NDC Code | 0378-8155-01 |
Package Description | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8155-01) |
Product NDC | 0378-8155 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Methylphenidate Hydrochloride |
Non-Proprietary Name | Methylphenidate Hydrochloride |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20161229 |
End Marketing Date | 20221031 |
Marketing Category Name | ANDA |
Application Number | ANDA206726 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | METHYLPHENIDATE HYDROCHLORIDE |
Strength | 18 |
Strength Unit | mg/1 |
Pharmacy Classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
DEA Schedule | CII |