Product NDC: | 50383-901 |
Proprietary Name: | Hydrocortisone and Acetic Acid |
Non Proprietary Name: | Hydrocortisone and Acetic Acid |
Active Ingredient(s): | 20.75; 10.375 mg/mL; mg/mL & nbsp; Hydrocortisone and Acetic Acid |
Administration Route(s): | AURICULAR (OTIC) |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50383-901 |
Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA012770 |
Marketing Category: | NDA |
Start Marketing Date: | 20090604 |
Package NDC: | 50383-901-10 |
Package Description: | 1 BOTTLE, DROPPER in 1 CARTON (50383-901-10) > 10 mL in 1 BOTTLE, DROPPER |
NDC Code | 50383-901-10 |
Proprietary Name | Hydrocortisone and Acetic Acid |
Package Description | 1 BOTTLE, DROPPER in 1 CARTON (50383-901-10) > 10 mL in 1 BOTTLE, DROPPER |
Product NDC | 50383-901 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Hydrocortisone and Acetic Acid |
Dosage Form Name | SOLUTION |
Route Name | AURICULAR (OTIC) |
Start Marketing Date | 20090604 |
Marketing Category Name | NDA |
Labeler Name | Hi-Tech Pharmacal Co., Inc. |
Substance Name | ACETIC ACID; HYDROCORTISONE |
Strength Number | 20.75; 10.375 |
Strength Unit | mg/mL; mg/mL |
Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |