{
"NDC": [
{
"NDCCode": "69607-0009-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (69607-0009-1) ",
"NDC11Code": "69607-0009-01",
"ProductNDC": "69607-0009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menopause",
"NonProprietaryName": "Agnus Castus, Angelica Sinensis Radix, Apis Mellifica, Aralia Quinquefolia, Arnica Montana, Cimicifuga Racemosa, Galium Aparine, Glycyrrhiza Glabra, Oophorinum Suis, Sepia, Thuja Occidentalis, Viscum Album",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150702",
"EndMarketingDate": "20220816",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "AMERICAN GINSENG; ANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; BLACK COHOSH; CHASTE TREE; GALIUM APARINE; GLYCYRRHIZA GLABRA; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 3; 6; 6; 3; 3; 3; 3; 30; 30; 6; 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_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150702",
"EndMarketingDatePackage": "20220816",
"SamplePackage": "N"
},
{
"NDCCode": "69607-0001-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (69607-0001-1) ",
"NDC11Code": "69607-0001-01",
"ProductNDC": "69607-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acne",
"NonProprietaryName": "Anthracinum, Antimonium Crudum, Hydrocotyle Asiatica, Juglans Regia, Kali Bromatum, Ledum Palustre, Natrum Sulphuratum, Pyrogenium, Radium Bromatum, Sanguinaria Canadensis, Sulphur Iodatum, Thuja Occidentalis, Uritica Urens",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150707",
"EndMarketingDate": "20220331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "ANTIMONY TRISULFIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; CENTELLA ASIATICA; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; LEDUM PALUSTRE TWIG; POTASSIUM BROMIDE; RADIUM BROMIDE; RANCID BEEF; SANGUINARIA CANADENSIS ROOT; SODIUM SULFIDE NONAHYDRATE; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS",
"StrengthNumber": "30; 200; 30; 6; 6; 6; 30; 200; 30; 3; 200; 200; 200; 3",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150707",
"EndMarketingDatePackage": "20220331",
"SamplePackage": "N"
},
{
"NDCCode": "69607-0002-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (69607-0002-1) ",
"NDC11Code": "69607-0002-01",
"ProductNDC": "69607-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Insomnia",
"NonProprietaryName": "Aquilegia Vulgaris, Avena Sativa, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Humulus Lupulus, Hypericum Perforatum, Kali Phosphoricum, Melatonin, Melissa Officinalis, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150702",
"EndMarketingDate": "20220323",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "AQUILEGIA VULGARIS; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; HOPS; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MELATONIN; MELISSA OFFICINALIS; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; VALERIAN",
"StrengthNumber": "2; 6; 2; 3; 3; 6; 2; 6; 3; 2; 12; 30; 2",
"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_C]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170511",
"EndMarketingDatePackage": "20220323",
"SamplePackage": "N"
},
{
"NDCCode": "69607-0003-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (69607-0003-1) ",
"NDC11Code": "69607-0003-01",
"ProductNDC": "69607-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hemorrhoid Relief",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Calcarea Fluorica, Carduus Marianus, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Ratanhia,",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150708",
"EndMarketingDate": "20220517",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "ARNICA MONTANA; CALCIUM FLUORIDE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT; MILK THISTLE",
"StrengthNumber": "3; 9; 3; 3; 1; 6; 3; 1",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150708",
"EndMarketingDatePackage": "20220517",
"SamplePackage": "N"
},
{
"NDCCode": "69607-0004-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (69607-0004-1) ",
"NDC11Code": "69607-0004-01",
"ProductNDC": "69607-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tension Heacache",
"NonProprietaryName": "Aconitum Napellus, Carduus Marianus, Coffea Cruda, Dioscorea Villosa, Gelsemium Sempervirens, Gnaphalium Polycephalum, Iris Versicolor, Passiflora Incarnata, Stellaria Media, Verbascum Thapsus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150707",
"EndMarketingDate": "20220322",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "ACONITUM NAPELLUS; ARABICA COFFEE BEAN; DIOSCOREA VILLOSA TUBER; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; MILK THISTLE; PASSIFLORA INCARNATA FLOWERING TOP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; STELLARIA MEDIA; VERBASCUM THAPSUS",
"StrengthNumber": "200; 200; 3; 3; 3; 3; 2; 3; 3; 3",
"StrengthUnit": "[hp_C]/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",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150707",
"EndMarketingDatePackage": "20220322",
"SamplePackage": "N"
},
{
"NDCCode": "69607-0005-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (69607-0005-1) ",
"NDC11Code": "69607-0005-01",
"ProductNDC": "69607-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Back And Neck Pain",
"NonProprietaryName": "Aconitum Napellus, Arnica Montana, Belladonna, Cimicifuga Racemosa, Euphorbium Officinarum, Gelsemium Sempervirens, Gnaphalium Polycephalum, Hypericum Perforatum, Magnesia Phosphorica, Phytolacca Decandra, Ranunculus Bulbosus, Rhus Tox",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150701",
"EndMarketingDate": "20220321",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BLACK COHOSH; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "200; 200; 6; 6; 6; 6; 200; 10; 3; 30; 30; 200",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [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_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], 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], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170511",
"EndMarketingDatePackage": "20220321",
"SamplePackage": "N"
},
{
"NDCCode": "69607-0006-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (69607-0006-1) ",
"NDC11Code": "69607-0006-01",
"ProductNDC": "69607-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anxiety",
"NonProprietaryName": "Agnus Castus, Avena Sativa, Cinchona Officinalis, Humulus Lupulus, Hyoscyamus Niger, Ignatia Amara, Passiflora Incarnata, Valeriana Officinalis",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150701",
"EndMarketingDate": "20220927",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; CHASTE TREE; CINCHONA OFFICINALIS BARK; HOPS; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS IGNATII SEED; VALERIAN",
"StrengthNumber": "1; 6; 6; 2; 200; 3; 200; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150701",
"EndMarketingDatePackage": "20220927",
"SamplePackage": "N"
},
{
"NDCCode": "69607-0007-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (69607-0007-1) ",
"NDC11Code": "69607-0007-01",
"ProductNDC": "69607-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Pain",
"NonProprietaryName": "Antimonium Tartaricum, Arsenicum Iodatum, Asafoetida, Baptisia Tinctoria, Echinacea (angustifolia), Eupatorium Perfoliatum, Euphorbia Pilulifera, Hepar Sulphuris Calcareum, Kali Bichromicum, Kreosotum, Lachesis Mutus, Mercurius Iodatus Ruber, Pyrogenium, Silicea, Teucrium Marum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"EndMarketingDate": "20210318",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIIODIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA HIRTA FLOWERING TOP; CALCIUM SULFIDE; POTASSIUM DICHROMATE; WOOD CREOSOTE; LACHESIS MUTA VENOM; MERCURIC IODIDE; RANCID BEEF; SILICON DIOXIDE; TEUCRIUM MARUM",
"StrengthNumber": "6; 200; 30; 3; 3; 3; 3; 30; 30; 30; 200; 10; 200; 30; 3",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150819",
"EndMarketingDatePackage": "20210318",
"SamplePackage": "N"
},
{
"NDCCode": "69607-0008-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (69607-0008-1) ",
"NDC11Code": "69607-0008-01",
"ProductNDC": "69607-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough And Congestion",
"NonProprietaryName": "Antimonium Tartaricum, Arsenicum Album, Arsenicum Iodatum, Arum Triphyllum, Baptisia Tinctoria, Bryonia (alba), Drosera (rotundifolia), Echinacea Angustifolia, Eupatorium Perfoliatum, Kali Bromatum, Lung Suis, Mercurius Corrosivus, Sticta Pulmonaria, Sulphur Iodatum, Urtica Urens",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150702",
"EndMarketingDate": "20220318",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ARISAEMA TRIPHYLLUM ROOT; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; LOBARIA PULMONARIA; MERCURIC CHLORIDE; POTASSIUM BROMIDE; SULFUR IODIDE; SUS SCROFA LUNG; URTICA URENS",
"StrengthNumber": "200; 30; 200; 200; 3; 200; 30; 3; 200; 200; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150702",
"EndMarketingDatePackage": "20220318",
"SamplePackage": "N"
},
{
"NDCCode": "69607-0010-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (69607-0010-1) ",
"NDC11Code": "69607-0010-01",
"ProductNDC": "69607-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stomach Ache",
"NonProprietaryName": "Arsenicum Album, Calcarea Phosphorica, Carbo Animalis, Carbo Vegetabilis, Cinchona Officinalis, Nux Vomica, Ornithogalum Umbellatum, Pyrogenium, Silicea",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150824",
"EndMarketingDate": "20221209",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; CARBO ANIMALIS; CINCHONA OFFICINALIS BARK; ORNITHOGALUM UMBELLATUM; RANCID BEEF; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "12; 200; 200; 12; 200; 12; 200; 12; 200",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150824",
"EndMarketingDatePackage": "20221209",
"SamplePackage": "N"
},
{
"NDCCode": "69607-0011-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (69607-0011-1) ",
"NDC11Code": "69607-0011-01",
"ProductNDC": "69607-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stress And Insomnia",
"NonProprietaryName": "Avena Sativa, Chamomilla , Humulus Lupulus, Passiflora Incarnata",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150706",
"EndMarketingDate": "20211020",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; HOPS; PASSIFLORA INCARNATA FLOWERING TOP",
"StrengthNumber": "3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150706",
"EndMarketingDatePackage": "20211020",
"SamplePackage": "N"
},
{
"NDCCode": "69607-0012-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (69607-0012-1)",
"NDC11Code": "69607-0012-01",
"ProductNDC": "69607-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acne",
"NonProprietaryName": "Anthracinum, Antimonium Crudum, Hydrocotyle Asiatica, Juglans Regia, Kali Bromatum, Ledum Palustre, Natrum Sulphuricum, Pyrogenium, Radium Bromatum, Sanguinaria Canadensis, Sulphur Iodatum, Thuja Occidentalis, Urtica Urens",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150813",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ANTIMONY TRISULFIDE; CENTELLA ASIATICA; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; POTASSIUM BROMIDE; LEDUM PALUSTRE TWIG; SODIUM SULFATE; RANCID BEEF; RADIUM BROMIDE; SANGUINARIA CANADENSIS ROOT; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS",
"StrengthNumber": "200; 30; 30; 6; 6; 30; 6; 200; 30; 200; 3; 200; 200; 3",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "69607-0013-1",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (69607-0013-1) ",
"NDC11Code": "69607-0013-01",
"ProductNDC": "69607-0013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Pain",
"NonProprietaryName": "Antimonium Tartaricum, Arsenicum Iodatum, Asafoetida, Baptisia Tinctoria, Echinacea (angustifolia), Eupatorium Perfoliatum, Euphorbia Pilulifera, Hepar Sulphuris Calcareum, Kali Bichromicum, Kreosotum, Lachesis Mutus, Mercurius Iodatus Ruber, Pyrogenium, Silicea, Teucrium Marum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20180207",
"EndMarketingDate": "20230301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biovea",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIIODIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA HIRTA FLOWERING TOP; LACHESIS MUTA VENOM; MERCURIC IODIDE; POTASSIUM DICHROMATE; RANCID BEEF; SILICON DIOXIDE; TEUCRIUM MARUM; WOOD CREOSOTE",
"StrengthNumber": "6; 200; 30; 3; 30; 3; 6; 3; 200; 200; 30; 200; 30; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL",
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"LastUpdate": "2023-03-02",
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"EndMarketingDatePackage": "20230301",
"SamplePackage": "N"
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{
"NDCCode": "69607-0867-6",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (69607-0867-6) / 60 TABLET, COATED in 1 BOTTLE, PLASTIC",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
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"RouteName": "ORAL",
"StartMarketingDate": "20200131",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"LabelerName": "WR Group, Inc.",
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"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
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"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin."
},
{
"NDCCode": "69607-0916-6",
"PackageDescription": "96 CAPSULE in 1 BOTTLE, PLASTIC (69607-0916-6) ",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Sleep Aid",
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"StartMarketingDate": "20210806",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "WR Group, Inc.",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210806",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness."
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{
"NDCCode": "69607-1970-1",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (69607-1970-1) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "69607-1970-01",
"ProductNDC": "69607-1970",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen Pm",
"NonProprietaryName": "Diphenhydramine Citrate, Ibuprofen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211404",
"LabelerName": "WR Group, Inc.",
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"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
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"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness when associated with minor aches and pains . helps you fall asleep and stay asleep."
},
{
"NDCCode": "69607-8438-0",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (69607-8438-0) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
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"ProductNDC": "69607-8438",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen Minis",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20250401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206568",
"LabelerName": "WR Group, Inc.",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250401",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps . temporarily reduces fever."
},
{
"NDCCode": "69607-8630-1",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (69607-8630-1) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC",
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"ProductNDC": "69607-8630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Reliever Pm",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250228",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "WR Group, Inc.",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness."
},
{
"NDCCode": "69607-9530-0",
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"NDC11Code": "69607-9530-00",
"ProductNDC": "69607-9530",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foligain Professional Series Extra Strength For Women Minoxidil Topical Hair Regrowth Treatment",
"NonProprietaryName": "Minoxidil",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20260505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078176",
"LabelerName": "WR Group, Inc.",
"SubstanceName": "MINOXIDIL",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the scalp. (see picture on side of carton)."
},
{
"NDCCode": "69607-9540-0",
"PackageDescription": "3 BOTTLE, DROPPER in 1 BOX (69607-9540-0) / 60 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "69607-9540-00",
"ProductNDC": "69607-9540",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foligain Professional Series Extra Strength For Men Minoxidil Hair Regrowth Treatment",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076239",
"LabelerName": "WR Group, Inc.",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the scalp. (vertex only, see picture on side of carton)."
},
{
"NDCCode": "0009-0003-02",
"PackageDescription": "1 VIAL in 1 CARTON (0009-0003-02) / 4 mL in 1 VIAL",
"NDC11Code": "00009-0003-02",
"ProductNDC": "0009-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-medrol",
"NonProprietaryName": "Methylprednisolone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19590402",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011856",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19590402",
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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": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19550427",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
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"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",
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"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
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"LastUpdate": "2026-10-07",
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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."
},
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"ProductNDC": "0009-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
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"MarketingCategoryName": "NDA",
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"LabelerName": "Pharmacia & Upjohn Company LLC",
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"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0009-0012-01",
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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]",
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"SamplePackage": "N",
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"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",
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"ProductNDC": "0009-0013",
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"ProprietaryName": "Solu-cortef",
"NonProprietaryName": "Hydrocortisone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
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"LabelerName": "Pharmacia & Upjohn Company LLC",
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"StrengthUnit": "mg/2mL",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
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"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0009-0013-06",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-0013-06) / 2 mL in 1 VIAL, SINGLE-DOSE",
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"ProductNDC": "0009-0013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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},
{
"NDCCode": "0009-0016-12",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"SamplePackage": "N",
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"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0009-0017-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (0009-0017-02) ",
"NDC11Code": "00009-0017-02",
"ProductNDC": "0009-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19821115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017892",
"LabelerName": "Pharmacia and Upjohn Company LLC",
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"StrengthUnit": "mg/1",
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"DEASchedule": "CIV",
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"LastUpdate": "2019-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19821115",
"SamplePackage": "N"
},
{
"NDCCode": "0009-0017-55",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0009-0017-55) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00009-0017-55",
"ProductNDC": "0009-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<Status>Deprecated</Status>
<LastUpdate>2022-03-24</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<NDCCode>69607-0003-1</NDCCode>
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<ProductNDC>69607-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Calcarea Fluorica, Carduus Marianus, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Ratanhia,</NonProprietaryName>
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<LabelerName>Biovea</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2022-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150708</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDCCode>69607-0004-1</NDCCode>
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<ProductNDC>69607-0004</ProductNDC>
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<LabelerName>Biovea</LabelerName>
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<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150707</StartMarketingDatePackage>
<EndMarketingDatePackage>20220322</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69607-0005-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (69607-0005-1) </PackageDescription>
<NDC11Code>69607-0005-01</NDC11Code>
<ProductNDC>69607-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Back And Neck Pain</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arnica Montana, Belladonna, Cimicifuga Racemosa, Euphorbium Officinarum, Gelsemium Sempervirens, Gnaphalium Polycephalum, Hypericum Perforatum, Magnesia Phosphorica, Phytolacca Decandra, Ranunculus Bulbosus, Rhus Tox</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<EndMarketingDate>20220321</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biovea</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BLACK COHOSH; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>200; 200; 6; 6; 6; 6; 200; 10; 3; 30; 30; 200</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [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_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], 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], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170511</StartMarketingDatePackage>
<EndMarketingDatePackage>20220321</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69607-0006-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (69607-0006-1) </PackageDescription>
<NDC11Code>69607-0006-01</NDC11Code>
<ProductNDC>69607-0006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anxiety</ProprietaryName>
<NonProprietaryName>Agnus Castus, Avena Sativa, Cinchona Officinalis, Humulus Lupulus, Hyoscyamus Niger, Ignatia Amara, Passiflora Incarnata, Valeriana Officinalis</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<EndMarketingDate>20220927</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biovea</LabelerName>
<SubstanceName>AVENA SATIVA FLOWERING TOP; CHASTE TREE; CINCHONA OFFICINALIS BARK; HOPS; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS IGNATII SEED; VALERIAN</SubstanceName>
<StrengthNumber>1; 6; 6; 2; 200; 3; 200; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<EndMarketingDatePackage>20220927</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69607-0007-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (69607-0007-1) </PackageDescription>
<NDC11Code>69607-0007-01</NDC11Code>
<ProductNDC>69607-0007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Pain</ProprietaryName>
<NonProprietaryName>Antimonium Tartaricum, Arsenicum Iodatum, Asafoetida, Baptisia Tinctoria, Echinacea (angustifolia), Eupatorium Perfoliatum, Euphorbia Pilulifera, Hepar Sulphuris Calcareum, Kali Bichromicum, Kreosotum, Lachesis Mutus, Mercurius Iodatus Ruber, Pyrogenium, Silicea, Teucrium Marum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150819</StartMarketingDate>
<EndMarketingDate>20210318</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biovea</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIIODIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA HIRTA FLOWERING TOP; CALCIUM SULFIDE; POTASSIUM DICHROMATE; WOOD CREOSOTE; LACHESIS MUTA VENOM; MERCURIC IODIDE; RANCID BEEF; SILICON DIOXIDE; TEUCRIUM MARUM</SubstanceName>
<StrengthNumber>6; 200; 30; 3; 3; 3; 3; 30; 30; 30; 200; 10; 200; 30; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150819</StartMarketingDatePackage>
<EndMarketingDatePackage>20210318</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69607-0008-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (69607-0008-1) </PackageDescription>
<NDC11Code>69607-0008-01</NDC11Code>
<ProductNDC>69607-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough And Congestion</ProprietaryName>
<NonProprietaryName>Antimonium Tartaricum, Arsenicum Album, Arsenicum Iodatum, Arum Triphyllum, Baptisia Tinctoria, Bryonia (alba), Drosera (rotundifolia), Echinacea Angustifolia, Eupatorium Perfoliatum, Kali Bromatum, Lung Suis, Mercurius Corrosivus, Sticta Pulmonaria, Sulphur Iodatum, Urtica Urens</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150702</StartMarketingDate>
<EndMarketingDate>20220318</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biovea</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ARISAEMA TRIPHYLLUM ROOT; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; LOBARIA PULMONARIA; MERCURIC CHLORIDE; POTASSIUM BROMIDE; SULFUR IODIDE; SUS SCROFA LUNG; URTICA URENS</SubstanceName>
<StrengthNumber>200; 30; 200; 200; 3; 200; 30; 3; 200; 200; 200; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150702</StartMarketingDatePackage>
<EndMarketingDatePackage>20220318</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69607-0010-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (69607-0010-1) </PackageDescription>
<NDC11Code>69607-0010-01</NDC11Code>
<ProductNDC>69607-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach Ache</ProprietaryName>
<NonProprietaryName>Arsenicum Album, Calcarea Phosphorica, Carbo Animalis, Carbo Vegetabilis, Cinchona Officinalis, Nux Vomica, Ornithogalum Umbellatum, Pyrogenium, Silicea</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150824</StartMarketingDate>
<EndMarketingDate>20221209</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biovea</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; CARBO ANIMALIS; CINCHONA OFFICINALIS BARK; ORNITHOGALUM UMBELLATUM; RANCID BEEF; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>12; 200; 200; 12; 200; 12; 200; 12; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150824</StartMarketingDatePackage>
<EndMarketingDatePackage>20221209</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69607-0011-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (69607-0011-1) </PackageDescription>
<NDC11Code>69607-0011-01</NDC11Code>
<ProductNDC>69607-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stress And Insomnia</ProprietaryName>
<NonProprietaryName>Avena Sativa, Chamomilla , Humulus Lupulus, Passiflora Incarnata</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150706</StartMarketingDate>
<EndMarketingDate>20211020</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biovea</LabelerName>
<SubstanceName>AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; HOPS; PASSIFLORA INCARNATA FLOWERING TOP</SubstanceName>
<StrengthNumber>3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150706</StartMarketingDatePackage>
<EndMarketingDatePackage>20211020</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69607-0012-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (69607-0012-1)</PackageDescription>
<NDC11Code>69607-0012-01</NDC11Code>
<ProductNDC>69607-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acne</ProprietaryName>
<NonProprietaryName>Anthracinum, Antimonium Crudum, Hydrocotyle Asiatica, Juglans Regia, Kali Bromatum, Ledum Palustre, Natrum Sulphuricum, Pyrogenium, Radium Bromatum, Sanguinaria Canadensis, Sulphur Iodatum, Thuja Occidentalis, Urtica Urens</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150813</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biovea</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ANTIMONY TRISULFIDE; CENTELLA ASIATICA; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; POTASSIUM BROMIDE; LEDUM PALUSTRE TWIG; SODIUM SULFATE; RANCID BEEF; RADIUM BROMIDE; SANGUINARIA CANADENSIS ROOT; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS</SubstanceName>
<StrengthNumber>200; 30; 30; 6; 6; 30; 6; 200; 30; 200; 3; 200; 200; 3</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69607-0013-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (69607-0013-1) </PackageDescription>
<NDC11Code>69607-0013-01</NDC11Code>
<ProductNDC>69607-0013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Pain</ProprietaryName>
<NonProprietaryName>Antimonium Tartaricum, Arsenicum Iodatum, Asafoetida, Baptisia Tinctoria, Echinacea (angustifolia), Eupatorium Perfoliatum, Euphorbia Pilulifera, Hepar Sulphuris Calcareum, Kali Bichromicum, Kreosotum, Lachesis Mutus, Mercurius Iodatus Ruber, Pyrogenium, Silicea, Teucrium Marum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180207</StartMarketingDate>
<EndMarketingDate>20230301</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biovea</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIIODIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA HIRTA FLOWERING TOP; LACHESIS MUTA VENOM; MERCURIC IODIDE; POTASSIUM DICHROMATE; RANCID BEEF; SILICON DIOXIDE; TEUCRIUM MARUM; WOOD CREOSOTE</SubstanceName>
<StrengthNumber>6; 200; 30; 3; 30; 3; 6; 3; 200; 200; 30; 200; 30; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180207</StartMarketingDatePackage>
<EndMarketingDatePackage>20230301</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69607-0867-6</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (69607-0867-6) / 60 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69607-0867-06</NDC11Code>
<ProductNDC>69607-0867</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200131</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>WR Group, Inc.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200131</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69607-0916-6</NDCCode>
<PackageDescription>96 CAPSULE in 1 BOTTLE, PLASTIC (69607-0916-6) </PackageDescription>
<NDC11Code>69607-0916-06</NDC11Code>
<ProductNDC>69607-0916</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Sleep Aid</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210806</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>WR Group, Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69607-1970-1</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (69607-1970-1) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69607-1970-01</NDC11Code>
<ProductNDC>69607-1970</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen Pm</ProprietaryName>
<NonProprietaryName>Diphenhydramine Citrate, Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211404</ApplicationNumber>
<LabelerName>WR Group, Inc.</LabelerName>
<SubstanceName>IBUPROFEN; DIPHENHYDRAMINE CITRATE</SubstanceName>
<StrengthNumber>200; 38</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional sleeplessness when associated with minor aches and pains . helps you fall asleep and stay asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69607-8438-0</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (69607-8438-0) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69607-8438-00</NDC11Code>
<ProductNDC>69607-8438</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen Minis</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206568</ApplicationNumber>
<LabelerName>WR Group, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps . temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69607-8630-1</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (69607-8630-1) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69607-8630-01</NDC11Code>
<ProductNDC>69607-8630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Reliever Pm</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250228</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>WR Group, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
</NDC>
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<PackageDescription>3 BOTTLE, DROPPER in 1 BOX (69607-9530-0) / 60 mL in 1 BOTTLE, DROPPER</PackageDescription>
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<ProductNDC>69607-9530</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foligain Professional Series Extra Strength For Women Minoxidil Topical Hair Regrowth Treatment</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260505</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078176</ApplicationNumber>
<LabelerName>WR Group, Inc.</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>to regrow hair on the scalp. (see picture on side of carton).</IndicationAndUsage>
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<LabelerName>WR Group, Inc.</LabelerName>
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<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
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<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>to regrow hair on the scalp. (vertex only, see picture on side of carton).</IndicationAndUsage>
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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>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</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-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
</NDC>
<NDC>
<NDCCode>0009-0005-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0005-01) / 8 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00009-0005-01</NDC11Code>
<ProductNDC>0009-0005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-cortef</ProprietaryName>
<NonProprietaryName>Hydrocortisone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19550427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009866</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>HYDROCORTISONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/8mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<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>0009-0011-03</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0011-03) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00009-0011-03</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>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<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>0009-0011-04</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-0011-04) / 2 mL in 1 VIAL, SINGLE-DOSE</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>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<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>0009-0012-01</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>
<StartMarketingDatePackage>19521215</StartMarketingDatePackage>
<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>
</NDC>
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<NDCCode>0009-0013-05</NDCCode>
<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>
<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>250</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<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>0009-0013-06</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-0013-06) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00009-0013-06</NDC11Code>
<ProductNDC>0009-0013</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>250</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<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>0009-0016-12</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0016-12) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00009-0016-12</NDC11Code>
<ProductNDC>0009-0016</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>500</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<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>
<PackageDescription>500 TABLET in 1 BOTTLE (0009-0017-02) </PackageDescription>
<NDC11Code>00009-0017-02</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 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>
</NDCList>