{
"NDC": [
{
"NDCCode": "49726-045-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-045-60) ",
"NDC11Code": "49726-0045-60",
"ProductNDC": "49726-045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rhumatol",
"NonProprietaryName": "Actaea Spicata, Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia (alba), Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Ledum Palustre, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla (pratensis), Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Zincum Metallicumk",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190723",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACTAEA SPICATA ROOT; ANEMONE PRATENSIS; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Mood Stabilizer [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190723",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. pain. inflammation. stiffness. swelling. weakness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-038-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-038-60) ",
"NDC11Code": "49726-0038-60",
"ProductNDC": "49726-038",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anxietin",
"NonProprietaryName": "Aconitum Napellus, Alfalfa, Argentum Nitricum, Aurum Metallicum, Avena Sativa, Baryta Carbonica, Calcarea Phosphorica, Chamomilla, Gelsemium Sempervirens, Glonoinum, Humulus Lupulus, Ignatia Amara, Kali Phosphoricum, Muriaticum Acidum, Natrum Phosphoricum, Passiflora Incarnata, Phosphorus, Staphysagria, Stramonium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180416",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; ALFALFA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIBASIC POTASSIUM PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HOPS; HYDROCHLORIC ACID; MATRICARIA CHAMOMILLA; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; SILVER NITRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS IGNATII SEED; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180416",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. anxiousness. social fear. panic. hypersensitivity. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-039-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-039-60) ",
"NDC11Code": "49726-0039-60",
"ProductNDC": "49726-039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Moodbrite",
"NonProprietaryName": "Anacardium Orientale, Avena Sativa, Aurum Metallicum, Calcarea Carbonica, Carpinus Betulus, Flos, Cimicifuga Racemosa, Cinchona Officinalis, Hypericum Perforatum, Ignatia Amara, Kali Bromatum, Larix Decidua, Flos, Natrum Carbonicum, Natrum Sulphuricum, Phosphoricum Acidum, Phosphorus, Pulsatilla (vulgaris), Sepia, Sinapis Arvensis, Flos, Tabacum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180416",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ANEMONE PULSATILLA; AVENA SATIVA FLOWERING TOP; BLACK COHOSH; CARPINUS BETULUS FLOWERING TOP; CINCHONA OFFICINALIS BARK; GOLD; HYPERICUM PERFORATUM; LARIX DECIDUA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM BROMIDE; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; TOBACCO LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180416",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. sadness. loss of interest. poor self-esteem. low motivation. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-040-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-040-60) ",
"NDC11Code": "49726-0040-60",
"ProductNDC": "49726-040",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Respitrol",
"NonProprietaryName": "Ammonium Carbonicum, Antimonium Tartaricum, Bromium, Carbo Vegetabilis, Chlorinum, Kali Carbonicum, Lobelia Inflata, Stannum Metallicum, Sulphuricum Acidum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180615",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACTIVATED CHARCOAL; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; BROMINE; CHLORINE; LOBELIA INFLATA; POTASSIUM CARBONATE; SULFURIC ACID; TIN",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180615",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as: tightness in chest, shortness of breath, cough, or wheezing. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-041-60",
"PackageDescription": "60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (49726-041-60) ",
"NDC11Code": "49726-0041-60",
"ProductNDC": "49726-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Synaptol",
"NonProprietaryName": "Aconitum Ferox, Adrenalinum, Aesculus Hippocastanum, Flos, Apis Mellifica, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Cochlearia Armoracia, Phosphorus, Scleranthus Annuus, Flos, Scutellaria Lateriflora, Sumbul, Viola Odorata",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; HORSERADISH; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; VIOLA ODORATA",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171211",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of hyperactivity & inattention symptoms including. poor focus. impulsivity. difficulty concentrating when reading or writing. Product indications based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-042-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-042-60) ",
"NDC11Code": "49726-0042-60",
"ProductNDC": "49726-042",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Compulsin",
"NonProprietaryName": "Calcarea Carbonica, Coffea Cruda, Iodium, Mancinella, Physostigma Venenosum, Silicea, Ulmus Procera, Flos",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181015",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ARABICA COFFEE BEAN; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE; ULMUS MINOR FLOWERING TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181015",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. nervous, repetitive thoughts. disproportionate fears. nervous, repetitive behaviors apprehensiveness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-043-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-043-60) ",
"NDC11Code": "49726-0043-60",
"ProductNDC": "49726-043",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Activive",
"NonProprietaryName": "Alfalfa, Ambra Grisea, Anacardium Orientale, Argentum Nitricum, Aurum Metallicum, Avena Sativa, Caladium Seguinum, Calcarea Carbonica, Cocculus Indicus, Gelsemium Sempervirens, Ignatia Amara, Kali Phosphoricum, Lycopodium Clavatum, Natrum Muriaticum, Nux Moschata, Phosphoricum Acidum, Phosphorus, Selenium Metallicum, Sepia, Silicea, Sulphur",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181019",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ALFALFA; AMBERGRIS; ANAMIRTA COCCULUS SEED; AVENA SATIVA FLOWERING TOP; DIBASIC POTASSIUM PHOSPHATE; DIEFFENBACHIA SEGUINE; GELSEMIUM SEMPERVIRENS ROOT; GOLD; LYCOPODIUM CLAVATUM SPORE; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; SULFUR",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181019",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. exhaustion. dullness. drowsiness. muscle weakness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-044-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-044-60) ",
"NDC11Code": "49726-0044-60",
"ProductNDC": "49726-044",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neuroveen",
"NonProprietaryName": "Aconitum Napellus, Agaricus Muscarius, Baryta Muriatica, Calendula Officinalis, Carbo Vegetabilis, Carduus Marianus, Chamomilla, Dulcamara, Glonoinum, Hamamelis Virginiana, Lycopersicum Esculentum, Magnesia Phosphorica, Phosphorus, Rhus Tox, Secale Cornutum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181015",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; ACTIVATED CHARCOAL; AMANITA MUSCARIA FRUITING BODY; BARIUM CHLORIDE DIHYDRATE; CALENDULA OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; NITROGLYCERIN; PHOSPHORUS; SILYBUM MARIANUM SEED; SOLANUM DULCAMARA TOP; TOMATO; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vasodilation [PE], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181015",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of nerve pain symptoms including: itching numbness swelling burning cramping tingling Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-046-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-046-60) ",
"NDC11Code": "49726-0046-60",
"ProductNDC": "49726-046",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Painazol",
"NonProprietaryName": "Actaea Spicata, Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia (alba), Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Hypericum Perforatum, Ledum Palustre, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla (pratensis), Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Sulphur, Zincum Metallicum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190528",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACTAEA SPICATA ROOT; ANEMONE PRATENSIS; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; SULFUR; TOXICODENDRON PUBESCENS LEAF; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Mood Stabilizer [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190528",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. pain. burning. weakness. sensitivity. tingling. numbness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-047-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-047-60) ",
"NDC11Code": "49726-0047-60",
"ProductNDC": "49726-047",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Restulex",
"NonProprietaryName": "Bufo Rana, Causticum, Chamomilla, Crotalus Horridus, Digitalis Purpurea, Lachesis Mutus, Lilium Tigrinum, Pulsatilla (pratensis) Rhus Tox, Sulphur, Tarentula Hispana, Viscum Album, Zincum Metallicum.",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191010",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ANEMONE PRATENSIS; BUFO BUFO CUTANEOUS GLAND; CAUSTICUM; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOSA TARANTULA; MATRICARIA CHAMOMILLA; SULFUR; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUIT; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191010",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. twitching. burning. heaviness. jerking. cramping. pain. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-048-60",
"PackageDescription": "60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (49726-048-60) ",
"NDC11Code": "49726-0048-60",
"ProductNDC": "49726-048",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Synaptol Lactose Free",
"NonProprietaryName": "Aconitum Ferox, Adrenalinum, Aesculus Hippocastanum, Flos, Apis Mellifica, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Cochlearia Armoracia, Phosphorus, Scleranthus Annuus, Flos, Scutellaria Lateriflora, Sumbul, Viola Odorata",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20220927",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; HORSERADISH; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA WHOLE; SILVER NITRATE; VIOLA ODORATA WHOLE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220927",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of hyperactivity & inattention symptoms including. poor focus. impulsivity. fidgeting. difficulty concentrating when reading or writing. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "13668-045-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (13668-045-60) ",
"NDC11Code": "13668-0045-60",
"ProductNDC": "13668-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078947",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090127",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine tablet is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets, USP are supplied for oral administration as 25-mg (white to off white), 100-mg (white to off white), 150-mg (white to off white), and 200-mg (white to off white) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; povidone; and sodium starch glycolate. Meets USP Dissolution Test 3."
},
{
"NDCCode": "16590-045-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (16590-045-60)",
"NDC11Code": "16590-0045-60",
"ProductNDC": "16590-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celebrex",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19981002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020998",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].",
"Description": "CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "21922-045-47",
"PackageDescription": "7 BOTTLE, DISPENSING in 1 CARTON (21922-045-47) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01) ",
"NDC11Code": "21922-0045-47",
"ProductNDC": "21922-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesalamine",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "SUSPENSION",
"RouteName": "RECTAL",
"StartMarketingDate": "20230601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216941",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/60mL",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "Mesalamine rectal suspension enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.",
"Description": "The active ingredient in mesalamine rectal suspension, USP enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C7H7NO3, representing a molecular weight of 153.14. The structural formula is. Mesalamine rectal suspension, USP enema is supplied as a suspension for rectal administration. Each rectal suspension enema unit contains 4 grams of mesalamine. The inactive ingredients are carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product."
},
{
"NDCCode": "21922-045-49",
"PackageDescription": "28 BOTTLE, DISPENSING in 1 CARTON (21922-045-49) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01) ",
"NDC11Code": "21922-0045-49",
"ProductNDC": "21922-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesalamine",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "SUSPENSION",
"RouteName": "RECTAL",
"StartMarketingDate": "20230601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216941",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/60mL",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "Mesalamine rectal suspension enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.",
"Description": "The active ingredient in mesalamine rectal suspension, USP enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C7H7NO3, representing a molecular weight of 153.14. The structural formula is. Mesalamine rectal suspension, USP enema is supplied as a suspension for rectal administration. Each rectal suspension enema unit contains 4 grams of mesalamine. The inactive ingredients are carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product."
},
{
"NDCCode": "33261-045-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (33261-045-60)",
"NDC11Code": "33261-0045-60",
"ProductNDC": "33261-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for. Fluoxetine capsules and olanzapine in combination for: 1 Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1.5) .",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, colloidal silicon dioxide, FD&C Blue #1, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, and gelatin. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "42794-045-10",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (42794-045-10) ",
"NDC11Code": "42794-0045-10",
"ProductNDC": "42794-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207746",
"LabelerName": "Sigmapharm Laboratories, LLC",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180611",
"SamplePackage": "N",
"IndicationAndUsage": "Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).",
"Description": "Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19H 27N 3O 5S 2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is: N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide Capsules contain the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, silicon dioxide, magnesium stearate, anhydrous citric acid and copovidone. Dofetilide Capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) opaque orange capsules, 250 mcg (0.25 mg) opaque peach and white capsules, and 500 mcg (0.5 mg) opaque peach capsules. The capsule shell contains FD&C Red# 40, D&C Yellow# 10, titanium dioxide, sodium lauryl sulfate, gelatin and edible imprinting ink. The 0.125 mg strength capsule shell also contains D&C Red# 28. The ingredients in the imprinting ink include Ferrosoferric oxide, n-butyl alcohol, propylene glycol, shellac glaze~45% (20% esterified) in ethanol, FD&C Blue #2 Indigo Carmine Aluminum Lake, FD&C Blue #1/ Brilliant Blue FCF Aluminum Lake, FD&C Red #40/ Allura Red AC Aluminum Lake and D&C Yellow #10 Aluminum Lake."
