{
"NDC": [
{
"NDCCode": "75053-0009-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0009-1) ",
"NDC11Code": "75053-0009-01",
"ProductNDC": "75053-0009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oxaltem",
"NonProprietaryName": "Berberis Vulgaris, Oxalicum Acidum, Sanguinaria Canadensis, Chimaphila Umbellata, Calcarea Fluorica, Calcarea Silicata, Uricum Acidum, Calcarea Phosphorica, Parathormonum, Pyridoxinum Hydrochloricum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220131",
"EndMarketingDate": "20280726",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK; OXALIC ACID; SANGUINARIA CANADENSIS WHOLE; CHIMAPHILA UMBELLATA WHOLE; CALCIUM FLUORIDE; CALCIUM SILICATE; URIC ACID; TRIBASIC CALCIUM PHOSPHATE; PARATHYROID HORMONE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "6; 6; 9; 9; 12; 12; 12; 6; 9; 12",
"StrengthUnit": "[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; [hp_C]/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], 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], Parathyroid Hormone [CS], Parathyroid Hormone [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220131",
"EndMarketingDatePackage": "20280726",
"SamplePackage": "N",
"IndicationAndUsage": "Homeopathic medicine for the regulation of oxalate deposition and related dysfunctions of drainage. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "75053-0001-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0001-1) ",
"NDC11Code": "75053-0001-01",
"ProductNDC": "75053-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neuroinflammacil",
"NonProprietaryName": "Aurum Muriaticum, Hyoscyaminum, Cerebrum Suis, Hedera Helix, Hura Brasiliensis, Cedron, Hypericum Perforatum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20200629",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "GOLD TRICHLORIDE; HYOSCYAMINE; SUS SCROFA CEREBRUM; HEDERA HELIX FLOWERING TWIG; HURA CREPITANS SAP; SIMABA CEDRON SEED; HYPERICUM PERFORATUM WHOLE",
"StrengthNumber": "12; 16; 3; 30; 30; 200; 200",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200629",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily alleviates symptoms of neuroinflammation while promoting drainage. *These \"uses\" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions see www.hpus.com."
},
{
"NDCCode": "75053-0002-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0002-1) ",
"NDC11Code": "75053-0002-01",
"ProductNDC": "75053-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lymphocil",
"NonProprietaryName": "Phytolacca Decandra, Arsenicum Iodatum, Agraphis Nutans, Apium Graveolens, Eriodictyon Californicum, Allium Sativum, Erigeron Canadensis, Euonymus Atropurpureus, Aconitum Lycoctonum, Aethiops Antimonialis, Euonymus Europaeus, Absinthium, Apis Mellifica, Causticum, Sanguinaria Canadensis, Uva Ursi, Capsicum Annuum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20200629",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "PHYTOLACCA AMERICANA ROOT; ARSENIC TRIIODIDE; HYACINTHOIDES NON-SCRIPTA WHOLE; CELERY SEED; ERIODICTYON CALIFORNICUM LEAF; GARLIC; ERIGERON CANADENSIS WHOLE; EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK; ACONITUM LYCOCTONUM WHOLE; MERCURIC SULFIDE; EUONYMUS EUROPAEUS SEED; WORMWOOD; APIS MELLIFERA; CAUSTICUM; SANGUINARIA CANADENSIS ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; CAPSICUM",
"StrengthNumber": "4; 12; 12; 3; 3; 6; 6; 6; 9; 9; 9; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200629",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves symptoms of lymphatic congestions and swelling. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated. *These \"uses\" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions see www.hpus.com."
},
{
"NDCCode": "75053-0003-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0003-1) ",
"NDC11Code": "75053-0003-01",
"ProductNDC": "75053-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Celltem",
"NonProprietaryName": "Carbo Vegetabilis, Anilinum, Radium Bromatum, Millefolium, Medulla Ossis Suis, Rna, Dna, Methylene Blue, Abrotanum, Calcarea Oxalica, Conium Maculatum, Euphorbia Corollata, Euphorbium Officinarum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210503",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "ACTIVATED CHARCOAL; ANILINE; RADIUM BROMIDE; ACHILLEA MILLEFOLIUM WHOLE; SUS SCROFA BONE MARROW; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; METHYLENE BLUE; ARTEMISIA ABROTANUM FLOWERING TOP; CALCIUM OXALATE MONOHYDRATE; CONIUM MACULATUM FLOWERING TOP; EUPHORBIA COROLLATA ROOT; EUPHORBIA RESINIFERA RESIN",
"StrengthNumber": "9; 9; 12; 13; 3; 5; 6; 9; 200; 200; 200; 200; 200",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210503",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily regulates cellular metabolism and fortifies RNA and DNA.*. *These \"uses\" have not been evaluated by the Food and Drug Administration."
},
{
"NDCCode": "75053-0004-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0004-1) ",
"NDC11Code": "75053-0004-01",
"ProductNDC": "75053-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excitathyrotem",
"NonProprietaryName": "Iodium, Kali Iodatum, Hypothalamus Suis, Hypophysis Suis, Thyroidinum (suis), Lithium Muriaticum, Ephedra Vulgaris",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20201013",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "IODINE; POTASSIUM IODIDE; BOS TAURUS HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; LITHIUM CHLORIDE; EPHEDRA DISTACHYA FLOWERING TWIG",
"StrengthNumber": "9; 9; 7; 7; 9; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201013",
"SamplePackage": "N",
"IndicationAndUsage": "Homeopathic medicine for the minor effects of increased metabolism such as anxiety, heart palpitation and irritability. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "75053-0005-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0005-1) ",
"NDC11Code": "75053-0005-01",
"ProductNDC": "75053-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerebellutem",
"NonProprietaryName": "Causticum, Absinthium, Ranunculus Glacialis, Theridion, Heloderma, Picrotoxinum, Succinum, Helleborus Niger",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210419",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "CAUSTICUM; WORMWOOD; RANUNCULUS GLACIALIS WHOLE; THERIDION CURASSAVICUM; HELODERMA HORRIDUM VENOM; PICROTOXIN; AMBER; HELLEBORUS NIGER ROOT",
"StrengthNumber": "5; 6; 10; 10; 12; 16; 30; 30",
"StrengthUnit": "[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": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210419",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily alleviates symptoms of concussion or trauma.*These “uses” have not been evaluated by the Food and Drug Administration."
},
{
"NDCCode": "75053-0006-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0006-1) ",
"NDC11Code": "75053-0006-01",
"ProductNDC": "75053-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gallcill",
"NonProprietaryName": "Chelidonium Majus, Berberis Aquifolium, Berberis Vulgaris, Dioscorea Villosa, Calcarea Sulphurica, Cupressus Lawsoniana, Hepar Sulphurica Calcareum, Cholesterinum, Fel Tauri, Lycopodium Clavatum, Magnesia Sulphurica",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210419",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "CHELIDONIUM MAJUS WHOLE; BERBERIS AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; DIOSCOREA VILLOSA TUBER; CALCIUM SULFATE ANHYDROUS; CHAMAECYPARIS LAWSONIANA FRUITING TWIG; CALCIUM SULFIDE; CHOLESTEROL; BOS TAURUS BILE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "5; 5; 5; 6; 6; 9; 12; 12; 12; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210419",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily alleviates symptoms of pain in the upper right quadrant and gas associated with gastric upset. *These \"uses\" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions: see www.hpus.com."
},
{
"NDCCode": "75053-0007-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0007-1) ",
"NDC11Code": "75053-0007-01",
"ProductNDC": "75053-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenseg",
"NonProprietaryName": "Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2020 2021), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210504",
"EndMarketingDate": "20260312",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "ACONITUM NAPELLUS WHOLE; AVENA SATIVA FLOWERING TOP; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; CAUSTICUM; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); IPECAC; POTASSIUM DICHROMATE; PRATIA PURPURASCENS; ZELTNERA VENUSTA WHOLE FLOWERING",
"StrengthNumber": "9; 12; 16; 6; 3; 6; 4; 12; 12; 12; 12; 6; 9; 16; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2026-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210504",
"EndMarketingDatePackage": "20260312",
"SamplePackage": "N",
"IndicationAndUsage": "Homeopathic medicine for the minor relief of headache, body heat, lethargy, fatigue and congestion. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "75053-0008-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0008-1) ",
"NDC11Code": "75053-0008-01",
"ProductNDC": "75053-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apnetem",
"NonProprietaryName": "Phosphoricum Acidum, Alumen, Phosphorus, Senega Officinalis, Adenosinum Cyclophosphoricum, Antimonium Tartaricum, Grindelia, Sabadilla, Alumina, Cuprum Metallicum, Sanguinarinum Nitricum, Silicea, Lachesis Mutus, Rheum (palmatum), Zincum Metallicum, Lycopodium Clavatum, Manganum Phosphoricum, Antipyrinum, Coenzyme A",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210518",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "PHOSPHORIC ACID; POTASSIUM ALUM; PHOSPHORUS; POLYGALA SENEGA ROOT; ADENOSINE CYCLIC PHOSPHATE; ANTIMONY POTASSIUM TARTRATE; GRINDELIA HIRSUTULA FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; ALUMINUM OXIDE; COPPER; SANGUINARINE NITRATE; SILICON DIOXIDE; LACHESIS MUTA VENOM; RHEUM PALMATUM ROOT; ZINC; LYCOPODIUM CLAVATUM SPORE; MANGANESE PHOSPHATE, DIBASIC; ANTIPYRINE; COENZYME A",
"StrengthNumber": "6; 6; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 13; 15; 18; 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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210518",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily alleviates symptoms of sleep disorders. These \"uses\" have not been evaluated by the Food and Drug Administration."
},
{
"NDCCode": "75053-0010-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0010-1) ",
"NDC11Code": "75053-0010-01",
"ProductNDC": "75053-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hypothaltem",
"NonProprietaryName": "Eupatorium Perfoliatum, Berberis Vulgaris, Mentha Pulegium, Moschus, Benzinum, Sepia, Baryta Carbonica, Glandula Suprarenalis Suis, Hypophysis Suis, Hypothalamus Suis, Thyroidinum (suis), Pyridoxinum Hydrochloricum, Gelsemium Sempervirens, Natrum Carbonicum, Nux Vomica, Staphysagria",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210511",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "EUPATORIUM PERFOLIATUM FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; MENTHA PULEGIUM WHOLE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; BENZENE; SEPIA OFFICINALIS JUICE; BARIUM CARBONATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; THYROID, UNSPECIFIED; PYRIDOXINE HYDROCHLORIDE; GELSEMIUM SEMPERVIRENS ROOT; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED",
"StrengthNumber": "6; 9; 9; 9; 9; 9; 12; 7; 7; 7; 7; 12; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], 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], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210511",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily helps alleviate symptoms of hormone imbalance.**These “uses” have not been evaluated by the Food and Drug Administration."
},
{
"NDCCode": "75053-0011-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0011-1) ",
"NDC11Code": "75053-0011-01",
"ProductNDC": "75053-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenseg",
"NonProprietaryName": "Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2021-2022), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220620",
"EndMarketingDate": "20270620",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "GALPHIMIA GLAUCA FLOWERING TOP; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; IPECAC; ACONITUM NAPELLUS WHOLE; POTASSIUM DICHROMATE; AVENA SATIVA FLOWERING TOP; INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); PRATIA PURPURASCENS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA ANGUSTIFOLIA WHOLE; ZELTNERA VENUSTA WHOLE FLOWERING",
"StrengthNumber": "4; 6; 6; 6; 9; 9; 12; 12; 12; 12; 12; 16; 16; 3; 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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
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"LastUpdate": "2025-10-08",
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},
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"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK; OXALIC ACID DIHYDRATE; SANGUINARIA CANADENSIS ROOT; CHIMAPHILA UMBELLATA WHOLE; CALCIUM FLUORIDE; CALCIUM SILICATE; URIC ACID; TRIBASIC CALCIUM PHOSPHATE; PARATHYROID HORMONE; PYRIDOXINE HYDROCHLORIDE",
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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_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], 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], Parathyroid Hormone [CS], Parathyroid Hormone [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
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"IndicationAndUsage": "Homeopathic remedy that regulates oxalate in the body. *These \"uses\" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions see www.hpus.com."
},
{
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"StartMarketingDate": "20260227",
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"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; IPECAC; ACONITUM NAPELLUS WHOLE; POTASSIUM DICHROMATE; AVENA SATIVA FLOWERING TOP; INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 WHOLE; INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B WHOLE; PRATIA PURPURASCENS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA ANGUSTIFOLIA WHOLE; ZELTNERA VENUSTA WHOLE FLOWERING",
"StrengthNumber": "3; 3; 4; 6; 6; 6; 9; 9; 12; 12; 12; 12; 12; 16; 16; 3; 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; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
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"LastUpdate": "2026-03-03",
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{
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"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]",
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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-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",
"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": "1000",
"StrengthUnit": "mg/8mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"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",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0009-0011-04) / 2 mL in 1 VIAL, SINGLE-DOSE (0009-0011-03) ",
"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]",
"Status": "Active",
"LastUpdate": "2026-08-31",
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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.",
"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) ",
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"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",
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"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."
},
{
"NDCCode": "0009-0013-05",
"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": "2026-08-31",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20271231",
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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": "0009-0013-06",
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"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",
"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": "2026-08-31",
"PackageNdcExcludeFlag": "N",
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},
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{
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},
{
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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-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."
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{
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"MarketingCategoryName": "NDA",
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"LabelerName": "Pharmacia & Upjohn Company LLC",
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"IndicationAndUsage": "MEDROL Tablets are indicated in the following conditions.",
"Description": "MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below. Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. Inactive ingredients."
},
{
"NDCCode": "0009-0022-01",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Pharmacia & Upjohn Company LLC",
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"IndicationAndUsage": "MEDROL Tablets are indicated in the following conditions.",
"Description": "MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below. Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. Inactive ingredients."
},
{
"NDCCode": "0009-0024-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0009-0024-01)",
"NDC11Code": "00009-0024-01",
"ProductNDC": "0009-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Didrex",
"NonProprietaryName": "Benzphetamine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19601026",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012427",
"LabelerName": "Pharmacia and Upjohn Company",
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"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "0009-0024-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (0009-0024-02)",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Pharmacia and Upjohn Company",
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"StrengthNumber": "50",
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"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "0009-0026-01",
"PackageDescription": "1 BAG in 1 CONTAINER (0009-0026-01) > 1.5 kg in 1 BAG",
"NDC11Code": "00009-0026-01",
"ProductNDC": "0009-0026",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Methylprednisolone Acetate",
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"StartMarketingDate": "20140703",
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"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2020-11-25",
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}
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<IndicationAndUsage>Homeopathic medicine for the regulation of oxalate deposition and related dysfunctions of drainage. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
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<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lymphocil</ProprietaryName>
<NonProprietaryName>Phytolacca Decandra, Arsenicum Iodatum, Agraphis Nutans, Apium Graveolens, Eriodictyon Californicum, Allium Sativum, Erigeron Canadensis, Euonymus Atropurpureus, Aconitum Lycoctonum, Aethiops Antimonialis, Euonymus Europaeus, Absinthium, Apis Mellifica, Causticum, Sanguinaria Canadensis, Uva Ursi, Capsicum Annuum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200629</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>PHYTOLACCA AMERICANA ROOT; ARSENIC TRIIODIDE; HYACINTHOIDES NON-SCRIPTA WHOLE; CELERY SEED; ERIODICTYON CALIFORNICUM LEAF; GARLIC; ERIGERON CANADENSIS WHOLE; EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK; ACONITUM LYCOCTONUM WHOLE; MERCURIC SULFIDE; EUONYMUS EUROPAEUS SEED; WORMWOOD; APIS MELLIFERA; CAUSTICUM; SANGUINARIA CANADENSIS ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; CAPSICUM</SubstanceName>
<StrengthNumber>4; 12; 12; 3; 3; 6; 6; 6; 9; 9; 9; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves symptoms of lymphatic congestions and swelling. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated. *These "uses" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions see www.hpus.com.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0003-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0003-1) </PackageDescription>
<NDC11Code>75053-0003-01</NDC11Code>
<ProductNDC>75053-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Celltem</ProprietaryName>
<NonProprietaryName>Carbo Vegetabilis, Anilinum, Radium Bromatum, Millefolium, Medulla Ossis Suis, Rna, Dna, Methylene Blue, Abrotanum, Calcarea Oxalica, Conium Maculatum, Euphorbia Corollata, Euphorbium Officinarum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210503</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; ANILINE; RADIUM BROMIDE; ACHILLEA MILLEFOLIUM WHOLE; SUS SCROFA BONE MARROW; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; METHYLENE BLUE; ARTEMISIA ABROTANUM FLOWERING TOP; CALCIUM OXALATE MONOHYDRATE; CONIUM MACULATUM FLOWERING TOP; EUPHORBIA COROLLATA ROOT; EUPHORBIA RESINIFERA RESIN</SubstanceName>
<StrengthNumber>9; 9; 12; 13; 3; 5; 6; 9; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily regulates cellular metabolism and fortifies RNA and DNA.*. *These "uses" have not been evaluated by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0004-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0004-1) </PackageDescription>
<NDC11Code>75053-0004-01</NDC11Code>
<ProductNDC>75053-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excitathyrotem</ProprietaryName>
<NonProprietaryName>Iodium, Kali Iodatum, Hypothalamus Suis, Hypophysis Suis, Thyroidinum (suis), Lithium Muriaticum, Ephedra Vulgaris</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201013</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>IODINE; POTASSIUM IODIDE; BOS TAURUS HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; LITHIUM CHLORIDE; EPHEDRA DISTACHYA FLOWERING TWIG</SubstanceName>
<StrengthNumber>9; 9; 7; 7; 9; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Homeopathic medicine for the minor effects of increased metabolism such as anxiety, heart palpitation and irritability. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0005-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0005-1) </PackageDescription>
<NDC11Code>75053-0005-01</NDC11Code>
<ProductNDC>75053-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerebellutem</ProprietaryName>
<NonProprietaryName>Causticum, Absinthium, Ranunculus Glacialis, Theridion, Heloderma, Picrotoxinum, Succinum, Helleborus Niger</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210419</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>CAUSTICUM; WORMWOOD; RANUNCULUS GLACIALIS WHOLE; THERIDION CURASSAVICUM; HELODERMA HORRIDUM VENOM; PICROTOXIN; AMBER; HELLEBORUS NIGER ROOT</SubstanceName>
<StrengthNumber>5; 6; 10; 10; 12; 16; 30; 30</StrengthNumber>
<StrengthUnit>[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>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily alleviates symptoms of concussion or trauma.*These “uses” have not been evaluated by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0006-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0006-1) </PackageDescription>
<NDC11Code>75053-0006-01</NDC11Code>
<ProductNDC>75053-0006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gallcill</ProprietaryName>
<NonProprietaryName>Chelidonium Majus, Berberis Aquifolium, Berberis Vulgaris, Dioscorea Villosa, Calcarea Sulphurica, Cupressus Lawsoniana, Hepar Sulphurica Calcareum, Cholesterinum, Fel Tauri, Lycopodium Clavatum, Magnesia Sulphurica</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210419</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>CHELIDONIUM MAJUS WHOLE; BERBERIS AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; DIOSCOREA VILLOSA TUBER; CALCIUM SULFATE ANHYDROUS; CHAMAECYPARIS LAWSONIANA FRUITING TWIG; CALCIUM SULFIDE; CHOLESTEROL; BOS TAURUS BILE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>5; 5; 5; 6; 6; 9; 12; 12; 12; 3; 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; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily alleviates symptoms of pain in the upper right quadrant and gas associated with gastric upset. *These "uses" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions: see www.hpus.com.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0007-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0007-1) </PackageDescription>
<NDC11Code>75053-0007-01</NDC11Code>
<ProductNDC>75053-0007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenseg</ProprietaryName>
<NonProprietaryName>Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2020 2021), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210504</StartMarketingDate>
<EndMarketingDate>20260312</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>ACONITUM NAPELLUS WHOLE; AVENA SATIVA FLOWERING TOP; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; CAUSTICUM; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); IPECAC; POTASSIUM DICHROMATE; PRATIA PURPURASCENS; ZELTNERA VENUSTA WHOLE FLOWERING</SubstanceName>
<StrengthNumber>9; 12; 16; 6; 3; 6; 4; 12; 12; 12; 12; 6; 9; 16; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210504</StartMarketingDatePackage>
<EndMarketingDatePackage>20260312</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Homeopathic medicine for the minor relief of headache, body heat, lethargy, fatigue and congestion. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0008-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0008-1) </PackageDescription>
<NDC11Code>75053-0008-01</NDC11Code>
<ProductNDC>75053-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apnetem</ProprietaryName>
<NonProprietaryName>Phosphoricum Acidum, Alumen, Phosphorus, Senega Officinalis, Adenosinum Cyclophosphoricum, Antimonium Tartaricum, Grindelia, Sabadilla, Alumina, Cuprum Metallicum, Sanguinarinum Nitricum, Silicea, Lachesis Mutus, Rheum (palmatum), Zincum Metallicum, Lycopodium Clavatum, Manganum Phosphoricum, Antipyrinum, Coenzyme A</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210518</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>PHOSPHORIC ACID; POTASSIUM ALUM; PHOSPHORUS; POLYGALA SENEGA ROOT; ADENOSINE CYCLIC PHOSPHATE; ANTIMONY POTASSIUM TARTRATE; GRINDELIA HIRSUTULA FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; ALUMINUM OXIDE; COPPER; SANGUINARINE NITRATE; SILICON DIOXIDE; LACHESIS MUTA VENOM; RHEUM PALMATUM ROOT; ZINC; LYCOPODIUM CLAVATUM SPORE; MANGANESE PHOSPHATE, DIBASIC; ANTIPYRINE; COENZYME A</SubstanceName>
<StrengthNumber>6; 6; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 13; 15; 18; 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; [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_C]/mL</StrengthUnit>
<Pharm_Classes>Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily alleviates symptoms of sleep disorders. These "uses" have not been evaluated by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0010-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0010-1) </PackageDescription>
<NDC11Code>75053-0010-01</NDC11Code>
<ProductNDC>75053-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hypothaltem</ProprietaryName>
<NonProprietaryName>Eupatorium Perfoliatum, Berberis Vulgaris, Mentha Pulegium, Moschus, Benzinum, Sepia, Baryta Carbonica, Glandula Suprarenalis Suis, Hypophysis Suis, Hypothalamus Suis, Thyroidinum (suis), Pyridoxinum Hydrochloricum, Gelsemium Sempervirens, Natrum Carbonicum, Nux Vomica, Staphysagria</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210511</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>EUPATORIUM PERFOLIATUM FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; MENTHA PULEGIUM WHOLE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; BENZENE; SEPIA OFFICINALIS JUICE; BARIUM CARBONATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; THYROID, UNSPECIFIED; PYRIDOXINE HYDROCHLORIDE; GELSEMIUM SEMPERVIRENS ROOT; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED</SubstanceName>
<StrengthNumber>6; 9; 9; 9; 9; 9; 12; 7; 7; 7; 7; 12; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], 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], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily helps alleviate symptoms of hormone imbalance.**These “uses” have not been evaluated by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0011-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0011-1) </PackageDescription>
<NDC11Code>75053-0011-01</NDC11Code>
<ProductNDC>75053-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenseg</ProprietaryName>
<NonProprietaryName>Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2021-2022), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220620</StartMarketingDate>
<EndMarketingDate>20270620</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>GALPHIMIA GLAUCA FLOWERING TOP; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; IPECAC; ACONITUM NAPELLUS WHOLE; POTASSIUM DICHROMATE; AVENA SATIVA FLOWERING TOP; INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); PRATIA PURPURASCENS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA ANGUSTIFOLIA WHOLE; ZELTNERA VENUSTA WHOLE FLOWERING</SubstanceName>
<StrengthNumber>4; 6; 6; 6; 9; 9; 12; 12; 12; 12; 12; 16; 16; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220620</StartMarketingDatePackage>
<EndMarketingDatePackage>20270620</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Homeopathic medicine for the minor relief of headache, body heat, lethargy, fatigue and congestion. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0012-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0012-1) </PackageDescription>
<NDC11Code>75053-0012-01</NDC11Code>
<ProductNDC>75053-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oxaltem</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris, Oxalicum Acidum, Sanguinaria Canadensis, Chimaphila Umbellata, Calcarea Fluorica, Calcarea Silicata, Uricum Acidum, Calcarea Phosphorica, Parathormonum, Pyridoxinum Hydrochloricum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240521</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK; OXALIC ACID DIHYDRATE; SANGUINARIA CANADENSIS ROOT; CHIMAPHILA UMBELLATA WHOLE; CALCIUM FLUORIDE; CALCIUM SILICATE; URIC ACID; TRIBASIC CALCIUM PHOSPHATE; PARATHYROID HORMONE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6; 6; 9; 9; 12; 12; 12; 6; 9; 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_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], 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], Parathyroid Hormone [CS], Parathyroid Hormone [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
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<LastUpdate>2025-11-25</LastUpdate>
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<IndicationAndUsage>Homeopathic remedy that regulates oxalate in the body. *These "uses" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions see www.hpus.com.</IndicationAndUsage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenseg</ProprietaryName>
<NonProprietaryName>Gelsemium Sempervirens, Sambucus Nigra, Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2024-2025), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20260227</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; IPECAC; ACONITUM NAPELLUS WHOLE; POTASSIUM DICHROMATE; AVENA SATIVA FLOWERING TOP; INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 WHOLE; INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B WHOLE; PRATIA PURPURASCENS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA ANGUSTIFOLIA WHOLE; ZELTNERA VENUSTA WHOLE FLOWERING</SubstanceName>
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<Status>Active</Status>
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<IndicationAndUsage>Homeopathic medicine for the minor relief of headache, body heat, lethargy, fatigue and congestion. These "uses" have not been evaluated by the Food and Drug Administration.</IndicationAndUsage>
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<NDCCode>0009-0003-02</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-medrol</ProprietaryName>
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<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>
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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-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>
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<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>
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<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>
<Status>Active</Status>
<LastUpdate>2026-08-31</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>
</NDC>
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<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0009-0011-04) / 2 mL in 1 VIAL, SINGLE-DOSE (0009-0011-03) </PackageDescription>
<NDC11Code>00009-0011-04</NDC11Code>
<ProductNDC>0009-0011</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>100</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
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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>
</NDC>
<NDC>
<NDCCode>0009-0012-01</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (0009-0012-01) </PackageDescription>
<NDC11Code>00009-0012-01</NDC11Code>
<ProductNDC>0009-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cortef</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19521215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA008697</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<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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<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0013-05) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00009-0013-05</NDC11Code>
<ProductNDC>0009-0013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-cortef</ProprietaryName>
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<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19550427</StartMarketingDate>
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<ApplicationNumber>NDA009866</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>HYDROCORTISONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</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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<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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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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<ApplicationNumber>NDA009866</ApplicationNumber>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>19550427</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-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>
<NDC>
<NDCCode>0009-0017-02</NDCCode>
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<ProductNDC>0009-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Halcion</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19821115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017892</ApplicationNumber>
<LabelerName>Pharmacia and Upjohn Company LLC</LabelerName>
<SubstanceName>TRIAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19821115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0009-0017-55</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0009-0017-55) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00009-0017-55</NDC11Code>
<ProductNDC>0009-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Halcion</ProprietaryName>
<NonProprietaryName>Triazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19821115</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017892</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>TRIAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19821115</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0009-0017-58</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (0009-0017-58) </PackageDescription>
<NDC11Code>00009-0017-58</NDC11Code>
<ProductNDC>0009-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Halcion</ProprietaryName>
<NonProprietaryName>Triazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19821115</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017892</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>TRIAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19821115</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0009-0017-59</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (0009-0017-59) > 10 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00009-0017-59</NDC11Code>
<ProductNDC>0009-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Halcion</ProprietaryName>
<NonProprietaryName>Triazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19821115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017892</ApplicationNumber>
<LabelerName>Pharmacia and Upjohn Company</LabelerName>
<SubstanceName>TRIAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0009-0018-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0009-0018-20) / 8 mL in 1 VIAL</PackageDescription>
<NDC11Code>00009-0018-20</NDC11Code>
<ProductNDC>0009-0018</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>1</StrengthNumber>
<StrengthUnit>g/8mL</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>0009-0020-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0009-0020-01) </PackageDescription>
<NDC11Code>00009-0020-01</NDC11Code>
<ProductNDC>0009-0020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011153</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MEDROL Tablets are indicated in the following conditions.</IndicationAndUsage>
<Description>MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below. Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. Inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0009-0022-01</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (0009-0022-01) </PackageDescription>
<NDC11Code>00009-0022-01</NDC11Code>
<ProductNDC>0009-0022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19571024</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011153</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19571024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MEDROL Tablets are indicated in the following conditions.</IndicationAndUsage>
<Description>MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below. Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. Inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0009-0024-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0009-0024-01)</PackageDescription>
<NDC11Code>00009-0024-01</NDC11Code>
<ProductNDC>0009-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Didrex</ProprietaryName>
<NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19601026</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012427</ApplicationNumber>
<LabelerName>Pharmacia and Upjohn Company</LabelerName>
<SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0009-0024-02</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0009-0024-02)</PackageDescription>
<NDC11Code>00009-0024-02</NDC11Code>
<ProductNDC>0009-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Didrex</ProprietaryName>
<NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19601026</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012427</ApplicationNumber>
<LabelerName>Pharmacia and Upjohn Company</LabelerName>
<SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0009-0026-01</NDCCode>
<PackageDescription>1 BAG in 1 CONTAINER (0009-0026-01) > 1.5 kg in 1 BAG</PackageDescription>
<NDC11Code>00009-0026-01</NDC11Code>
<ProductNDC>0009-0026</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Methylprednisolone Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140703</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Pharmacia and Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-11-25</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
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