{
"NDC": [
{
"NDCCode": "83014-0006-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0006-1) ",
"NDC11Code": "83014-0006-01",
"ProductNDC": "83014-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Thyroid",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin, Rutinic Acid, Iodium, Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Spongia Tosta, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Lapis Albus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPRIC ACID; IODINE; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM HEXAFLUOROSILICATE",
"StrengthNumber": "2; 3; 3; 3; 3; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 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",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [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], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230822",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides thyroid support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0001-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0001-1) ",
"NDC11Code": "83014-0001-01",
"ProductNDC": "83014-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Female Balance",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Caulophyllum Thalictroides, Cimicifuga Racemosa, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Rubus Idaeus, Thyroidinum (bovine), Pituitarum Posterium Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Hepar Sulphuris Calcareum, Oxytocin, Progesterone",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230321",
"EndMarketingDate": "20290214",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM SULFIDE; OXYTOCIN; PROGESTERONE",
"StrengthNumber": "2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 12; 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",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Progesterone [CS], Progesterone [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230321",
"EndMarketingDatePackage": "20290214",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides female hormonogenic balance support. †. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0002-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0002-1) ",
"NDC11Code": "83014-0002-01",
"ProductNDC": "83014-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Adrenal",
"NonProprietaryName": "Glycyrrhiza Glabra, Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Aralia Quinquefolia, Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Glandula Suprarenalis (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Adrenocorticotrophin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230321",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "GLYCYRRHIZA GLABRA; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; AMERICAN GINSENG; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS ADRENAL GLAND; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CORTICOTROPIN",
"StrengthNumber": "1; 2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 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_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [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], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230321",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant, to control empty feeling in stomach otherwise relieved by eating, helps with metabolic tendencies to gain weight, cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides adrenal support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0003-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0003-1) ",
"NDC11Code": "83014-0003-01",
"ProductNDC": "83014-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Male Balance",
"NonProprietaryName": "Agnus Castus, Foeniculum Vulgare, Ammonium Bromatum, Caladium Seguinum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Selenium Metallicum, Adrenalinum, Phosphorus, Orchitinum (bovine), Onosmodium Virginianum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230310",
"EndMarketingDate": "20280614",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "CHASTE TREE FRUIT; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; DIEFFENBACHIA SEGUINE WHOLE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SELENIUM; EPINEPHRINE; PHOSPHORUS; BOS TAURUS TESTICLE; ONOSMODIUM VIRGINIANUM",
"StrengthNumber": "2; 2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 9; 12; 12; 16; 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_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [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], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230310",
"EndMarketingDatePackage": "20280614",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides male hormonogenic support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0004-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0004-1) ",
"NDC11Code": "83014-0004-01",
"ProductNDC": "83014-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Pituitarum Posterium (bovine), Thyroidinum (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230216",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; BOS TAURUS PITUITARY GLAND, POSTERIOR; THYROID, BOVINE; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS",
"StrengthNumber": "2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 8; 6; 9; 9; 9; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [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], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230216",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue and resets the hypothalamus.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0005-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0005-1) ",
"NDC11Code": "83014-0005-01",
"ProductNDC": "83014-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Immune Support",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Petroselinum Sativum, Capsicum Annuum, Galium Aparine, Hydrastis Canadensis, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Thymus (bovine Thymus Gland), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; PETROSELINUM CRISPUM WHOLE; CAPSICUM; GALIUM APARINE WHOLE; GOLDENSEAL; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS THYMUS; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS",