},
{
"NDCCode": "43063-045-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (43063-045-60) ",
"NDC11Code": "43063-0045-60",
"ProductNDC": "43063-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19860730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085223",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140414",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride, USP is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine hydrochloride capsules, USP for oral use contain 10 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride USP, 10 mg capsules also contain inactive ingredients: ammonium hydroxide, D&C Red No. 28, FD&C Blue No. 1, gelatin, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, simethicone, and titanium dioxide., 2 Dicyclomine hydrochloride tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride USP, 20 mg tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "49999-045-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (49999-045-60)",
"NDC11Code": "49999-0045-60",
"ProductNDC": "49999-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070920",
"LabelerName": "Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "52343-045-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (52343-045-60) ",
"NDC11Code": "52343-0045-60",
"ProductNDC": "52343-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zidovudine",
"NonProprietaryName": "Zidovudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077267",
"LabelerName": "ACETRIS HEALTH, LLC",
"SubstanceName": "ZIDOVUDINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20050919",
"SamplePackage": "N"
},
{
"NDCCode": "52565-045-60",
"PackageDescription": "1 TUBE in 1 CARTON (52565-045-60) > 60 g in 1 TUBE",
"NDC11Code": "52565-0045-60",
"ProductNDC": "52565-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209973",
"LabelerName": "Teligent Pharma, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181023",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone Ointment USP, 0.05% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.05% contains 0.5 mg of desoximetasone in an ointment base consisting of mineral oil and white petrolatum. The chemical name of desoximetasone is Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "57237-045-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (57237-045-60) ",
"NDC11Code": "57237-0045-60",
"ProductNDC": "57237-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065489",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120725",
"SamplePackage": "N",
"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: 1 Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1), 2 Acute Maxillary Sinusitis (1.2), 3 Community-Acquired Pneumonia (1.3), 4 Pharyngitis/Tonsillitis (1.4), 5 Uncomplicated Skin and Skin Structure Infections (1.5) , 6 Acute Otitis Media in Pediatric Patients (1.6), 7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7), 8 Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults (1.8) .",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.96. The structural formula is:. Figure 1: Structure of Clarithromycin. Clarithromycin USP is a white or almost white, crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each film-coated tablet contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, hypromellose, titanium dioxide, hydroxypropyl cellulose, iron oxide yellow, propylene glycol, vanillin, and sorbic acid."
},
{
"NDCCode": "61715-045-60",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (61715-045-60) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "61715-0045-60",
"ProductNDC": "61715-045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gas Relief",
"ProprietaryNameSuffix": "Ultra Strength",
"NonProprietaryName": "Simethicone",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20100707",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Preferred Plus (Kinray)",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100707",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "61919-045-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (61919-045-60)",
"NDC11Code": "61919-0045-60",
"ProductNDC": "61919-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020998",
"LabelerName": "DIRECT RX",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. 1.1 Osteoarthritis (OA). Celecoxib is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA). Celecoxib is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)]. 1.3 Juvenile Rheumatoid Arthritis (JRA). Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]. 1.4 Ankylosing Spondylitis (AS). Celecoxib is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)]. 1.5 Acute Pain (AP). Celecoxib is indicated for the management of AP in adults [see Clinical Studies (14.5)]. 1.6 Primary Dysmenorrhea (PD). Celecoxib is indicated for the treatment of PD [see Clinical Studies (14.5)].",
"Description": "Celecoxib is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
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{
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"PackageDescription": "1 INHALER in 1 CARTON (63379-045-00) > 60 POWDER in 1 INHALER",
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"ProductNDC": "63379-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Advair",
"ProprietaryNameSuffix": "Diskus",
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"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20010305",
"MarketingCategoryName": "APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
"ApplicationNumber": "NDA021077",
"LabelerName": "Glaxo Operations UK Ltd",
"SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
"StrengthNumber": "50; 500",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63552-045-01",
"PackageDescription": "216 BOTTLE, PLASTIC in 1 CASE (63552-045-01) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "63552-0045-01",
"ProductNDC": "63552-045",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ivabradine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20150420",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Patheon Manufacturing Services LLC",
"SubstanceName": "IVABRADINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2019-02-21",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "65841-045-14",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (65841-045-14) ",
"NDC11Code": "65841-0045-14",
"ProductNDC": "65841-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077106",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171202",
"SamplePackage": "N"
},
{
"NDCCode": "67438-045-01",
"PackageDescription": "60 SPRAY, METERED in 1 BOTTLE (67438-045-01) ",
"NDC11Code": "67438-0045-01",
"ProductNDC": "67438-045",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "SPRAY, METERED",
"StartMarketingDate": "20150619",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "55",
"StrengthUnit": "ug/1",
"Status": "Unfinished",
"LastUpdate": "2021-09-22",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "12-OCT-16"
},
{
"NDCCode": "68382-045-14",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (68382-045-14) ",
"NDC11Code": "68382-0045-14",
"ProductNDC": "68382-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171202",
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"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171202",
"SamplePackage": "N"
},
{
"NDCCode": "69924-045-02",
"PackageDescription": "1 POUCH in 1 CARTON (69924-045-02) > 60 mL in 1 POUCH (69924-045-01)",
"NDC11Code": "69924-0045-02",
"ProductNDC": "69924-045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neogen Dermalogy White Truffle Hydramax Knit Mask",
"NonProprietaryName": "Niacinamide, Adenosine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "OUTIN FUTURES CORP.",
"SubstanceName": "NIACINAMIDE; ADENOSINE",
"StrengthNumber": "1.2; .24",
"StrengthUnit": "g/60mL; g/60mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-08"
}
]
}
{"NDC":[{"NDCCode":"49726-045-60","ProprietaryName":"Rhumatol","NonProprietaryName":"Actaea Spicata, Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia (alba), Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Ledum Palustre, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla (pratensis), Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Zincum Metallicumk"},{"NDCCode":"49726-038-60","ProprietaryName":"Anxietin","NonProprietaryName":"Aconitum Napellus, Alfalfa, Argentum Nitricum, Aurum Metallicum, Avena Sativa, Baryta Carbonica, Calcarea Phosphorica, Chamomilla, Gelsemium Sempervirens, Glonoinum, Humulus Lupulus, Ignatia Amara, Kali Phosphoricum, Muriaticum Acidum, Natrum Phosphoricum, Passiflora Incarnata, Phosphorus, Staphysagria, Stramonium"},{"NDCCode":"49726-039-60","ProprietaryName":"Moodbrite","NonProprietaryName":"Anacardium Orientale, Avena Sativa, Aurum 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<NDCList>
<NDC>
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<LastUpdate>2024-12-11</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<StartMarketingDate>20180416</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
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<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. anxiousness. social fear. panic. hypersensitivity. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
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<ProductNDC>49726-039</ProductNDC>
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<StartMarketingDate>20180416</StartMarketingDate>
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<LabelerName>HelloLife, Inc.</LabelerName>
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<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. sadness. loss of interest. poor self-esteem. low motivation. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-040-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-040-60) </PackageDescription>
<NDC11Code>49726-0040-60</NDC11Code>
<ProductNDC>49726-040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Respitrol</ProprietaryName>
<NonProprietaryName>Ammonium Carbonicum, Antimonium Tartaricum, Bromium, Carbo Vegetabilis, Chlorinum, Kali Carbonicum, Lobelia Inflata, Stannum Metallicum, Sulphuricum Acidum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; BROMINE; CHLORINE; LOBELIA INFLATA; POTASSIUM CARBONATE; SULFURIC ACID; TIN</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as: tightness in chest, shortness of breath, cough, or wheezing. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-041-60</NDCCode>
<PackageDescription>60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (49726-041-60) </PackageDescription>
<NDC11Code>49726-0041-60</NDC11Code>
<ProductNDC>49726-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Synaptol</ProprietaryName>
<NonProprietaryName>Aconitum Ferox, Adrenalinum, Aesculus Hippocastanum, Flos, Apis Mellifica, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Cochlearia Armoracia, Phosphorus, Scleranthus Annuus, Flos, Scutellaria Lateriflora, Sumbul, Viola Odorata</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; HORSERADISH; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; VIOLA ODORATA</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of hyperactivity & inattention symptoms including. poor focus. impulsivity. difficulty concentrating when reading or writing. Product indications based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-042-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-042-60) </PackageDescription>
<NDC11Code>49726-0042-60</NDC11Code>
<ProductNDC>49726-042</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Compulsin</ProprietaryName>
<NonProprietaryName>Calcarea Carbonica, Coffea Cruda, Iodium, Mancinella, Physostigma Venenosum, Silicea, Ulmus Procera, Flos</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181015</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE; ULMUS MINOR FLOWERING TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. nervous, repetitive thoughts. disproportionate fears. nervous, repetitive behaviors apprehensiveness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-043-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-043-60) </PackageDescription>
<NDC11Code>49726-0043-60</NDC11Code>
<ProductNDC>49726-043</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Activive</ProprietaryName>
<NonProprietaryName>Alfalfa, Ambra Grisea, Anacardium Orientale, Argentum Nitricum, Aurum Metallicum, Avena Sativa, Caladium Seguinum, Calcarea Carbonica, Cocculus Indicus, Gelsemium Sempervirens, Ignatia Amara, Kali Phosphoricum, Lycopodium Clavatum, Natrum Muriaticum, Nux Moschata, Phosphoricum Acidum, Phosphorus, Selenium Metallicum, Sepia, Silicea, Sulphur</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181019</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ALFALFA; AMBERGRIS; ANAMIRTA COCCULUS SEED; AVENA SATIVA FLOWERING TOP; DIBASIC POTASSIUM PHOSPHATE; DIEFFENBACHIA SEGUINE; GELSEMIUM SEMPERVIRENS ROOT; GOLD; LYCOPODIUM CLAVATUM SPORE; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; SULFUR</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. exhaustion. dullness. drowsiness. muscle weakness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-044-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-044-60) </PackageDescription>
<NDC11Code>49726-0044-60</NDC11Code>
<ProductNDC>49726-044</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neuroveen</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Agaricus Muscarius, Baryta Muriatica, Calendula Officinalis, Carbo Vegetabilis, Carduus Marianus, Chamomilla, Dulcamara, Glonoinum, Hamamelis Virginiana, Lycopersicum Esculentum, Magnesia Phosphorica, Phosphorus, Rhus Tox, Secale Cornutum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181015</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ACTIVATED CHARCOAL; AMANITA MUSCARIA FRUITING BODY; BARIUM CHLORIDE DIHYDRATE; CALENDULA OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; NITROGLYCERIN; PHOSPHORUS; SILYBUM MARIANUM SEED; SOLANUM DULCAMARA TOP; TOMATO; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vasodilation [PE], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of nerve pain symptoms including: itching numbness swelling burning cramping tingling Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-046-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-046-60) </PackageDescription>
<NDC11Code>49726-0046-60</NDC11Code>
<ProductNDC>49726-046</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Painazol</ProprietaryName>
<NonProprietaryName>Actaea Spicata, Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia (alba), Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Hypericum Perforatum, Ledum Palustre, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla (pratensis), Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Sulphur, Zincum Metallicum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190528</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACTAEA SPICATA ROOT; ANEMONE PRATENSIS; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; SULFUR; TOXICODENDRON PUBESCENS LEAF; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Mood Stabilizer [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. pain. burning. weakness. sensitivity. tingling. numbness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-047-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-047-60) </PackageDescription>
<NDC11Code>49726-0047-60</NDC11Code>
<ProductNDC>49726-047</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Restulex</ProprietaryName>
<NonProprietaryName>Bufo Rana, Causticum, Chamomilla, Crotalus Horridus, Digitalis Purpurea, Lachesis Mutus, Lilium Tigrinum, Pulsatilla (pratensis) Rhus Tox, Sulphur, Tarentula Hispana, Viscum Album, Zincum Metallicum.</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191010</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ANEMONE PRATENSIS; BUFO BUFO CUTANEOUS GLAND; CAUSTICUM; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOSA TARANTULA; MATRICARIA CHAMOMILLA; SULFUR; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUIT; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. twitching. burning. heaviness. jerking. cramping. pain. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-048-60</NDCCode>
<PackageDescription>60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (49726-048-60) </PackageDescription>
<NDC11Code>49726-0048-60</NDC11Code>
<ProductNDC>49726-048</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Synaptol Lactose Free</ProprietaryName>
<NonProprietaryName>Aconitum Ferox, Adrenalinum, Aesculus Hippocastanum, Flos, Apis Mellifica, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Cochlearia Armoracia, Phosphorus, Scleranthus Annuus, Flos, Scutellaria Lateriflora, Sumbul, Viola Odorata</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220927</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; HORSERADISH; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA WHOLE; SILVER NITRATE; VIOLA ODORATA WHOLE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of hyperactivity & inattention symptoms including. poor focus. impulsivity. fidgeting. difficulty concentrating when reading or writing. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-045-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (13668-045-60) </PackageDescription>
<NDC11Code>13668-0045-60</NDC11Code>
<ProductNDC>13668-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078947</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine tablet is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets, USP are supplied for oral administration as 25-mg (white to off white), 100-mg (white to off white), 150-mg (white to off white), and 200-mg (white to off white) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; povidone; and sodium starch glycolate. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>16590-045-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (16590-045-60)</PackageDescription>
<NDC11Code>16590-0045-60</NDC11Code>
<ProductNDC>16590-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celebrex</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020998</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>21922-045-47</NDCCode>
<PackageDescription>7 BOTTLE, DISPENSING in 1 CARTON (21922-045-47) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01) </PackageDescription>
<NDC11Code>21922-0045-47</NDC11Code>
<ProductNDC>21922-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mesalamine</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20230601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216941</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mesalamine rectal suspension enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.</IndicationAndUsage>
<Description>The active ingredient in mesalamine rectal suspension, USP enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C7H7NO3, representing a molecular weight of 153.14. The structural formula is. Mesalamine rectal suspension, USP enema is supplied as a suspension for rectal administration. Each rectal suspension enema unit contains 4 grams of mesalamine. The inactive ingredients are carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.</Description>
</NDC>
<NDC>
<NDCCode>21922-045-49</NDCCode>
<PackageDescription>28 BOTTLE, DISPENSING in 1 CARTON (21922-045-49) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01) </PackageDescription>
<NDC11Code>21922-0045-49</NDC11Code>
<ProductNDC>21922-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mesalamine</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20230601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216941</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mesalamine rectal suspension enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.</IndicationAndUsage>
<Description>The active ingredient in mesalamine rectal suspension, USP enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C7H7NO3, representing a molecular weight of 153.14. The structural formula is. Mesalamine rectal suspension, USP enema is supplied as a suspension for rectal administration. Each rectal suspension enema unit contains 4 grams of mesalamine. The inactive ingredients are carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.</Description>
</NDC>
<NDC>
<NDCCode>33261-045-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (33261-045-60)</PackageDescription>
<NDC11Code>33261-0045-60</NDC11Code>
<ProductNDC>33261-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for. Fluoxetine capsules and olanzapine in combination for: 1 Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1.5) .</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, colloidal silicon dioxide, FD&C Blue #1, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, and gelatin. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>42794-045-10</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (42794-045-10) </PackageDescription>
<NDC11Code>42794-0045-10</NDC11Code>
<ProductNDC>42794-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207746</ApplicationNumber>
<LabelerName>Sigmapharm Laboratories, LLC</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).</IndicationAndUsage>
<Description>Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19H 27N 3O 5S 2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is: N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide Capsules contain the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, silicon dioxide, magnesium stearate, anhydrous citric acid and copovidone. Dofetilide Capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) opaque orange capsules, 250 mcg (0.25 mg) opaque peach and white capsules, and 500 mcg (0.5 mg) opaque peach capsules. The capsule shell contains FD&C Red# 40, D&C Yellow# 10, titanium dioxide, sodium lauryl sulfate, gelatin and edible imprinting ink. The 0.125 mg strength capsule shell also contains D&C Red# 28. The ingredients in the imprinting ink include Ferrosoferric oxide, n-butyl alcohol, propylene glycol, shellac glaze~45% (20% esterified) in ethanol, FD&C Blue #2 Indigo Carmine Aluminum Lake, FD&C Blue #1/ Brilliant Blue FCF Aluminum Lake, FD&C Red #40/ Allura Red AC Aluminum Lake and D&C Yellow #10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>43063-045-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (43063-045-60) </PackageDescription>
<NDC11Code>43063-0045-60</NDC11Code>
<ProductNDC>43063-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085223</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride, USP is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine hydrochloride capsules, USP for oral use contain 10 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride USP, 10 mg capsules also contain inactive ingredients: ammonium hydroxide, D&C Red No. 28, FD&C Blue No. 1, gelatin, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, simethicone, and titanium dioxide., 2 Dicyclomine hydrochloride tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride USP, 20 mg tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>49999-045-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (49999-045-60)</PackageDescription>
<NDC11Code>49999-0045-60</NDC11Code>
<ProductNDC>49999-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070920</ApplicationNumber>
<LabelerName>Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>52343-045-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (52343-045-60) </PackageDescription>
<NDC11Code>52343-0045-60</NDC11Code>
