Hydrocortisone 5 mg/1
Hydrocortisone · TABLET · PD-Rx Pharmaceuticals, Inc.
Hydrocortisone is a corticosteroid tablet taken by mouth that reduces inflammation and suppresses the immune system to treat conditions like adrenal insufficiency, certain allergies, and inflammatory disorders. Your doctor will determine the appropriate dose based on your specific condition and medical needs.
Key Facts
- Brand Name
- Hydrocortisone
- Generic Name
- Hydrocortisone
- NDC Code (Product)
72789-227- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Strength
- 5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207029
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 12/22/2021
Recall History
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Valeant Pharmaceuticals North America LLC
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Lucky Mart Inc.
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Bausch Health Companies, Inc.
SUBPOTENT DRUG
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Valeant Pharmaceuticals International
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Perrigo New York
Failed Stability Specifications
Aidapak Services, LLC
Labeling: Label Mixup; HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRINE CITRATE ER, Tablet, 100 mg, NDC 43386048024, Pedigree: W002962, EXP: 6/11/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003045, EXP: 6/12/2014.
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Subpotent Drug
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use(s) For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital, feminine, and anal itching
Dosage & Administration
Directions • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: Consult a doctor. • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: Consult a doctor before using for anal itching.
Warnings
Warnings For External Use Only If pregnant or breast-feeding Ask a health professional before use Do not use • In the eyes • For diaper rash • For external genital or feminine itching if you have a vaginal discharge • More than the recommended daily dosage unless directed by a doctor • In the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days (do not continue to use this or any other hydrocortisone product for longer than 7 days) • Bleeding occurs due to anal itching Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Frequently Asked Questions
What is Hydrocortisone used for?
Hydrocortisone is a corticosteroid tablet taken by mouth that reduces inflammation and suppresses the immune system to treat conditions like adrenal insufficiency, certain allergies, and inflammatory disorders. Your doctor will determine the appropriate dose based on your specific condition and medical needs.
Is Hydrocortisone a controlled substance?
Hydrocortisone is not classified as a controlled substance by the DEA.
What is the generic name for Hydrocortisone?
The generic name for Hydrocortisone is Hydrocortisone. There are 9 other brand versions of Hydrocortisone.
What is the NDC code for Hydrocortisone 5 mg/1?
The NDC (National Drug Code) for Hydrocortisone 5 mg/1 is 72789-227, listed by PD-Rx Pharmaceuticals, Inc..
Other Hydrocortisone Dosages
Other Hydrocortisone Brands
See all →- hydrocortisone1 g/100g72162-2283
- FixMySkin Healing Balm Unflavored10 mg/mL76314-003
- Hydrocortisone Acetate30 mg/10574-7093
- Equate Cortisone1 g/100g79903-213
- Thera Plus Maximum Strength Hydrocortisone10 mg/g80684-145
- THERAPLEX AIM Anti-Itch Moisturizing10 mg/g82280-478
- pramosone10 mg/g83107-015
- Quality Choice10 mg/g83324-297
- Hydrocortisone Valerate2 mg/g0713-0560
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)