| NDC Code | 66993-781-30 |
| Package Description | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (66993-781-30) |
| Product NDC | 66993-781 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Phentermine And Topiramate |
| Non-Proprietary Name | Phentermine And Topiramate |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20250601 |
| Marketing Category Name | NDA AUTHORIZED GENERIC |
| Application Number | NDA022580 |
| Manufacturer | Prasco Laboratories |
| Substance Name | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE |
| Strength | 7.5; 46 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC] |
| DEA Schedule | CIV |