{
"NDC": [
{
"NDCCode": "27281-007-96",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (27281-007-96)",
"NDC11Code": "27281-0007-96",
"ProductNDC": "27281-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diabetigen",
"NonProprietaryName": "Arnica Montana, Arsenic Trioxide, Herring Sperm Nda, Echinacea, Unspecified, Hamamelis Virginiana Leaf, Chamaelirium Luteum Root, Pork Liver, Iris Versicolor Root, Sus Scrofa Pancreas, Phosphoric Acid, Rosmarinus Officinalis Flowering Top, Claviceps Purpurea Sclerotium, Syzygium Cumini Seed, And Uranyl Nitrate Hexahydrate",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20131209",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "ARNICA MONTANA; ARSENIC TRIOXIDE; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; CHAMAELIRIUM LUTEUM ROOT; PORK LIVER; IRIS VERSICOLOR ROOT; SUS SCROFA PANCREAS; PHOSPHORIC ACID; ROSMARINUS OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE",
"StrengthNumber": "1.5; 200; 3; 1.5; 1.5; 1.5; 3; 3; 3; 200; 1.5; 30; 1.5; 30",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Temporarily relieves symptoms associated with type II diabetes, including: pancreatic deficiency; liver weakness; apathy and generalized feelings of weakness."
},
{
"NDCCode": "71301-007-01",
"PackageDescription": "96 TUBE in 1 PACKAGE (71301-007-01) > 59.14 mL in 1 TUBE",
"NDC11Code": "71301-0007-01",
"ProductNDC": "71301-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Zone Pain Relieving Gel- Dg Health",
"NonProprietaryName": "Menthol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180122",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Yash Pharmaceuticals",
"SubstanceName": "MENTHOL",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180412",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief from minor aches and pains of sore muscles and joints associated with: - arthritis - backache - strains - sprains."
},
{
"NDCCode": "72164-007-00",
"PackageDescription": "96 g in 1 TUBE (72164-007-00) ",
"NDC11Code": "72164-0007-00",
"ProductNDC": "72164-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanilla Lavender Mint",
"NonProprietaryName": "Potassium Nitrate, Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Smiletwice, Inc.",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 1.5",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. Aids in prevention of dental cavities."
},
{
"NDCCode": "27281-001-96",
"PackageDescription": "30 mL in 1 PACKAGE (27281-001-96)",
"NDC11Code": "27281-0001-96",
"ProductNDC": "27281-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Brain Power",
"NonProprietaryName": "Semecarpus Anacardium Juice, Arnica Montana, Calcium Fluoride, Silybum Marianum Seed, Chincona Officinalis Bark, Herring Sperm Dna, Ginkgo, Egg Phospholipids, Achillea Millefolium, Phosphoric Acid, Saccharomyces Cerevisia Rna, Silicon Dioxide, And Zinc Sulphate Heptahydrate",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20131118",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "SEMECARPUS ANACARDIUM JUICE; ARNICA MONTANA; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED OIL; CINCHONA OFFICINALIS BARK; HERRING SPERM DNA; GINKGO; EGG PHOSPHOLIPIDS; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE; ZINC SULFATE HEPTAHYDRATE",
"StrengthNumber": "30; 1.5; 30; 1.5; 3; 3; 3; 6; 1.5; 30; 6; 6; 6",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Temporarily relieves symptoms of mental fatigue, including: lapses in memory; feelings of confusion or difficulty collecting one's thoughts; short attention span; poor mood."
},
{
"NDCCode": "27281-002-96",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (27281-002-96)",
"NDC11Code": "27281-0002-96",
"ProductNDC": "27281-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Livergen",
"NonProprietaryName": "Arnica Montana, Byronia Alba Root, Silybum Marianum Seed, Chelidonium Majus, Herring Sperm Dna, Pork Liver, Cervus Elaphus Horn Oil, Sus Scrofa Pancreas, And Taraxacum Officinale",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20131113",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED OIL; CHELIDONIUM MAJUS; HERRING SPERM DNA; PORK LIVER; CERVUS ELAPHUS HORN OIL; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE",
"StrengthNumber": "1.5; 200; .5; 200; 3; 3; 4; 4; 1",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Helps detoxify the liver and temporarily relieves symptoms associated with an overworked or toxic liver, including: fatigue; poor sugar metabolism; poor liver function; ill effects of excessive alcohol consumption."
},
{
"NDCCode": "27281-004-96",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (27281-004-96)",
"NDC11Code": "27281-0004-96",
"ProductNDC": "27281-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Immune Booster",
"NonProprietaryName": "Apis Mellifera, Baptisia Tinctoria, Silybum Marianum Seed, Herring Sperm Dna, Echinacea, Galium Aparine, Mercuric Chloride, Mercuric Sulfide, Nitric Acid, Sulfur Iodide, And Thuja Occidentalis Leafy Twig",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20131113",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "APIS MELLIFERA; BAPTISIA TINCTORIA; SILYBUM MARIANUM SEED OIL; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "200; 3; 1.5; 3; 3; 1.5; 200; 30; 30; 200; 200",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Helps support the body's natural defense mechanisms and temporarily relieves: tendencies toward flu & cold; joint pain; minor allergies; low endocrine function."
},
{
"NDCCode": "27281-008-96",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (27281-008-96)",
"NDC11Code": "27281-0008-96",
"ProductNDC": "27281-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heartery",
"NonProprietaryName": "American Ginseng, Arnica Montana, Gold, Barium Carbonate, Atropa Belladonna, Calcium Fluoride, Cholesterol, Herring Sperm Dna, Ginkgo, Saccharomyces Cerevisia Rna, Visbum Album Fruiting Top, And Ginger",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20131209",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "AMERICAN GINSENG; ARNICA MONTANA; GOLD; BARIUM CARBONATE; ATROPA BELLADONNA; CALCIUM FLUORIDE; CHOLESTEROL; HERRING SPERM DNA; GINKGO; SACCHAROMYCES CEREVISIAE RNA; VISCUM ALBUM FRUITING TOP; GINGER",
"StrengthNumber": "1; 1.5; 30; 30; 3; 6; 15; 3; 3; 3; 1.5; 30",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Temporarily relieves symptoms associated with hypertension, such as: high blood pressure; constricted blood vessels; arteriosclerosis; inelastic blood vessels."
},
{
"NDCCode": "27281-009-96",
"PackageDescription": "30 mg in 1 BOTTLE, SPRAY (27281-009-96)",
"NDC11Code": "27281-0009-96",
"ProductNDC": "27281-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Female Energy",
"NonProprietaryName": "Chaste Tree, Arnica Montana, Caulophyllum Thalictroides Root, Cinchona Officinalis Bark, Turnera Diffusa Leafy Twig, Herring Sperm Dna, Lactuca Virosa, Onosmodium Virginianum Whole, Sus Scrofa Ovary, Phosphoric Acid, Sus Scrofa Pituitary Gland, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20140807",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "CHASTE TREE; ARNICA MONTANA; CAULOPHYLLUM THALICTROIDES ROOT; CINCHONA OFFICINALIS BARK; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE; SUS SCROFA OVARY; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1.5; 1.5; 3; 1.5; .5; 3; 1.5; 30; 30; 200; 6; 30; 30",
"StrengthUnit": "[hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Temporarily relieves some symptoms of low female sexual energy, such as: decrease in sexual desire; feelings of fatigue; decrease in responsiveness and enjoyment."
},
{
"NDCCode": "27281-010-96",
"PackageDescription": "30 mg in 1 BOTTLE, SPRAY (27281-010-96)",
"NDC11Code": "27281-0010-96",
"ProductNDC": "27281-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Male Tonicity",
"NonProprietaryName": "American Ginseng, Arnica Montana, Turnera Diffusa Leafy Twig, Herring Sperm Dna, Galium Aparine, Hamamelis Virginiana Root Bark/stem Bark, Pork Liver, Cervus Elaphus Horn Oil, Ovis Aries Testicle, Phosphoric Acid, Sus Scrofa Pituitary Gland, Thuja Occidentalis Leafy Twig, Thyroid, Unspecified, Tribulus Terrestris, Ginger",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20140808",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "AMERICAN GINSENG; ARNICA MONTANA; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; CERVUS ELAPHUS HORN OIL; OVIS ARIES TESTICLE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBULUS TERRESTRIS; GINGER",
"StrengthNumber": "1.5; 1.5; 1; 3; 1.5; 1.5; 3; 4; 3; 200; 4; 1.5; 6; 1; 1.5",
"StrengthUnit": "[hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Temporarily relieves symptoms of low male sexual energy, including: decrease in sexual desire; feelings of fatigue; decrease in performance and enjoyment."
},
{
"NDCCode": "27281-011-96",
"PackageDescription": "30 mg in 1 BOTTLE, SPRAY (27281-011-96)",
"NDC11Code": "27281-0011-96",
"ProductNDC": "27281-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lung Detox",
"NonProprietaryName": "Silver Nitrate, Arsenic Trioxide, Activated Charcoal, Silybum Marianum Seed, Herring Sperm Dna, Pork Liver, Mercuric Chloride, Lead",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20140808",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "SILVER NITRATE; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; SILYBUM MARIANUM SEED; HERRING SPERM DNA; PORK LIVER; MERCURIC CHLORIDE; LEAD",
"StrengthNumber": "200; 200; 200; .5; 3; 3; 200; 200",
"StrengthUnit": "[hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Detoxifies the lungs and provides temporary relief from symtpoms associated with inhaling polluted air, both indoors and outdoors, such as: shortness of breath; wheezing; coughing; lack of energy."
},
{
"NDCCode": "16590-007-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (16590-007-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "16590-0007-05",
"ProductNDC": "16590-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alrex",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19980309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020803",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ALREX Ophthalmic Suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.",
"Description": "ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 2 mg (0.2%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.4-5.5. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%."
},
{
"NDCCode": "65862-007-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (65862-007-01) ",
"NDC11Code": "65862-0007-01",
"ProductNDC": "65862-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20041028",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets."
},
{
"NDCCode": "65862-007-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65862-007-05) ",
"NDC11Code": "65862-0007-05",
"ProductNDC": "65862-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20041028",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets."
},
{
"NDCCode": "65862-007-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65862-007-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "65862-0007-10",
"ProductNDC": "65862-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20041028",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets."
},
{
"NDCCode": "65862-007-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (65862-007-30) ",
"NDC11Code": "65862-0007-30",
"ProductNDC": "65862-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20041028",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets."
},
{
"NDCCode": "65862-007-32",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (65862-007-32) ",
"NDC11Code": "65862-0007-32",
"ProductNDC": "65862-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20041028",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets."
},
{
"NDCCode": "65862-007-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (65862-007-60) ",
"NDC11Code": "65862-0007-60",
"ProductNDC": "65862-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20041028",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets."
},
{
"NDCCode": "65862-007-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (65862-007-90) ",
"NDC11Code": "65862-0007-90",
"ProductNDC": "65862-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20041028",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets."
},
{
"NDCCode": "73190-007-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (73190-007-10) ",
"NDC11Code": "73190-0007-10",
"ProductNDC": "73190-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213748",
"LabelerName": "AvKARE",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "97; 103",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260225",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. ( 1.1) , 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2) .",
"Description": "Sacubitril and valsartan tablet is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the drug substance dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The drug substance is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1 '-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutonoate-(N-pentanoyl-N-{[2'-(1H-tetrazol-1-id-5-yl)[1,1’-biphenyl]-4-yl]methyl}-L-valinate). Its molecular formula is C 48H 55N 6O 8Na 3Its molecular mass is 912.96 g/mol and its schematic structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and talc. The film-coat inactive ingredients are hypromellose, titanium dioxide, macrogol, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow."
},
{
"NDCCode": "73190-007-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (73190-007-18) ",
"NDC11Code": "73190-0007-18",
"ProductNDC": "73190-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213748",
"LabelerName": "AvKARE",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "97; 103",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250121",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. ( 1.1) , 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2) .",
"Description": "Sacubitril and valsartan tablet is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the drug substance dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The drug substance is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1 '-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutonoate-(N-pentanoyl-N-{[2'-(1H-tetrazol-1-id-5-yl)[1,1’-biphenyl]-4-yl]methyl}-L-valinate). Its molecular formula is C 48H 55N 6O 8Na 3Its molecular mass is 912.96 g/mol and its schematic structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and talc. The film-coat inactive ingredients are hypromellose, titanium dioxide, macrogol, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow."
},
{
"NDCCode": "73190-007-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (73190-007-60) ",
"NDC11Code": "73190-0007-60",
"ProductNDC": "73190-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213748",
"LabelerName": "AvKARE",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "97; 103",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250121",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. ( 1.1) , 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2) .",
"Description": "Sacubitril and valsartan tablet is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the drug substance dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The drug substance is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1 '-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutonoate-(N-pentanoyl-N-{[2'-(1H-tetrazol-1-id-5-yl)[1,1’-biphenyl]-4-yl]methyl}-L-valinate). Its molecular formula is C 48H 55N 6O 8Na 3Its molecular mass is 912.96 g/mol and its schematic structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and talc. The film-coat inactive ingredients are hypromellose, titanium dioxide, macrogol, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow."
},
{
"NDCCode": "82804-007-21",
"PackageDescription": "21 TABLET in 1 BOTTLE (82804-007-21) ",
"NDC11Code": "82804-0007-21",
"ProductNDC": "82804-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylprednisolone",
"NonProprietaryName": "Methylprednisolone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206751",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METHYLPREDNISOLONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230908",
"SamplePackage": "N",
"IndicationAndUsage": "Methylprednisolone tablets are indicated in the following conditions:.",
"Description": "Methylprednisolone tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It melts at about 240°C, with some decomposition. It is practically insoluble in water, sparingly soluble in ethanol (96 %), in dioxane, in methanol and slightly soluble in acetone, in methylene chloride and in chloroform, very slightly soluble in ether. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C22H30O5. Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. In addition each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli."
},
{
"NDCCode": "82804-007-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (82804-007-30) ",
"NDC11Code": "82804-0007-30",
"ProductNDC": "82804-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylprednisolone",
"NonProprietaryName": "Methylprednisolone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206751",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METHYLPREDNISOLONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230908",
"SamplePackage": "N",
"IndicationAndUsage": "Methylprednisolone tablets are indicated in the following conditions:.",
"Description": "Methylprednisolone tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It melts at about 240°C, with some decomposition. It is practically insoluble in water, sparingly soluble in ethanol (96 %), in dioxane, in methanol and slightly soluble in acetone, in methylene chloride and in chloroform, very slightly soluble in ether. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C22H30O5. Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. In addition each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli."
},
{
"NDCCode": "82804-007-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (82804-007-60) ",
"NDC11Code": "82804-0007-60",
"ProductNDC": "82804-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylprednisolone",
"NonProprietaryName": "Methylprednisolone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206751",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METHYLPREDNISOLONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230908",
"SamplePackage": "N",
"IndicationAndUsage": "Methylprednisolone tablets are indicated in the following conditions:.",
"Description": "Methylprednisolone tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It melts at about 240°C, with some decomposition. It is practically insoluble in water, sparingly soluble in ethanol (96 %), in dioxane, in methanol and slightly soluble in acetone, in methylene chloride and in chloroform, very slightly soluble in ether. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C22H30O5. Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. In addition each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli."
},
{
"NDCCode": "82804-007-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (82804-007-90) ",
"NDC11Code": "82804-0007-90",
"ProductNDC": "82804-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylprednisolone",
"NonProprietaryName": "Methylprednisolone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206751",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METHYLPREDNISOLONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230908",
"SamplePackage": "N",
"IndicationAndUsage": "Methylprednisolone tablets are indicated in the following conditions:.",
"Description": "Methylprednisolone tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It melts at about 240°C, with some decomposition. It is practically insoluble in water, sparingly soluble in ethanol (96 %), in dioxane, in methanol and slightly soluble in acetone, in methylene chloride and in chloroform, very slightly soluble in ether. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C22H30O5. Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. In addition each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli."
},
{
"NDCCode": "27281-003-01",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (27281-003-01)",
"NDC11Code": "27281-0003-01",
"ProductNDC": "27281-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vivacity",
"NonProprietaryName": "Alfalfa, Aralia Quinquefolia, Arnica Montana, Avena Sativa, Dna, Galium Aparine, Hypericum Perforatum, Oleum Animale, Pituitarium Posterium, Rhus Toxicodendron, Rna, Thuja Occidentalis, Alcohol, Glycerin, Water",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20131113",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "ALFALFA; ARNICA MONTANA; AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; GALIUM APARINE; HERRING SPERM DNA; HYPERICUM PERFORATUM; CERVUS ELAPHUS HORN OIL; SUS SCROFA PITUITARY GLAND; TOXICODENDRON PUBESCENS LEAF; SACCHAROMYCES CEREVISIAE RNA; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1; 1.5; 1; 1; 1.5; 3; 200; 3; 4; 200; 3; 30",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Temporarily relieves symptoms of general physical weakness and listlessness, including: fatigue; sore muscles & joints; dry skin; absence of sexual desire; occasional sleeplessness."
},
{
"NDCCode": "27281-003-02",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (27281-003-02)",
"NDC11Code": "27281-0003-02",
"ProductNDC": "27281-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vivacity",
"NonProprietaryName": "Alfalfa, Aralia Quinquefolia, Arnica Montana, Avena Sativa, Dna, Galium Aparine, Hypericum Perforatum, Oleum Animale, Pituitarium Posterium, Rhus Toxicodendron, Rna, Thuja Occidentalis, Alcohol, Glycerin, Water",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20131113",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "ALFALFA; ARNICA MONTANA; AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; GALIUM APARINE; HERRING SPERM DNA; HYPERICUM PERFORATUM; CERVUS ELAPHUS HORN OIL; SUS SCROFA PITUITARY GLAND; TOXICODENDRON PUBESCENS LEAF; SACCHAROMYCES CEREVISIAE RNA; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1; 1.5; 1; 1; 1.5; 3; 200; 3; 4; 200; 3; 30",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Temporarily relieves symptoms of general physical weakness and listlessness, including: fatigue; sore muscles & joints; dry skin; absence of sexual desire; occasional sleeplessness."
},
{
"NDCCode": "27281-029-63",
"PackageDescription": "30 mL in 1 PACKAGE (27281-029-63) ",
"NDC11Code": "27281-0029-63",
"ProductNDC": "27281-029",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Livergen",
"NonProprietaryName": "Arnica Montana, Bryonia, Carduus Marianus, Chelidonium Majus, Dna, Hepar Suis, Oleum Animale, Pancreas Suis, Taraxacum Officinale.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131113",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; MILK THISTLE; CHELIDONIUM MAJUS; HERRING SPERM DNA; PORK LIVER; CERVUS ELAPHUS HORN OIL; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE",
"StrengthNumber": "3; 200; 1; 200; 6; 6; 8; 8; 2",
"StrengthUnit": "[hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131113",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Relieves symptoms of aging or a rundown condition, including: Relief for feelings of fatigue that may be caused by an over-worked liver or by liver toxixity; supports proper sugar metabolism; stimulates proper liver function; protects against the ill-effects of excessive alcohol consumption.*. *Claims based on traditional homeopathic practice, not accepted by medical evidence. Not FDA evaluated."
},
{
"NDCCode": "27281-039-64",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (27281-039-64) ",
"NDC11Code": "27281-0039-64",
"ProductNDC": "27281-039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vivacity",
"NonProprietaryName": "Alfalfa, Arnica Montana, Avena Sativa, Galium Aparine, Hepar Suis, Hypericum Perforatum, Korean Ginseng, Oleum Animale, Pituitary Suis, Rhus Toxicodendron, Rna, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180205",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "ALFALFA; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; GALIUM APARINE; PORK LIVER; HYPERICUM PERFORATUM; ASIAN GINSENG; CERVUS ELAPHUS HORN OIL; SUS SCROFA PITUITARY GLAND; TOXICODENDRON PUBESCENS LEAF; SACCHAROMYCES CEREVISIAE RNA; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "2; 3; 2; 3; 6; 200; 2; 6; 8; 200; 6; 30",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180205",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Relieves symptoms of aging or a rundown condition, including: Low energy; poor muscle balance; poor stamina; occssional sleeplessnees.*. *Claims based on traditional homeopathic practice, not accepted by medical evidence. Not FDA evaluated."
},
{
"NDCCode": "27281-049-65",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (27281-049-65) ",
"NDC11Code": "27281-0049-65",
"ProductNDC": "27281-049",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Immune Booster",
"NonProprietaryName": "Apis Mellifica, Baptisia Tinctoria, Carduus Marianus, Echinacea Angustifolia, Gallum Aparine, Mercurius Corrosivus, Mercurius Sulphuratus Ruber, Nitricum Acidum, Sulphur Iodatum, Thuja Occidentalis.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131113",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; MILK THISTLE; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "200; 6; 3; 6; 3; 200; 30; 30; 200; 200",
"StrengthUnit": "[hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"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": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131113",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Supports the body's natural defense mechanisms, temporarily relieves: tendency towards flu & cold; joint pain; minor allergy. Helps balance the body's level of Human Growth Hormone, supporting healthy immune response. Stimulates the endocrine glands*. *Claims based on traditional homeopathic practice, not accepted by medical evidence. Not FDA evaluated."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>27281-007-96</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (27281-007-96)</PackageDescription>
<NDC11Code>27281-0007-96</NDC11Code>
<ProductNDC>27281-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diabetigen</ProprietaryName>
<NonProprietaryName>Arnica Montana, Arsenic Trioxide, Herring Sperm Nda, Echinacea, Unspecified, Hamamelis Virginiana Leaf, Chamaelirium Luteum Root, Pork Liver, Iris Versicolor Root, Sus Scrofa Pancreas, Phosphoric Acid, Rosmarinus Officinalis Flowering Top, Claviceps Purpurea Sclerotium, Syzygium Cumini Seed, And Uranyl Nitrate Hexahydrate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131209</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>ARNICA MONTANA; ARSENIC TRIOXIDE; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; CHAMAELIRIUM LUTEUM ROOT; PORK LIVER; IRIS VERSICOLOR ROOT; SUS SCROFA PANCREAS; PHOSPHORIC ACID; ROSMARINUS OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE</SubstanceName>
<StrengthNumber>1.5; 200; 3; 1.5; 1.5; 1.5; 3; 3; 3; 200; 1.5; 30; 1.5; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Temporarily relieves symptoms associated with type II diabetes, including: pancreatic deficiency; liver weakness; apathy and generalized feelings of weakness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71301-007-01</NDCCode>
<PackageDescription>96 TUBE in 1 PACKAGE (71301-007-01) > 59.14 mL in 1 TUBE</PackageDescription>
<NDC11Code>71301-0007-01</NDC11Code>
<ProductNDC>71301-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold Zone Pain Relieving Gel- Dg Health</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Yash Pharmaceuticals</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief from minor aches and pains of sore muscles and joints associated with: - arthritis - backache - strains - sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72164-007-00</NDCCode>
<PackageDescription>96 g in 1 TUBE (72164-007-00) </PackageDescription>
<NDC11Code>72164-0007-00</NDC11Code>
<ProductNDC>72164-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanilla Lavender Mint</ProprietaryName>
<NonProprietaryName>Potassium Nitrate, Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Smiletwice, Inc.</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>50; 1.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. Aids in prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27281-001-96</NDCCode>
<PackageDescription>30 mL in 1 PACKAGE (27281-001-96)</PackageDescription>
<NDC11Code>27281-0001-96</NDC11Code>
<ProductNDC>27281-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Brain Power</ProprietaryName>
<NonProprietaryName>Semecarpus Anacardium Juice, Arnica Montana, Calcium Fluoride, Silybum Marianum Seed, Chincona Officinalis Bark, Herring Sperm Dna, Ginkgo, Egg Phospholipids, Achillea Millefolium, Phosphoric Acid, Saccharomyces Cerevisia Rna, Silicon Dioxide, And Zinc Sulphate Heptahydrate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>SEMECARPUS ANACARDIUM JUICE; ARNICA MONTANA; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED OIL; CINCHONA OFFICINALIS BARK; HERRING SPERM DNA; GINKGO; EGG PHOSPHOLIPIDS; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE; ZINC SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>30; 1.5; 30; 1.5; 3; 3; 3; 6; 1.5; 30; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Temporarily relieves symptoms of mental fatigue, including: lapses in memory; feelings of confusion or difficulty collecting one's thoughts; short attention span; poor mood.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27281-002-96</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (27281-002-96)</PackageDescription>
<NDC11Code>27281-0002-96</NDC11Code>
<ProductNDC>27281-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Livergen</ProprietaryName>
<NonProprietaryName>Arnica Montana, Byronia Alba Root, Silybum Marianum Seed, Chelidonium Majus, Herring Sperm Dna, Pork Liver, Cervus Elaphus Horn Oil, Sus Scrofa Pancreas, And Taraxacum Officinale</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131113</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>ARNICA MONTANA; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED OIL; CHELIDONIUM MAJUS; HERRING SPERM DNA; PORK LIVER; CERVUS ELAPHUS HORN OIL; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>1.5; 200; .5; 200; 3; 3; 4; 4; 1</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Helps detoxify the liver and temporarily relieves symptoms associated with an overworked or toxic liver, including: fatigue; poor sugar metabolism; poor liver function; ill effects of excessive alcohol consumption.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27281-004-96</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (27281-004-96)</PackageDescription>
<NDC11Code>27281-0004-96</NDC11Code>
<ProductNDC>27281-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Immune Booster</ProprietaryName>
<NonProprietaryName>Apis Mellifera, Baptisia Tinctoria, Silybum Marianum Seed, Herring Sperm Dna, Echinacea, Galium Aparine, Mercuric Chloride, Mercuric Sulfide, Nitric Acid, Sulfur Iodide, And Thuja Occidentalis Leafy Twig</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131113</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>APIS MELLIFERA; BAPTISIA TINCTORIA; SILYBUM MARIANUM SEED OIL; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>200; 3; 1.5; 3; 3; 1.5; 200; 30; 30; 200; 200</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Helps support the body's natural defense mechanisms and temporarily relieves: tendencies toward flu & cold; joint pain; minor allergies; low endocrine function.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27281-008-96</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (27281-008-96)</PackageDescription>
<NDC11Code>27281-0008-96</NDC11Code>
<ProductNDC>27281-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heartery</ProprietaryName>
<NonProprietaryName>American Ginseng, Arnica Montana, Gold, Barium Carbonate, Atropa Belladonna, Calcium Fluoride, Cholesterol, Herring Sperm Dna, Ginkgo, Saccharomyces Cerevisia Rna, Visbum Album Fruiting Top, And Ginger</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131209</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>AMERICAN GINSENG; ARNICA MONTANA; GOLD; BARIUM CARBONATE; ATROPA BELLADONNA; CALCIUM FLUORIDE; CHOLESTEROL; HERRING SPERM DNA; GINKGO; SACCHAROMYCES CEREVISIAE RNA; VISCUM ALBUM FRUITING TOP; GINGER</SubstanceName>
<StrengthNumber>1; 1.5; 30; 30; 3; 6; 15; 3; 3; 3; 1.5; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Temporarily relieves symptoms associated with hypertension, such as: high blood pressure; constricted blood vessels; arteriosclerosis; inelastic blood vessels.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27281-009-96</NDCCode>
<PackageDescription>30 mg in 1 BOTTLE, SPRAY (27281-009-96)</PackageDescription>
<NDC11Code>27281-0009-96</NDC11Code>
<ProductNDC>27281-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Female Energy</ProprietaryName>
<NonProprietaryName>Chaste Tree, Arnica Montana, Caulophyllum Thalictroides Root, Cinchona Officinalis Bark, Turnera Diffusa Leafy Twig, Herring Sperm Dna, Lactuca Virosa, Onosmodium Virginianum Whole, Sus Scrofa Ovary, Phosphoric Acid, Sus Scrofa Pituitary Gland, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140807</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>CHASTE TREE; ARNICA MONTANA; CAULOPHYLLUM THALICTROIDES ROOT; CINCHONA OFFICINALIS BARK; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE; SUS SCROFA OVARY; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1.5; 1.5; 3; 1.5; .5; 3; 1.5; 30; 30; 200; 6; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Temporarily relieves some symptoms of low female sexual energy, such as: decrease in sexual desire; feelings of fatigue; decrease in responsiveness and enjoyment.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27281-010-96</NDCCode>
<PackageDescription>30 mg in 1 BOTTLE, SPRAY (27281-010-96)</PackageDescription>
<NDC11Code>27281-0010-96</NDC11Code>
<ProductNDC>27281-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Male Tonicity</ProprietaryName>
<NonProprietaryName>American Ginseng, Arnica Montana, Turnera Diffusa Leafy Twig, Herring Sperm Dna, Galium Aparine, Hamamelis Virginiana Root Bark/stem Bark, Pork Liver, Cervus Elaphus Horn Oil, Ovis Aries Testicle, Phosphoric Acid, Sus Scrofa Pituitary Gland, Thuja Occidentalis Leafy Twig, Thyroid, Unspecified, Tribulus Terrestris, Ginger</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140808</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>AMERICAN GINSENG; ARNICA MONTANA; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; CERVUS ELAPHUS HORN OIL; OVIS ARIES TESTICLE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBULUS TERRESTRIS; GINGER</SubstanceName>
<StrengthNumber>1.5; 1.5; 1; 3; 1.5; 1.5; 3; 4; 3; 200; 4; 1.5; 6; 1; 1.5</StrengthNumber>
<StrengthUnit>[hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Temporarily relieves symptoms of low male sexual energy, including: decrease in sexual desire; feelings of fatigue; decrease in performance and enjoyment.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27281-011-96</NDCCode>
<PackageDescription>30 mg in 1 BOTTLE, SPRAY (27281-011-96)</PackageDescription>
<NDC11Code>27281-0011-96</NDC11Code>
<ProductNDC>27281-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lung Detox</ProprietaryName>
<NonProprietaryName>Silver Nitrate, Arsenic Trioxide, Activated Charcoal, Silybum Marianum Seed, Herring Sperm Dna, Pork Liver, Mercuric Chloride, Lead</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140808</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>SILVER NITRATE; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; SILYBUM MARIANUM SEED; HERRING SPERM DNA; PORK LIVER; MERCURIC CHLORIDE; LEAD</SubstanceName>
<StrengthNumber>200; 200; 200; .5; 3; 3; 200; 200</StrengthNumber>
<StrengthUnit>[hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Detoxifies the lungs and provides temporary relief from symtpoms associated with inhaling polluted air, both indoors and outdoors, such as: shortness of breath; wheezing; coughing; lack of energy.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16590-007-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (16590-007-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>16590-0007-05</NDC11Code>
<ProductNDC>16590-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alrex</ProprietaryName>
<NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19980309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020803</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ALREX Ophthalmic Suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.</IndicationAndUsage>
<Description>ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 2 mg (0.2%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.4-5.5. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>65862-007-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (65862-007-01) </PackageDescription>
<NDC11Code>65862-0007-01</NDC11Code>
<ProductNDC>65862-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>65862-007-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65862-007-05) </PackageDescription>
<NDC11Code>65862-0007-05</NDC11Code>
<ProductNDC>65862-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>65862-007-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65862-007-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65862-0007-10</NDC11Code>
<ProductNDC>65862-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>65862-007-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65862-007-30) </PackageDescription>
<NDC11Code>65862-0007-30</NDC11Code>
<ProductNDC>65862-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>65862-007-32</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (65862-007-32) </PackageDescription>
<NDC11Code>65862-0007-32</NDC11Code>
<ProductNDC>65862-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>65862-007-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (65862-007-60) </PackageDescription>
<NDC11Code>65862-0007-60</NDC11Code>
<ProductNDC>65862-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>65862-007-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (65862-007-90) </PackageDescription>
<NDC11Code>65862-0007-90</NDC11Code>
