{
"NDC": [
{
"NDCCode": "43695-0003-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0003-1)",
"NDC11Code": "43695-0003-01",
"ProductNDC": "43695-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Venapro",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Calcarea Fluorica, Carduus Marianus, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Ratanhia,",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20140515",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Pacific Naturals",
"SubstanceName": "HORSE CHESTNUT; ARNICA MONTANA; CALCIUM FLUORIDE; MILK THISTLE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT",
"StrengthNumber": "1; 3; 10; 1; 3; 1; 6; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Treats symptoms associated with hemorrhoids."
},
{
"NDCCode": "43695-0001-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0001-1)",
"NDC11Code": "43695-0001-01",
"ProductNDC": "43695-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Libido For Her",
"NonProprietaryName": "Agnus Castus, Berberis Vulgaris, Damiana, Graphites, Ignatia Amara, Lactuca Virosa, Onosmodium Virginianum,",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120425",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Pacific Naturals",
"SubstanceName": "CHASTE TREE; BERBERIS VULGARIS ROOT BARK; TURNERA DIFFUSA LEAFY TWIG; GRAPHITE; STRYCHNOS IGNATII SEED; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE",
"StrengthNumber": "3; 6; 1; 8; 6; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INDICATIONS: Temporarily relieves symptoms of low female sexual energy."
},
{
"NDCCode": "43695-0002-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0002-1)",
"NDC11Code": "43695-0002-01",
"ProductNDC": "43695-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smoke Deter",
"NonProprietaryName": "Abies Nigra, Aconitum Napellus, Arsenicum Iodatum, Avena Sativa, Ignatia Amara, Lung Suis, Nux Vomica,",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20141218",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Pacific Naturals",
"SubstanceName": "PICEA MARIANA RESIN; ACONITUM NAPELLUS; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; SUS SCROFA LUNG; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; TOBACCO LEAF",
"StrengthNumber": "10; 200; 200; 1; 200; 6; 10; 3; 3; 200; 200",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Temporarily relieves symptoms associated with nicotine withdrawal, such as: craving for cigarettes, nervousness, insomnia, cough, and increased appetite."
},
{
"NDCCode": "43695-0004-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0004-1)",
"NDC11Code": "43695-0004-01",
"ProductNDC": "43695-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Miracet",
"NonProprietaryName": "Abies Nigra, Aconitum Napellus, Arsenicum Iodatum, Avena Sativa, Ignatia Amara, Lung Suis, Nux Vomica, Plantago Major, Quebracho",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Pacific Naturals",
"SubstanceName": "PICEA MARIANA RESIN; ACONITUM NAPELLUS; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; SUS SCROFA LUNG; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; TOBACCO LEAF",
"StrengthNumber": "10; 200; 200; 1; 200; 6; 10; 3; 3; 200; 200",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Relieves symptoms associated with nicotine withdrawal, such as: craving for cigarettes, nervousness, insomnia, cough, and increased appetite."
},
{
"NDCCode": "43695-0005-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0005-1)",
"NDC11Code": "43695-0005-01",
"ProductNDC": "43695-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zeta Clear",
"NonProprietaryName": "Antimonium Crudum, Arsenicum Album, Mancinella, Nitricum Acidum, Sulphur, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130425",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Pacific Naturals",
"SubstanceName": "ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; NITRIC ACID; SULFUR; THUJA OCCIDENTALIS LEAF",
"StrengthNumber": "200; 200; 30; 30; 12; 200",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Treats the symptoms of funal infections of the toenail such as toenails that are: discolored; brittle, crumbly or ragged; separated from the nail bed; and or painful."
},
{
"NDCCode": "43695-0006-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0006-1)",
"NDC11Code": "43695-0006-01",
"ProductNDC": "43695-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Yeastrol",
"NonProprietaryName": "Baptisia Tinctoria, Borax, Candida Albicans, Candida Parapsilosis, Echinacea (angustifolia), Kreosotum, Mercurius Cyanatus, Mercurius Sulphuratus Ruber, Nitricum Acidum, Pyrogenium, Sulphuricum Acidum, Thuja Occidentalis",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150318",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Pacific Naturals",
"SubstanceName": "BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA ANGUSTIFOLIA; WOOD CREOSOTE; MERCURIC CYANIDE; MERCURIC SULFIDE; NITRIC ACID; RANCID BEEF; SULFURIC ACID; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "3; 30; 12; 12; 3; 30; 30; 30; 30; 200; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Relieves symptoms associated with fungus or yeast infections in Men and Women, including: abdominal distention and bloating, urgent need to urinate, vaginal discomfort and vaginal discharge."
},
{
"NDCCode": "43695-0007-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0007-1) ",
"NDC11Code": "43695-0007-01",
"ProductNDC": "43695-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boilx",
"NonProprietaryName": "Anthracinum, Baptisia Tinctoria, Calcarea Picrata, Echinacea (angustifolia), Hepar Sulphuris Calcareum, Mercurius Corrosivus, Pyrogenium",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150109",
"EndMarketingDate": "20181014",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Global Naturals, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; CALCIUM PICRATE; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; MERCURIC CHLORIDE; RANCID BEEF",
"StrengthNumber": "30; 3; 6; 3; 200; 200; 200",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2018-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170104",
"EndMarketingDatePackage": "20181014",
"SamplePackage": "N"
},
{
"NDCCode": "43695-0008-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0008-1)",
"NDC11Code": "43695-0008-01",
"ProductNDC": "43695-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wartrol",
"NonProprietaryName": "Antimonioum Crudum, Baptisia Tinctoria, Causticum, Nitricum Acidum, Thuja Occidentalis",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Pacific Naturals",
"SubstanceName": "ANTIMONY TRISULFIDE; BAPTISIA TINCTORIA ROOT; CAUSTICUM; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "30; 3; 200; 200; 200",
"StrengthUnit": "[hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Helps reduce appearance and discomfort of warts on any area of the body."
},
{
"NDCCode": "43695-0009-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0009-1)",
"NDC11Code": "43695-0009-01",
"ProductNDC": "43695-0009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tinnitus Control",
"NonProprietaryName": "Not Applicable",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20141014",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Pacific Naturals",
"SubstanceName": "ARNICA MONTANA; QUININE SULFATE; IRON; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; ALLYLTHIOUREA",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Helps relieve symptoms of Tinnitus."
},
{
"NDCCode": "43695-0010-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0010-1) ",
"NDC11Code": "43695-0010-01",
"ProductNDC": "43695-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oxyhives",
"NonProprietaryName": "Apis Mellifica, Arnica Montana, Hepar Suis, Ichthyolum, Lachesis Mutus, Mercurius Solubilis, Rhus Tox, Urtica Urens",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150326",
"EndMarketingDate": "20260813",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Global Naturals, Inc.",
"SubstanceName": "APIS MELLIFERA; ARNICA MONTANA; PORK LIVER; ICHTHAMMOL; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; TOXICODENDRON PUBESCENS LEAF; URTICA URENS",
"StrengthNumber": "200; 6; 6; 30; 200; 6; 200; 200",
"StrengthUnit": "[hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160504",
"EndMarketingDatePackage": "20260813",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves symptoms associated with Hives."
},
{
"NDCCode": "43695-0011-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0011-1) ",
"NDC11Code": "43695-0011-01",
"ProductNDC": "43695-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Herpeset",
"NonProprietaryName": "Apis Mellifica, Arsenicum Album, Baptisia Tinctoria, Capsicum Annuum, Dulcamara, Echinacea, Nitricum Acidum, Pyrogenium, Rhus Tox",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170406",
"EndMarketingDate": "20230912",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Global Naturals, Inc.",
"SubstanceName": "APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CAPSICUM; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; RANCID BEEF; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "3; 200; 3; 6; 3; 200; 200; 30; 200",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170406",
"EndMarketingDatePackage": "20230912",
"SamplePackage": "N"
},
{
"NDCCode": "43695-0012-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43695-0012-1) ",
"NDC11Code": "43695-0012-01",
"ProductNDC": "43695-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boilx",
"NonProprietaryName": "Anthracinum, Baptisia Tinctoria, Calcarea Picrata, Echinacea (angustifolia), Hepar Sulphuris Calcareum, Mercurius Corrosivus, Pyrogenium",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"EndMarketingDate": "20260719",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Global Naturals, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; CALCIUM PICRATE; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; MERCURIC CHLORIDE; RANCID BEEF",
"StrengthNumber": "30; 3; 10; 200; 3; 200; 200",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180601",
"EndMarketingDatePackage": "20260719",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves symptoms associated with Boils."
},
{
"NDCCode": "0003-0011-01",
"PackageDescription": "28 TABLET in 1 BOTTLE (0003-0011-01) ",
"NDC11Code": "00003-0011-01",
"ProductNDC": "0003-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daklinza",
"NonProprietaryName": "Daclatasvir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160518",
"EndMarketingDate": "20190430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206843",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "DACLATASVIR DIHYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160518",
"EndMarketingDatePackage": "20190430",
"SamplePackage": "N"
},
{
"NDCCode": "0003-0050-14",
"PackageDescription": "14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-0050-14) ",
"NDC11Code": "00003-0050-14",
"ProductNDC": "0003-0050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "XANOMELINE; TROSPIUM CHLORIDE",
"StrengthNumber": "50; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240927",
"SamplePackage": "Y",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0003-0050-60",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-0050-60) ",
"NDC11Code": "00003-0050-60",
"ProductNDC": "0003-0050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "XANOMELINE; TROSPIUM CHLORIDE",
"StrengthNumber": "50; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240927",
"SamplePackage": "N",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0003-0050-98",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0003-0050-98) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK",
"NDC11Code": "00003-0050-98",
"ProductNDC": "0003-0050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "XANOMELINE; TROSPIUM CHLORIDE",
"StrengthNumber": "50; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20260615",
"SamplePackage": "N",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0003-0125-14",
"PackageDescription": "14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-0125-14) ",
"NDC11Code": "00003-0125-14",
"ProductNDC": "0003-0125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "XANOMELINE; TROSPIUM CHLORIDE",
"StrengthNumber": "125; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20240927",
"SamplePackage": "Y",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0003-0125-60",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-0125-60) ",
"NDC11Code": "00003-0125-60",
"ProductNDC": "0003-0125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "XANOMELINE; TROSPIUM CHLORIDE",
"StrengthNumber": "125; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0003-0125-98",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0003-0125-98) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK",
"NDC11Code": "00003-0125-98",
"ProductNDC": "0003-0125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "XANOMELINE; TROSPIUM CHLORIDE",
"StrengthNumber": "125; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260615",
"SamplePackage": "N",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0003-0213-01",
"PackageDescription": "28 TABLET in 1 BOTTLE (0003-0213-01) ",
"NDC11Code": "00003-0213-01",
"ProductNDC": "0003-0213",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daklinza",
"NonProprietaryName": "Daclatasvir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150727",
"EndMarketingDate": "20200630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206843",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "DACLATASVIR DIHYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150727",
"EndMarketingDatePackage": "20200630",
"SamplePackage": "N"
},
{
"NDCCode": "0003-0215-01",
"PackageDescription": "28 TABLET in 1 BOTTLE (0003-0215-01) ",
"NDC11Code": "00003-0215-01",
"ProductNDC": "0003-0215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daklinza",
"NonProprietaryName": "Daclatasvir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150727",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206843",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "DACLATASVIR DIHYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150727",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "0003-0249-15",
"PackageDescription": "20 mL in 1 BOTTLE, PLASTIC (0003-0249-15)",
"NDC11Code": "00003-0249-15",
"ProductNDC": "0003-0249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Halog",
"NonProprietaryName": "Halcinonide",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017823",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "HALCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2014-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090101",
"SamplePackage": "N"
},
{
"NDCCode": "0003-0249-20",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (0003-0249-20)",
"NDC11Code": "00003-0249-20",
"ProductNDC": "0003-0249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Halog",
"NonProprietaryName": "Halcinonide",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017823",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "HALCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2014-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090101",
"SamplePackage": "N"
},
{
"NDCCode": "0003-0293-05",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0003-0293-05) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00003-0293-05",
"ProductNDC": "0003-0293",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kenalog-40",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRA-ARTICULAR; INTRAMUSCULAR",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014901",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090601",
"SamplePackage": "N",
"IndicationAndUsage": "Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol."
},
{
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"NDC11Code": "00003-0293-20",
"ProductNDC": "0003-0293",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kenalog-40",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRA-ARTICULAR; INTRAMUSCULAR",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014901",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090601",
"SamplePackage": "N",
"IndicationAndUsage": "Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol."
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"ProductNDC": "0003-0293",
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"MarketingCategoryName": "NDA",
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"LabelerName": "E.R. Squibb & Sons, L.L.C.",
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"IndicationAndUsage": "Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol."
},
{
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"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0003-0315-05) / 1 mL in 1 VIAL, SINGLE-DOSE",
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"ProductNDC": "0003-0315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kenalog-80",
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"StartMarketingDate": "20190412",
"MarketingCategoryName": "NDA",
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"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
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"IndicationAndUsage": "Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol."
},
{
"NDCCode": "0003-0315-20",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0003-0315-20) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00003-0315-20",
"ProductNDC": "0003-0315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kenalog-80",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRA-ARTICULAR; INTRAMUSCULAR",
"StartMarketingDate": "20190412",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014901",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
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"StrengthUnit": "mg/mL",
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"Status": "Active",
"LastUpdate": "2024-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol."
},
{
"NDCCode": "0003-0371-13",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0003-0371-13) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE",
"NDC11Code": "00003-0371-13",
"ProductNDC": "0003-0371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nulojix",
"NonProprietaryName": "Belatacept",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125288",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "BELATACEPT",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "CD80-directed Antibody Interactions [MoA], CD86-directed Antibody Interactions [MoA], Selective T Cell Costimulation Blocker [EPC], T Lymphocyte Costimulation Activity Blockade [PE]",
"Status": "Active",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "NULOJIX is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. (1.1). Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. (1.1).",
"Description": "NULOJIX® (belatacept), a selective T cell costimulation blocker, is a soluble fusion protein consisting of the modified extracellular domain of CTLA-4 fused to a portion (hinge-CH2-CH3 domains) of the Fc domain of a human immunoglobulin G1 antibody. Belatacept is produced by recombinant DNA technology in a mammalian cell expression system. Two amino acid substitutions (L104 to E; A29 to Y) were made in the ligand binding region of CTLA-4. As a result of these modifications, belatacept binds CD80 and CD86 more avidly than abatacept, the parent CTLA4-Immunoglobulin (CTLA4-Ig) molecule from which it is derived. The molecular weight of belatacept is approximately 90 kilodaltons. NULOJIX is supplied as a sterile, white or off-white lyophilized powder for intravenous administration. Prior to use, the lyophile is reconstituted with a suitable fluid to obtain a clear to slightly opalescent, colorless to pale yellow solution, with a pH in the range of 7.2 to 7.8. Suitable fluids for constitution of the lyophile include SWFI, 0.9% NS, or D5W [see Dosage and Administration (2.2)]. Each 250 mg single-use vial of NULOJIX also contains: monobasic sodium phosphate (34.5 mg), sodium chloride (5.8 mg), and sucrose (500 mg)."
},
{
"NDCCode": "0003-0494-20",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0003-0494-20) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00003-0494-20",
"ProductNDC": "0003-0494",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kenalog-10",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRA-ARTICULAR; INTRALESIONAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012041",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-28",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20090601",
"SamplePackage": "N",
"IndicationAndUsage": "The intra-articular or soft tissue administration of KENALOG-10 Injection (triamcinolone acetonide injectable suspension, USP) is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.",
"Description": "KENALOG®-10 Injection (triamcinolone acetonide injectable suspension, USP) is triamcinolone acetonide, a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra-articular injection. THIS FORMULATION IS SUITABLE FOR INTRA-ARTICULAR AND INTRALESIONAL USE ONLY. Each mL of the sterile aqueous suspension provides 10 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50."
}
]
}
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<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141218</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Pacific Naturals</LabelerName>
<SubstanceName>PICEA MARIANA RESIN; ACONITUM NAPELLUS; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; SUS SCROFA LUNG; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; TOBACCO LEAF</SubstanceName>
<StrengthNumber>10; 200; 200; 1; 200; 6; 10; 3; 3; 200; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily relieves symptoms associated with nicotine withdrawal, such as: craving for cigarettes, nervousness, insomnia, cough, and increased appetite.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43695-0004-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (43695-0004-1)</PackageDescription>
<NDC11Code>43695-0004-01</NDC11Code>
<ProductNDC>43695-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Miracet</ProprietaryName>
<NonProprietaryName>Abies Nigra, Aconitum Napellus, Arsenicum Iodatum, Avena Sativa, Ignatia Amara, Lung Suis, Nux Vomica, Plantago Major, Quebracho</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Pacific Naturals</LabelerName>
<SubstanceName>PICEA MARIANA RESIN; ACONITUM NAPELLUS; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; SUS SCROFA LUNG; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; TOBACCO LEAF</SubstanceName>
<StrengthNumber>10; 200; 200; 1; 200; 6; 10; 3; 3; 200; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Relieves symptoms associated with nicotine withdrawal, such as: craving for cigarettes, nervousness, insomnia, cough, and increased appetite.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43695-0005-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (43695-0005-1)</PackageDescription>
<NDC11Code>43695-0005-01</NDC11Code>
<ProductNDC>43695-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zeta Clear</ProprietaryName>
<NonProprietaryName>Antimonium Crudum, Arsenicum Album, Mancinella, Nitricum Acidum, Sulphur, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130425</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Pacific Naturals</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; NITRIC ACID; SULFUR; THUJA OCCIDENTALIS LEAF</SubstanceName>
<StrengthNumber>200; 200; 30; 30; 12; 200</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Treats the symptoms of funal infections of the toenail such as toenails that are: discolored; brittle, crumbly or ragged; separated from the nail bed; and or painful.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43695-0006-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (43695-0006-1)</PackageDescription>
<NDC11Code>43695-0006-01</NDC11Code>
<ProductNDC>43695-0006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Yeastrol</ProprietaryName>
<NonProprietaryName>Baptisia Tinctoria, Borax, Candida Albicans, Candida Parapsilosis, Echinacea (angustifolia), Kreosotum, Mercurius Cyanatus, Mercurius Sulphuratus Ruber, Nitricum Acidum, Pyrogenium, Sulphuricum Acidum, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150318</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Pacific Naturals</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA ANGUSTIFOLIA; WOOD CREOSOTE; MERCURIC CYANIDE; MERCURIC SULFIDE; NITRIC ACID; RANCID BEEF; SULFURIC ACID; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>3; 30; 12; 12; 3; 30; 30; 30; 30; 200; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Relieves symptoms associated with fungus or yeast infections in Men and Women, including: abdominal distention and bloating, urgent need to urinate, vaginal discomfort and vaginal discharge.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43695-0007-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (43695-0007-1) </PackageDescription>
<NDC11Code>43695-0007-01</NDC11Code>
<ProductNDC>43695-0007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boilx</ProprietaryName>
<NonProprietaryName>Anthracinum, Baptisia Tinctoria, Calcarea Picrata, Echinacea (angustifolia), Hepar Sulphuris Calcareum, Mercurius Corrosivus, Pyrogenium</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150109</StartMarketingDate>
<EndMarketingDate>20181014</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Global Naturals, Inc.</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; CALCIUM PICRATE; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; MERCURIC CHLORIDE; RANCID BEEF</SubstanceName>
<StrengthNumber>30; 3; 6; 3; 200; 200; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170104</StartMarketingDatePackage>
<EndMarketingDatePackage>20181014</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43695-0008-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (43695-0008-1)</PackageDescription>
<NDC11Code>43695-0008-01</NDC11Code>
<ProductNDC>43695-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wartrol</ProprietaryName>
<NonProprietaryName>Antimonioum Crudum, Baptisia Tinctoria, Causticum, Nitricum Acidum, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150109</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Pacific Naturals</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; BAPTISIA TINCTORIA ROOT; CAUSTICUM; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>30; 3; 200; 200; 200</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps reduce appearance and discomfort of warts on any area of the body.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43695-0009-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (43695-0009-1)</PackageDescription>
<NDC11Code>43695-0009-01</NDC11Code>
<ProductNDC>43695-0009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tinnitus Control</ProprietaryName>
<NonProprietaryName>Not Applicable</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141014</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Pacific Naturals</LabelerName>
<SubstanceName>ARNICA MONTANA; QUININE SULFATE; IRON; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; ALLYLTHIOUREA</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps relieve symptoms of Tinnitus.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43695-0010-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (43695-0010-1) </PackageDescription>
<NDC11Code>43695-0010-01</NDC11Code>
<ProductNDC>43695-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oxyhives</ProprietaryName>
<NonProprietaryName>Apis Mellifica, Arnica Montana, Hepar Suis, Ichthyolum, Lachesis Mutus, Mercurius Solubilis, Rhus Tox, Urtica Urens</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150326</StartMarketingDate>
<EndMarketingDate>20260813</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Global Naturals, Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; ARNICA MONTANA; PORK LIVER; ICHTHAMMOL; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; TOXICODENDRON PUBESCENS LEAF; URTICA URENS</SubstanceName>
<StrengthNumber>200; 6; 6; 30; 200; 6; 200; 200</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160504</StartMarketingDatePackage>
<EndMarketingDatePackage>20260813</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves symptoms associated with Hives.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43695-0011-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (43695-0011-1) </PackageDescription>
<NDC11Code>43695-0011-01</NDC11Code>
<ProductNDC>43695-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Herpeset</ProprietaryName>
<NonProprietaryName>Apis Mellifica, Arsenicum Album, Baptisia Tinctoria, Capsicum Annuum, Dulcamara, Echinacea, Nitricum Acidum, Pyrogenium, Rhus Tox</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170406</StartMarketingDate>
<EndMarketingDate>20230912</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Global Naturals, Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CAPSICUM; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; RANCID BEEF; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>3; 200; 3; 6; 3; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170406</StartMarketingDatePackage>
<EndMarketingDatePackage>20230912</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43695-0012-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (43695-0012-1) </PackageDescription>
<NDC11Code>43695-0012-01</NDC11Code>
<ProductNDC>43695-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boilx</ProprietaryName>
<NonProprietaryName>Anthracinum, Baptisia Tinctoria, Calcarea Picrata, Echinacea (angustifolia), Hepar Sulphuris Calcareum, Mercurius Corrosivus, Pyrogenium</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<EndMarketingDate>20260719</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Global Naturals, Inc.</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; CALCIUM PICRATE; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; MERCURIC CHLORIDE; RANCID BEEF</SubstanceName>
<StrengthNumber>30; 3; 10; 200; 3; 200; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<EndMarketingDatePackage>20260719</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves symptoms associated with Boils.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0003-0011-01</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (0003-0011-01) </PackageDescription>
<NDC11Code>00003-0011-01</NDC11Code>
<ProductNDC>0003-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daklinza</ProprietaryName>
<NonProprietaryName>Daclatasvir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160518</StartMarketingDate>
