{
"NDC": [
{
"NDCCode": "49304-0009-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (49304-0009-1)",
"NDC11Code": "49304-0009-01",
"ProductNDC": "49304-0009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Adrenal Energy",
"NonProprietaryName": "Berberis Vulgaris, Agaricus Muscarius, Urtica Urens, Glandula Suprarenalis Bovinum, Echinacea, Atropinum Sulphuricum, Ceanothus Americanus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130809",
"EndMarketingDate": "20181210",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK; AMANITA MUSCARIA FRUITING BODY; URTICA URENS; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; ECHINACEA, UNSPECIFIED; ATROPINE SULFATE; CEANOTHUS AMERICANUS LEAF",
"StrengthNumber": "3; 3; 3; 8; 8; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2018-12-11",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "49304-0001-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0001-1) ",
"NDC11Code": "49304-0001-01",
"ProductNDC": "49304-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Male Energy",
"NonProprietaryName": "Dehydroepiandrosterone, Sabal Serrulata, Setotonin, Orchitinum (suis), Pituitary (suis), Thyroidinum (suis), Conium Maculatum, Testosterone,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120507",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "CONIUM MACULATUM FLOWERING TOP; PRASTERONE; SAW PALMETTO; SEROTONIN; SUS SCROFA PITUITARY GLAND, POSTERIOR; SUS SCROFA TESTICLE; TESTOSTERONE; THYROID, PORCINE",
"StrengthNumber": "12; 6; 6; 6; 8; 8; 12; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120507",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0002-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (49304-0002-1)",
"NDC11Code": "49304-0002-01",
"ProductNDC": "49304-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Happy Happy",
"NonProprietaryName": "Aurum Metallicum, Lithium Carbonicum, Serotonin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"EndMarketingDate": "20170819",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "GOLD; LITHIUM CARBONATE; SEROTONIN HYDROCHLORIDE",
"StrengthNumber": "12; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2017-08-23"
},
{
"NDCCode": "49304-0003-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (49304-0003-1) ",
"NDC11Code": "49304-0003-01",
"ProductNDC": "49304-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Happy Bones",
"NonProprietaryName": "Boron, Calcarea Carbonica, Calcarea Fluorica, Calcarea Hypophosphorosa, Calcarea Phosphorica, Hekla Lava, Mezereum, Natrum Phosphoricum, Silicea, Symphytum Officinale, Urtica Dioica, Vanadium Metallicum,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121018",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "BORON; CALCIUM FLUORIDE; CALCIUM HYPOPHOSPHITE; COMFREY ROOT; DAPHNE MEZEREUM BARK; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TRIBASIC CALCIUM PHOSPHATE; URTICA DIOICA; VANADIUM",
"StrengthNumber": "12; 8; 6; 6; 6; 12; 30; 12; 6; 8; 4; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Cations, Divalent [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121018",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0004-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (49304-0004-1) ",
"NDC11Code": "49304-0004-01",
"ProductNDC": "49304-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flexible",
"NonProprietaryName": "Arnica Montana, Causticum, Colchicum Autumnale, Hypericum Perforatum, Kalmia Latifolia, Phytolacca Decandra, Rhododendrom Chrysanthum,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "ARNICA MONTANA; CAUSTICUM; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; ZINC",
"StrengthNumber": "6; 6; 6; 6; 12; 6; 4; 4; 6; 6; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121106",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0005-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0005-1) ",
"NDC11Code": "49304-0005-01",
"ProductNDC": "49304-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu Solution",
"NonProprietaryName": "Aconitum Napellus, Belladonna, Echinacea, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ferrum Phosphoricum, Anas Barbariae, Hepatis Et Cordis Extractum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130910",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "ACONITUM NAPELLUS; ATROPA BELLADONNA; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT",
"StrengthNumber": "3; 3; 200; 3; 3; 4; 3",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130910",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0006-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0006-1) ",
"NDC11Code": "49304-0006-01",
"ProductNDC": "49304-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quiet Calm",
"NonProprietaryName": "Ammonium Bromatum, Avena Sativa, Chamomilla, Coffea Cruda, Gelsemium Sempervirens, Phosphoricum Acidum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130306",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "AMMONIUM BROMIDE; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; PHOSPHORIC ACID; TRYPTOPHAN; VALERIAN",
"StrengthNumber": "3; 6; 1; 6; 6; 6; 6; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130306",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0007-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0007-1) ",
"NDC11Code": "49304-0007-01",
"ProductNDC": "49304-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "High Potency Heal Grief",
"NonProprietaryName": "Ignatia Amara, Natrum Muriaticum, Staphysagria",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130424",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "DELPHINIUM STAPHISAGRIA SEED; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED",
"StrengthNumber": "200; 200; 200",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130424",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0008-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0008-1)",
"NDC11Code": "49304-0008-01",
"ProductNDC": "49304-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighty Nite",
"NonProprietaryName": "Grindelia, Melatonin, Passiflora Incarnata",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130424",
"EndMarketingDate": "20171109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "GRINDELIA HIRSUTULA FLOWERING TOP; MELATONIN; PASSIFLORA INCARNATA FLOWERING TOP",
"StrengthNumber": "6; 12; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-10"
},
{
"NDCCode": "49304-0010-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0010-1) ",
"NDC11Code": "49304-0010-01",
"ProductNDC": "49304-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ur In Control",
"NonProprietaryName": "Apis Mellifica, Argentum Nitricum, Belladonna, Cantharis, Causticum, Equsetum Arvense, Petroselinum Sativum, Pulsatilla, Sarsaparilla, Terebinthina",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130821",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "APIS MELLIFERA; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM ARVENSE TOP; LYTTA VESICATORIA; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SARSAPARILLA; SILVER NITRATE; TURPENTINE OIL",
"StrengthNumber": "6; 4; 8; 6; 6; 8; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130821",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0011-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0011-1) ",
"NDC11Code": "49304-0011-01",
"ProductNDC": "49304-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stay Well",
"NonProprietaryName": "Argentum Nitricum, Baptisia Tinctoria, Echinacea, Echinacea Purpurea, Galium Aparine, Phosphorus, Pulstilla, Sulphur, Thuma Occidentalis, Thymus Serpyllum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130821",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "BAPTISIA TINCTORIA; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; PHOSPHORUS; PULSATILLA VULGARIS; SILVER NITRATE; SULFUR; THUJA OCCIDENTALIS LEAF; THYMUS SERPYLLUM",
"StrengthNumber": "6; 3; 6; 6; 6; 6; 6; 12; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130821",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0012-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0012-1) ",
"NDC11Code": "49304-0012-01",
"ProductNDC": "49304-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thyroid Rhythm",
"NonProprietaryName": "Adrenalinum, Calarea Carbonica, Calcarea Fluorica, Calcarea Iodata, Ferrum Iodatum, Fucus Vesiculosus, Iodium, Kali Iodatum, Naturm Muriaticum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131003",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "BOS TAURUS PITUITARY GLAND; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM FLUORIDE; CALCIUM IODIDE; EPINEPHRINE; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM IODIDE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID",
"StrengthNumber": "6; 6; 6; 8; 6; 6; 8; 6; 9; 30; 6; 30; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Catecholamine [EPC], Catecholamines [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131003",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0013-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0013-1) ",
"NDC11Code": "49304-0013-01",
"ProductNDC": "49304-0013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Energize",
"NonProprietaryName": "Aralia Quinquefolia, Avena Sativa, Kali Phosphoricum, Phosphoricum Acidum, Picricum Acidum, Zingiber Officinale",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternate Pharmacy",
"SubstanceName": "AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; GINGER; PHOSPHORIC ACID; PICRIC ACID; POTASSIUM PHOSPHATE, DIBASIC",
"StrengthNumber": "6; 3; 3; 6; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131002",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0014-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (49304-0014-1) ",
"NDC11Code": "49304-0014-01",
"ProductNDC": "49304-0014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Happy Happy",
"NonProprietaryName": "Not Applicable",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140724",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "GOLD; LITHIUM CARBONATE; SEROTONIN HYDROCHLORIDE",
"StrengthNumber": "12; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Mood Stabilizer [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140724",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0015-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0015-1) ",
"NDC11Code": "49304-0015-01",
"ProductNDC": "49304-0015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stomach Relief",
"NonProprietaryName": "Not Applicable",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140724",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ROBINIA PSEUDOACACIA BARK; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "30; 30; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140724",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0016-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0016-1) ",
"NDC11Code": "49304-0016-01",
"ProductNDC": "49304-0016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trauma Drama",
"NonProprietaryName": "Arnica Montana, Belladonna, Bellis Perennis, Calendula Officinalis, Chamomilla, Hypericum Perforatum, Mercurius Solubilis, Rhus Tox, Ruta Graveolens, Symphytum Officinale",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140724",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Alternative Pharmacy",
"SubstanceName": "ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "30; 6; 6; 6; 30; 6; 6; 12; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140724",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "49304-0017-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0017-1) ",
"NDC11Code": "49304-0017-01",
"ProductNDC": "49304-0017",
"ProductTypeName": "HUMAN OTC DRUG",
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"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N"
},
{
"NDCCode": "49304-0018-1",
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"ProductTypeName": "HUMAN OTC DRUG",
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"EndMarketingDate": "20230331",
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"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; POTASSIUM CARBONATE; RANUNCULUS BULBOSUS; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; SULFUR",
"StrengthNumber": "30; 30; 10; 6; 6; 10; 4; 8; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
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},
{
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"ProductTypeName": "HUMAN OTC DRUG",
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"EndMarketingDate": "20230331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
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"SubstanceName": "AMANITA MUSCARIA FRUITING BODY; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGUSTIFOLIA; URTICA URENS",
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"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
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"EndMarketingDatePackage": "20230331",
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},
{
"NDCCode": "49304-0020-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (49304-0020-1) ",
"NDC11Code": "49304-0020-01",
"ProductNDC": "49304-0020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighty Nite",
"NonProprietaryName": "Grindelia, Melatonin, Passiflora Incarnata",
"DosageFormName": "LIQUID",
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"StartMarketingDate": "20140905",
"EndMarketingDate": "20230331",
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"LabelerName": "Alternative Pharmacy",
"SubstanceName": "GRINDELIA HIRSUTULA WHOLE; MELATONIN; PASSIFLORA INCARNATA FLOWERING TOP",
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"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
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{
"NDCCode": "0009-0003-02",
"PackageDescription": "1 VIAL in 1 CARTON (0009-0003-02) / 4 mL in 1 VIAL",
"NDC11Code": "00009-0003-02",
"ProductNDC": "0009-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-medrol",
"NonProprietaryName": "Methylprednisolone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19590402",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011856",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-17",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8."
},
{
"NDCCode": "0009-0005-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0005-01) / 8 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00009-0005-01",
"ProductNDC": "0009-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-cortef",
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"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19550427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009866",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE SODIUM SUCCINATE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/8mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
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"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0009-0011-03",
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"NDC11Code": "00009-0011-03",
"ProductNDC": "0009-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-cortef",
"NonProprietaryName": "Hydrocortisone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19550427",
"MarketingCategoryName": "NDA",
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"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE SODIUM SUCCINATE",
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"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
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"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0009-0011-04",
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"NDC11Code": "00009-0011-04",
"ProductNDC": "0009-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-cortef",
"NonProprietaryName": "Hydrocortisone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19550427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009866",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE SODIUM SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
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"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0009-0012-01",
"PackageDescription": "50 TABLET in 1 BOTTLE (0009-0012-01) ",
"NDC11Code": "00009-0012-01",
"ProductNDC": "0009-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cortef",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19521215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA008697",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19521215",
"SamplePackage": "N",
"IndicationAndUsage": "CORTEF Tablets are indicated in the following conditions.",
"Description": "CORTEF Tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. CORTEF Tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose."
},
{
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"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0013-05) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00009-0013-05",
"ProductNDC": "0009-0013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-cortef",
"NonProprietaryName": "Hydrocortisone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19550427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009866",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE SODIUM SUCCINATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19550427",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0009-0013-06",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-0013-06) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00009-0013-06",
"ProductNDC": "0009-0013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-cortef",
"NonProprietaryName": "Hydrocortisone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
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"ProductNdcExcludeFlag": "N",
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},
{
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"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0009-0017-02",
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"StrengthUnit": "mg/1",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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},
{
"NDCCode": "0009-0017-55",
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"PackageNdcExcludeFlag": "N",
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]
}
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<StrengthNumber>12; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-08-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>49304-0003-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (49304-0003-1) </PackageDescription>
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<ProductNDC>49304-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121018</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>49304-0004-1</NDCCode>
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<NDC11Code>49304-0004-01</NDC11Code>
<ProductNDC>49304-0004</ProductNDC>
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<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
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<Status>Deprecated</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121106</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>49304-0005-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (49304-0005-1) </PackageDescription>
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<ProductNDC>49304-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130910</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0006-1</NDCCode>
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<ProductNDC>49304-0006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20130306</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>AMMONIUM BROMIDE; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; PHOSPHORIC ACID; TRYPTOPHAN; VALERIAN</SubstanceName>
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<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130306</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0007-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (49304-0007-1) </PackageDescription>
<NDC11Code>49304-0007-01</NDC11Code>
<ProductNDC>49304-0007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>High Potency Heal Grief</ProprietaryName>
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<StartMarketingDate>20130424</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130424</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0008-1</NDCCode>
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<NDC11Code>49304-0008-01</NDC11Code>
<ProductNDC>49304-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighty Nite</ProprietaryName>
<NonProprietaryName>Grindelia, Melatonin, Passiflora Incarnata</NonProprietaryName>
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<StartMarketingDate>20130424</StartMarketingDate>
<EndMarketingDate>20171109</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>GRINDELIA HIRSUTULA FLOWERING TOP; MELATONIN; PASSIFLORA INCARNATA FLOWERING TOP</SubstanceName>
<StrengthNumber>6; 12; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>49304-0010-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (49304-0010-1) </PackageDescription>
<NDC11Code>49304-0010-01</NDC11Code>
<ProductNDC>49304-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ur In Control</ProprietaryName>
<NonProprietaryName>Apis Mellifica, Argentum Nitricum, Belladonna, Cantharis, Causticum, Equsetum Arvense, Petroselinum Sativum, Pulsatilla, Sarsaparilla, Terebinthina</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130821</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>APIS MELLIFERA; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM ARVENSE TOP; LYTTA VESICATORIA; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SARSAPARILLA; SILVER NITRATE; TURPENTINE OIL</SubstanceName>
<StrengthNumber>6; 4; 8; 6; 6; 8; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130821</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0011-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (49304-0011-1) </PackageDescription>
<NDC11Code>49304-0011-01</NDC11Code>
<ProductNDC>49304-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stay Well</ProprietaryName>
<NonProprietaryName>Argentum Nitricum, Baptisia Tinctoria, Echinacea, Echinacea Purpurea, Galium Aparine, Phosphorus, Pulstilla, Sulphur, Thuma Occidentalis, Thymus Serpyllum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130821</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; PHOSPHORUS; PULSATILLA VULGARIS; SILVER NITRATE; SULFUR; THUJA OCCIDENTALIS LEAF; THYMUS SERPYLLUM</SubstanceName>
<StrengthNumber>6; 3; 6; 6; 6; 6; 6; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130821</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0012-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (49304-0012-1) </PackageDescription>
<NDC11Code>49304-0012-01</NDC11Code>
<ProductNDC>49304-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thyroid Rhythm</ProprietaryName>
<NonProprietaryName>Adrenalinum, Calarea Carbonica, Calcarea Fluorica, Calcarea Iodata, Ferrum Iodatum, Fucus Vesiculosus, Iodium, Kali Iodatum, Naturm Muriaticum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131003</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>BOS TAURUS PITUITARY GLAND; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM FLUORIDE; CALCIUM IODIDE; EPINEPHRINE; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM IODIDE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID</SubstanceName>
<StrengthNumber>6; 6; 6; 8; 6; 6; 8; 6; 9; 30; 6; 30; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Catecholamine [EPC], Catecholamines [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131003</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0013-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (49304-0013-1) </PackageDescription>
<NDC11Code>49304-0013-01</NDC11Code>
<ProductNDC>49304-0013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Energize</ProprietaryName>
<NonProprietaryName>Aralia Quinquefolia, Avena Sativa, Kali Phosphoricum, Phosphoricum Acidum, Picricum Acidum, Zingiber Officinale</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternate Pharmacy</LabelerName>
<SubstanceName>AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; GINGER; PHOSPHORIC ACID; PICRIC ACID; POTASSIUM PHOSPHATE, DIBASIC</SubstanceName>
<StrengthNumber>6; 3; 3; 6; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131002</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0014-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (49304-0014-1) </PackageDescription>
<NDC11Code>49304-0014-01</NDC11Code>
<ProductNDC>49304-0014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Happy Happy</ProprietaryName>
<NonProprietaryName>Not Applicable</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140724</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>GOLD; LITHIUM CARBONATE; SEROTONIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Mood Stabilizer [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140724</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0015-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (49304-0015-1) </PackageDescription>
<NDC11Code>49304-0015-01</NDC11Code>
<ProductNDC>49304-0015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach Relief</ProprietaryName>
<NonProprietaryName>Not Applicable</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140724</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ROBINIA PSEUDOACACIA BARK; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>30; 30; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140724</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0016-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (49304-0016-1) </PackageDescription>
<NDC11Code>49304-0016-01</NDC11Code>
<ProductNDC>49304-0016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trauma Drama</ProprietaryName>
<NonProprietaryName>Arnica Montana, Belladonna, Bellis Perennis, Calendula Officinalis, Chamomilla, Hypericum Perforatum, Mercurius Solubilis, Rhus Tox, Ruta Graveolens, Symphytum Officinale</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140724</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>30; 6; 6; 6; 30; 6; 6; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140724</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0017-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (49304-0017-1) </PackageDescription>
<NDC11Code>49304-0017-01</NDC11Code>
<ProductNDC>49304-0017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ticked</ProprietaryName>
<NonProprietaryName>Not Applicable</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140724</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA; BORRELIA BURGDORFERI; CALENDULA OFFICINALIS FLOWERING TOP; EPINEPHRINE; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT</SubstanceName>
<StrengthNumber>30; 30; 12; 3; 8; 12; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140724</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0018-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (49304-0018-1) </PackageDescription>
<NDC11Code>49304-0018-01</NDC11Code>
<ProductNDC>49304-0018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Happy Heart</ProprietaryName>
<NonProprietaryName>Not Applicable</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140724</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; POTASSIUM CARBONATE; RANUNCULUS BULBOSUS; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; SULFUR</SubstanceName>
<StrengthNumber>30; 30; 10; 6; 6; 10; 4; 8; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140724</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0019-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (49304-0019-1) </PackageDescription>
<NDC11Code>49304-0019-01</NDC11Code>
<ProductNDC>49304-0019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Adrenal Energy</ProprietaryName>
<NonProprietaryName>Agaricus Muscarius, Atropinum Sulphuricum, Berberis Vulgaris, Ceanothus Americanus, Echinacea (angustifolia), Glandula Suprarenalis Bovine, Spleen (bovine), Urtica Urens</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140902</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>AMANITA MUSCARIA FRUITING BODY; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGUSTIFOLIA; URTICA URENS</SubstanceName>
<StrengthNumber>3; 12; 3; 8; 8; 12; 12; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140902</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49304-0020-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (49304-0020-1) </PackageDescription>
<NDC11Code>49304-0020-01</NDC11Code>
<ProductNDC>49304-0020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighty Nite</ProprietaryName>
<NonProprietaryName>Grindelia, Melatonin, Passiflora Incarnata</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140905</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Alternative Pharmacy</LabelerName>
<SubstanceName>GRINDELIA HIRSUTULA WHOLE; MELATONIN; PASSIFLORA INCARNATA FLOWERING TOP</SubstanceName>
<StrengthNumber>6; 12; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140905</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0009-0003-02</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0009-0003-02) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>00009-0003-02</NDC11Code>
<ProductNDC>0009-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19590402</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011856</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19590402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
</NDC>
<NDC>
<NDCCode>0009-0005-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0005-01) / 8 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00009-0005-01</NDC11Code>
<ProductNDC>0009-0005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-cortef</ProprietaryName>
<NonProprietaryName>Hydrocortisone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19550427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009866</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>HYDROCORTISONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/8mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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<LastUpdate>2026-10-07</LastUpdate>
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<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
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<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
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<LastUpdate>2026-10-07</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
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<ProprietaryName>Cortef</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19521215</StartMarketingDate>
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<ApplicationNumber>NDA008697</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
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<Status>Active</Status>
<LastUpdate>2025-02-20</LastUpdate>
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<IndicationAndUsage>CORTEF Tablets are indicated in the following conditions.</IndicationAndUsage>
<Description>CORTEF Tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. CORTEF Tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose.</Description>
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<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
</NDC>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
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<ProprietaryName>Halcion</ProprietaryName>
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<LastUpdate>2019-01-17</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>100 BLISTER PACK in 1 CARTON (0009-0017-55) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
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<ProprietaryName>Halcion</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
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<EndMarketingDate>20260630</EndMarketingDate>
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<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
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<LastUpdate>2026-07-01</LastUpdate>
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