| NDC Code | 10135-811-01 |
|---|
| Package Description | 100 TABLET, FILM COATED in 1 BOTTLE (10135-811-01) |
|---|
| Product NDC | 10135-811 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydroxyzine Hydrochloride |
|---|
| Non-Proprietary Name | Hydroxyzine Hydrochloride |
|---|
| Dosage Form | TABLET, FILM COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20250301 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA207121 |
|---|
| Manufacturer | Marlex Pharmaceuticals, Inc. |
|---|
| Substance Name | HYDROXYZINE DIHYDROCHLORIDE |
|---|
| Strength | 25 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |
|---|