<EndMarketingDate>20190430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206843</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>DACLATASVIR DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160518</StartMarketingDatePackage>
<EndMarketingDatePackage>20190430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0003-0050-14</NDCCode>
<PackageDescription>14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-0050-14) </PackageDescription>
<NDC11Code>00003-0050-14</NDC11Code>
<ProductNDC>0003-0050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cobenfy</ProprietaryName>
<NonProprietaryName>Xanomeline And Trospium Chloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216158</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>XANOMELINE; TROSPIUM CHLORIDE</SubstanceName>
<StrengthNumber>50; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240927</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>COBENFY is indicated for the treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
</NDC>
<NDC>
<NDCCode>0003-0050-60</NDCCode>
<PackageDescription>60 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-0050-60) </PackageDescription>
<NDC11Code>00003-0050-60</NDC11Code>
<ProductNDC>0003-0050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cobenfy</ProprietaryName>
<NonProprietaryName>Xanomeline And Trospium Chloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216158</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>XANOMELINE; TROSPIUM CHLORIDE</SubstanceName>
<StrengthNumber>50; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COBENFY is indicated for the treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
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<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
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<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
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<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
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<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
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<Pharm_Classes>Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]</Pharm_Classes>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Halog</ProprietaryName>
<NonProprietaryName>Halcinonide</NonProprietaryName>
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<ProprietaryName>Kenalog-40</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
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<IndicationAndUsage>Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol.</Description>
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<Description>KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol.</Description>
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<Description>KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol.</Description>
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<Description>KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol.</Description>
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<Description>KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol.</Description>
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<Description>NULOJIX® (belatacept), a selective T cell costimulation blocker, is a soluble fusion protein consisting of the modified extracellular domain of CTLA-4 fused to a portion (hinge-CH2-CH3 domains) of the Fc domain of a human immunoglobulin G1 antibody. Belatacept is produced by recombinant DNA technology in a mammalian cell expression system. Two amino acid substitutions (L104 to E; A29 to Y) were made in the ligand binding region of CTLA-4. As a result of these modifications, belatacept binds CD80 and CD86 more avidly than abatacept, the parent CTLA4-Immunoglobulin (CTLA4-Ig) molecule from which it is derived. The molecular weight of belatacept is approximately 90 kilodaltons. NULOJIX is supplied as a sterile, white or off-white lyophilized powder for intravenous administration. Prior to use, the lyophile is reconstituted with a suitable fluid to obtain a clear to slightly opalescent, colorless to pale yellow solution, with a pH in the range of 7.2 to 7.8. Suitable fluids for constitution of the lyophile include SWFI, 0.9% NS, or D5W [see Dosage and Administration (2.2)]. Each 250 mg single-use vial of NULOJIX also contains: monobasic sodium phosphate (34.5 mg), sodium chloride (5.8 mg), and sucrose (500 mg).</Description>
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<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRA-ARTICULAR; INTRALESIONAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012041</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The intra-articular or soft tissue administration of KENALOG-10 Injection (triamcinolone acetonide injectable suspension, USP) is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.</IndicationAndUsage>
<Description>KENALOG®-10 Injection (triamcinolone acetonide injectable suspension, USP) is triamcinolone acetonide, a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra-articular injection. THIS FORMULATION IS SUITABLE FOR INTRA-ARTICULAR AND INTRALESIONAL USE ONLY. Each mL of the sterile aqueous suspension provides 10 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50.</Description>
</NDC>
</NDCList>