| 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] |