{
"NDC": [
{
"NDCCode": "57955-0818-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0818-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-0818-03",
"ProductNDC": "57955-0818",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wart Remover",
"NonProprietaryName": "Antimonium Crudum, Causticum, Dulcamara, Kali Muriaticum, Nitricum Acidum, Sabina, Staphysagria, Sulfur, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140318",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ANTIMONY TRISULFIDE; CAUSTICUM; SOLANUM DULCAMARA TOP; POTASSIUM CHLORIDE; NITRIC ACID; JUNIPERUS SABINA LEAFY TWIG; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomatic treatment of smooth or rough warts and dry, itching or unhealthy skin. †as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested."
},
{
"NDCCode": "37662-0818-3",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-0818-3) ",
"NDC11Code": "37662-0818-03",
"ProductNDC": "37662-0818",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Digitalis Purpurea",
"NonProprietaryName": "Digitalis Purpurea",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220712",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "DIGITALIS",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220712",
"SamplePackage": "N"
},
{
"NDCCode": "49288-0818-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0818-3)",
"NDC11Code": "49288-0818-03",
"ProductNDC": "49288-0818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Treatment Set Ts341824",
"NonProprietaryName": "Treatment Set Ts341824",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19861031",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "SORGHUM HALEPENSE POLLEN; LOLIUM PERENNE POLLEN; FRAXINUS AMERICANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; PLANTAGO LANCEOLATA POLLEN; BASSIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN",
"StrengthNumber": ".0029; 5882; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .00145; .00145; .00145; .00145; .00097; .00097; .00097; .00097; .00097; .00097; .00048; .00048; .00048; .00048; .00048; .00048",
"StrengthUnit": "g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11. THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.",
"Description": "Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the individual physician's prescription order and will be expressed in most cases on a weight/volume basis (or AU/ml with standardized extract) diluted either 1:10 or 1:5. Where mixtures of pollens and non-pollens have been ordered, the ingredients are listed on the final container label. To insure maximum potency for the entire dating period, dilutions will be prepared with 50% v/v glycerine unless otherwise specified. Ingredients - Active allergens, preservative and stabilizer are noted on the Physicians Prescription Ingredients Insert enclosed with each individual allergenic extract treatment vial. Dating Period - A twelve month dating period (expiration date) for the prescription vial will be on the container label. Extract Treatment Sets should be reordered when outdated. Government requirements include a two week holding period for sterility tests. Please allow three weeks minimum for delivery."
},
{
"NDCCode": "51552-0818-3",
"PackageDescription": "50 g in 1 CONTAINER (51552-0818-3) ",
"NDC11Code": "51552-0818-03",
"ProductNDC": "51552-0818",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Flurbiprofen",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "FLURBIPROFEN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2023-12-09",
"StartMarketingDatePackage": "20-JAN-20",
"EndMarketingDatePackage": "31-DEC-26"
},
{
"NDCCode": "52372-0818-3",
"PackageDescription": "5 g in 1 CONTAINER (52372-0818-3)",
"NDC11Code": "52372-0818-03",
"ProductNDC": "52372-0818",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120301",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Freedom Pharmaceuticals, Inc.",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54868-0818-3",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (54868-0818-3)",
"NDC11Code": "54868-0818-03",
"ProductNDC": "54868-0818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040161",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form. Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. They also contain the following inactive ingredients: Anhydrous Lactose, FD&C Blue No. 1 Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose. Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride with the structural formula. Molecular Formula. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether."
},
{
"NDCCode": "71335-0818-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-0818-3) ",
"NDC11Code": "71335-0818-03",
"ProductNDC": "71335-0818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020301",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021342",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "137",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150810",
"SamplePackage": "N"
},
{
"NDCCode": "57955-0815-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0815-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-0815-03",
"ProductNDC": "57955-0815",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mole Remover",
"NonProprietaryName": "Carbo Vegetabilis, Graphites, Lycopodium Clavatum, Phytolacca Decandra, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140813",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CARBO ANIMALIS; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180112",
"SamplePackage": "N",
"IndicationAndUsage": "Uses † for symptomatic treatment of moles, birthmarks, brown spots, or freckles. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested."
