NDC Code | 42858-401-45 |
Package Description | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-401-45) |
Product NDC | 42858-401 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Aptensio Xr |
Non-Proprietary Name | Methylphenidate Hydrochloride |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20150417 |
Marketing Category Name | NDA |
Application Number | NDA205831 |
Manufacturer | Rhodes Pharmaceuticals L.P. |
Substance Name | METHYLPHENIDATE HYDROCHLORIDE |
Strength | 10 |
Strength Unit | mg/1 |
Pharmacy Classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
DEA Schedule | CII |