| NDC Code | 64980-448-01 |
| Package Description | 1 BOTTLE in 1 CARTON (64980-448-01) / 10 mL in 1 BOTTLE |
| Product NDC | 64980-448 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Neomycin And Polymyxin B Sulfates And Hydrocortisone Otic Suspension |
| Non-Proprietary Name | Neomycin And Polymyxin B Sulfates And Hydrocortisone Otic |
| Dosage Form | SUSPENSION |
| Usage | AURICULAR (OTIC) |
| Start Marketing Date | 20190315 |
| Marketing Category Name | NDA AUTHORIZED GENERIC |
| Application Number | NDA060613 |
| Manufacturer | Rising Pharma Holdings, Inc. |
| Substance Name | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
| Strength | 10; 3.5; 10000 |
| Strength Unit | mg/mL; mg/mL; [USP'U]/mL |
| Pharmacy Classes | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |