Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension is a Auricular (otic) Suspension in the Human Prescription Drug category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate.
| Product ID | 64980-448_35768adc-b578-4c2e-b461-22de3135a789 |
| NDC | 64980-448 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension |
| Generic Name | Neomycin And Polymyxin B Sulfates And Hydrocortisone Otic |
| Dosage Form | Suspension |
| Route of Administration | AURICULAR (OTIC) |
| Marketing Start Date | 2019-03-15 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA060613 |
| Labeler Name | Rising Pharmaceuticals, Inc. |
| Substance Name | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
| Active Ingredient Strength | 10 mg/mL; mg/mL; [USP'U]/mL |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |