{
"NDC": [
{
"NDCCode": "17089-467-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-467-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0467-20",
"ProductNDC": "17089-467",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna Defense",
"NonProprietaryName": "Calcium Sulfide - Centella Asiatica - Echinacea Angustifolia Whole - Echinacea Purpurea - Thuja Occidentalis Leafy Twig - Vincetoxicum Hirundinaria Root - Phytolacca Americana Root - Sulfur -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "CENTELLA ASIATICA; ECHINACEA ANGUSTIFOLIA WHOLE; ECHINACEA PURPUREA; CALCIUM SULFIDE; THUJA OCCIDENTALIS LEAFY TWIG; VINCETOXICUM HIRUNDINARIA ROOT; PHYTOLACCA AMERICANA ROOT; SULFUR",
"StrengthNumber": "4; 2; 2; 10; 6; 6; 4; 10",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Status": "Active",
"LastUpdate": "2021-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Relieves respiratory or intestinal symptoms of viral infections, such as: cough, sore throat; cold sores; fever; diarrhea."
},
{
"NDCCode": "17089-467-21",
"PackageDescription": "1 TUBE in 1 BOX (17089-467-21) > 4 g in 1 TUBE",
"NDC11Code": "17089-0467-21",
"ProductNDC": "17089-467",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna Defense",
"NonProprietaryName": "Calcium Sulfide - Centella Asiatica - Echinacea Angustifolia Whole - Echinacea Purpurea - Thuja Occidentalis Leafy Twig - Vincetoxicum Hirundinaria Root - Phytolacca Americana Root - Sulfur -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "CENTELLA ASIATICA; ECHINACEA ANGUSTIFOLIA WHOLE; ECHINACEA PURPUREA; CALCIUM SULFIDE; THUJA OCCIDENTALIS LEAFY TWIG; VINCETOXICUM HIRUNDINARIA ROOT; PHYTOLACCA AMERICANA ROOT; SULFUR",
"StrengthNumber": "4; 2; 2; 10; 6; 6; 4; 10",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Status": "Active",
"LastUpdate": "2021-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211215",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Relieves respiratory or intestinal symptoms of viral infections, such as: cough, sore throat; cold sores; fever; diarrhea."
},
{
"NDCCode": "43063-467-20",
"PackageDescription": "20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-20) ",
"NDC11Code": "43063-0467-20",
"ProductNDC": "43063-467",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19960326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074514",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130823",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation) . Diclofenac sodium delayed-release tablets are indicated: 1 for relief of the signs and symptoms of osteoarthritis, 2 for relief of the signs and symptoms of rheumatoid arthritis, 3 for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium, USP is a white to almost white crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13 g/mol. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide."
},
{
"NDCCode": "51079-467-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-467-20) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-467-01) ",
"NDC11Code": "51079-0467-20",
"ProductNDC": "51079-467",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felodipine",
"NonProprietaryName": "Felodipine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080501",
"EndMarketingDate": "20190630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078855",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "FELODIPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080501",
"EndMarketingDatePackage": "20190630",
"SamplePackage": "N"
},
{
"NDCCode": "99207-467-01",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (99207-467-01) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "99207-0467-01",
"ProductNDC": "99207-467",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solodyn",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050808",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "105",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100927",
"SamplePackage": "N"
},
{
"NDCCode": "17089-046-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-046-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0046-20",
"ProductNDC": "17089-046",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Age Skin",
"NonProprietaryName": "Alpha-tocopherol - Ascophyllum Nodosum - Botryoglossum Platycarpum - Fucus Serratus - Fucus Vesiculosus - Isoleucine - Leucine - Retinol - Selenium - Sus Scrofa Capillary Tissue - Sus Scrofa Collagen - Sus Scrofa Placenta - Sus Scrofa Skin - Ubidecarenone - Ulva Lactuca Extract - Laminaria Digitata",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ALPHA-TOCOPHEROL; LAMINARIA DIGITATA; BOTRYOGLOSSUM PLATYCARPUM; FUCUS SERRATUS; SUS SCROFA CAPILLARY TISSUE; UBIDECARENONE; SUS SCROFA COLLAGEN; FUCUS VESICULOSUS; ISOLEUCINE; ASCOPHYLLUM NODOSUM; LEUCINE; SUS SCROFA PLACENTA; RETINOL; ULVA LACTUCA EXTRACT; SELENIUM; SUS SCROFA SKIN",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4",
"StrengthUnit": "[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2019-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals."
},
{
"NDCCode": "17089-061-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-061-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0061-20",
"ProductNDC": "17089-061",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Age Face",
"NonProprietaryName": "Asian Ginseng - Canakinumab - Eleuthero - Germanium Dioxide - Isoleucine - Leucine - Proline - Sus Scrofa Collagen - Sus Scrofa Skin - Valine - Witch Hazel -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"EndMarketingDate": "20180701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "SUS SCROFA COLLAGEN; GERMANIUM DIOXIDE; ASIAN GINSENG; HAMAMELIS VIRGINIANA LEAF; CANAKINUMAB; ISOLEUCINE; LEUCINE; PROLINE; ELEUTHERO; SUS SCROFA SKIN; VALINE",
"StrengthNumber": "4; 4; 3; 3; 5; 4; 4; 4; 3; 4; 9",
"StrengthUnit": "[hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g",
"Status": "Deprecated",
"LastUpdate": "2018-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060523",
"EndMarketingDatePackage": "20180701",
"SamplePackage": "N"
},
{
"NDCCode": "17089-067-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-067-20) / 4 g in 1 TUBE",
"NDC11Code": "17089-0067-20",
"ProductNDC": "17089-067",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Age Stress",
"NonProprietaryName": "Acetylcysteine - Ballota Foetida - Epinephrine - Glutathione - Interferon Gamma-1b - Lenograstim - Lithium Carbonate - Melatonin - Penicillium Glabrum - Potassium Carbonate - Pummelo - Rhodotorula Rubra - Silver Nitrate - Strychnos Nux-vomica Seed - Sus Scrofa Cerebral Cortex - Sus Scrofa Stomach - Sus Scrofa Superior Gastric Plexus - Sus Scrofa Thalamus -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "MELATONIN; ACETYLCYSTEINE; STRYCHNOS NUX-VOMICA SEED; PENICILLIUM GLABRUM; RHODOTORULA RUBRA; SUS SCROFA STOMACH; SUS SCROFA SUPERIOR GASTRIC PLEXUS; SUS SCROFA THALAMUS; EPINEPHRINE; SILVER NITRATE; BALLOTA FOETIDA; PUMMELO; SUS SCROFA CEREBRAL CORTEX; POTASSIUM CARBONATE; LENOGRASTIM; GLUTATHIONE; INTERFERON GAMMA-1B; LITHIUM CARBONATE",
"StrengthNumber": "15; 4; 5; 8; 8; 7; 7; 7; 9; 9; 3; 3; 4; 9; 4; 4; 5; 8",
"StrengthUnit": "[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Respiratory Secretion Viscosity [PE], Fungal Proteins [CS], Increased Glutathione Concentration [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Mood Stabilizer [EPC], Mucolytic [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Reduction Activity [MoA], Seed Storage Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. ."
},
{
"NDCCode": "17089-068-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-068-20) / 4 g in 1 TUBE",
"NDC11Code": "17089-0068-20",
"ProductNDC": "17089-068",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Age Vein",
"NonProprietaryName": "Aconitum Napellus - Apis Mellifera - Arnica Montana - Arsenic Trioxide - Atropa Belladonna - Calcium Fluoride - Centella Asiatica - Cinchona Officinalis Bark - Cranberry - Horse Chestnut - Iron - Lachesis Muta Venom - Mercury - Pineapple - Pulsatilla Vulgaris - Sus Scrofa Artery - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Vein - Viscum Album Fruit - Witch Hazel -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ACONITUM NAPELLUS; HORSE CHESTNUT; PINEAPPLE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; SUS SCROFA ARTERY; ATROPA BELLADONNA; CALCIUM FLUORIDE; CINCHONA OFFICINALIS BARK; IRON; WITCH HAZEL; CENTELLA ASIATICA; LACHESIS MUTA VENOM; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MERCURY; CRANBERRY; PULSATILLA VULGARIS; SUS SCROFA VEIN; VISCUM ALBUM FRUIT",
"StrengthNumber": "10; 3; 3; 10; 10; 12; 4; 10; 8; 10; 10; 3; 3; 10; 7; 10; 3; 10; 4; 3",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. ."
},
{
"NDCCode": "17089-075-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-075-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0075-20",
"ProductNDC": "17089-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Omeosport",
"NonProprietaryName": ".alpha.-ketoglutaric Acid - Aconitic Acid, Cis - Adenosine Triphosphate - Alpha Lipoic Acid - Ascorbic Acid - Asian Ginseng - Barium Cation - Beet - Cerous Oxalate Nonahydrate - Coenzyme A - Cysteine - Fumaric Acid - Lactic Acid, Dl - Magnesium Carbonate - Malic Acid - Manganese Phosphate, Dibasic - Pork - Pyridoxine Hydrochloride - Riboflavin - Sodium Diethyl Oxalacetate - Sodium Pyruvate - Succinic Acid - Sus Scrofa Adrenal Gland - Thiamine Hydrochloride - Sus Scrofa Embryo -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ADENOSINE TRIPHOSPHATE; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BEET; CEROUS OXALATE NONAHYDRATE; ACONITIC ACID, (Z)-; COENZYME A; CYSTEINE; SUS SCROFA EMBRYO; FUMARIC ACID; ASIAN GINSENG; SUS SCROFA ADRENAL GLAND; LACTIC ACID; MAGNESIUM CARBONATE; MALIC ACID; MANGANESE PHOSPHATE, DIBASIC; PORK; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SUCCINIC ACID; THIAMINE HYDROCHLORIDE",
"StrengthNumber": "8; 6; 6; 4; 6; 2; 6; 6; 6; 6; 6; 6; 3; 10; 8; 2; 6; 6; 6; 6; 6; 6; 6; 6; 4",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Magnetic Resonance Contrast Activity [MoA], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Paramagnetic Contrast Agent [EPC], Plant Proteins [CS], Vegetable Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2019-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 Turn tube upside down and rotate cap to release pellets into cap., 2 Unscrew cap and without touching pellets tip them into the mouth under the tongue., 3 Allow to dissolve, 4 Take 15 minutes before meals. ."
},
{
"NDCCode": "17089-076-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-076-20) / 4 g in 1 TUBE",
"NDC11Code": "17089-0076-20",
"ProductNDC": "17089-076",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Citomix",
"NonProprietaryName": "Aldesleukin - Binetrakin - Canakinumab - Centella Asiatica - Cranberry - Human Interleukin-6 (nonglycosylated) - Interferon Gamma-1b - Lenograstim - Pineapple - Sus Scrofa Bone Marrow - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Thymus -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "PINEAPPLE; LENOGRASTIM; CENTELLA ASIATICA; INTERFERON GAMMA-1B; CANAKINUMAB; ALDESLEUKIN; BINETRAKIN; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA BONE MARROW; CRANBERRY; SUS SCROFA THYMUS",
"StrengthNumber": "3; 4; 3; 4; 5; 5; 4; 7; 4; 4; 3; 4",
"StrengthUnit": "[hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060523",
"SamplePackage": "N",
"IndicationAndUsage": "Immune support suring times of: : 1 Seasonal colds and flu."
},
{
"NDCCode": "17089-235-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-235-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0235-20",
"ProductNDC": "17089-235",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-tonsils",
"NonProprietaryName": "Angelica Sinensis Root - Binetrakin - Interleukin-3 - Lenograstim - Melatonin - Reishi - Shiitake Mushroom - Sus Scrofa Blood - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Spleen - Interleukin-11 -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ANGELICA SINENSIS ROOT; SUS SCROFA BLOOD; LENOGRASTIM; INTERLEUKIN-11; INTERLEUKIN-3; BINETRAKIN; SHIITAKE MUSHROOM; REISHI; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MELATONIN; SUS SCROFA SPLEEN",
"StrengthNumber": "3; 7; 4; 5; 5; 4; 8; 8; 4; 4; 4",
"StrengthUnit": "[hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g",
"Status": "Active",
"LastUpdate": "2019-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals."
},
{
"NDCCode": "17089-237-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-237-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0237-20",
"ProductNDC": "17089-237",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-react",
"NonProprietaryName": "Angelica Sinensis Root - Arnica Montana - Asian Ginseng - Echinacea Angustifolia - Fomitopsis Pinicola Fruiting Body - Interferon Gamma-1b - Paeonia Officinalis Root - Pork Liver - Reishi - Silybum Marianum Seed - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Turmeric -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "TURMERIC; ANGELICA SINENSIS ROOT; ARNICA MONTANA; SILYBUM MARIANUM SEED; ECHINACEA ANGUSTIFOLIA; ASIAN GINSENG; PORK LIVER; INTERFERON GAMMA-1B; REISHI; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; PAEONIA OFFICINALIS ROOT; FOMITOPSIS PINICOLA FRUITING BODY",
"StrengthNumber": "3; 3; 4; 3; 3; 1; 4; 4; 8; 4; 3; 8",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Interferon gamma [EPC], Interferon-gamma [CS]",
"Status": "Active",
"LastUpdate": "2019-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Directions:. Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals."
},
{
"NDCCode": "17089-251-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-251-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0251-20",
"ProductNDC": "17089-251",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-virus",
"NonProprietaryName": "Aldesleukin - Everlasting Extract - Fomitopsis Pinicola Fruiting Body - Interferon Gamma-1b - Melatonin - Metenkefalin - Reishi - Rice - Serotonin - Soybean - Sus Scrofa Blood - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Spleen -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ALDESLEUKIN; EVERLASTING EXTRACT; FOMITOPSIS PINICOLA FRUITING BODY; INTERFERON GAMMA-1B; METENKEFALIN; REISHI; BROWN RICE; SEROTONIN; SOYBEAN; SUS SCROFA BLOOD; SUS SCROFA SPLEEN; MELATONIN; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE",
"StrengthNumber": "5; 3; 8; 3; 4; 8; 3; 6; 3; 4; 4; 15; 7",
"StrengthUnit": "[hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. ."
},
{
"NDCCode": "17089-302-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-302-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0302-20",
"ProductNDC": "17089-302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-stomach",
"NonProprietaryName": "Activated Charcoal - Antimony Trisulfide - Bismuth Subnitrate - Dioscorea Villosa Root - Dopamine - Human Epidermal Growth Factor - Ipecac - Oregano - Picea Mariana Resin - Robinia Pseudoacacia Bark - Semecarpus Anacardium Juice - Silver Nitrate - Sus Scrofa Stomach - Sus Scrofa Sympathetic Nerve - Momordica Balsamina Immature Fruit -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180515",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "PICEA MARIANA RESIN; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; IPECAC; DIOSCOREA VILLOSA ROOT; DOPAMINE; HUMAN EPIDERMAL GROWTH FACTOR; MOMORDICA BALSAMINA IMMATURE FRUIT; OREGANO; ROBINIA PSEUDOACACIA BARK; SUS SCROFA STOMACH; SUS SCROFA SYMPATHETIC NERVE",
"StrengthNumber": "3; 30; 30; 30; 6; 6; 30; 3; 6; 4; 3; 10; 2; 30; 6",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Bismuth [CS], Bismuth [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180515",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals."
},
{
"NDCCode": "17089-311-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-311-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0311-20",
"ProductNDC": "17089-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-liver",
"NonProprietaryName": "Ceanothus Americanus Leaf - Chelidonium Majus - Chionanthus Virginicus Bark - Choline Hydroxide - Cobalamin - Culver Root - Fumaric Acid - Inositol - Lycopodium Clavatum Spore - Niacin - Pork Liver - Potassium Sulfate - Pyridoxine Hydrochloride - Riboflavin - Silybum Marianum Seed - Sodium Diethyl Oxalacetate - Sodium Pyruvate - Sodium Sulfate - Sus Scrofa Gall Bladder - Sus Scrofa Jejunum - Sus Scrofa Pancreas - Sus Scrofa Spleen - Taraxacum Officinale - Thiamine Hydrochloride -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "SILYBUM MARIANUM SEED; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE HYDROXIDE; COBALAMIN; FUMARIC ACID; SUS SCROFA GALLBLADDER; PORK LIVER; INOSITOL; SUS SCROFA JEJUNUM; POTASSIUM SULFATE; CULVER'S ROOT; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; NIACIN; SUS SCROFA PANCREAS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; THIAMINE HYDROCHLORIDE",
"StrengthNumber": "2; 6; 2; 6; 4; 4; 4; 8; 6; 4; 8; 12; 6; 6; 4; 4; 8; 6; 8; 6; 6; 8; 2; 6",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2019-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals."
},
{
"NDCCode": "17089-476-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-476-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0476-20",
"ProductNDC": "17089-476",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna Hay Fever Relief",
"NonProprietaryName": "Strychnos Nux Vomica Seed - Histamine Dihydrochloride - Manganese - Schoenocaulon Officinale Seed - Apis Mellifera - Arsenic Trioxide - Silver Nitrate - Onion - Euphrasia Stricta - Galphimia Glauca Flowering Top - Sulfur -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "STRYCHNOS NUX-VOMICA SEED; HISTAMINE DIHYDROCHLORIDE; MANGANESE; SCHOENOCAULON OFFICINALE SEED; ONION; APIS MELLIFERA; SILVER NITRATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; SULFUR; ARSENIC TRIOXIDE",
"StrengthNumber": "4; 200; 8; 6; 30; 200; 6; 5; 4; 30; 30",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210217",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves hay fever symptoms, such as. ● sneezing. ● coughing. ● inflamed, runny nose."
},
{
"NDCCode": "17089-477-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-477-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0477-20",
"ProductNDC": "17089-477",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna Stomach Plus",
"NonProprietaryName": "Antimonium Crudum - Argentum Nitricum - Arsenicum Album - Ipecacuanha - Nux Vomica - Origanum Majorana - Cuprum Metallicum - Taraxacum Officinale - Natrum Phosphoricum -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "STRYCHNOS NUX-VOMICA SEED; ANTIMONY TRISULFIDE; COPPER; IPECAC; SILVER NITRATE; ORIGANUM MAJORANA; TARAXACUM OFFICINALE ROOT; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; ARSENIC TRIOXIDE",
"StrengthNumber": "4; 6; 4; 8; 6; 6; 6; 4; 6",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210217",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves symptoms of acid reflux and gastritis such as: 1 heartburn, 2 sour stomach, 3 nausea after eating."
},
{
"NDCCode": "17089-478-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-478-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0478-20",
"ProductNDC": "17089-478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna Liver Plus",
"NonProprietaryName": "Sodium Pyruvate - Silybum Marianum Seed - Chelidonium Majus - Fumaric Acid - Pork Liver - Taraxacum Officinale - Lycopodium Clavatum Spore - Sodium Sulfate - Phosphorus - Berberis Vulgaris Root Bark",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; FUMARIC ACID; PORK LIVER; SODIUM PYRUVATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; PHOSPHORUS; BERBERIS VULGARIS ROOT BARK; TARAXACUM OFFICINALE",
"StrengthNumber": "2; 4; 6; 6; 3; 6; 6; 8; 3; 3",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210217",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals."
},
{
"NDCCode": "17089-503-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-503-20) / 4 g in 1 TUBE",
"NDC11Code": "17089-0503-20",
"ProductNDC": "17089-503",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-virus",
"NonProprietaryName": "Aldesleukin - Everlasting Extract - Fomitopsis Pinicola Fruiting Body - Interferon Gamma-1b - Melatonin - Metenkefalin - Reishi - Serotonin - Soybean - Sus Scrofa Blood - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Spleen -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ALDESLEUKIN; EVERLASTING EXTRACT; FOMITOPSIS PINICOLA FRUITING BODY; INTERFERON GAMMA-1B; METENKEFALIN; REISHI; SEROTONIN; SOYBEAN; SUS SCROFA BLOOD; SUS SCROFA SPLEEN; MELATONIN; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE",
"StrengthNumber": "5; 3; 8; 3; 4; 8; 6; 3; 4; 4; 15; 7",
"StrengthUnit": "[hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals."
},
{
"NDCCode": "17089-382-18",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (17089-382-18) / 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17089-0382-18",
"ProductNDC": "17089-382",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-il 4",
"NonProprietaryName": "Binetrakin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20080617",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "BINETRAKIN",
"StrengthNumber": "4",
"StrengthUnit": "[hp_C]/30mL",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080617",
"SamplePackage": "N",
"IndicationAndUsage": "Take 15 minutes before meals. Adults and children 12 years and older 20 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow. Children between 12 years and 6 years of age 10 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow. Children under 6 years consult a physician."
},
{
"NDCCode": "17089-470-18",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (17089-470-18) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17089-0470-18",
"ProductNDC": "17089-470",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna Bowel Plus",
"NonProprietaryName": "Activated Charcoal - Aloe - Aluminum Oxide - Bryonia Alba Root - Chelidonium Majus - Collinsonia - Frangula Alnus Bark - Lycopodium Clavatum Spore - Potassium Carbonate- Rhubarb - Strychnos Nux Vomica Seed - Silybum Marianum Seed - Skatole - Sodium Carbonate - Sus Scrofa Pancreas - Taraxacum Officinale - Thiamine -",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20210117",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; ACTIVATED CHARCOAL; COLLINSONIA; SUS SCROFA PANCREAS; POTASSIUM CARBONATE; SODIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; FRANGULA ALNUS BARK; RHUBARB; SKATOLE; TARAXACUM OFFICINALE; THIAMINE",
"StrengthNumber": "4; 6; 6; 2; 2; 6; 2; 6; 6; 6; 2; 6; 2; 2; 6; 2; 4",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210117",
"SamplePackage": "N",
"IndicationAndUsage": "Take 15 minutes before meals."
},
{
"NDCCode": "17089-471-18",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (17089-471-18) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17089-0471-18",
"ProductNDC": "17089-471",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna Sleep Support",
"NonProprietaryName": "Avena Sativa Flowering Top - Caffeine - Matricaria Chamomilla Whole - Passiflora Incarnata Flowering Top -potassium Bromide - Zinc Valerate Dihydrate - Silver Nitrate - Strychnos Ingatii Seed -",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20210117",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "POTASSIUM BROMIDE; CAFFEINE; AVENA SATIVA FLOWERING TOP; MATRICARIA CHAMOMILLA WHOLE; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; SILVER NITRATE; ZINC VALERATE DIHYDRATE",
"StrengthNumber": "4; 6; 2; 2; 4; 2; 30; 4",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2021-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210117",
"SamplePackage": "N",
"IndicationAndUsage": "Take 15 minutes before meals."
},
{
"NDCCode": "0049-0054-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0049-0054-60) ",
"NDC11Code": "00049-0054-60",
"ProductNDC": "0049-0054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Geodon",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190319",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020825",
"LabelerName": "ROERIG",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190319",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)].",
"Description": "GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS ∙ HCl ∙ H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS ∙ CH3SO3H ∙ 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
},
{
"NDCCode": "0049-0056-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0049-0056-60) ",
"NDC11Code": "00049-0056-60",
"ProductNDC": "0049-0056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Geodon",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020825",
"LabelerName": "ROERIG",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].",
"Description": "GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
},
{
"NDCCode": "0049-0058-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0049-0058-60) ",
"NDC11Code": "00049-0058-60",
"ProductNDC": "0049-0058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Geodon",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020825",
"LabelerName": "ROERIG",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].",
"Description": "GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
},
{
"NDCCode": "0049-0352-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0049-0352-60) ",
"NDC11Code": "00049-0352-60",
"ProductNDC": "0049-0352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Geodon",
"NonProprietaryName": "Ziprasidone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020825",
"LabelerName": "ROERIG",
"SubstanceName": "ZIPRASIDONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211108",
"SamplePackage": "N",
"IndicationAndUsage": "GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].",
"Description": "GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
},
{
"NDCCode": "0049-0354-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0049-0354-60) ",
"NDC11Code": "00049-0354-60",
"ProductNDC": "0049-0354",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Geodon",
"NonProprietaryName": "Ziprasidone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230714",
"EndMarketingDate": "20270930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020825",
"LabelerName": "ROERIG",
"SubstanceName": "ZIPRASIDONE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230714",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].",
"Description": "GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
},
{
"NDCCode": "0049-0356-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0049-0356-60) ",
"NDC11Code": "00049-0356-60",
"ProductNDC": "0049-0356",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Geodon",
"NonProprietaryName": "Ziprasidone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020825",
"LabelerName": "ROERIG",
"SubstanceName": "ZIPRASIDONE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211108",
"SamplePackage": "N",
"IndicationAndUsage": "GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].",
"Description": "GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"EndMarketingDate": "20261231",
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"LabelerName": "ROERIG",
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"Pharm_Classes": "Atypical Antipsychotic [EPC]",
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"IndicationAndUsage": "GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].",
"Description": "GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
}
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<NonProprietaryName>Aconitum Napellus - Apis Mellifera - Arnica Montana - Arsenic Trioxide - Atropa Belladonna - Calcium Fluoride - Centella Asiatica - Cinchona Officinalis Bark - Cranberry - Horse Chestnut - Iron - Lachesis Muta Venom - Mercury - Pineapple - Pulsatilla Vulgaris - Sus Scrofa Artery - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Vein - Viscum Album Fruit - Witch Hazel -</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; HORSE CHESTNUT; PINEAPPLE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; SUS SCROFA ARTERY; ATROPA BELLADONNA; CALCIUM FLUORIDE; CINCHONA OFFICINALIS BARK; IRON; WITCH HAZEL; CENTELLA ASIATICA; LACHESIS MUTA VENOM; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MERCURY; CRANBERRY; PULSATILLA VULGARIS; SUS SCROFA VEIN; VISCUM ALBUM FRUIT</SubstanceName>
<StrengthNumber>10; 3; 3; 10; 10; 12; 4; 10; 8; 10; 10; 3; 3; 10; 7; 10; 3; 10; 4; 3</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-075-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-075-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0075-20</NDC11Code>
<ProductNDC>17089-075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Omeosport</ProprietaryName>
<NonProprietaryName>.alpha.-ketoglutaric Acid - Aconitic Acid, Cis - Adenosine Triphosphate - Alpha Lipoic Acid - Ascorbic Acid - Asian Ginseng - Barium Cation - Beet - Cerous Oxalate Nonahydrate - Coenzyme A - Cysteine - Fumaric Acid - Lactic Acid, Dl - Magnesium Carbonate - Malic Acid - Manganese Phosphate, Dibasic - Pork - Pyridoxine Hydrochloride - Riboflavin - Sodium Diethyl Oxalacetate - Sodium Pyruvate - Succinic Acid - Sus Scrofa Adrenal Gland - Thiamine Hydrochloride - Sus Scrofa Embryo -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ADENOSINE TRIPHOSPHATE; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BEET; CEROUS OXALATE NONAHYDRATE; ACONITIC ACID, (Z)-; COENZYME A; CYSTEINE; SUS SCROFA EMBRYO; FUMARIC ACID; ASIAN GINSENG; SUS SCROFA ADRENAL GLAND; LACTIC ACID; MAGNESIUM CARBONATE; MALIC ACID; MANGANESE PHOSPHATE, DIBASIC; PORK; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SUCCINIC ACID; THIAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8; 6; 6; 4; 6; 2; 6; 6; 6; 6; 6; 6; 3; 10; 8; 2; 6; 6; 6; 6; 6; 6; 6; 6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Magnetic Resonance Contrast Activity [MoA], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Paramagnetic Contrast Agent [EPC], Plant Proteins [CS], Vegetable Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 Turn tube upside down and rotate cap to release pellets into cap., 2 Unscrew cap and without touching pellets tip them into the mouth under the tongue., 3 Allow to dissolve, 4 Take 15 minutes before meals. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-076-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-076-20) / 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0076-20</NDC11Code>
<ProductNDC>17089-076</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Citomix</ProprietaryName>
<NonProprietaryName>Aldesleukin - Binetrakin - Canakinumab - Centella Asiatica - Cranberry - Human Interleukin-6 (nonglycosylated) - Interferon Gamma-1b - Lenograstim - Pineapple - Sus Scrofa Bone Marrow - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Thymus -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>PINEAPPLE; LENOGRASTIM; CENTELLA ASIATICA; INTERFERON GAMMA-1B; CANAKINUMAB; ALDESLEUKIN; BINETRAKIN; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA BONE MARROW; CRANBERRY; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>3; 4; 3; 4; 5; 5; 4; 7; 4; 4; 3; 4</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Immune support suring times of: : 1 Seasonal colds and flu.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-235-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-235-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0235-20</NDC11Code>
<ProductNDC>17089-235</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-tonsils</ProprietaryName>
<NonProprietaryName>Angelica Sinensis Root - Binetrakin - Interleukin-3 - Lenograstim - Melatonin - Reishi - Shiitake Mushroom - Sus Scrofa Blood - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Spleen - Interleukin-11 -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ANGELICA SINENSIS ROOT; SUS SCROFA BLOOD; LENOGRASTIM; INTERLEUKIN-11; INTERLEUKIN-3; BINETRAKIN; SHIITAKE MUSHROOM; REISHI; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MELATONIN; SUS SCROFA SPLEEN</SubstanceName>
<StrengthNumber>3; 7; 4; 5; 5; 4; 8; 8; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-237-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-237-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0237-20</NDC11Code>
<ProductNDC>17089-237</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-react</ProprietaryName>
<NonProprietaryName>Angelica Sinensis Root - Arnica Montana - Asian Ginseng - Echinacea Angustifolia - Fomitopsis Pinicola Fruiting Body - Interferon Gamma-1b - Paeonia Officinalis Root - Pork Liver - Reishi - Silybum Marianum Seed - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Turmeric -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>TURMERIC; ANGELICA SINENSIS ROOT; ARNICA MONTANA; SILYBUM MARIANUM SEED; ECHINACEA ANGUSTIFOLIA; ASIAN GINSENG; PORK LIVER; INTERFERON GAMMA-1B; REISHI; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; PAEONIA OFFICINALIS ROOT; FOMITOPSIS PINICOLA FRUITING BODY</SubstanceName>
<StrengthNumber>3; 3; 4; 3; 3; 1; 4; 4; 8; 4; 3; 8</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Interferon gamma [EPC], Interferon-gamma [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions:. Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-251-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-251-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0251-20</NDC11Code>
<ProductNDC>17089-251</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-virus</ProprietaryName>
<NonProprietaryName>Aldesleukin - Everlasting Extract - Fomitopsis Pinicola Fruiting Body - Interferon Gamma-1b - Melatonin - Metenkefalin - Reishi - Rice - Serotonin - Soybean - Sus Scrofa Blood - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Spleen -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ALDESLEUKIN; EVERLASTING EXTRACT; FOMITOPSIS PINICOLA FRUITING BODY; INTERFERON GAMMA-1B; METENKEFALIN; REISHI; BROWN RICE; SEROTONIN; SOYBEAN; SUS SCROFA BLOOD; SUS SCROFA SPLEEN; MELATONIN; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE</SubstanceName>
<StrengthNumber>5; 3; 8; 3; 4; 8; 3; 6; 3; 4; 4; 15; 7</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-302-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-302-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0302-20</NDC11Code>
<ProductNDC>17089-302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-stomach</ProprietaryName>
<NonProprietaryName>Activated Charcoal - Antimony Trisulfide - Bismuth Subnitrate - Dioscorea Villosa Root - Dopamine - Human Epidermal Growth Factor - Ipecac - Oregano - Picea Mariana Resin - Robinia Pseudoacacia Bark - Semecarpus Anacardium Juice - Silver Nitrate - Sus Scrofa Stomach - Sus Scrofa Sympathetic Nerve - Momordica Balsamina Immature Fruit -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180515</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>PICEA MARIANA RESIN; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; IPECAC; DIOSCOREA VILLOSA ROOT; DOPAMINE; HUMAN EPIDERMAL GROWTH FACTOR; MOMORDICA BALSAMINA IMMATURE FRUIT; OREGANO; ROBINIA PSEUDOACACIA BARK; SUS SCROFA STOMACH; SUS SCROFA SYMPATHETIC NERVE</SubstanceName>
<StrengthNumber>3; 30; 30; 30; 6; 6; 30; 3; 6; 4; 3; 10; 2; 30; 6</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bismuth [CS], Bismuth [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-311-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-311-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0311-20</NDC11Code>
<ProductNDC>17089-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-liver</ProprietaryName>
<NonProprietaryName>Ceanothus Americanus Leaf - Chelidonium Majus - Chionanthus Virginicus Bark - Choline Hydroxide - Cobalamin - Culver Root - Fumaric Acid - Inositol - Lycopodium Clavatum Spore - Niacin - Pork Liver - Potassium Sulfate - Pyridoxine Hydrochloride - Riboflavin - Silybum Marianum Seed - Sodium Diethyl Oxalacetate - Sodium Pyruvate - Sodium Sulfate - Sus Scrofa Gall Bladder - Sus Scrofa Jejunum - Sus Scrofa Pancreas - Sus Scrofa Spleen - Taraxacum Officinale - Thiamine Hydrochloride -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>SILYBUM MARIANUM SEED; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE HYDROXIDE; COBALAMIN; FUMARIC ACID; SUS SCROFA GALLBLADDER; PORK LIVER; INOSITOL; SUS SCROFA JEJUNUM; POTASSIUM SULFATE; CULVER'S ROOT; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; NIACIN; SUS SCROFA PANCREAS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; THIAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; 6; 2; 6; 4; 4; 4; 8; 6; 4; 8; 12; 6; 6; 4; 4; 8; 6; 8; 6; 6; 8; 2; 6</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-476-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-476-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0476-20</NDC11Code>
<ProductNDC>17089-476</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna Hay Fever Relief</ProprietaryName>
<NonProprietaryName>Strychnos Nux Vomica Seed - Histamine Dihydrochloride - Manganese - Schoenocaulon Officinale Seed - Apis Mellifera - Arsenic Trioxide - Silver Nitrate - Onion - Euphrasia Stricta - Galphimia Glauca Flowering Top - Sulfur -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210217</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>STRYCHNOS NUX-VOMICA SEED; HISTAMINE DIHYDROCHLORIDE; MANGANESE; SCHOENOCAULON OFFICINALE SEED; ONION; APIS MELLIFERA; SILVER NITRATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; SULFUR; ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>4; 200; 8; 6; 30; 200; 6; 5; 4; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves hay fever symptoms, such as. ● sneezing. ● coughing. ● inflamed, runny nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-477-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-477-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0477-20</NDC11Code>
<ProductNDC>17089-477</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna Stomach Plus</ProprietaryName>
<NonProprietaryName>Antimonium Crudum - Argentum Nitricum - Arsenicum Album - Ipecacuanha - Nux Vomica - Origanum Majorana - Cuprum Metallicum - Taraxacum Officinale - Natrum Phosphoricum -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210217</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>STRYCHNOS NUX-VOMICA SEED; ANTIMONY TRISULFIDE; COPPER; IPECAC; SILVER NITRATE; ORIGANUM MAJORANA; TARAXACUM OFFICINALE ROOT; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>4; 6; 4; 8; 6; 6; 6; 4; 6</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves symptoms of acid reflux and gastritis such as: 1 heartburn, 2 sour stomach, 3 nausea after eating.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-478-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-478-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0478-20</NDC11Code>
<ProductNDC>17089-478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna Liver Plus</ProprietaryName>
<NonProprietaryName>Sodium Pyruvate - Silybum Marianum Seed - Chelidonium Majus - Fumaric Acid - Pork Liver - Taraxacum Officinale - Lycopodium Clavatum Spore - Sodium Sulfate - Phosphorus - Berberis Vulgaris Root Bark</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210217</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; FUMARIC ACID; PORK LIVER; SODIUM PYRUVATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; PHOSPHORUS; BERBERIS VULGARIS ROOT BARK; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>2; 4; 6; 6; 3; 6; 6; 8; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-503-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-503-20) / 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0503-20</NDC11Code>
<ProductNDC>17089-503</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-virus</ProprietaryName>
<NonProprietaryName>Aldesleukin - Everlasting Extract - Fomitopsis Pinicola Fruiting Body - Interferon Gamma-1b - Melatonin - Metenkefalin - Reishi - Serotonin - Soybean - Sus Scrofa Blood - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Spleen -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ALDESLEUKIN; EVERLASTING EXTRACT; FOMITOPSIS PINICOLA FRUITING BODY; INTERFERON GAMMA-1B; METENKEFALIN; REISHI; SEROTONIN; SOYBEAN; SUS SCROFA BLOOD; SUS SCROFA SPLEEN; MELATONIN; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE</SubstanceName>
<StrengthNumber>5; 3; 8; 3; 4; 8; 6; 3; 4; 4; 15; 7</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-382-18</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (17089-382-18) / 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17089-0382-18</NDC11Code>
<ProductNDC>17089-382</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-il 4</ProprietaryName>
<NonProprietaryName>Binetrakin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080617</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>BINETRAKIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_C]/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Take 15 minutes before meals. Adults and children 12 years and older 20 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow. Children between 12 years and 6 years of age 10 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow. Children under 6 years consult a physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-470-18</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (17089-470-18) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17089-0470-18</NDC11Code>
<ProductNDC>17089-470</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna Bowel Plus</ProprietaryName>
<NonProprietaryName>Activated Charcoal - Aloe - Aluminum Oxide - Bryonia Alba Root - Chelidonium Majus - Collinsonia - Frangula Alnus Bark - Lycopodium Clavatum Spore - Potassium Carbonate- Rhubarb - Strychnos Nux Vomica Seed - Silybum Marianum Seed - Skatole - Sodium Carbonate - Sus Scrofa Pancreas - Taraxacum Officinale - Thiamine -</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210117</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; ACTIVATED CHARCOAL; COLLINSONIA; SUS SCROFA PANCREAS; POTASSIUM CARBONATE; SODIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; FRANGULA ALNUS BARK; RHUBARB; SKATOLE; TARAXACUM OFFICINALE; THIAMINE</SubstanceName>
<StrengthNumber>4; 6; 6; 2; 2; 6; 2; 6; 6; 6; 2; 6; 2; 2; 6; 2; 4</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-471-18</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (17089-471-18) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17089-0471-18</NDC11Code>
<ProductNDC>17089-471</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna Sleep Support</ProprietaryName>
<NonProprietaryName>Avena Sativa Flowering Top - Caffeine - Matricaria Chamomilla Whole - Passiflora Incarnata Flowering Top -potassium Bromide - Zinc Valerate Dihydrate - Silver Nitrate - Strychnos Ingatii Seed -</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210117</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>POTASSIUM BROMIDE; CAFFEINE; AVENA SATIVA FLOWERING TOP; MATRICARIA CHAMOMILLA WHOLE; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; SILVER NITRATE; ZINC VALERATE DIHYDRATE</SubstanceName>
<StrengthNumber>4; 6; 2; 2; 4; 2; 30; 4</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0049-0054-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0049-0054-60) </PackageDescription>
<NDC11Code>00049-0054-60</NDC11Code>
<ProductNDC>0049-0054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Geodon</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190319</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020825</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190319</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS ∙ HCl ∙ H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS ∙ CH3SO3H ∙ 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
</NDC>
<NDC>
<NDCCode>0049-0056-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0049-0056-60) </PackageDescription>
<NDC11Code>00049-0056-60</NDC11Code>
<ProductNDC>0049-0056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Geodon</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020825</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
</NDC>
<NDC>
<NDCCode>0049-0058-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0049-0058-60) </PackageDescription>
<NDC11Code>00049-0058-60</NDC11Code>
<ProductNDC>0049-0058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Geodon</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020825</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
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<IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
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<IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
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<IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
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<IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
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