<ProductNDC>65862-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>73190-007-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (73190-007-10) </PackageDescription>
<NDC11Code>73190-0007-10</NDC11Code>
<ProductNDC>73190-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213748</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>97; 103</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. ( 1.1) , 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2) .</IndicationAndUsage>
<Description>Sacubitril and valsartan tablet is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the drug substance dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The drug substance is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1 '-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutonoate-(N-pentanoyl-N-{[2'-(1H-tetrazol-1-id-5-yl)[1,1’-biphenyl]-4-yl]methyl}-L-valinate). Its molecular formula is C 48H 55N 6O 8Na 3Its molecular mass is 912.96 g/mol and its schematic structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and talc. The film-coat inactive ingredients are hypromellose, titanium dioxide, macrogol, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>73190-007-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (73190-007-18) </PackageDescription>
<NDC11Code>73190-0007-18</NDC11Code>
<ProductNDC>73190-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213748</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>97; 103</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. ( 1.1) , 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2) .</IndicationAndUsage>
<Description>Sacubitril and valsartan tablet is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the drug substance dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The drug substance is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1 '-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutonoate-(N-pentanoyl-N-{[2'-(1H-tetrazol-1-id-5-yl)[1,1’-biphenyl]-4-yl]methyl}-L-valinate). Its molecular formula is C 48H 55N 6O 8Na 3Its molecular mass is 912.96 g/mol and its schematic structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and talc. The film-coat inactive ingredients are hypromellose, titanium dioxide, macrogol, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>73190-007-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (73190-007-60) </PackageDescription>
<NDC11Code>73190-0007-60</NDC11Code>
<ProductNDC>73190-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213748</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>97; 103</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. ( 1.1) , 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2) .</IndicationAndUsage>
<Description>Sacubitril and valsartan tablet is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the drug substance dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The drug substance is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1 '-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutonoate-(N-pentanoyl-N-{[2'-(1H-tetrazol-1-id-5-yl)[1,1’-biphenyl]-4-yl]methyl}-L-valinate). Its molecular formula is C 48H 55N 6O 8Na 3Its molecular mass is 912.96 g/mol and its schematic structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and talc. The film-coat inactive ingredients are hypromellose, titanium dioxide, macrogol, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>82804-007-21</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (82804-007-21) </PackageDescription>
<NDC11Code>82804-0007-21</NDC11Code>
<ProductNDC>82804-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylprednisolone</ProprietaryName>
<NonProprietaryName>Methylprednisolone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206751</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METHYLPREDNISOLONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylprednisolone tablets are indicated in the following conditions:.</IndicationAndUsage>
<Description>Methylprednisolone tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It melts at about 240°C, with some decomposition. It is practically insoluble in water, sparingly soluble in ethanol (96 %), in dioxane, in methanol and slightly soluble in acetone, in methylene chloride and in chloroform, very slightly soluble in ether. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C22H30O5. Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. In addition each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.</Description>
</NDC>
<NDC>
<NDCCode>82804-007-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (82804-007-30) </PackageDescription>
<NDC11Code>82804-0007-30</NDC11Code>
<ProductNDC>82804-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylprednisolone</ProprietaryName>
<NonProprietaryName>Methylprednisolone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206751</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METHYLPREDNISOLONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylprednisolone tablets are indicated in the following conditions:.</IndicationAndUsage>
<Description>Methylprednisolone tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It melts at about 240°C, with some decomposition. It is practically insoluble in water, sparingly soluble in ethanol (96 %), in dioxane, in methanol and slightly soluble in acetone, in methylene chloride and in chloroform, very slightly soluble in ether. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C22H30O5. Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. In addition each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.</Description>
</NDC>
<NDC>
<NDCCode>82804-007-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (82804-007-60) </PackageDescription>
<NDC11Code>82804-0007-60</NDC11Code>
<ProductNDC>82804-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylprednisolone</ProprietaryName>
<NonProprietaryName>Methylprednisolone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206751</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METHYLPREDNISOLONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylprednisolone tablets are indicated in the following conditions:.</IndicationAndUsage>
<Description>Methylprednisolone tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It melts at about 240°C, with some decomposition. It is practically insoluble in water, sparingly soluble in ethanol (96 %), in dioxane, in methanol and slightly soluble in acetone, in methylene chloride and in chloroform, very slightly soluble in ether. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C22H30O5. Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. In addition each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.</Description>
</NDC>
<NDC>
<NDCCode>82804-007-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (82804-007-90) </PackageDescription>
<NDC11Code>82804-0007-90</NDC11Code>
<ProductNDC>82804-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylprednisolone</ProprietaryName>
<NonProprietaryName>Methylprednisolone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206751</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METHYLPREDNISOLONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylprednisolone tablets are indicated in the following conditions:.</IndicationAndUsage>
<Description>Methylprednisolone tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It melts at about 240°C, with some decomposition. It is practically insoluble in water, sparingly soluble in ethanol (96 %), in dioxane, in methanol and slightly soluble in acetone, in methylene chloride and in chloroform, very slightly soluble in ether. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C22H30O5. Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. In addition each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.</Description>
</NDC>
<NDC>
<NDCCode>27281-003-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (27281-003-01)</PackageDescription>
<NDC11Code>27281-0003-01</NDC11Code>
<ProductNDC>27281-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vivacity</ProprietaryName>
<NonProprietaryName>Alfalfa, Aralia Quinquefolia, Arnica Montana, Avena Sativa, Dna, Galium Aparine, Hypericum Perforatum, Oleum Animale, Pituitarium Posterium, Rhus Toxicodendron, Rna, Thuja Occidentalis, Alcohol, Glycerin, Water</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131113</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>ALFALFA; ARNICA MONTANA; AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; GALIUM APARINE; HERRING SPERM DNA; HYPERICUM PERFORATUM; CERVUS ELAPHUS HORN OIL; SUS SCROFA PITUITARY GLAND; TOXICODENDRON PUBESCENS LEAF; SACCHAROMYCES CEREVISIAE RNA; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1; 1.5; 1; 1; 1.5; 3; 200; 3; 4; 200; 3; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Temporarily relieves symptoms of general physical weakness and listlessness, including: fatigue; sore muscles & joints; dry skin; absence of sexual desire; occasional sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27281-003-02</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (27281-003-02)</PackageDescription>
<NDC11Code>27281-0003-02</NDC11Code>
<ProductNDC>27281-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vivacity</ProprietaryName>
<NonProprietaryName>Alfalfa, Aralia Quinquefolia, Arnica Montana, Avena Sativa, Dna, Galium Aparine, Hypericum Perforatum, Oleum Animale, Pituitarium Posterium, Rhus Toxicodendron, Rna, Thuja Occidentalis, Alcohol, Glycerin, Water</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131113</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>ALFALFA; ARNICA MONTANA; AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; GALIUM APARINE; HERRING SPERM DNA; HYPERICUM PERFORATUM; CERVUS ELAPHUS HORN OIL; SUS SCROFA PITUITARY GLAND; TOXICODENDRON PUBESCENS LEAF; SACCHAROMYCES CEREVISIAE RNA; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1; 1.5; 1; 1; 1.5; 3; 200; 3; 4; 200; 3; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Temporarily relieves symptoms of general physical weakness and listlessness, including: fatigue; sore muscles & joints; dry skin; absence of sexual desire; occasional sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27281-029-63</NDCCode>
<PackageDescription>30 mL in 1 PACKAGE (27281-029-63) </PackageDescription>
<NDC11Code>27281-0029-63</NDC11Code>
<ProductNDC>27281-029</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Livergen</ProprietaryName>
<NonProprietaryName>Arnica Montana, Bryonia, Carduus Marianus, Chelidonium Majus, Dna, Hepar Suis, Oleum Animale, Pancreas Suis, Taraxacum Officinale.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131113</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>ARNICA MONTANA; BRYONIA ALBA ROOT; MILK THISTLE; CHELIDONIUM MAJUS; HERRING SPERM DNA; PORK LIVER; CERVUS ELAPHUS HORN OIL; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>3; 200; 1; 200; 6; 6; 8; 8; 2</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Relieves symptoms of aging or a rundown condition, including: Relief for feelings of fatigue that may be caused by an over-worked liver or by liver toxixity; supports proper sugar metabolism; stimulates proper liver function; protects against the ill-effects of excessive alcohol consumption.*. *Claims based on traditional homeopathic practice, not accepted by medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27281-039-64</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (27281-039-64) </PackageDescription>
<NDC11Code>27281-0039-64</NDC11Code>
<ProductNDC>27281-039</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vivacity</ProprietaryName>
<NonProprietaryName>Alfalfa, Arnica Montana, Avena Sativa, Galium Aparine, Hepar Suis, Hypericum Perforatum, Korean Ginseng, Oleum Animale, Pituitary Suis, Rhus Toxicodendron, Rna, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180205</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>ALFALFA; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; GALIUM APARINE; PORK LIVER; HYPERICUM PERFORATUM; ASIAN GINSENG; CERVUS ELAPHUS HORN OIL; SUS SCROFA PITUITARY GLAND; TOXICODENDRON PUBESCENS LEAF; SACCHAROMYCES CEREVISIAE RNA; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>2; 3; 2; 3; 6; 200; 2; 6; 8; 200; 6; 30</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Relieves symptoms of aging or a rundown condition, including: Low energy; poor muscle balance; poor stamina; occssional sleeplessnees.*. *Claims based on traditional homeopathic practice, not accepted by medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27281-049-65</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (27281-049-65) </PackageDescription>
<NDC11Code>27281-0049-65</NDC11Code>
<ProductNDC>27281-049</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Immune Booster</ProprietaryName>
<NonProprietaryName>Apis Mellifica, Baptisia Tinctoria, Carduus Marianus, Echinacea Angustifolia, Gallum Aparine, Mercurius Corrosivus, Mercurius Sulphuratus Ruber, Nitricum Acidum, Sulphur Iodatum, Thuja Occidentalis.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131113</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; MILK THISTLE; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>200; 6; 3; 6; 3; 200; 30; 30; 200; 200</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</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>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Supports the body's natural defense mechanisms, temporarily relieves: tendency towards flu & cold; joint pain; minor allergy. Helps balance the body's level of Human Growth Hormone, supporting healthy immune response. Stimulates the endocrine glands*. *Claims based on traditional homeopathic practice, not accepted by medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
</NDCList>