<ProductNDC>52343-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zidovudine</ProprietaryName>
<NonProprietaryName>Zidovudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077267</ApplicationNumber>
<LabelerName>ACETRIS HEALTH, LLC</LabelerName>
<SubstanceName>ZIDOVUDINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52565-045-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52565-045-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>52565-0045-60</NDC11Code>
<ProductNDC>52565-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209973</ApplicationNumber>
<LabelerName>Teligent Pharma, Inc.</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone Ointment USP, 0.05% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.05% contains 0.5 mg of desoximetasone in an ointment base consisting of mineral oil and white petrolatum. The chemical name of desoximetasone is Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>57237-045-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (57237-045-60) </PackageDescription>
<NDC11Code>57237-0045-60</NDC11Code>
<ProductNDC>57237-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065489</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: 1 Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1), 2 Acute Maxillary Sinusitis (1.2), 3 Community-Acquired Pneumonia (1.3), 4 Pharyngitis/Tonsillitis (1.4), 5 Uncomplicated Skin and Skin Structure Infections (1.5) , 6 Acute Otitis Media in Pediatric Patients (1.6), 7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7), 8 Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults (1.8) .</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.96. The structural formula is:. Figure 1: Structure of Clarithromycin. Clarithromycin USP is a white or almost white, crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each film-coated tablet contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, hypromellose, titanium dioxide, hydroxypropyl cellulose, iron oxide yellow, propylene glycol, vanillin, and sorbic acid.</Description>
</NDC>
<NDC>
<NDCCode>61715-045-60</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (61715-045-60) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>61715-0045-60</NDC11Code>
<ProductNDC>61715-045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gas Relief</ProprietaryName>
<ProprietaryNameSuffix>Ultra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100707</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>Preferred Plus (Kinray)</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100707</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61919-045-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (61919-045-60)</PackageDescription>
<NDC11Code>61919-0045-60</NDC11Code>
<ProductNDC>61919-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020998</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. 1.1 Osteoarthritis (OA). Celecoxib is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA). Celecoxib is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)]. 1.3 Juvenile Rheumatoid Arthritis (JRA). Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]. 1.4 Ankylosing Spondylitis (AS). Celecoxib is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)]. 1.5 Acute Pain (AP). Celecoxib is indicated for the management of AP in adults [see Clinical Studies (14.5)]. 1.6 Primary Dysmenorrhea (PD). Celecoxib is indicated for the treatment of PD [see Clinical Studies (14.5)].</IndicationAndUsage>
<Description>Celecoxib is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
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<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
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<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
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<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Patheon Manufacturing Services LLC</LabelerName>
<SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2019-02-21</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65841-045-14</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (65841-045-14) </PackageDescription>
<NDC11Code>65841-0045-14</NDC11Code>
<ProductNDC>65841-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077106</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
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<PackageDescription>60 SPRAY, METERED in 1 BOTTLE (67438-045-01) </PackageDescription>
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<ProductNDC>67438-045</ProductNDC>
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<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
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<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>55</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-09-22</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-OCT-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68382-045-14</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68382-045-14) </PackageDescription>
<NDC11Code>68382-0045-14</NDC11Code>
<ProductNDC>68382-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077106</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69924-045-02</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (69924-045-02) > 60 mL in 1 POUCH (69924-045-01)</PackageDescription>
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<ProductNDC>69924-045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neogen Dermalogy White Truffle Hydramax Knit Mask</ProprietaryName>
<NonProprietaryName>Niacinamide, Adenosine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>OUTIN FUTURES CORP.</LabelerName>
<SubstanceName>NIACINAMIDE; ADENOSINE</SubstanceName>
<StrengthNumber>1.2; .24</StrengthNumber>
<StrengthUnit>g/60mL; g/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-08</LastUpdate>
</NDC>
</NDCList>