{
"NDC": [
{
"NDCCode": "58066-7042-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-7042-7) ",
"NDC11Code": "58066-7042-07",
"ProductNDC": "58066-7042",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthritis Pain Relief",
"NonProprietaryName": "Actaea, Aesculus Hipp, Arnica, Bellis, Bryonia, Calc Carb, Calc Fluor, Causticum, Cimicifuga, Formicum Acidum, Hypericum, Lac Vac, Ledum, Lithium Carb, Mag Phos, Phos, Phytolacca, Pulsatilla, Rhododendron, Rhus Tox, Ruta, Salicylicum Ac, Sepia, Zinc Met.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "ACTAEA CIMICIFUGA ROOT; HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; COW MILK; RHODODENDRON TOMENTOSUM LEAFY TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; ANEMONE PULSATILLA; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; 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]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Indications: For temporary relief of: symptoms of joint pain, Stiffness & discomfort associated with arthritis."
},
{
"NDCCode": "58066-7001-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-7001-7)",
"NDC11Code": "58066-7001-07",
"ProductNDC": "58066-7001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acne Free",
"NonProprietaryName": "Antimonium Tartaricum, Asterias Rubens, Ferrum Metallicum, Hepar Sulphuris Calcareum, Kali Bromatum, Lac Defloratum, Natrum Muriaticum, Sanguinaria Canadensis, Selenium Metallicum, Sepia, Silicea, Sulphur, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140115",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ASTERIAS RUBENS; IRON; CALCIUM SULFIDE; POTASSIUM BROMIDE; SKIM MILK; SODIUM CHLORIDE; SANGUINARIA CANADENSIS ROOT; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Indications: For temporary relief of: pimples & blemishes associated with acne."
},
{
"NDCCode": "58066-7002-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-7002-7)",
"NDC11Code": "58066-7002-07",
"ProductNDC": "58066-7002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skin Irritation And Itch Response",
"NonProprietaryName": "Agaricus Muscarius, Alumina, Anagallis Arvensis, Antimonium Tartaricum, Apis Mellifica, Arsenicum Album, Arsenicum Iodatum, Bovista, Causticum, Dolichos Pruriens, Fagapyrum Esculentum, Graphites, Kali Muriaticum, Lac Defloratum, Muriaticum Acidum, Oleander, Petroleum, Pix Liquida, Radium Bromatum, Rhus Toxicodendron, Selenium Metallicum, Sulphur, Urtica Urens",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130116",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "AMANITA MUSCARIA FRUITING BODY; ALUMINUM OXIDE; ANAGALLIS ARVENSIS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; LYCOPERDON UTRIFORME FRUITING BODY; CAUSTICUM; MUCUNA PRURIENS FRUIT TRICHOME; FAGOPYRUM ESCULENTUM; GRAPHITE; POTASSIUM CHLORIDE; SKIM MILK; HYDROCHLORIC ACID; NERIUM OLEANDER LEAF; KEROSENE; PINE TAR; RADIUM BROMIDE; TOXICODENDRON PUBESCENS LEAF; SELENIUM; SULFUR; URTICA URENS",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications: For temporary relief of: red, irritated, itchy skin, symptoms of impetigo, mild abscesses and boils."
},
{
"NDCCode": "58066-7003-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-7003-7)",
"NDC11Code": "58066-7003-07",
"ProductNDC": "58066-7003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gland Discomfort Relief",
"NonProprietaryName": "Astacus Fluviatilis, Baryta Iodata, Calcarea Iodata, Cistus Canadensis, Clematis Erecta, Conium Maculatum, Iodium, Lacticum Acidum, Lac Defloratum, Mercurius Iodatus Ruber, Mercurius Vivus, Phytolacca Decandra, Scrophularia Nodosa, Spongia Tosta",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "ASTACUS ASTACUS; BARIUM IODIDE; CALCIUM IODIDE; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; IODINE; LACTIC ACID, DL-; SKIM MILK; MERCURIC IODIDE; MERCURY; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SPONGIA OFFICINALIS SKELETON, ROASTED",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Indications: For temporary relief of: enlarged and swollen glands, painful and inflamed glands of the jaw, neck, armpit and groin area. Associated with viral inflammations such as colds and flu."
},
{
"NDCCode": "58066-7011-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-7011-7)",
"NDC11Code": "58066-7011-07",
"ProductNDC": "58066-7011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy And Hay Fever Relief",
"NonProprietaryName": "Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Arum Triphyllum, Arundo Mauritanica, Euphrasia Officinalis, Lac Defloratum, Naphthalinum, Natrum Muriaticum, Sabadilla, Wyethia Helenioides",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160502",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; EUPHRASIA STRICTA; SKIM MILK; NAPHTHALENE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; WYETHIA HELENIOIDES ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications: For temporary relief of allergy and hay fever symptoms such as: sneezing, runny nose, watery, red or itchy eyes. Use according to label indications and/or standard homeopathic indications."
},
{
"NDCCode": "58066-7012-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-7012-7)",
"NDC11Code": "58066-7012-07",
"ProductNDC": "58066-7012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colds And Flu Response",
"NonProprietaryName": "Anas Barbariae, Hepatis Et Cordis Extractum, Arsenicum Album, Baptisia Tinctoria, Bryonia, Dulcamara, Echinacea, Echinacea Purpurea, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Kali Muriaticum, Lac Defloratum, Phosphorus, Pulsatilla, Sulphur, Zincum Aceticum, Zincum Carbonicum, Zincum Metallicum, Zincum Muriaticum, Zincum Oxydatum, Zincum Picricum, Zincum Valerianicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160428",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; SOLANUM DULCAMARA TOP; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM CHLORIDE; SKIM MILK; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; ZINC ACETATE ANHYDROUS; ZINC CARBONATE; ZINC; ZINC CHLORIDE; ZINC OXIDE; ZINC PICRATE NONAHYDRATE; ZINC VALERATE DIHYDRATE",
"StrengthNumber": "50; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_C]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; 1/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications: For temporary relief of: body aches & pains nasal congestion headaches & fevers associated with the common cold and flu. Use according to label indications under standard homeopathic indications."
},
{
"NDCCode": "58066-7013-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-7013-7)",
"NDC11Code": "58066-7013-07",
"ProductNDC": "58066-7013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Response",
"NonProprietaryName": "Apis Mellifica, Baptisia Tinctoria, Colocynthis, Hepar Sulphuris Calcareum, Histaminum Hydrochloricum, Hydrastis Canadensis, Ignatia Amara, Kali Bichromicum, Lac Defloratum, Lemna Minor, Mercurius Vivus, Pulsatilla, Rhus Toxicodendron, Sabadilla, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160912",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; SKIM MILK; LEMNA MINOR; MERCURY; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications: For temporary relief of: nasal congestion, sinus pressure, sinus headaches associated with the common cold and flu."
},
{
"NDCCode": "58066-7014-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-7014-7)",
"NDC11Code": "58066-7014-07",
"ProductNDC": "58066-7014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sore Throat And Laryngitis Response",
"NonProprietaryName": "Aconitum Napellus, Antimonium Crudum, Arum Triphyllum, Borax, Causticum, Ferrum Phosphoricum, Graphites, Hepar Sulphuris Calcareum, Kali Bichromicum, Lac Defloratum, Phosphorus, Selenium Metallicum, Spongia Tosta",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111220",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARISAEMA TRIPHYLLUM ROOT; SODIUM BORATE; CAUSTICUM; FERROSOFERRIC PHOSPHATE; GRAPHITE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; SKIM MILK; PHOSPHORUS; SELENIUM; SPONGIA OFFICINALIS SKELETON, ROASTED",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications: For temporary relief of: minor throat pain and irritation inflammation and laryngitis (loss of voice) associated with the common cold or flu."
},
{
"NDCCode": "58066-7022-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-7022-7)",
"NDC11Code": "58066-7022-07",
"ProductNDC": "58066-7022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diarrhea Response",
"NonProprietaryName": "Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Colostrum, Croton Tiglium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110908",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; BOS TAURUS COLOSTRUM; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications: For temporary relief of: upset stomach and symptoms of stomach flu such as nausea and diarrhea. Use according to label indications and/or standard homeopathic indications."
},
{
"NDCCode": "58066-7041-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-7041-7)",
"NDC11Code": "58066-7041-07",
"ProductNDC": "58066-7041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Muscle And Joint Pain Relief",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Cimicifuga Racemosa, Cobaltum Metallicum, Gnaphalium Polycephalum, Hypericum Perforatum, Kali Carbonicum, Kali Phosphoricum, Lac Vaccinum, Magnesia Phosphorica, Oxalicum Acidum, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; COW MILK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications: For temporary relief of: symptoms of muscle, joint pain and discomfort."
},
{
"NDCCode": "58066-8012-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-8012-7)",
"NDC11Code": "58066-8012-07",
"ProductNDC": "58066-8012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Four Seasons Flu Relief",
"NonProprietaryName": "Anas Barbariae, Hepatis Et Cordis Extractum, Arsenicum Album, Baptisia Tinctoria, Bryonia Alba, Causticum, Cinchona Officinalis, Dulcamara, Echinacea Purpurea, Eucalyptus Globulus, Eupatorium Purpureum, Gelsemium Sempervirens, Influenzinum, Lac Defloratum, Lachesis Mutus, Phytolacca Decandra, Rhus Toxicodendron, Sarcolacticum Acidum, Sulphur, Wyethia Helenioides",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150108",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUTROCHIUM PURPUREUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; SKIM MILK; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; WYETHIA HELENIOIDES ROOT",
"StrengthNumber": "35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_C]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Indications: For temporary relief of flu-like symptoms: Fever Fatigue Nausea Cough Runny nose Congestion Sore throat Diarrhea Headache. Use according to label indications and/or standard homeopathic indications."
},
{
"NDCCode": "0074-7042-04",
"PackageDescription": "4 CARTON in 1 CARTON (0074-7042-04) / 1 KIT in 1 CARTON * 1 mL in 1 SYRINGE, GLASS (0074-7032-01) ",
"NDC11Code": "00074-7042-04",
"ProductNDC": "0074-7042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skyrizi",
"NonProprietaryName": "Risankizumab-rzaa",
"DosageFormName": "KIT",
"StartMarketingDate": "20240304",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761105",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240304",
"SamplePackage": "N",
"IndicationAndUsage": "SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).",
"Description": "Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7."
},
{
"NDCCode": "50090-7042-0",
"PackageDescription": "30 TABLET in 1 BOTTLE (50090-7042-0) ",
"NDC11Code": "50090-7042-00",
"ProductNDC": "50090-7042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209587",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240111",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients. Inactive Ingredients: silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula."
},
{
"NDCCode": "50090-7042-3",
"PackageDescription": "100 TABLET in 1 BOTTLE (50090-7042-3) ",
"NDC11Code": "50090-7042-03",
"ProductNDC": "50090-7042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209587",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240205",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients. Inactive Ingredients: silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula."
},
{
"NDCCode": "53002-7042-1",
"PackageDescription": "6 CAPSULE in 1 BOTTLE (53002-7042-1) ",
"NDC11Code": "53002-7042-01",
"ProductNDC": "53002-7042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin",
"ProprietaryNameSuffix": "(monohydrate/macrocrystals)",
"NonProprietaryName": "Nitrofurantoin Monohydrate/macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207372",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin, USP is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin, USP in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Inactive Ingredients: Each capsule contains carbomer 934P, carboxymethylcellulose, corn starch, D&C Yellow No. 10, FD&C Red No. 40, gelatin, iron oxide black, iron oxide yellow, lactose, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate, sugar, talc and titanium dioxide. The black monogramming ink contains butyl alcohol, dehydrated alcohol, iron oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Meets USP Dissolution Test 7."
},
{
"NDCCode": "53002-7042-2",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (53002-7042-2) ",
"NDC11Code": "53002-7042-02",
"ProductNDC": "53002-7042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin",
"ProprietaryNameSuffix": "(monohydrate/macrocrystals)",
"NonProprietaryName": "Nitrofurantoin Monohydrate/macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207372",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin, USP is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin, USP in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Inactive Ingredients: Each capsule contains carbomer 934P, carboxymethylcellulose, corn starch, D&C Yellow No. 10, FD&C Red No. 40, gelatin, iron oxide black, iron oxide yellow, lactose, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate, sugar, talc and titanium dioxide. The black monogramming ink contains butyl alcohol, dehydrated alcohol, iron oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Meets USP Dissolution Test 7."
},
{
"NDCCode": "53002-7042-3",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (53002-7042-3) ",
"NDC11Code": "53002-7042-03",
"ProductNDC": "53002-7042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin",
"ProprietaryNameSuffix": "(monohydrate/macrocrystals)",
"NonProprietaryName": "Nitrofurantoin Monohydrate/macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207372",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin, USP is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin, USP in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Inactive Ingredients: Each capsule contains carbomer 934P, carboxymethylcellulose, corn starch, D&C Yellow No. 10, FD&C Red No. 40, gelatin, iron oxide black, iron oxide yellow, lactose, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate, sugar, talc and titanium dioxide. The black monogramming ink contains butyl alcohol, dehydrated alcohol, iron oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Meets USP Dissolution Test 7."
},
{
"NDCCode": "53002-7042-4",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (53002-7042-4) ",
"NDC11Code": "53002-7042-04",
"ProductNDC": "53002-7042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin",
"ProprietaryNameSuffix": "(monohydrate/macrocrystals)",
"NonProprietaryName": "Nitrofurantoin Monohydrate/macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207372",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin, USP is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin, USP in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Inactive Ingredients: Each capsule contains carbomer 934P, carboxymethylcellulose, corn starch, D&C Yellow No. 10, FD&C Red No. 40, gelatin, iron oxide black, iron oxide yellow, lactose, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate, sugar, talc and titanium dioxide. The black monogramming ink contains butyl alcohol, dehydrated alcohol, iron oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Meets USP Dissolution Test 7."
},
{
"NDCCode": "0904-7042-06",
"PackageDescription": "50 BLISTER PACK in 1 CARTON (0904-7042-06) / 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00904-7042-06",
"ProductNDC": "0904-7042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine Hydrochloride",
"NonProprietaryName": "Amantadine Hydrochloride",
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<NDCCode>58066-7042-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-7042-7) </PackageDescription>
<NDC11Code>58066-7042-07</NDC11Code>
<ProductNDC>58066-7042</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthritis Pain Relief</ProprietaryName>
<NonProprietaryName>Actaea, Aesculus Hipp, Arnica, Bellis, Bryonia, Calc Carb, Calc Fluor, Causticum, Cimicifuga, Formicum Acidum, Hypericum, Lac Vac, Ledum, Lithium Carb, Mag Phos, Phos, Phytolacca, Pulsatilla, Rhododendron, Rhus Tox, Ruta, Salicylicum Ac, Sepia, Zinc Met.</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>ACTAEA CIMICIFUGA ROOT; HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; COW MILK; RHODODENDRON TOMENTOSUM LEAFY TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; ANEMONE PULSATILLA; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; ZINC</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications: For temporary relief of: symptoms of joint pain, Stiffness & discomfort associated with arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58066-7001-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-7001-7)</PackageDescription>
<NDC11Code>58066-7001-07</NDC11Code>
<ProductNDC>58066-7001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acne Free</ProprietaryName>
<NonProprietaryName>Antimonium Tartaricum, Asterias Rubens, Ferrum Metallicum, Hepar Sulphuris Calcareum, Kali Bromatum, Lac Defloratum, Natrum Muriaticum, Sanguinaria Canadensis, Selenium Metallicum, Sepia, Silicea, Sulphur, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140115</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ASTERIAS RUBENS; IRON; CALCIUM SULFIDE; POTASSIUM BROMIDE; SKIM MILK; SODIUM CHLORIDE; SANGUINARIA CANADENSIS ROOT; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of: pimples & blemishes associated with acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58066-7002-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-7002-7)</PackageDescription>
<NDC11Code>58066-7002-07</NDC11Code>
<ProductNDC>58066-7002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin Irritation And Itch Response</ProprietaryName>
