| Product NDC: | 51672-3007 |
| Proprietary Name: | Hydrocortisone and Acetic Acid |
| Non Proprietary Name: | Hydrocortisone and Acetic Acid |
| Active Ingredient(s): | 20.8; 10.4 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: | 51672-3007 |
| Labeler Name: | Taro Pharmaceuticals U.S.A., Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA088759 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20050428 |
| Package NDC: | 51672-3007-1 |
| Package Description: | 1 BOTTLE in 1 CARTON (51672-3007-1) > 10 mL in 1 BOTTLE |
| NDC Code | 51672-3007-1 |
| Proprietary Name | Hydrocortisone and Acetic Acid |
| Package Description | 1 BOTTLE in 1 CARTON (51672-3007-1) > 10 mL in 1 BOTTLE |
| Product NDC | 51672-3007 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hydrocortisone and Acetic Acid |
| Dosage Form Name | SOLUTION |
| Route Name | AURICULAR (OTIC) |
| Start Marketing Date | 20050428 |
| Marketing Category Name | ANDA |
| Labeler Name | Taro Pharmaceuticals U.S.A., Inc. |
| Substance Name | ACETIC ACID; HYDROCORTISONE |
| Strength Number | 20.8; 10.4 |
| Strength Unit | mg/mL; mg/mL |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |