{
"NDC": [
{
"NDCCode": "69780-0006-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (69780-0006-1) ",
"NDC11Code": "69780-0006-01",
"ProductNDC": "69780-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fat Loss Activation Complex",
"NonProprietaryName": "Fucus Vesiculosus, Kali Carbonicum, Agave Americana, Capsicum Annuum, Phytolacca Decandra, Aurum Metallicum, Calcarea Carbonica, Ferrum Metallicum, Graphites",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180717",
"EndMarketingDate": "20230921",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Weight Loss Solutions",
"SubstanceName": "AGAVE AMERICANA LEAF; CAPSICUM; FUCUS VESICULOSUS; GOLD; GRAPHITE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE",
"StrengthNumber": "4; 4; 2; 8; 8; 8; 8; 4; 2",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180717",
"EndMarketingDatePackage": "20230921",
"SamplePackage": "N"
},
{
"NDCCode": "69780-0001-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (69780-0001-1) ",
"NDC11Code": "69780-0001-01",
"ProductNDC": "69780-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fat Loss Activation Complex",
"NonProprietaryName": "Fucus Vesiculosus, Kali Carbonicum, Phytolacca Decandra, Agave Americana, Capsicum Annuum, Aurum Metallicum, Calcarea Carbonica, Ferrum Metallicum, Graphites,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150701",
"EndMarketingDate": "20220427",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Weight Loss Solutions",
"SubstanceName": "AGAVE AMERICANA LEAF; CAPSICUM; FUCUS VESICULOSUS; GOLD; GRAPHITE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE",
"StrengthNumber": "3; 4; 2; 8; 8; 8; 8; 2; 2",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150701",
"EndMarketingDatePackage": "20220427",
"SamplePackage": "N"
},
{
"NDCCode": "69780-0002-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (69780-0002-1) ",
"NDC11Code": "69780-0002-01",
"ProductNDC": "69780-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Detox Complex",
"NonProprietaryName": "Carduus Marianus, Cynara Scolymus, Solidago Virgaurea, Taraxacum Officinale, Benzoicum Acidum, Berberis Vulgaris, Bryonia (alba), Cantharis, Carduus Benedictus, Ceanothus Americanus, Dioscorea Villosa, Dolichos Pruriens, Iris Versicolor, Juniperus Communis, Nux Vomica, Ptelea Trifoliata, Uricum Acidum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160229",
"EndMarketingDate": "20230813",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Weight Loss Solutions",
"SubstanceName": "BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; JUNIPER BERRY; LYTTA VESICATORIA; MILK THISTLE; MUCUNA PRURIENS FRUIT TRICHOME; PTELEA TRIFOLIATA BARK; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; URIC ACID",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 3; 15; 3; 15",
"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",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160229",
"EndMarketingDatePackage": "20230813",
"SamplePackage": "N"
},
{
"NDCCode": "69780-0003-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (69780-0003-1) ",
"NDC11Code": "69780-0003-01",
"ProductNDC": "69780-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Energy Complex",
"NonProprietaryName": "Echinacea (angustifolia), Lappa Major, Solidago Virgaurea, Taraxacum Officinale, Adrenalinum, Aloe, Arsenicum Album, Baptisia Tinctoria, Berberis Aquifolium, Berberis Vulgaris, Bryonia (alba), Chelidonium Majus, Crotalus Horridus, Digitalis Purpurea, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Iodium, Iris Versicolor, Lachesis Mutus, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Ruta Graveolens, Thuja Occidentalis, Thyroidinum (bovine)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160229",
"EndMarketingDate": "20230806",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Weight Loss Solutions",
"SubstanceName": "ALOE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CENTELLA ASIATICA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA ANGUSTIFOLIA; EPINEPHRINE; GLYCYRRHIZA GLABRA; IODINE; IRIS VERSICOLOR ROOT; IRON; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; NITROGLYCERIN; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, BOVINE; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15",
"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",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vasodilation [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160229",
"EndMarketingDatePackage": "20230806",
"SamplePackage": "N"
},
{
"NDCCode": "69780-0004-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (69780-0004-1) ",
"NDC11Code": "69780-0004-01",
"ProductNDC": "69780-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Appetite Control",
"NonProprietaryName": "Chamomilla, Passiflora Incarnata, Valeriana Officinalis, Chamomilla, Passiflora Incarnata, Valeriana Officinalis, Anacardium Orientale, Antimonium Crudum, Argentum Nitricum, Berberis Vulgaris, Bryonia (alba), Chelidonium Majus, Digitalis Purpurea, Graphites, Humulus Lupulus, Iris Versicolor, Kali Carbonicum, Lycopodium Clavatum, Natrum Carbonicum, Natrum Sulphuricum, Nux Vomica, Pulsatilla (pratensis), Rhus Tox, Scutellaria Lateriflora, Sepia, Stramonium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160229",
"EndMarketingDate": "20220504",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Weight Loss Solutions",
"SubstanceName": "ANEMONE PRATENSIS; ANTIMONY TRISULFIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DATURA STRAMONIUM; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; SCUTELLARIA LATERIFLORA; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN",
"StrengthNumber": "20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 3; 3; 20; 20; 20; 20; 20; 20; 20; 20; 20; 3",
"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",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160229",
"EndMarketingDatePackage": "20220504",
"SamplePackage": "N"
},
{
"NDCCode": "69780-0005-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (69780-0005-1) ",
"NDC11Code": "69780-0005-01",
"ProductNDC": "69780-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fat Loss Activation Complex",
"NonProprietaryName": "Fucus Vesiculosus, Kali Carbonicum, Phytolacca Decandra, Agave Americana, Capsicum Annuum, Aurum Metallicum, Calcarea Carbonica, Ferrum Metallicum, Graphites",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"EndMarketingDate": "20220815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Weight Loss Solutions",
"SubstanceName": "AGAVE AMERICANA LEAF; CAPSICUM; FUCUS VESICULOSUS; GOLD; GRAPHITE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE",
"StrengthNumber": "4; 4; 2; 8; 8; 8; 8; 2; 2",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170728",
"EndMarketingDatePackage": "20220815",
"SamplePackage": "N"
},
{
"NDCCode": "69780-0011-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (69780-0011-1)",
"NDC11Code": "69780-0011-01",
"ProductNDC": "69780-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Detox Complex",
"NonProprietaryName": "Benzoicum Acidum, Berberis Vulg., Bryonia, Cantharis, Carduus Benedictus, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Dioscorea, Dolichos, Iris Versicolor, Juniperus Com., Nux Vom., Ptelea, Taraxacum, Uricum Acidum, Carduus Mar., Cynara Scolymus, Solidago",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150615",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Weight Loss Solutions",
"SubstanceName": "BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; URIC ACID; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3",
"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",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Detox Complex: Formulated for liver, kidney and colon functions and for symptoms associated with toxic conditions."
},
{
"NDCCode": "69780-0012-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (69780-0012-1)",
"NDC11Code": "69780-0012-01",
"ProductNDC": "69780-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Energy Complex",
"NonProprietaryName": "Adrenalinum, Aloe Socotrina, Arsenicum Album, Baptisia Tinctoris, Berberis Acquifolium, Berberis Vulgaris, Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis Purpurea, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Iodium, Iris Versicolor, Lachesis Mutus, Lycoodium Clavatum, Natrum Muriaticum, Nux Vomica, Rhus Toxicodendron, Ruta Graveolens, Thuja Occidentalis, Thyroidinum, Echinacea, Lappa Major, Solidago Virgaurea, Taraxacum Officinale",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150615",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Weight Loss Solutions",
"SubstanceName": "EPINEPHRINE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ALOE; TARAXACUM OFFICINALE; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 3; 3",
"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",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Energy Complex: Formulated for symptoms associated with low energy, mild stress and weakness."
},
{
"NDCCode": "69780-0013-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (69780-0013-1)",
"NDC11Code": "69780-0013-01",
"ProductNDC": "69780-0013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Appetite Control",
"NonProprietaryName": "Anacardium Orientale, Antimon. Crud., Arg. Nit., Berber. Vulg., Bryonia, Chelidonium Majus, Digitalis, Graphites, Humulus, Iris Versicolor, Kali Carb., Lycopodium, Nat. Carb. , Nat. Sulphuricum, Nux Vom., Pulsatilla, Rhus Toxicodendron, Scutellaria Lateriflora, Sepia, Stramonium, Chamomilla, Passiflora, Valeriana",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150615",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Weight Loss Solutions",
"SubstanceName": "LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE",
"StrengthNumber": "20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20",
"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",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Appetite Control Formulated for symptoms associated with compromised glucose metabolism such as overeating, cravings, fatigue and emotional discomfort."
},
{
"NDCCode": "0006-0001-01",
"PackageDescription": "1 BAG in 1 DRUM (0006-0001-01) > 480000 TABLET, FILM COATED in 1 BAG",
"NDC11Code": "00006-0001-01",
"ProductNDC": "0006-0001",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Suvorexant",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20140815",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck Sharp & Dohme LLC.",
"SubstanceName": "SUVOREXANT",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2022-11-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "15-AUG-14"
},
{
"NDCCode": "0006-0002-01",
"PackageDescription": "1 BAG in 1 DRUM (0006-0002-01) > 240000 TABLET, FILM COATED in 1 BAG",
"NDC11Code": "00006-0002-01",
"ProductNDC": "0006-0002",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Suvorexant",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20140815",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck Sharp & Dohme LLC.",
"SubstanceName": "SUVOREXANT",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2022-11-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "15-AUG-14"
},
{
"NDCCode": "0006-0003-01",
"PackageDescription": "1 BAG in 1 DRUM (0006-0003-01) > 160000 TABLET, FILM COATED in 1 BAG",
"NDC11Code": "00006-0003-01",
"ProductNDC": "0006-0003",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Suvorexant",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20140815",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck Sharp & Dohme LLC.",
"SubstanceName": "SUVOREXANT",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2022-11-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "15-AUG-14"
},
{
"NDCCode": "0006-0004-01",
"PackageDescription": "1 BAG in 1 DRUM (0006-0004-01) > 120000 TABLET, FILM COATED in 1 BAG",
"NDC11Code": "00006-0004-01",
"ProductNDC": "0006-0004",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Suvorexant",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20140815",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck Sharp & Dohme LLC.",
"SubstanceName": "SUVOREXANT",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2022-11-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "15-AUG-14"
},
{
"NDCCode": "0006-0005-13",
"PackageDescription": "1 BLISTER PACK in 1 CASE (0006-0005-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00006-0005-13",
"ProductNDC": "0006-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belsomra",
"NonProprietaryName": "Suvorexant",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140829",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204569",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "SUVOREXANT",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140829",
"SamplePackage": "N",
"IndicationAndUsage": "BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.",
"Description": "BELSOMRA tablets contain suvorexant, an orexin receptor antagonist. Suvorexant is described chemically as. [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone. Its empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Its structural formula is. Suvorexant is a white to off-white powder that is insoluble in water. Each film coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of suvorexant and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone). In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow."
},
{
"NDCCode": "0006-0005-30",
"PackageDescription": "3 CASE in 1 CARTON (0006-0005-30) / 1 BLISTER PACK in 1 CASE (0006-0005-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00006-0005-30",
"ProductNDC": "0006-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belsomra",
"NonProprietaryName": "Suvorexant",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140829",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204569",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "SUVOREXANT",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140829",
"SamplePackage": "N",
"IndicationAndUsage": "BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.",
"Description": "BELSOMRA tablets contain suvorexant, an orexin receptor antagonist. Suvorexant is described chemically as. [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone. Its empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Its structural formula is. Suvorexant is a white to off-white powder that is insoluble in water. Each film coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of suvorexant and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone). In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow."
},
{
"NDCCode": "0006-0007-01",
"PackageDescription": "1 BAG in 1 DRUM (0006-0007-01) > 5 kg in 1 BAG",
"NDC11Code": "00006-0007-01",
"ProductNDC": "0006-0007",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Carbidopa",
"DosageFormName": "POWDER",
"StartMarketingDate": "19750502",
"MarketingCategoryName": "EXPORT ONLY",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "CARBIDOPA",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "0006-0007-02",
"PackageDescription": "1 BAG in 1 DRUM (0006-0007-02) > 50 kg in 1 BAG",
"NDC11Code": "00006-0007-02",
"ProductNDC": "0006-0007",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Carbidopa",
"DosageFormName": "POWDER",
"StartMarketingDate": "19750502",
"MarketingCategoryName": "EXPORT ONLY",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "CARBIDOPA",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "0006-0019-54",
"PackageDescription": "90 TABLET in 1 BOTTLE (0006-0019-54) ",
"NDC11Code": "00006-0019-54",
"ProductNDC": "0006-0019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prinivil",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19871229",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019558",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19871229",
"SamplePackage": "N"
},
{
"NDCCode": "0006-0031-44",
"PackageDescription": "4 TABLET in 1 BLISTER PACK (0006-0031-44) ",
"NDC11Code": "00006-0031-44",
"ProductNDC": "0006-0031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosamax",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950929",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020560",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19950929",
"SamplePackage": "N"
},
{
"NDCCode": "0006-0032-01",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0006-0032-01) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00006-0032-01",
"ProductNDC": "0006-0032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Stromectol",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961122",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050742",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240920",
"SamplePackage": "N",
"IndicationAndUsage": "STROMECTOL is indicated for the treatment of the following infections:. Strongyloidiasis of the intestinal tract. STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: STROMECTOL has no activity against adult Onchocerca volvulus parasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.",
"Description": "STROMECTOL® (Ivermectin) is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5-O-demethyl-22,23-dihydroavermectin A1a and less than 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl) avermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b, or H2B1a and H2B1b, respectively. The respective empirical formulas are C48H74O14 and C47H72O14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. STROMECTOL is available in 3 mg tablets containing the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate, butylated hydroxyanisole, and citric acid powder (anhydrous)."
},
{
"NDCCode": "0006-0032-20",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0006-0032-20) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00006-0032-20",
"ProductNDC": "0006-0032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Stromectol",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961122",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050742",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19961122",
"SamplePackage": "N",
"IndicationAndUsage": "STROMECTOL is indicated for the treatment of the following infections:. Strongyloidiasis of the intestinal tract. STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: STROMECTOL has no activity against adult Onchocerca volvulus parasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.",
"Description": "STROMECTOL® (Ivermectin) is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5-O-demethyl-22,23-dihydroavermectin A1a and less than 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl) avermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b, or H2B1a and H2B1b, respectively. The respective empirical formulas are C48H74O14 and C47H72O14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. STROMECTOL is available in 3 mg tablets containing the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate, butylated hydroxyanisole, and citric acid powder (anhydrous)."
},
{
"NDCCode": "0006-0033-13",
"PackageDescription": "1 BLISTER PACK in 1 CASE (0006-0033-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00006-0033-13",
"ProductNDC": "0006-0033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belsomra",
"NonProprietaryName": "Suvorexant",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140829",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204569",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "SUVOREXANT",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140829",
"SamplePackage": "N",
"IndicationAndUsage": "BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.",
"Description": "BELSOMRA tablets contain suvorexant, an orexin receptor antagonist. Suvorexant is described chemically as. [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone. Its empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Its structural formula is. Suvorexant is a white to off-white powder that is insoluble in water. Each film coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of suvorexant and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone). In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow."
},
{
"NDCCode": "0006-0033-30",
"PackageDescription": "3 CASE in 1 CARTON (0006-0033-30) / 1 BLISTER PACK in 1 CASE (0006-0033-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00006-0033-30",
"ProductNDC": "0006-0033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belsomra",
"NonProprietaryName": "Suvorexant",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140829",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204569",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "SUVOREXANT",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140829",
"SamplePackage": "N",
"IndicationAndUsage": "BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.",
"Description": "BELSOMRA tablets contain suvorexant, an orexin receptor antagonist. Suvorexant is described chemically as. [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone. Its empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Its structural formula is. Suvorexant is a white to off-white powder that is insoluble in water. Each film coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of suvorexant and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone). In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow."
},
{
"NDCCode": "0006-0071-07",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0006-0071-07) > 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00006-0071-07",
"ProductNDC": "0006-0071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propecia",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19971219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020788",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19971219",
"SamplePackage": "N"
},
{
"NDCCode": "0006-0071-31",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0006-0071-31) ",
"NDC11Code": "00006-0071-31",
"ProductNDC": "0006-0071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propecia",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19971219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020788",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19971219",
"SamplePackage": "N"
},
{
"NDCCode": "0006-0071-54",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0006-0071-54) ",
"NDC11Code": "00006-0071-54",
"ProductNDC": "0006-0071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propecia",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19971219",
"MarketingCategoryName": "NDA",
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<SamplePackage>N</SamplePackage>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>True Weight Loss Solutions</LabelerName>
<SubstanceName>ANEMONE PRATENSIS; ANTIMONY TRISULFIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DATURA STRAMONIUM; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; SCUTELLARIA LATERIFLORA; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN</SubstanceName>
<StrengthNumber>20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 3; 3; 20; 20; 20; 20; 20; 20; 20; 20; 20; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160229</StartMarketingDatePackage>
<EndMarketingDatePackage>20220504</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69780-0005-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (69780-0005-1) </PackageDescription>
<NDC11Code>69780-0005-01</NDC11Code>
<ProductNDC>69780-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fat Loss Activation Complex</ProprietaryName>
<NonProprietaryName>Fucus Vesiculosus, Kali Carbonicum, Phytolacca Decandra, Agave Americana, Capsicum Annuum, Aurum Metallicum, Calcarea Carbonica, Ferrum Metallicum, Graphites</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<EndMarketingDate>20220815</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>True Weight Loss Solutions</LabelerName>
<SubstanceName>AGAVE AMERICANA LEAF; CAPSICUM; FUCUS VESICULOSUS; GOLD; GRAPHITE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE</SubstanceName>
<StrengthNumber>4; 4; 2; 8; 8; 8; 8; 2; 2</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170728</StartMarketingDatePackage>
<EndMarketingDatePackage>20220815</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69780-0011-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (69780-0011-1)</PackageDescription>
<NDC11Code>69780-0011-01</NDC11Code>
<ProductNDC>69780-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Detox Complex</ProprietaryName>
<NonProprietaryName>Benzoicum Acidum, Berberis Vulg., Bryonia, Cantharis, Carduus Benedictus, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Dioscorea, Dolichos, Iris Versicolor, Juniperus Com., Nux Vom., Ptelea, Taraxacum, Uricum Acidum, Carduus Mar., Cynara Scolymus, Solidago</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>True Weight Loss Solutions</LabelerName>
<SubstanceName>BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; URIC ACID; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Detox Complex: Formulated for liver, kidney and colon functions and for symptoms associated with toxic conditions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69780-0012-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (69780-0012-1)</PackageDescription>
<NDC11Code>69780-0012-01</NDC11Code>
<ProductNDC>69780-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Energy Complex</ProprietaryName>
<NonProprietaryName>Adrenalinum, Aloe Socotrina, Arsenicum Album, Baptisia Tinctoris, Berberis Acquifolium, Berberis Vulgaris, Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis Purpurea, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Iodium, Iris Versicolor, Lachesis Mutus, Lycoodium Clavatum, Natrum Muriaticum, Nux Vomica, Rhus Toxicodendron, Ruta Graveolens, Thuja Occidentalis, Thyroidinum, Echinacea, Lappa Major, Solidago Virgaurea, Taraxacum Officinale</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>True Weight Loss Solutions</LabelerName>
<SubstanceName>EPINEPHRINE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ALOE; TARAXACUM OFFICINALE; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Energy Complex: Formulated for symptoms associated with low energy, mild stress and weakness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69780-0013-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (69780-0013-1)</PackageDescription>
<NDC11Code>69780-0013-01</NDC11Code>
<ProductNDC>69780-0013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Appetite Control</ProprietaryName>
<NonProprietaryName>Anacardium Orientale, Antimon. Crud., Arg. Nit., Berber. Vulg., Bryonia, Chelidonium Majus, Digitalis, Graphites, Humulus, Iris Versicolor, Kali Carb., Lycopodium, Nat. Carb. , Nat. Sulphuricum, Nux Vom., Pulsatilla, Rhus Toxicodendron, Scutellaria Lateriflora, Sepia, Stramonium, Chamomilla, Passiflora, Valeriana</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>True Weight Loss Solutions</LabelerName>
<SubstanceName>LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE</SubstanceName>
<StrengthNumber>20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Appetite Control Formulated for symptoms associated with compromised glucose metabolism such as overeating, cravings, fatigue and emotional discomfort.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0006-0001-01</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (0006-0001-01) > 480000 TABLET, FILM COATED in 1 BAG</PackageDescription>
<NDC11Code>00006-0001-01</NDC11Code>
<ProductNDC>0006-0001</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Suvorexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20140815</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck Sharp & Dohme LLC.</LabelerName>
<SubstanceName>SUVOREXANT</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2022-11-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-AUG-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0006-0002-01</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (0006-0002-01) > 240000 TABLET, FILM COATED in 1 BAG</PackageDescription>
<NDC11Code>00006-0002-01</NDC11Code>
<ProductNDC>0006-0002</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Suvorexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20140815</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck Sharp & Dohme LLC.</LabelerName>
<SubstanceName>SUVOREXANT</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2022-11-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-AUG-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0006-0003-01</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (0006-0003-01) > 160000 TABLET, FILM COATED in 1 BAG</PackageDescription>
<NDC11Code>00006-0003-01</NDC11Code>
<ProductNDC>0006-0003</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Suvorexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20140815</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck Sharp & Dohme LLC.</LabelerName>
<SubstanceName>SUVOREXANT</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2022-11-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-AUG-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0006-0004-01</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (0006-0004-01) > 120000 TABLET, FILM COATED in 1 BAG</PackageDescription>
<NDC11Code>00006-0004-01</NDC11Code>
<ProductNDC>0006-0004</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Suvorexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20140815</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck Sharp & Dohme LLC.</LabelerName>
<SubstanceName>SUVOREXANT</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2022-11-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-AUG-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0006-0005-13</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CASE (0006-0005-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00006-0005-13</NDC11Code>
<ProductNDC>0006-0005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belsomra</ProprietaryName>
<NonProprietaryName>Suvorexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140829</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204569</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>SUVOREXANT</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.</IndicationAndUsage>
<Description>BELSOMRA tablets contain suvorexant, an orexin receptor antagonist. Suvorexant is described chemically as. [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone. Its empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Its structural formula is. Suvorexant is a white to off-white powder that is insoluble in water. Each film coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of suvorexant and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone). In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>0006-0005-30</NDCCode>
<PackageDescription>3 CASE in 1 CARTON (0006-0005-30) / 1 BLISTER PACK in 1 CASE (0006-0005-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00006-0005-30</NDC11Code>
<ProductNDC>0006-0005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belsomra</ProprietaryName>
<NonProprietaryName>Suvorexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140829</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204569</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>SUVOREXANT</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.</IndicationAndUsage>
<Description>BELSOMRA tablets contain suvorexant, an orexin receptor antagonist. Suvorexant is described chemically as. [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone. Its empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Its structural formula is. Suvorexant is a white to off-white powder that is insoluble in water. Each film coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of suvorexant and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone). In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>0006-0007-01</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (0006-0007-01) > 5 kg in 1 BAG</PackageDescription>
<NDC11Code>00006-0007-01</NDC11Code>
<ProductNDC>0006-0007</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Carbidopa</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19750502</StartMarketingDate>
<MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>CARBIDOPA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0006-0007-02</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (0006-0007-02) > 50 kg in 1 BAG</PackageDescription>
<NDC11Code>00006-0007-02</NDC11Code>
<ProductNDC>0006-0007</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Carbidopa</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19750502</StartMarketingDate>
<MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>CARBIDOPA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0006-0019-54</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (0006-0019-54) </PackageDescription>
<NDC11Code>00006-0019-54</NDC11Code>
<ProductNDC>0006-0019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prinivil</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19871229</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019558</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19871229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0006-0031-44</NDCCode>
<PackageDescription>4 TABLET in 1 BLISTER PACK (0006-0031-44) </PackageDescription>
<NDC11Code>00006-0031-44</NDC11Code>
<ProductNDC>0006-0031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosamax</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020560</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0006-0032-01</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0006-0032-01) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00006-0032-01</NDC11Code>
<ProductNDC>0006-0032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Stromectol</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050742</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STROMECTOL is indicated for the treatment of the following infections:. Strongyloidiasis of the intestinal tract. STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: STROMECTOL has no activity against adult Onchocerca volvulus parasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.</IndicationAndUsage>
<Description>STROMECTOL® (Ivermectin) is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5-O-demethyl-22,23-dihydroavermectin A1a and less than 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl) avermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b, or H2B1a and H2B1b, respectively. The respective empirical formulas are C48H74O14 and C47H72O14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. STROMECTOL is available in 3 mg tablets containing the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate, butylated hydroxyanisole, and citric acid powder (anhydrous).</Description>