"StrengthNumber": "2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [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], Catecholamine [EPC], Catecholamines [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], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230217",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides immune support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0007-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0007-1) ",
"NDC11Code": "83014-0007-01",
"ProductNDC": "83014-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Male Balance",
"NonProprietaryName": "Agnus Castus, Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Selenium Metallicum, Adrenalinum, Phosphorus, Orchitinum (bovine), Caladium Seguinum, Onosmodium Virginianum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20231030",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "CHASTE TREE FRUIT; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SELENIUM; EPINEPHRINE; PHOSPHORUS; BOS TAURUS TESTICLE; DIEFFENBACHIA SEGUINE WHOLE; ONOSMODIUM VIRGINIANUM",
"StrengthNumber": "2; 2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 9; 12; 12; 16; 18; 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_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [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], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231030",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides male hormonogenic support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0008-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0008-1) ",
"NDC11Code": "83014-0008-01",
"ProductNDC": "83014-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Female Balance",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Caulophyllum Thalictrines, Cimicifuga Racemosa, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Rubus Idaeus, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Hepar Sulphuris Calcareum, Progesterone, Oxytocin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20240523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM SULFIDE; PROGESTERONE; OXYTOCIN",
"StrengthNumber": "2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 12; 30; 34",
"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",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Progesterone [CS], Progesterone [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240523",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides female hormonogenic balance support. †. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0100-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0100-1) ",
"NDC11Code": "83014-0100-01",
"ProductNDC": "83014-0100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus - Glp 1 Booster",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Berberis Vulgaris, Cinnamomum, Fucus Vesiculosus, Lecithin (derived From Egg), Trigonella Foenum-graecum, Panax Ginseng, Capsicum Annuum, Curcuma Longa, Galium Aparine, Hepar Suis, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Pancreas Suis, Phytolacca Decandra, Small Intestine (suis), Pituitarum Posterium (bovine), Thyroidinum (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20260129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; BERBERIS VULGARIS ROOT BARK; CINNAMON; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; FENUGREEK SEED; ASIAN GINSENG; CAPSICUM; TURMERIC; GALIUM APARINE WHOLE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; SUS SCROFA PANCREAS; PHYTOLACCA AMERICANA ROOT; SUS SCROFA INTESTINAL MUCOSA; BOS TAURUS PITUITARY GLAND, POSTERIOR; THYROID, BOVINE; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS",
"StrengthNumber": "2; 3; 3; 3; 3; 3; 3; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 9; 9; 9; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [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], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260129",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating, helps with metabolic tendencies to gain weight, cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides support for the body's production of GLP 1.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"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",
"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": "0006-0072-31",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0006-0072-31) ",
"NDC11Code": "00006-0072-31",
"ProductNDC": "0006-0072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proscar",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920619",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020180",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "5",
"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": "19920619",
"SamplePackage": "N"
},
{
"NDCCode": "0006-0072-58",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0006-0072-58) ",
"NDC11Code": "00006-0072-58",
"ProductNDC": "0006-0072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proscar",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920619",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020180",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "5",
"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": "19920619",
"SamplePackage": "N"
},
{
"NDCCode": "0006-0078-28",
"PackageDescription": "2 BOTTLE in 1 CARTON (0006-0078-28) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14) ",
"NDC11Code": "00006-0078-28",
"ProductNDC": "0006-0078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Janumet",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Sitagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202270",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "50; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120202",
"SamplePackage": "Y",
"IndicationAndUsage": "JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "JANUMET XR tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin extended-release."
},
{
"NDCCode": "0006-0078-61",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61) ",
"NDC11Code": "00006-0078-61",
"ProductNDC": "0006-0078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Janumet",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Sitagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202270",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "50; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120202",
"SamplePackage": "N",
"IndicationAndUsage": "JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "JANUMET XR tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin extended-release."
}
]
}
{"NDC":[{"NDCCode":"83014-0006-1","ProprietaryName":"Weight Loss Support Plus Thyroid","NonProprietaryName":"Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin, Rutinic Acid, Iodium, Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Spongia Tosta, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Lapis Albus"},{"NDCCode":"83014-0001-1","ProprietaryName":"Weight Loss Support Plus Female Balance","NonProprietaryName":"Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Caulophyllum Thalictroides, Cimicifuga Racemosa, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Rubus Idaeus, Thyroidinum (bovine), Pituitarum Posterium Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Hepar Sulphuris Calcareum, Oxytocin, Progesterone"},{"NDCCode":"83014-0002-1","ProprietaryName":"Weight Loss Support Plus Adrenal","NonProprietaryName":"Glycyrrhiza Glabra, Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Aralia Quinquefolia, Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Glandula Suprarenalis (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Adrenocorticotrophin"},{"NDCCode":"83014-0003-1","ProprietaryName":"Weight Loss Support Plus Male Balance","NonProprietaryName":"Agnus Castus, Foeniculum Vulgare, Ammonium Bromatum, Caladium Seguinum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Selenium Metallicum, Adrenalinum, Phosphorus, Orchitinum (bovine), Onosmodium Virginianum"},{"NDCCode":"83014-0004-1","ProprietaryName":"Weight Loss Support Plus","NonProprietaryName":"Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Pituitarum Posterium (bovine), Thyroidinum (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus"},{"NDCCode":"83014-0005-1","ProprietaryName":"Weight Loss Support Plus Immune Support","NonProprietaryName":"Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Petroselinum Sativum, Capsicum Annuum, Galium Aparine, Hydrastis Canadensis, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Thymus (bovine Thymus Gland), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus"},{"NDCCode":"83014-0007-1","ProprietaryName":"Weight Loss Support Plus Male Balance","NonProprietaryName":"Agnus Castus, Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Selenium Metallicum, Adrenalinum, Phosphorus, Orchitinum (bovine), Caladium Seguinum, Onosmodium Virginianum"},{"NDCCode":"83014-0008-1","ProprietaryName":"Weight Loss Support Plus Female Balance","NonProprietaryName":"Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Caulophyllum Thalictrines, Cimicifuga Racemosa, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Rubus Idaeus, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Hepar Sulphuris Calcareum, Progesterone, Oxytocin"},{"NDCCode":"83014-0100-1","ProprietaryName":"Weight Loss Support Plus - Glp 1 Booster","NonProprietaryName":"Foeniculum Vulgare, Ammonium Bromatum, Berberis Vulgaris, Cinnamomum, Fucus Vesiculosus, Lecithin (derived From Egg), Trigonella Foenum-graecum, Panax Ginseng, Capsicum Annuum, Curcuma Longa, Galium Aparine, Hepar Suis, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Pancreas Suis, Phytolacca Decandra, Small Intestine (suis), Pituitarum Posterium (bovine), Thyroidinum (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus"},{"NDCCode":"0006-0001-01","NonProprietaryName":"Suvorexant"},{"NDCCode":"0006-0002-01","NonProprietaryName":"Suvorexant"},{"NDCCode":"0006-0003-01","NonProprietaryName":"Suvorexant"},{"NDCCode":"0006-0004-01","NonProprietaryName":"Suvorexant"},{"NDCCode":"0006-0005-13","ProprietaryName":"Belsomra","NonProprietaryName":"Suvorexant"},{"NDCCode":"0006-0005-30","ProprietaryName":"Belsomra","NonProprietaryName":"Suvorexant"},{"NDCCode":"0006-0007-01","NonProprietaryName":"Carbidopa"},{"NDCCode":"0006-0007-02","NonProprietaryName":"Carbidopa"},{"NDCCode":"0006-0019-54","ProprietaryName":"Prinivil","NonProprietaryName":"Lisinopril"},{"NDCCode":"0006-0031-44","ProprietaryName":"Fosamax","NonProprietaryName":"Alendronate Sodium"},{"NDCCode":"0006-0032-01","ProprietaryName":"Stromectol","NonProprietaryName":"Ivermectin"},{"NDCCode":"0006-0032-20","ProprietaryName":"Stromectol","NonProprietaryName":"Ivermectin"},{"NDCCode":"0006-0033-13","ProprietaryName":"Belsomra","NonProprietaryName":"Suvorexant"},{"NDCCode":"0006-0033-30","ProprietaryName":"Belsomra","NonProprietaryName":"Suvorexant"},{"NDCCode":"0006-0071-07","ProprietaryName":"Propecia","NonProprietaryName":"Finasteride"},{"NDCCode":"0006-0071-31","ProprietaryName":"Propecia","NonProprietaryName":"Finasteride"},{"NDCCode":"0006-0071-54","ProprietaryName":"Propecia","NonProprietaryName":"Finasteride"},{"NDCCode":"0006-0072-31","ProprietaryName":"Proscar","NonProprietaryName":"Finasteride"},{"NDCCode":"0006-0072-58","ProprietaryName":"Proscar","NonProprietaryName":"Finasteride"},{"NDCCode":"0006-0078-28","ProprietaryName":"Janumet","NonProprietaryName":"Sitagliptin And Metformin Hydrochloride"},{"NDCCode":"0006-0078-61","ProprietaryName":"Janumet","NonProprietaryName":"Sitagliptin And Metformin Hydrochloride"}]}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>83014-0006-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (83014-0006-1) </PackageDescription>
<NDC11Code>83014-0006-01</NDC11Code>
<ProductNDC>83014-0006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Weight Loss Support Plus Thyroid</ProprietaryName>
