Product NDC: | 54868-4489 |
Proprietary Name: | Concerta |
Non Proprietary Name: | Methylphenidate hydrochloride |
Active Ingredient(s): | 18 mg/1 & nbsp; Methylphenidate hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54868-4489 |
Labeler Name: | Physicians Total Care, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021121 |
Marketing Category: | NDA |
Start Marketing Date: | 20030321 |
Package NDC: | 54868-4489-3 |
Package Description: | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-4489-3) |
NDC Code | 54868-4489-3 |
Proprietary Name | Concerta |
Package Description | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-4489-3) |
Product NDC | 54868-4489 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Methylphenidate hydrochloride |
Dosage Form Name | TABLET, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20030321 |
Marketing Category Name | NDA |
Labeler Name | Physicians Total Care, Inc. |
Substance Name | METHYLPHENIDATE HYDROCHLORIDE |
Strength Number | 18 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |