| Product NDC: | 45963-412 |
| Proprietary Name: | Hydrocortisone and Acetic Acid |
| Non Proprietary Name: | Hydrocortisone and Acetic Acid |
| Active Ingredient(s): | 2.41; 3.15 g/100mL; g/100mL & nbsp; Hydrocortisone and Acetic Acid |
| Administration Route(s): | AURICULAR (OTIC) |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 45963-412 |
| Labeler Name: | Actavis Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA087143 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20090629 |
| Package NDC: | 45963-412-61 |
| Package Description: | 1 BOTTLE in 1 CARTON (45963-412-61) > 10 mL in 1 BOTTLE |
| NDC Code | 45963-412-61 |
| Proprietary Name | Hydrocortisone and Acetic Acid |
| Package Description | 1 BOTTLE in 1 CARTON (45963-412-61) > 10 mL in 1 BOTTLE |
| Product NDC | 45963-412 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hydrocortisone and Acetic Acid |
| Dosage Form Name | SOLUTION |
| Route Name | AURICULAR (OTIC) |
| Start Marketing Date | 20090629 |
| Marketing Category Name | ANDA |
| Labeler Name | Actavis Inc. |
| Substance Name | ACETIC ACID; HYDROCORTISONE |
| Strength Number | 2.41; 3.15 |
| Strength Unit | g/100mL; g/100mL |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |