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CONCERTA
CONCERTA - 50458-587-01 - (Methylphenidate hydrochloride)
Drug Information of CONCERTA
| Product NDC: | 50458-587 |
| Proprietary Name: | CONCERTA |
| Non Proprietary Name: | Methylphenidate hydrochloride |
| Active Ingredient(s): | 54 mg/1 & nbsp; Methylphenidate hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of CONCERTA
| Product NDC: | 50458-587 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021121 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20000801 |
Package Information of CONCERTA
| Package NDC: | 50458-587-01 |
| Package Description: | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-587-01) |
NDC Information of CONCERTA
| NDC Code | 50458-587-01 |
| Proprietary Name | CONCERTA |
| Package Description | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-587-01) |
| Product NDC | 50458-587 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Methylphenidate hydrochloride |
| Dosage Form Name | TABLET, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20000801 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | METHYLPHENIDATE HYDROCHLORIDE |
| Strength Number | 54 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