<NonProprietaryName>Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin, Rutinic Acid, Iodium, Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Spongia Tosta, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Lapis Albus</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230822</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPRIC ACID; IODINE; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM HEXAFLUOROSILICATE</SubstanceName>
<StrengthNumber>2; 3; 3; 3; 3; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 15</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</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [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], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides thyroid support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83014-0001-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (83014-0001-1) </PackageDescription>
<NDC11Code>83014-0001-01</NDC11Code>
<ProductNDC>83014-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Weight Loss Support Plus Female Balance</ProprietaryName>
<NonProprietaryName>Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Caulophyllum Thalictroides, Cimicifuga Racemosa, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Rubus Idaeus, Thyroidinum (bovine), Pituitarum Posterium Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Hepar Sulphuris Calcareum, Oxytocin, Progesterone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230321</StartMarketingDate>
<EndMarketingDate>20290214</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM SULFIDE; OXYTOCIN; PROGESTERONE</SubstanceName>
<StrengthNumber>2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 12; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Progesterone [CS], Progesterone [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230321</StartMarketingDatePackage>
<EndMarketingDatePackage>20290214</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides female hormonogenic balance support. †. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83014-0002-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (83014-0002-1) </PackageDescription>
<NDC11Code>83014-0002-01</NDC11Code>
<ProductNDC>83014-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Weight Loss Support Plus Adrenal</ProprietaryName>
<NonProprietaryName>Glycyrrhiza Glabra, Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Aralia Quinquefolia, Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Glandula Suprarenalis (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Adrenocorticotrophin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230321</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>GLYCYRRHIZA GLABRA; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; AMERICAN GINSENG; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS ADRENAL GLAND; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CORTICOTROPIN</SubstanceName>
<StrengthNumber>1; 2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 15</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_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [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], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant, to control empty feeling in stomach otherwise relieved by eating, helps with metabolic tendencies to gain weight, cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides adrenal support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83014-0003-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (83014-0003-1) </PackageDescription>
<NDC11Code>83014-0003-01</NDC11Code>
<ProductNDC>83014-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Weight Loss Support Plus Male Balance</ProprietaryName>
<NonProprietaryName>Agnus Castus, Foeniculum Vulgare, Ammonium Bromatum, Caladium Seguinum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Selenium Metallicum, Adrenalinum, Phosphorus, Orchitinum (bovine), Onosmodium Virginianum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230310</StartMarketingDate>
<EndMarketingDate>20280614</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>CHASTE TREE FRUIT; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; DIEFFENBACHIA SEGUINE WHOLE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SELENIUM; EPINEPHRINE; PHOSPHORUS; BOS TAURUS TESTICLE; ONOSMODIUM VIRGINIANUM</SubstanceName>
<StrengthNumber>2; 2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 9; 12; 12; 16; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [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], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230310</StartMarketingDatePackage>
<EndMarketingDatePackage>20280614</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides male hormonogenic support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83014-0004-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (83014-0004-1) </PackageDescription>
<NDC11Code>83014-0004-01</NDC11Code>
<ProductNDC>83014-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Weight Loss Support Plus</ProprietaryName>
<NonProprietaryName>Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Pituitarum Posterium (bovine), Thyroidinum (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230216</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; BOS TAURUS PITUITARY GLAND, POSTERIOR; THYROID, BOVINE; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS</SubstanceName>
