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FOCALIN
FOCALIN - 16590-649-60 - (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Drug Information of FOCALIN
| Product NDC: | 16590-649 |
| Proprietary Name: | FOCALIN |
| Non Proprietary Name: | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| Active Ingredient(s): | 15 mg/1 & nbsp; DEXMETHYLPHENIDATE HYDROCHLORIDE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of FOCALIN
| Product NDC: | 16590-649 |
| Labeler Name: | STAT RX USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021802 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20050531 |
Package Information of FOCALIN
| Package NDC: | 16590-649-60 |
| Package Description: | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16590-649-60) |
NDC Information of FOCALIN
| NDC Code | 16590-649-60 |
| Proprietary Name | FOCALIN |
| Package Description | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16590-649-60) |
| Product NDC | 16590-649 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| Dosage Form Name | CAPSULE, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20050531 |
| Marketing Category Name | NDA |
| Labeler Name | STAT RX USA LLC |
| Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| Strength Number | 15 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