},
{
"NDCCode": "57955-0816-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0816-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-0816-03",
"ProductNDC": "57955-0816",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scar Remover",
"NonProprietaryName": "Arnica Montana, Calcarea Fluorica, Calcarea Phosphorica, Calendula Officinalis, Graphites, Hydrofluoricum Acidum, Phytolacca Decandra, Sabina, Silicea, Thiosinaminum, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140318",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARNICA MONTANA; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; HYDROFLUORIC ACID; PHYTOLACCA AMERICANA ROOT; JUNIPERUS SABINA LEAFY TWIG; SILICON DIOXIDE; ALLYLTHIOUREA; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomatic treatment of scar tissue."
},
{
"NDCCode": "57955-0817-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0817-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-0817-03",
"ProductNDC": "57955-0817",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cherry Angioma Remover",
"NonProprietaryName": "Benzoicum Acidum, Calcarea Carbonica, Calcarea Iodata, Iodium, Phosphoricum Acidum, Phosphorus, Sulphuricum Acidum",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140805",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BENZOIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM IODIDE; IODINE; PHOSPHORIC ACID; PHOSPHORUS; SULFURIC ACID",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomatic treatment of red spots or blood boils associated with angiomas."
},
{
"NDCCode": "57955-0919-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-0919-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-0919-03",
"ProductNDC": "57955-0919",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rosacea Symptom Relief",
"NonProprietaryName": "Calendula Officinalis, Cardiospermum, Chamomilla, Hydrocotyle Asiatica, Rhus Tox, Thuja Occidentalis",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; CARDIOSPERMUM HALICACABUM FLOWERING TOP; MATRICARIA RECUTITA; CENTELLA ASIATICA; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 2; 10; 10; 10; 3",
"StrengthUnit": "[hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of multiple symptoms of rosacea: facial redness burning stinging allergic skin eruptions itching dermatitis pimples swelling thickening of skin. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested."
},
{
"NDCCode": "57955-0920-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-0920-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-0920-03",
"ProductNDC": "57955-0920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Psoriasis Symptom Relief",
"NonProprietaryName": "Cardiospermum, Chamomilla, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Lappa Major, Phytolacca Decandra, Rumex Crispus, Ruta Graveolens, Taraxacum Officinale",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CARDIOSPERMUM HALICACABUM FLOWERING TOP; MATRICARIA RECUTITA; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; RUMEX CRISPUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE",
"StrengthNumber": "2; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of multiple symptoms of psoriasis: itching rash redness thickening of skin exfoliation of scales and crusts allergic skin eruptions. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested."
},
{
"NDCCode": "57955-0921-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-0921-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-0921-03",
"ProductNDC": "57955-0921",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eczema Symptom Relief",
"NonProprietaryName": "Cardiospermum, Hydrastis Canadensis, Hydrocotyle Asiatica, Lappa Major, Rhus Tox, Rumex Crispus, Ruta Graveolens, Sanguinaria Canadensis, Taraxacum Officinale",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CARDIOSPERMUM HALICACABUM FLOWERING TOP; GOLDENSEAL; CENTELLA ASIATICA; ARCTIUM LAPPA ROOT; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; TARAXACUM OFFICINALE",
"StrengthNumber": "2; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of eczema: redness intense itching allergic skin eruptions dry or moist eruptions thickened, crusty, scaly skin inflamed skin general unhealthy skin."
},
{
"NDCCode": "57955-0935-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-0935-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-0935-03",
"ProductNDC": "57955-0935",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warming Arthritic Pain And Joint Relief",
"NonProprietaryName": "Actaea Spicata, Aescuculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Hypericum Perforatum, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla, Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Zincum Metallicum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ACTAEA SPICATA ROOT; HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; ANEMONE PULSATILLA; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g",
"Pharm_Classes": "Mood Stabilizer [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of symptoms: minor aches & pains associated with arthitis, backache, leg cramps, stiff, swollen joints, physical weakness, sore tendons and ligaments, body aches, hip & knee discomforts, muscular soreness, restless limbs."
},
{
"NDCCode": "57955-3203-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-3203-3) > 73 g in 1 TUBE",
"NDC11Code": "57955-3203-03",
"ProductNDC": "57955-3203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Gel",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160307",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/73g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses Temporarily relieves: swelling form minor injuries muscle pain and stiffness, and bruising, due to minor injuries or overexertion. †as per various materia medicas. Product \"Uses\" have not been evaluated by the FDA. Product has not been clinically tested."
},
{
"NDCCode": "57955-4000-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-4000-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-4000-03",
"ProductNDC": "57955-4000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soothing Advanced Arnica",
"NonProprietaryName": "Arnica Montana, Arnica Montana, Radix",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120718",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARNICA MONTANA; ARNICA MONTANA ROOT",
"StrengthNumber": "6; 6",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: 1 pain or stiffness in muscles or joints, 2 bruising and discoloration, 3 inflammation, 4 soreness after exercise."
},
{
"NDCCode": "57955-4001-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-4001-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-4001-03",
"ProductNDC": "57955-4001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cooling Acute Pain Relief",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Cimicifuga Racemosa, Cobaltum Metallicum, Gnaphalium Polycephalum, Hypericum Perforatum, Kali Carbonicum, Kali Phosphoricum, Magnesia Phosphorica, Oxalicum Acidum, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Zincum Metallicum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180220",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180220",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: for temporary relief of symptoms: back and neck pain muscle and joint pain muscle cramps and stiffness inflamed muscles and joints muscle tension and soreness body aches tired legs and feet stiff and swollen joints."
},
{
"NDCCode": "57955-7301-3",
"PackageDescription": "85 g in 1 TUBE (57955-7301-3)",
"NDC11Code": "57955-7301-03",
"ProductNDC": "57955-7301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soothing Advanced Arnica",
"NonProprietaryName": "Arnica Montana, Arnica Montana, Radix",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140507",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARNICA MONTANA; ARNICA MONTANA ROOT",
"StrengthNumber": "6; 6",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: stiff muscles or joints inflammation bruising and discoloration. soreness after exercise."
},
{
"NDCCode": "57955-7302-3",
"PackageDescription": "85 g in 1 TUBE (57955-7302-3)",
"NDC11Code": "57955-7302-03",
"ProductNDC": "57955-7302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cooling Acute Pain Relief",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Cimicifuga Racemosa, Cobaltum Metallicum, Gnaphalium Polycephalum, Hypericum Perforatum, Kali Carbonicum, Kali Phosphoricum, Magnesia Phosphorica, Oxalicum Acidum, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Zincum Metallicum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: back and neck pain muscle and joint pain muscle cramps and stiffness inflamed muscles and joints muscle tension and soreness body aches tired legs and feet stiff and swollen joints."
},
{
"NDCCode": "57955-7800-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-7800-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-7800-03",
"ProductNDC": "57955-7800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skin Tag Remover",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130426",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "For symptomatic treatment of skin tags. † as per various homeopathic Materia Medicas."
},
{
"NDCCode": "57955-8699-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-8699-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-8699-03",
"ProductNDC": "57955-8699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skin Tag Remover",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140108",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomatic treatment of skin tags. † as per various homeopathic Materia Medicas."
},
{
"NDCCode": "0078-0818-81",
"PackageDescription": "1 KIT in 1 KIT (0078-0818-81) * 6 mL in 1 VIAL (0078-0797-61) * 2 mL in 1 SYRINGE",
"NDC11Code": "00078-0818-81",
"ProductNDC": "0078-0818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sandostatin Lar Depot",
"NonProprietaryName": "Octreotide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021008",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.",
"Description": "Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is. SANDOSTATIN LAR DEPOT is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. SANDOSTATIN LAR DEPOT is available as: sterile 6-mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of SANDOSTATIN LAR DEPOT delivers."
},
{
"NDCCode": "11344-818-32",
"PackageDescription": "354 mL in 1 BOTTLE, PUMP (11344-818-32) ",
"NDC11Code": "11344-0818-32",
"ProductNDC": "11344-818",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Moisturizing Antibacterial",
"NonProprietaryName": "Benzalkonium Chloride 0.13%",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220105",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220105",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "16571-818-02",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (16571-818-02) ",
"NDC11Code": "16571-0818-02",
"ProductNDC": "16571-818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206309",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221004",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2) Treatment of adults with refractory anaplastic astrocytoma. (1.2) .",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for Temozolomide Capsules, USP are as follows. Temozolomide Capsules 5 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 20 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 100 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 140 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 180 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 250 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. Temozolomide Capsules 5 mg: The green cap contains gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue 2.Temozolomide Capsules 20 mg: The yellow cap contains gelatin, titanium dioxide, and yellow iron oxide.Temozolomide Capsules 100 mg: The pink cap contains gelatin, titanium dioxide, and yellow iron oxide, and red iron oxide.Temozolomide Capsules 140 mg: The blue cap contains gelatin, titanium dioxide, yellow iron oxide and FD&C Blue #2.Temozolomide Capsules 180 mg: The orange cap contains gelatin, titanium dioxide and red iron oxide.Temozolomide Capsules 250 mg: The white cap contains gelatin, titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "16571-818-41",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (16571-818-41) ",
"NDC11Code": "16571-0818-41",