</NDC>
<NDC>
<NDCCode>0006-0032-20</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0006-0032-20) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00006-0032-20</NDC11Code>
<ProductNDC>0006-0032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Stromectol</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050742</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STROMECTOL is indicated for the treatment of the following infections:. Strongyloidiasis of the intestinal tract. STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: STROMECTOL has no activity against adult Onchocerca volvulus parasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.</IndicationAndUsage>
<Description>STROMECTOL® (Ivermectin) is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5-O-demethyl-22,23-dihydroavermectin A1a and less than 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl) avermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b, or H2B1a and H2B1b, respectively. The respective empirical formulas are C48H74O14 and C47H72O14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. STROMECTOL is available in 3 mg tablets containing the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate, butylated hydroxyanisole, and citric acid powder (anhydrous).</Description>
</NDC>
<NDC>
<NDCCode>0006-0033-13</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CASE (0006-0033-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00006-0033-13</NDC11Code>
<ProductNDC>0006-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belsomra</ProprietaryName>
<NonProprietaryName>Suvorexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140829</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204569</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>SUVOREXANT</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.</IndicationAndUsage>
<Description>BELSOMRA tablets contain suvorexant, an orexin receptor antagonist. Suvorexant is described chemically as. [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone. Its empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Its structural formula is. Suvorexant is a white to off-white powder that is insoluble in water. Each film coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of suvorexant and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone). In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>0006-0033-30</NDCCode>
<PackageDescription>3 CASE in 1 CARTON (0006-0033-30) / 1 BLISTER PACK in 1 CASE (0006-0033-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00006-0033-30</NDC11Code>
<ProductNDC>0006-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belsomra</ProprietaryName>
<NonProprietaryName>Suvorexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140829</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204569</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>SUVOREXANT</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.</IndicationAndUsage>
<Description>BELSOMRA tablets contain suvorexant, an orexin receptor antagonist. Suvorexant is described chemically as. [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone. Its empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Its structural formula is. Suvorexant is a white to off-white powder that is insoluble in water. Each film coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of suvorexant and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone). In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>0006-0071-07</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0006-0071-07) > 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00006-0071-07</NDC11Code>
<ProductNDC>0006-0071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propecia</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020788</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0006-0071-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0006-0071-31) </PackageDescription>
<NDC11Code>00006-0071-31</NDC11Code>
<ProductNDC>0006-0071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propecia</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020788</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0006-0071-54</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0006-0071-54) </PackageDescription>
<NDC11Code>00006-0071-54</NDC11Code>
<ProductNDC>0006-0071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propecia</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020788</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0006-0072-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0006-0072-31) </PackageDescription>
<NDC11Code>00006-0072-31</NDC11Code>
<ProductNDC>0006-0072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proscar</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920619</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020180</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0006-0072-58</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0006-0072-58) </PackageDescription>
<NDC11Code>00006-0072-58</NDC11Code>
<ProductNDC>0006-0072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proscar</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920619</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020180</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0006-0078-28</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (0006-0078-28) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14) </PackageDescription>
<NDC11Code>00006-0078-28</NDC11Code>
<ProductNDC>0006-0078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Janumet</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Sitagliptin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202270</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120202</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>JANUMET XR tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin extended-release.</Description>
</NDC>
<NDC>
<NDCCode>0006-0078-61</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61) </PackageDescription>
<NDC11Code>00006-0078-61</NDC11Code>
<ProductNDC>0006-0078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Janumet</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Sitagliptin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202270</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>JANUMET XR tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin extended-release.</Description>
</NDC>
</NDCList>