NDC Code | 54868-5683-0 |
Package Description | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5683-0) |
Product NDC | 54868-5683 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Focalinxr |
Non-Proprietary Name | Dexmethylphenidate Hydrochloride |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20061011 |
Marketing Category Name | NDA |
Application Number | NDA021802 |
Manufacturer | Physicians Total Care, Inc. |
Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
Strength | 15 |
Strength Unit | mg/1 |
Pharmacy Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
DEA Schedule | CII |