<StrengthNumber>2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 8; 6; 9; 9; 9; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [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], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue and resets the hypothalamus.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83014-0005-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (83014-0005-1) </PackageDescription>
<NDC11Code>83014-0005-01</NDC11Code>
<ProductNDC>83014-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Weight Loss Support Plus Immune Support</ProprietaryName>
<NonProprietaryName>Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Petroselinum Sativum, Capsicum Annuum, Galium Aparine, Hydrastis Canadensis, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Thymus (bovine Thymus Gland), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230217</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; PETROSELINUM CRISPUM WHOLE; CAPSICUM; GALIUM APARINE WHOLE; GOLDENSEAL; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS THYMUS; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS</SubstanceName>
<StrengthNumber>2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [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], Allergens [CS], Catecholamine [EPC], Catecholamines [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], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides immune support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83014-0007-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (83014-0007-1) </PackageDescription>
<NDC11Code>83014-0007-01</NDC11Code>
<ProductNDC>83014-0007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Weight Loss Support Plus Male Balance</ProprietaryName>
<NonProprietaryName>Agnus Castus, Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Selenium Metallicum, Adrenalinum, Phosphorus, Orchitinum (bovine), Caladium Seguinum, Onosmodium Virginianum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231030</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>CHASTE TREE FRUIT; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SELENIUM; EPINEPHRINE; PHOSPHORUS; BOS TAURUS TESTICLE; DIEFFENBACHIA SEGUINE WHOLE; ONOSMODIUM VIRGINIANUM</SubstanceName>
<StrengthNumber>2; 2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 9; 12; 12; 16; 18; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [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], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides male hormonogenic support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83014-0008-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (83014-0008-1) </PackageDescription>
<NDC11Code>83014-0008-01</NDC11Code>
<ProductNDC>83014-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Weight Loss Support Plus Female Balance</ProprietaryName>
<NonProprietaryName>Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Caulophyllum Thalictrines, Cimicifuga Racemosa, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Rubus Idaeus, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Hepar Sulphuris Calcareum, Progesterone, Oxytocin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM SULFIDE; PROGESTERONE; OXYTOCIN</SubstanceName>
<StrengthNumber>2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 12; 30; 34</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_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Progesterone [CS], Progesterone [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides female hormonogenic balance support. †. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83014-0100-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (83014-0100-1) </PackageDescription>
<NDC11Code>83014-0100-01</NDC11Code>
<ProductNDC>83014-0100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Weight Loss Support Plus - Glp 1 Booster</ProprietaryName>
<NonProprietaryName>Foeniculum Vulgare, Ammonium Bromatum, Berberis Vulgaris, Cinnamomum, Fucus Vesiculosus, Lecithin (derived From Egg), Trigonella Foenum-graecum, Panax Ginseng, Capsicum Annuum, Curcuma Longa, Galium Aparine, Hepar Suis, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Pancreas Suis, Phytolacca Decandra, Small Intestine (suis), Pituitarum Posterium (bovine), Thyroidinum (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260129</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; BERBERIS VULGARIS ROOT BARK; CINNAMON; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; FENUGREEK SEED; ASIAN GINSENG; CAPSICUM; TURMERIC; GALIUM APARINE WHOLE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; SUS SCROFA PANCREAS; PHYTOLACCA AMERICANA ROOT; SUS SCROFA INTESTINAL MUCOSA; BOS TAURUS PITUITARY GLAND, POSTERIOR; THYROID, BOVINE; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS</SubstanceName>
<StrengthNumber>2; 3; 3; 3; 3; 3; 3; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 9; 9; 9; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [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], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant to control empty feeling in stomach otherwise relieved by eating, helps with metabolic tendencies to gain weight, cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides support for the body's production of GLP 1.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</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>
</NDC>
<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>