| NDC Code | 71656-090-16 |
|---|
| Package Description | 473 mL in 1 BOTTLE (71656-090-16) |
|---|
| Product NDC | 71656-090 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydroxyzine Hydrochloride |
|---|
| Non-Proprietary Name | Hydroxyzine Hydrochloride |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20260617 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA220271 |
|---|
| Manufacturer | Saptalis Pharmaceuticals, LLC. |
|---|
| Substance Name | HYDROXYZINE HYDROCHLORIDE |
|---|
| Strength | 10 |
|---|
| Strength Unit | mg/5mL |
|---|
| Pharmacy Classes | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |
|---|