| NDC Code | 71656-064-10 |
|---|
| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER |
|---|
| Product NDC | 71656-064 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydrocortisone And Acetic Acid |
|---|
| Non-Proprietary Name | Hydrocortisone And Acetic Acid Otic |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | AURICULAR (OTIC) |
|---|
| Start Marketing Date | 20240116 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA012770 |
|---|
| Manufacturer | Saptalis Pharmaceuticals, LLC |
|---|
| Substance Name | ACETIC ACID; HYDROCORTISONE |
|---|
| Strength | 20.75; 10.375 |
|---|
| Strength Unit | mg/mL; mg/mL |
|---|
| Pharmacy Classes | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
|---|