NDC Code | 64980-448-10 |
Package Description | 1 BOTTLE in 1 CARTON (64980-448-10) > 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 Pharmaceuticals, 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 | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS] |