"ProductNDC": "16571-818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206309",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221004",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2) Treatment of adults with refractory anaplastic astrocytoma. (1.2) .",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for Temozolomide Capsules, USP are as follows. Temozolomide Capsules 5 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 20 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 100 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 140 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 180 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 250 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. Temozolomide Capsules 5 mg: The green cap contains gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue 2.Temozolomide Capsules 20 mg: The yellow cap contains gelatin, titanium dioxide, and yellow iron oxide.Temozolomide Capsules 100 mg: The pink cap contains gelatin, titanium dioxide, and yellow iron oxide, and red iron oxide.Temozolomide Capsules 140 mg: The blue cap contains gelatin, titanium dioxide, yellow iron oxide and FD&C Blue #2.Temozolomide Capsules 180 mg: The orange cap contains gelatin, titanium dioxide and red iron oxide.Temozolomide Capsules 250 mg: The white cap contains gelatin, titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "16571-818-51",
"PackageDescription": "5 CAPSULE in 1 BOTTLE (16571-818-51) ",
"NDC11Code": "16571-0818-51",
"ProductNDC": "16571-818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206309",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221004",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2) Treatment of adults with refractory anaplastic astrocytoma. (1.2) .",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for Temozolomide Capsules, USP are as follows. Temozolomide Capsules 5 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 20 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 100 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 140 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 180 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 250 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. Temozolomide Capsules 5 mg: The green cap contains gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue 2.Temozolomide Capsules 20 mg: The yellow cap contains gelatin, titanium dioxide, and yellow iron oxide.Temozolomide Capsules 100 mg: The pink cap contains gelatin, titanium dioxide, and yellow iron oxide, and red iron oxide.Temozolomide Capsules 140 mg: The blue cap contains gelatin, titanium dioxide, yellow iron oxide and FD&C Blue #2.Temozolomide Capsules 180 mg: The orange cap contains gelatin, titanium dioxide and red iron oxide.Temozolomide Capsules 250 mg: The white cap contains gelatin, titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "16714-818-01",
"PackageDescription": "10 CAPSULE in 1 CARTON (16714-818-01) ",
"NDC11Code": "16714-0818-01",
"ProductNDC": "16714-818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209438",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180903",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).",
"Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:."
},
{
"NDCCode": "21695-818-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (21695-818-60)",
"NDC11Code": "21695-0818-60",
"ProductNDC": "21695-818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"ProprietaryNameSuffix": "Dr",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078790",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Mania. Divalproex sodium delayed-release tablets are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgement, aggressiveness, and possible hostility. The efficacy of divalproex sodium delayed-release tablets was established in 3-week trials with patients meeting DSMIII-R criteria for bipolar disorder who were hospitalized for acute mania (See Clinical Trials under CLINICAL PHARMACOLOGY ). The safety and effectiveness of divalproex sodium delayed-release tablets for long-term use in mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use divalproex sodium delayed-release tablets for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient. Epilepsy. Divalproex sodium delayed-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. Migraine. Divalproex sodium delayed-release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that Divalproex sodium delayed-release tablets are useful in the acute treatment of migraine headaches. Because valproic acid may be a hazard to the fetus, divalproex sodium delayed-release tablets should be considered for women of childbearing potential only after this risk has been thoroughly discussed with the patient and weighed against the potential benefits of treatment (see WARNINGS - Usage In Pregnancy, PRECAUTIONS - Information for Patients). SEE WARNINGS FOR STATEMENT REGARDING FATAL HEPATIC DYSFUNCTION.",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2- propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets are for oral administration. Divalproex sodium delayed-release tablets are supplied in three dosage strengths containing divalproex sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets: antifoam DC, colloidal silicon dioxide, D&C Red No. 30, FD&C Blue No. 2, hydroxylpropyl cellulose, hypromellose, hypromellose phthalate, iron oxides, lecithin, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinised starch, shellac, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "24208-818-25",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (24208-818-25) > 5 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "24208-0818-25",
"ProductNDC": "24208-818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20180214",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020330",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180214",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol Maleate Sterile Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol Maleate Ophthalmic Gel Forming Solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. 25°. [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol Maleate Sterile Ophthalmic Gel Forming Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260-330 mOsm. Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol Maleate Ophthalmic Gel Forming Solution forms a gel that is subsequently removed by the flow of tears."
},
{
"NDCCode": "41520-818-16",
"PackageDescription": "1 BOTTLE in 1 CARTON (41520-818-16) / 59 mL in 1 BOTTLE",
"NDC11Code": "41520-0818-16",
"ProductNDC": "41520-818",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Careone Infants Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20161214",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "American Sales Company",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161214",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache."
}
]
}
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<NDCCode>57955-0818-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0818-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-0818-03</NDC11Code>
<ProductNDC>57955-0818</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wart Remover</ProprietaryName>
<NonProprietaryName>Antimonium Crudum, Causticum, Dulcamara, Kali Muriaticum, Nitricum Acidum, Sabina, Staphysagria, Sulfur, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140318</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; CAUSTICUM; SOLANUM DULCAMARA TOP; POTASSIUM CHLORIDE; NITRIC ACID; JUNIPERUS SABINA LEAFY TWIG; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomatic treatment of smooth or rough warts and dry, itching or unhealthy skin. †as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0818-3</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-0818-3) </PackageDescription>
<NDC11Code>37662-0818-03</NDC11Code>
<ProductNDC>37662-0818</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Digitalis Purpurea</ProprietaryName>
<NonProprietaryName>Digitalis Purpurea</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220712</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>DIGITALIS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49288-0818-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0818-3)</PackageDescription>
<NDC11Code>49288-0818-03</NDC11Code>
<ProductNDC>49288-0818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Treatment Set Ts341824</ProprietaryName>
<NonProprietaryName>Treatment Set Ts341824</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19861031</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>SORGHUM HALEPENSE POLLEN; LOLIUM PERENNE POLLEN; FRAXINUS AMERICANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; PLANTAGO LANCEOLATA POLLEN; BASSIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN</SubstanceName>
<StrengthNumber>.0029; 5882; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .00145; .00145; .00145; .00145; .00097; .00097; .00097; .00097; .00097; .00097; .00048; .00048; .00048; .00048; .00048; .00048</StrengthNumber>
<StrengthUnit>g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11. THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.</IndicationAndUsage>
<Description>Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the individual physician's prescription order and will be expressed in most cases on a weight/volume basis (or AU/ml with standardized extract) diluted either 1:10 or 1:5. Where mixtures of pollens and non-pollens have been ordered, the ingredients are listed on the final container label. To insure maximum potency for the entire dating period, dilutions will be prepared with 50% v/v glycerine unless otherwise specified. Ingredients - Active allergens, preservative and stabilizer are noted on the Physicians Prescription Ingredients Insert enclosed with each individual allergenic extract treatment vial. Dating Period - A twelve month dating period (expiration date) for the prescription vial will be on the container label. Extract Treatment Sets should be reordered when outdated. Government requirements include a two week holding period for sterility tests. Please allow three weeks minimum for delivery.</Description>
</NDC>
<NDC>
<NDCCode>51552-0818-3</NDCCode>
<PackageDescription>50 g in 1 CONTAINER (51552-0818-3) </PackageDescription>
<NDC11Code>51552-0818-03</NDC11Code>
<ProductNDC>51552-0818</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Flurbiprofen</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>FLURBIPROFEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-09</LastUpdate>
<StartMarketingDatePackage>20-JAN-20</StartMarketingDatePackage>
<EndMarketingDatePackage>31-DEC-26</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>52372-0818-3</NDCCode>
<PackageDescription>5 g in 1 CONTAINER (52372-0818-3)</PackageDescription>
<NDC11Code>52372-0818-03</NDC11Code>
<ProductNDC>52372-0818</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120301</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Freedom Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-0818-3</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (54868-0818-3)</PackageDescription>
<NDC11Code>54868-0818-03</NDC11Code>
<ProductNDC>54868-0818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040161</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form. Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. They also contain the following inactive ingredients: Anhydrous Lactose, FD&C Blue No. 1 Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose. Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride with the structural formula. Molecular Formula. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>71335-0818-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-0818-3) </PackageDescription>
<NDC11Code>71335-0818-03</NDC11Code>
<ProductNDC>71335-0818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020301</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021342</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>137</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57955-0815-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0815-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-0815-03</NDC11Code>
<ProductNDC>57955-0815</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mole Remover</ProprietaryName>
<NonProprietaryName>Carbo Vegetabilis, Graphites, Lycopodium Clavatum, Phytolacca Decandra, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140813</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CARBO ANIMALIS; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses † for symptomatic treatment of moles, birthmarks, brown spots, or freckles. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0816-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0816-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-0816-03</NDC11Code>
<ProductNDC>57955-0816</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scar Remover</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calcarea Fluorica, Calcarea Phosphorica, Calendula Officinalis, Graphites, Hydrofluoricum Acidum, Phytolacca Decandra, Sabina, Silicea, Thiosinaminum, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140318</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; HYDROFLUORIC ACID; PHYTOLACCA AMERICANA ROOT; JUNIPERUS SABINA LEAFY TWIG; SILICON DIOXIDE; ALLYLTHIOUREA; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomatic treatment of scar tissue.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0817-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0817-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-0817-03</NDC11Code>
<ProductNDC>57955-0817</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cherry Angioma Remover</ProprietaryName>
<NonProprietaryName>Benzoicum Acidum, Calcarea Carbonica, Calcarea Iodata, Iodium, Phosphoricum Acidum, Phosphorus, Sulphuricum Acidum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140805</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BENZOIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM IODIDE; IODINE; PHOSPHORIC ACID; PHOSPHORUS; SULFURIC ACID</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomatic treatment of red spots or blood boils associated with angiomas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0919-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-0919-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-0919-03</NDC11Code>
<ProductNDC>57955-0919</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rosacea Symptom Relief</ProprietaryName>
<NonProprietaryName>Calendula Officinalis, Cardiospermum, Chamomilla, Hydrocotyle Asiatica, Rhus Tox, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; CARDIOSPERMUM HALICACABUM FLOWERING TOP; MATRICARIA RECUTITA; CENTELLA ASIATICA; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 2; 10; 10; 10; 3</StrengthNumber>
<StrengthUnit>[hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of multiple symptoms of rosacea: facial redness burning stinging allergic skin eruptions itching dermatitis pimples swelling thickening of skin. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0920-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-0920-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-0920-03</NDC11Code>
<ProductNDC>57955-0920</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Psoriasis Symptom Relief</ProprietaryName>
<NonProprietaryName>Cardiospermum, Chamomilla, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Lappa Major, Phytolacca Decandra, Rumex Crispus, Ruta Graveolens, Taraxacum Officinale</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CARDIOSPERMUM HALICACABUM FLOWERING TOP; MATRICARIA RECUTITA; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; RUMEX CRISPUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>2; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of multiple symptoms of psoriasis: itching rash redness thickening of skin exfoliation of scales and crusts allergic skin eruptions. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0921-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-0921-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-0921-03</NDC11Code>
<ProductNDC>57955-0921</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eczema Symptom Relief</ProprietaryName>
<NonProprietaryName>Cardiospermum, Hydrastis Canadensis, Hydrocotyle Asiatica, Lappa Major, Rhus Tox, Rumex Crispus, Ruta Graveolens, Sanguinaria Canadensis, Taraxacum Officinale</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CARDIOSPERMUM HALICACABUM FLOWERING TOP; GOLDENSEAL; CENTELLA ASIATICA; ARCTIUM LAPPA ROOT; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>2; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of eczema: redness intense itching allergic skin eruptions dry or moist eruptions thickened, crusty, scaly skin inflamed skin general unhealthy skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0935-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-0935-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-0935-03</NDC11Code>
<ProductNDC>57955-0935</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warming Arthritic Pain And Joint Relief</ProprietaryName>
<NonProprietaryName>Actaea Spicata, Aescuculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Hypericum Perforatum, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla, Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Zincum Metallicum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ACTAEA SPICATA ROOT; HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; ANEMONE PULSATILLA; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of symptoms: minor aches & pains associated with arthitis, backache, leg cramps, stiff, swollen joints, physical weakness, sore tendons and ligaments, body aches, hip & knee discomforts, muscular soreness, restless limbs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-3203-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-3203-3) > 73 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-3203-03</NDC11Code>
<ProductNDC>57955-3203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Gel</ProprietaryName>
<NonProprietaryName>Arnica Montana</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160307</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/73g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses Temporarily relieves: swelling form minor injuries muscle pain and stiffness, and bruising, due to minor injuries or overexertion. †as per various materia medicas. Product "Uses" have not been evaluated by the FDA. Product has not been clinically tested.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-4000-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-4000-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-4000-03</NDC11Code>
<ProductNDC>57955-4000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soothing Advanced Arnica</ProprietaryName>
<NonProprietaryName>Arnica Montana, Arnica Montana, Radix</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120718</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; ARNICA MONTANA ROOT</SubstanceName>
<StrengthNumber>6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: 1 pain or stiffness in muscles or joints, 2 bruising and discoloration, 3 inflammation, 4 soreness after exercise.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-4001-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-4001-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-4001-03</NDC11Code>
<ProductNDC>57955-4001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cooling Acute Pain Relief</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Cimicifuga Racemosa, Cobaltum Metallicum, Gnaphalium Polycephalum, Hypericum Perforatum, Kali Carbonicum, Kali Phosphoricum, Magnesia Phosphorica, Oxalicum Acidum, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Zincum Metallicum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: for temporary relief of symptoms: back and neck pain muscle and joint pain muscle cramps and stiffness inflamed muscles and joints muscle tension and soreness body aches tired legs and feet stiff and swollen joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7301-3</NDCCode>
<PackageDescription>85 g in 1 TUBE (57955-7301-3)</PackageDescription>
<NDC11Code>57955-7301-03</NDC11Code>
<ProductNDC>57955-7301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soothing Advanced Arnica</ProprietaryName>
<NonProprietaryName>Arnica Montana, Arnica Montana, Radix</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; ARNICA MONTANA ROOT</SubstanceName>
<StrengthNumber>6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: stiff muscles or joints inflammation bruising and discoloration. soreness after exercise.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7302-3</NDCCode>
<PackageDescription>85 g in 1 TUBE (57955-7302-3)</PackageDescription>
<NDC11Code>57955-7302-03</NDC11Code>
<ProductNDC>57955-7302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cooling Acute Pain Relief</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Cimicifuga Racemosa, Cobaltum Metallicum, Gnaphalium Polycephalum, Hypericum Perforatum, Kali Carbonicum, Kali Phosphoricum, Magnesia Phosphorica, Oxalicum Acidum, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Zincum Metallicum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: back and neck pain muscle and joint pain muscle cramps and stiffness inflamed muscles and joints muscle tension and soreness body aches tired legs and feet stiff and swollen joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7800-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-7800-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-7800-03</NDC11Code>
<ProductNDC>57955-7800</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin Tag Remover</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130426</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For symptomatic treatment of skin tags. † as per various homeopathic Materia Medicas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-8699-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-8699-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-8699-03</NDC11Code>
<ProductNDC>57955-8699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin Tag Remover</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomatic treatment of skin tags. † as per various homeopathic Materia Medicas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0078-0818-81</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0078-0818-81) * 6 mL in 1 VIAL (0078-0797-61) * 2 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00078-0818-81</NDC11Code>
<ProductNDC>0078-0818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sandostatin Lar Depot</ProprietaryName>
<NonProprietaryName>Octreotide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021008</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.</IndicationAndUsage>
<Description>Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is. SANDOSTATIN LAR DEPOT is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. SANDOSTATIN LAR DEPOT is available as: sterile 6-mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of SANDOSTATIN LAR DEPOT delivers.</Description>
</NDC>
<NDC>
<NDCCode>11344-818-32</NDCCode>
<PackageDescription>354 mL in 1 BOTTLE, PUMP (11344-818-32) </PackageDescription>
<NDC11Code>11344-0818-32</NDC11Code>
<ProductNDC>11344-818</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Moisturizing Antibacterial</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride 0.13%</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16571-818-02</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (16571-818-02) </PackageDescription>
<NDC11Code>16571-0818-02</NDC11Code>
<ProductNDC>16571-818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206309</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temozolomide is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2) Treatment of adults with refractory anaplastic astrocytoma. (1.2) .</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for Temozolomide Capsules, USP are as follows. Temozolomide Capsules 5 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 20 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 100 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 140 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 180 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 250 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. Temozolomide Capsules 5 mg: The green cap contains gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue 2.Temozolomide Capsules 20 mg: The yellow cap contains gelatin, titanium dioxide, and yellow iron oxide.Temozolomide Capsules 100 mg: The pink cap contains gelatin, titanium dioxide, and yellow iron oxide, and red iron oxide.Temozolomide Capsules 140 mg: The blue cap contains gelatin, titanium dioxide, yellow iron oxide and FD&C Blue #2.Temozolomide Capsules 180 mg: The orange cap contains gelatin, titanium dioxide and red iron oxide.Temozolomide Capsules 250 mg: The white cap contains gelatin, titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16571-818-41</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (16571-818-41) </PackageDescription>
<NDC11Code>16571-0818-41</NDC11Code>
<ProductNDC>16571-818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206309</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temozolomide is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2) Treatment of adults with refractory anaplastic astrocytoma. (1.2) .</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for Temozolomide Capsules, USP are as follows. Temozolomide Capsules 5 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 20 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 100 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 140 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 180 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 250 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. Temozolomide Capsules 5 mg: The green cap contains gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue 2.Temozolomide Capsules 20 mg: The yellow cap contains gelatin, titanium dioxide, and yellow iron oxide.Temozolomide Capsules 100 mg: The pink cap contains gelatin, titanium dioxide, and yellow iron oxide, and red iron oxide.Temozolomide Capsules 140 mg: The blue cap contains gelatin, titanium dioxide, yellow iron oxide and FD&C Blue #2.Temozolomide Capsules 180 mg: The orange cap contains gelatin, titanium dioxide and red iron oxide.Temozolomide Capsules 250 mg: The white cap contains gelatin, titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16571-818-51</NDCCode>
<PackageDescription>5 CAPSULE in 1 BOTTLE (16571-818-51) </PackageDescription>
<NDC11Code>16571-0818-51</NDC11Code>
<ProductNDC>16571-818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206309</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temozolomide is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2) Treatment of adults with refractory anaplastic astrocytoma. (1.2) .</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for Temozolomide Capsules, USP are as follows. Temozolomide Capsules 5 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 20 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 100 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 140 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 180 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 250 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. Temozolomide Capsules 5 mg: The green cap contains gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue 2.Temozolomide Capsules 20 mg: The yellow cap contains gelatin, titanium dioxide, and yellow iron oxide.Temozolomide Capsules 100 mg: The pink cap contains gelatin, titanium dioxide, and yellow iron oxide, and red iron oxide.Temozolomide Capsules 140 mg: The blue cap contains gelatin, titanium dioxide, yellow iron oxide and FD&C Blue #2.Temozolomide Capsules 180 mg: The orange cap contains gelatin, titanium dioxide and red iron oxide.Temozolomide Capsules 250 mg: The white cap contains gelatin, titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16714-818-01</NDCCode>
<PackageDescription>10 CAPSULE in 1 CARTON (16714-818-01) </PackageDescription>
<NDC11Code>16714-0818-01</NDC11Code>
<ProductNDC>16714-818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209438</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
<Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>21695-818-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (21695-818-60)</PackageDescription>
<NDC11Code>21695-0818-60</NDC11Code>
<ProductNDC>21695-818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<ProprietaryNameSuffix>Dr</ProprietaryNameSuffix>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078790</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Mania. Divalproex sodium delayed-release tablets are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgement, aggressiveness, and possible hostility. The efficacy of divalproex sodium delayed-release tablets was established in 3-week trials with patients meeting DSMIII-R criteria for bipolar disorder who were hospitalized for acute mania (See Clinical Trials under CLINICAL PHARMACOLOGY ). The safety and effectiveness of divalproex sodium delayed-release tablets for long-term use in mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use divalproex sodium delayed-release tablets for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient. Epilepsy. Divalproex sodium delayed-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. Migraine. Divalproex sodium delayed-release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that Divalproex sodium delayed-release tablets are useful in the acute treatment of migraine headaches. Because valproic acid may be a hazard to the fetus, divalproex sodium delayed-release tablets should be considered for women of childbearing potential only after this risk has been thoroughly discussed with the patient and weighed against the potential benefits of treatment (see WARNINGS - Usage In Pregnancy, PRECAUTIONS - Information for Patients). SEE WARNINGS FOR STATEMENT REGARDING FATAL HEPATIC DYSFUNCTION.</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2- propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets are for oral administration. Divalproex sodium delayed-release tablets are supplied in three dosage strengths containing divalproex sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets: antifoam DC, colloidal silicon dioxide, D&C Red No. 30, FD&C Blue No. 2, hydroxylpropyl cellulose, hypromellose, hypromellose phthalate, iron oxides, lecithin, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinised starch, shellac, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>24208-818-25</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (24208-818-25) > 5 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>24208-0818-25</NDC11Code>
<ProductNDC>24208-818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20180214</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020330</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol Maleate Sterile Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol Maleate Ophthalmic Gel Forming Solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. 25°. [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol Maleate Sterile Ophthalmic Gel Forming Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260-330 mOsm. Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol Maleate Ophthalmic Gel Forming Solution forms a gel that is subsequently removed by the flow of tears.</Description>
</NDC>
<NDC>
<NDCCode>41520-818-16</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41520-818-16) / 59 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41520-0818-16</NDC11Code>
<ProductNDC>41520-818</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Careone Infants Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache.</IndicationAndUsage>
</NDC>
</NDCList>