| NDC Code | 64380-792-08 |
| Package Description | 1000 TABLET in 1 BOTTLE, PLASTIC (64380-792-08) |
| Product NDC | 64380-792 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Promethazine Hydrochloride |
| Non-Proprietary Name | Promethazine Hydrochloride |
| Dosage Form | TABLET |
| Usage | ORAL |
| Start Marketing Date | 20170630 |
| Marketing Category Name | ANDA |
| Application Number | ANDA209177 |
| Manufacturer | Strides Pharma Science Limited |
| Substance Name | PROMETHAZINE HYDROCHLORIDE |
| Strength | 12.5 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Phenothiazine [EPC], Phenothiazines [CS] |