CONCERTA - Methylphenidate hydrochloride
Navigation: NDC > Supplier starting with: J > JANSSEN PHARMACEUTICALS, INC.| Field | Value |
|---|---|
| NDC Code: | 50458-587 |
| Proprietary Name: | CONCERTA |
| Suffix: | |
| Non-Proprietary Name: | Methylphenidate hydrochloride |
| Dosage Form: | TABLET, EXTENDED RELEASE |
| Method: | ORAL |
| Original Marketing Date: | 01-08-2000 |
| Category Name: | NDA |
| Application Number: | NDA021121 |
| Labeler: | JANSSEN PHARMACEUTICALS, INC. |
| Substance Name: | METHYLPHENIDATE HYDROCHLORIDE |
| Active Numerator Strength: | 54 |
| Active Ingredient Unit: | mg/1 |
| Pharm Classes: | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
| DEA Schedule: | CII |