Application Nr Approved Date Route Status External Links
NDA008697 1985-04-11 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hydrocortisone Tablets Are Indicated In The Following Conditions. 1. Endocrine Disorders Primary Or Secondary Adrenocortical Insufficiency (hydrocortisone Or Cortisone Is The First Choice; Synthetic Analogs May Be Used In Conjunction With Mineralocorticoids Where Applicable; In Infancy Mineralocorticoid Supplementation Is Of Particular Importance) Congenital Adrenal Hyperplasia Non Suppurative Thyroiditis Hypercalcemia Associated With Cancer 2. Rheumatic Disorders As Adjunctive Therapy For Short-Term Administration (to Tide The Patient Over An Acute Episode Or Exacerbation) In: Psoriatic Arthritis Rheumatoid Arthritis, Including Juvenile Rheumatoid Arthritis (selected Cases May Require Low-Dose Maintenance Therapy) Ankylosing Spondylitis Acute And Subacute Bursitis Acute Nonspecific Tenosynovitis Acute Gouty Arthritis Post-Traumatic Osteoarthritis Synovitis Of Osteoarthritis Epicondylitis 3. Collagen Diseases During An Exacerbation Or As Maintenance Therapy In Selected Cases Of: Systemic Lupus Erythematosus Systemic Dermatomyositis (polymyositis) Acute Rheumatic Carditis 4. Dermatologic Diseases Pemphigus Bullous Dermatitis Herpetiformis Severe Erythema Multiforme (stevens-Johnson Syndrome) Exfoliative Dermatitis Mycosis Fungoides Severe Psoriasis Severe Seborrheic Dermatitis 5. Allergic States Control Of Severe Or Incapacitating Allergic Conditions Intractable To Adequate Trials Of Conventional Treatment: Seasonal Or Perennial Allergic Rhinitis Serum Sickness Bronchial Asthma Contact Dermatitis Atopic Dermatitis Drug Hypersensitivity Reactions 6. Ophthalmic Diseases Severe Acute And Chronic Allergic And Inflammatory Processes Involving The Eye And Its Adnexa Such As: Allergic Conjunctivitis Keratitis Allergic Corneal Marginal Ulcers Herpes Zoster Ophthalmicus Iritis And Iridocyclitis Chorioretinitis Anterior Segment Inflammation Diffuse Posterior Uveitis And Choroiditis Optic Neuritis Sympathetic Ophthalmia 7. Respiratory Diseases Symptomatic Sarcoidosis Loeffler's Syndrome Not Manageable By Other Means Berylliosis Fulminating Or Disseminated Pulmonary Tuberculosis When Used Concurrently With Appropriate Antituberculous Chemotherapy Aspiration Pneumonitis 8. Hematologic Disorders Idiopathic Thrombocytopenic Purpura In Adults Secondary Thrombocytopenia In Adults Acquired (autoimmune) Hemolytic Anemia Erythroblastopenia (rbc Anemia) Congenital (erythroid) Hypoplastic Anemia 9. Neoplastic Diseases For Palliative Management Of: Leukemias And Lymphomas In Adults Acute Leukemia Of Childhood 10. Edematous States To Induce A Diuresis Or Remission Of Proteinuria In The Nephrotic Syndrome, Without Uremia, Of The Idiopathic Type Or That Due To Lupus Erythematosus. 11. Gastrointestinal Diseases To Tide The Patient Over A Critical Period Of The Disease In: Ulcerative Colitis Regional Enteritis 12. Nervous System Acute Exacerbations Of Multiple Sclerosis 13. Miscellaneous Tuberculous Meningitis With Subarachnoid Block Or Impending Block When Used Concurrently With Appropriate Antituberculous Chemotherapy Trichinosis With Neurologic Or Myocardial Involvement

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Calcium Stearate CALCIUM STEARATE Molecular AC-Anticaking agent , AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM Molecular
4. Mineral Oil MINERAL OIL Unresolved
5. Sorbic Acid SORBIC ACID Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
6. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Hydrocortisone HYDROCORTISONE ZINC13540519