<NonProprietaryName>Agaricus Muscarius, Alumina, Anagallis Arvensis, Antimonium Tartaricum, Apis Mellifica, Arsenicum Album, Arsenicum Iodatum, Bovista, Causticum, Dolichos Pruriens, Fagapyrum Esculentum, Graphites, Kali Muriaticum, Lac Defloratum, Muriaticum Acidum, Oleander, Petroleum, Pix Liquida, Radium Bromatum, Rhus Toxicodendron, Selenium Metallicum, Sulphur, Urtica Urens</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130116</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>AMANITA MUSCARIA FRUITING BODY; ALUMINUM OXIDE; ANAGALLIS ARVENSIS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; LYCOPERDON UTRIFORME FRUITING BODY; CAUSTICUM; MUCUNA PRURIENS FRUIT TRICHOME; FAGOPYRUM ESCULENTUM; GRAPHITE; POTASSIUM CHLORIDE; SKIM MILK; HYDROCHLORIC ACID; NERIUM OLEANDER LEAF; KEROSENE; PINE TAR; RADIUM BROMIDE; TOXICODENDRON PUBESCENS LEAF; SELENIUM; SULFUR; URTICA URENS</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of: red, irritated, itchy skin, symptoms of impetigo, mild abscesses and boils.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58066-7003-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-7003-7)</PackageDescription>
<NDC11Code>58066-7003-07</NDC11Code>
<ProductNDC>58066-7003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gland Discomfort Relief</ProprietaryName>
<NonProprietaryName>Astacus Fluviatilis, Baryta Iodata, Calcarea Iodata, Cistus Canadensis, Clematis Erecta, Conium Maculatum, Iodium, Lacticum Acidum, Lac Defloratum, Mercurius Iodatus Ruber, Mercurius Vivus, Phytolacca Decandra, Scrophularia Nodosa, Spongia Tosta</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>ASTACUS ASTACUS; BARIUM IODIDE; CALCIUM IODIDE; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; IODINE; LACTIC ACID, DL-; SKIM MILK; MERCURIC IODIDE; MERCURY; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SPONGIA OFFICINALIS SKELETON, ROASTED</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of: enlarged and swollen glands, painful and inflamed glands of the jaw, neck, armpit and groin area. Associated with viral inflammations such as colds and flu.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58066-7011-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-7011-7)</PackageDescription>
<NDC11Code>58066-7011-07</NDC11Code>
<ProductNDC>58066-7011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy And Hay Fever Relief</ProprietaryName>
<NonProprietaryName>Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Arum Triphyllum, Arundo Mauritanica, Euphrasia Officinalis, Lac Defloratum, Naphthalinum, Natrum Muriaticum, Sabadilla, Wyethia Helenioides</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160502</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; EUPHRASIA STRICTA; SKIM MILK; NAPHTHALENE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; WYETHIA HELENIOIDES ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of allergy and hay fever symptoms such as: sneezing, runny nose, watery, red or itchy eyes. Use according to label indications and/or standard homeopathic indications.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58066-7012-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-7012-7)</PackageDescription>
<NDC11Code>58066-7012-07</NDC11Code>
<ProductNDC>58066-7012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colds And Flu Response</ProprietaryName>
<NonProprietaryName>Anas Barbariae, Hepatis Et Cordis Extractum, Arsenicum Album, Baptisia Tinctoria, Bryonia, Dulcamara, Echinacea, Echinacea Purpurea, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Kali Muriaticum, Lac Defloratum, Phosphorus, Pulsatilla, Sulphur, Zincum Aceticum, Zincum Carbonicum, Zincum Metallicum, Zincum Muriaticum, Zincum Oxydatum, Zincum Picricum, Zincum Valerianicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160428</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; SOLANUM DULCAMARA TOP; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM CHLORIDE; SKIM MILK; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; ZINC ACETATE ANHYDROUS; ZINC CARBONATE; ZINC; ZINC CHLORIDE; ZINC OXIDE; ZINC PICRATE NONAHYDRATE; ZINC VALERATE DIHYDRATE</SubstanceName>
<StrengthNumber>50; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_C]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; 1/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of: body aches & pains nasal congestion headaches & fevers associated with the common cold and flu. Use according to label indications under standard homeopathic indications.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58066-7013-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-7013-7)</PackageDescription>
<NDC11Code>58066-7013-07</NDC11Code>
<ProductNDC>58066-7013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Response</ProprietaryName>
<NonProprietaryName>Apis Mellifica, Baptisia Tinctoria, Colocynthis, Hepar Sulphuris Calcareum, Histaminum Hydrochloricum, Hydrastis Canadensis, Ignatia Amara, Kali Bichromicum, Lac Defloratum, Lemna Minor, Mercurius Vivus, Pulsatilla, Rhus Toxicodendron, Sabadilla, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160912</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; SKIM MILK; LEMNA MINOR; MERCURY; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of: nasal congestion, sinus pressure, sinus headaches associated with the common cold and flu.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58066-7014-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-7014-7)</PackageDescription>
<NDC11Code>58066-7014-07</NDC11Code>
<ProductNDC>58066-7014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sore Throat And Laryngitis Response</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Antimonium Crudum, Arum Triphyllum, Borax, Causticum, Ferrum Phosphoricum, Graphites, Hepar Sulphuris Calcareum, Kali Bichromicum, Lac Defloratum, Phosphorus, Selenium Metallicum, Spongia Tosta</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARISAEMA TRIPHYLLUM ROOT; SODIUM BORATE; CAUSTICUM; FERROSOFERRIC PHOSPHATE; GRAPHITE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; SKIM MILK; PHOSPHORUS; SELENIUM; SPONGIA OFFICINALIS SKELETON, ROASTED</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of: minor throat pain and irritation inflammation and laryngitis (loss of voice) associated with the common cold or flu.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58066-7022-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-7022-7)</PackageDescription>
<NDC11Code>58066-7022-07</NDC11Code>
<ProductNDC>58066-7022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diarrhea Response</ProprietaryName>
<NonProprietaryName>Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Colostrum, Croton Tiglium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110908</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; BOS TAURUS COLOSTRUM; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of: upset stomach and symptoms of stomach flu such as nausea and diarrhea. Use according to label indications and/or standard homeopathic indications.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58066-7041-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-7041-7)</PackageDescription>
<NDC11Code>58066-7041-07</NDC11Code>
<ProductNDC>58066-7041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Muscle And Joint Pain Relief</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Cimicifuga Racemosa, Cobaltum Metallicum, Gnaphalium Polycephalum, Hypericum Perforatum, Kali Carbonicum, Kali Phosphoricum, Lac Vaccinum, Magnesia Phosphorica, Oxalicum Acidum, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; COW MILK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of: symptoms of muscle, joint pain and discomfort.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58066-8012-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-8012-7)</PackageDescription>
<NDC11Code>58066-8012-07</NDC11Code>
<ProductNDC>58066-8012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Four Seasons Flu Relief</ProprietaryName>
<NonProprietaryName>Anas Barbariae, Hepatis Et Cordis Extractum, Arsenicum Album, Baptisia Tinctoria, Bryonia Alba, Causticum, Cinchona Officinalis, Dulcamara, Echinacea Purpurea, Eucalyptus Globulus, Eupatorium Purpureum, Gelsemium Sempervirens, Influenzinum, Lac Defloratum, Lachesis Mutus, Phytolacca Decandra, Rhus Toxicodendron, Sarcolacticum Acidum, Sulphur, Wyethia Helenioides</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150108</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUTROCHIUM PURPUREUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; SKIM MILK; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; WYETHIA HELENIOIDES ROOT</SubstanceName>
<StrengthNumber>35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_C]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of flu-like symptoms: Fever Fatigue Nausea Cough Runny nose Congestion Sore throat Diarrhea Headache. Use according to label indications and/or standard homeopathic indications.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0074-7042-04</NDCCode>
<PackageDescription>4 CARTON in 1 CARTON (0074-7042-04) / 1 KIT in 1 CARTON * 1 mL in 1 SYRINGE, GLASS (0074-7032-01) </PackageDescription>
<NDC11Code>00074-7042-04</NDC11Code>
<ProductNDC>0074-7042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Skyrizi</ProprietaryName>
<NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240304</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761105</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
<Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
</NDC>
<NDC>
<NDCCode>50090-7042-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (50090-7042-0) </PackageDescription>
<NDC11Code>50090-7042-00</NDC11Code>
<ProductNDC>50090-7042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209587</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients. Inactive Ingredients: silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>50090-7042-3</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (50090-7042-3) </PackageDescription>
<NDC11Code>50090-7042-03</NDC11Code>
<ProductNDC>50090-7042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209587</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients. Inactive Ingredients: silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>53002-7042-1</NDCCode>
<PackageDescription>6 CAPSULE in 1 BOTTLE (53002-7042-1) </PackageDescription>
<NDC11Code>53002-7042-01</NDC11Code>
<ProductNDC>53002-7042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin</ProprietaryName>
<ProprietaryNameSuffix>(monohydrate/macrocrystals)</ProprietaryNameSuffix>
<NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207372</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin, USP is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin, USP in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Inactive Ingredients: Each capsule contains carbomer 934P, carboxymethylcellulose, corn starch, D&C Yellow No. 10, FD&C Red No. 40, gelatin, iron oxide black, iron oxide yellow, lactose, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate, sugar, talc and titanium dioxide. The black monogramming ink contains butyl alcohol, dehydrated alcohol, iron oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>53002-7042-2</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE (53002-7042-2) </PackageDescription>
<NDC11Code>53002-7042-02</NDC11Code>
<ProductNDC>53002-7042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin</ProprietaryName>
<ProprietaryNameSuffix>(monohydrate/macrocrystals)</ProprietaryNameSuffix>
<NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207372</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin, USP is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin, USP in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Inactive Ingredients: Each capsule contains carbomer 934P, carboxymethylcellulose, corn starch, D&C Yellow No. 10, FD&C Red No. 40, gelatin, iron oxide black, iron oxide yellow, lactose, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate, sugar, talc and titanium dioxide. The black monogramming ink contains butyl alcohol, dehydrated alcohol, iron oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>53002-7042-3</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (53002-7042-3) </PackageDescription>
<NDC11Code>53002-7042-03</NDC11Code>
<ProductNDC>53002-7042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin</ProprietaryName>
<ProprietaryNameSuffix>(monohydrate/macrocrystals)</ProprietaryNameSuffix>
<NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207372</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin, USP is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin, USP in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Inactive Ingredients: Each capsule contains carbomer 934P, carboxymethylcellulose, corn starch, D&C Yellow No. 10, FD&C Red No. 40, gelatin, iron oxide black, iron oxide yellow, lactose, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate, sugar, talc and titanium dioxide. The black monogramming ink contains butyl alcohol, dehydrated alcohol, iron oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Meets USP Dissolution Test 7.</Description>
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<NDCCode>53002-7042-4</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (53002-7042-4) </PackageDescription>
<NDC11Code>53002-7042-04</NDC11Code>
<ProductNDC>53002-7042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin</ProprietaryName>
<ProprietaryNameSuffix>(monohydrate/macrocrystals)</ProprietaryNameSuffix>
<NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207372</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin, USP is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin, USP in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Inactive Ingredients: Each capsule contains carbomer 934P, carboxymethylcellulose, corn starch, D&C Yellow No. 10, FD&C Red No. 40, gelatin, iron oxide black, iron oxide yellow, lactose, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate, sugar, talc and titanium dioxide. The black monogramming ink contains butyl alcohol, dehydrated alcohol, iron oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>0904-7042-06</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 CARTON (0904-7042-06) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7042-06</NDC11Code>
<ProductNDC>0904-7042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209171</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride capsules are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules. : 1 Amantadine hydrochloride capsules are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices., 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules.</IndicationAndUsage>
<Description>Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H17N.HCl. It has the following structural formula. Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each amantadine hydrochloride capsule, USP intended for oral administration contains 100 mg amantadine hydrochloride, USP. Each capsule also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The capsule shell contains the following: FD&C Blue No. 1, FD&C Red No. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains the following: potassium hydroxide, shellac and titanium dioxide. Product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0904-7042-40</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (0904-7042-40) </PackageDescription>
<NDC11Code>00904-7042-40</NDC11Code>
<ProductNDC>0904-7042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209171</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride capsules are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules. : 1 Amantadine hydrochloride capsules are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices., 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules.</IndicationAndUsage>
<Description>Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H17N.HCl. It has the following structural formula. Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each amantadine hydrochloride capsule, USP intended for oral administration contains 100 mg amantadine hydrochloride, USP. Each capsule also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The capsule shell contains the following: FD&C Blue No. 1, FD&C Red No. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains the following: potassium hydroxide, shellac and titanium dioxide. Product meets USP Dissolution Test 2.</Description>
</NDC>
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<NDCCode>0904-7042-59</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0904-7042-59) </PackageDescription>
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<ProductNDC>0904-7042</ProductNDC>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209171</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride capsules are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules. : 1 Amantadine hydrochloride capsules are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices., 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules.</IndicationAndUsage>
<Description>Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H17N.HCl. It has the following structural formula. Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each amantadine hydrochloride capsule, USP intended for oral administration contains 100 mg amantadine hydrochloride, USP. Each capsule also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The capsule shell contains the following: FD&C Blue No. 1, FD&C Red No. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains the following: potassium hydroxide, shellac and titanium dioxide. Product meets USP Dissolution Test 2.</Description>
</NDC>
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<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride capsules are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules. : 1 Amantadine hydrochloride capsules are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices., 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules.</IndicationAndUsage>
<Description>Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H17N.HCl. It has the following structural formula. Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each amantadine hydrochloride capsule, USP intended for oral administration contains 100 mg amantadine hydrochloride, USP. Each capsule also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The capsule shell contains the following: FD&C Blue No. 1, FD&C Red No. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains the following: potassium hydroxide, shellac and titanium dioxide. Product meets USP Dissolution Test 2.</Description>
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<LabelerName>Uriel Pharmacy Inc.</LabelerName>
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<StrengthUnit>[hp_X]/mL</StrengthUnit>
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<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
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<NonProprietaryName>Aconitum Napellus, Argentum Nitricum, Arnica Montana, Valeriana Officinalis</NonProprietaryName>
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<LabelerName>Nova Homeopathic Therapeutics, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; SILVER NITRATE; ARNICA MONTANA; VALERIAN</SubstanceName>
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<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For oral use only.</IndicationAndUsage>
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<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxytocin</NonProprietaryName>
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<EndMarketingDate>20180731</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
</NDC>
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<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxytocin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140325</StartMarketingDate>
<EndMarketingDate>20180731</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>58597-7042-3</NDCCode>
<PackageDescription>1 g in 1 BOTTLE (58597-7042-3)</PackageDescription>
<NDC11Code>58597-7042-03</NDC11Code>
<ProductNDC>58597-7042</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxytocin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140325</StartMarketingDate>
<EndMarketingDate>20180731</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>58937-7042-1</NDCCode>
<PackageDescription>1 g in 1 CONTAINER (58937-7042-1)</PackageDescription>
<NDC11Code>58937-7042-01</NDC11Code>
<ProductNDC>58937-7042</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxytocin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140320</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>LUMIS GLOBAL PHARMACEUTICALS CO LTD</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58937-7042-4</NDCCode>
<PackageDescription>25 g in 1 CONTAINER (58937-7042-4)</PackageDescription>
<NDC11Code>58937-7042-04</NDC11Code>
<ProductNDC>58937-7042</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxytocin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140320</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>LUMIS GLOBAL PHARMACEUTICALS CO LTD</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58937-7042-6</NDCCode>
<PackageDescription>100 g in 1 CONTAINER (58937-7042-6)</PackageDescription>
<NDC11Code>58937-7042-06</NDC11Code>
<ProductNDC>58937-7042</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxytocin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140320</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>LUMIS GLOBAL PHARMACEUTICALS CO LTD</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>