDCCode>0008-0606-01</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0606-01)</PackageDescription>
<NDC11Code>00008-0606-01</NDC11Code>
<ProductNDC>0008-0606</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20170930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0607-01</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0607-01)</PackageDescription>
<NDC11Code>00008-0607-01</NDC11Code>
<ProductNDC>0008-0607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20171031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0607-04</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0607-04) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00008-0607-04</NDC11Code>
<ProductNDC>0008-0607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0833-03</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0833-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0833-02) </PackageDescription>
<NDC11Code>00008-0833-03</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0833-20</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-20) </PackageDescription>
<NDC11Code>00008-0833-20</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0833-21</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-21) </PackageDescription>
<NDC11Code>00008-0833-21</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0833-22</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-22) </PackageDescription>
<NDC11Code>00008-0833-22</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0836-03</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0836-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0836-02) </PackageDescription>
<NDC11Code>00008-0836-03</NDC11Code>
<ProductNDC>0008-0836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0836-20</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-20) </PackageDescription>
<NDC11Code>00008-0836-20</NDC11Code>
<ProductNDC>0008-0836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0836-21</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-21) </PackageDescription>
<NDC11Code>00008-0836-21</NDC11Code>
<ProductNDC>0008-0836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
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<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
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<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
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<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0837-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0837-02) </PackageDescription>
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<ProductNDC>0008-0837</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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