54868-5683 : Focalin XR 15 mg 24 Hr Extended Release Capsule


NDC54868-5683
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Focalinxr
Dosage Form: Oral Capsule, Extended Release
Application #: NDA021802
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: NVR;D15
Shapes:  Capsule
Colors:  Green
Size (mm): 19
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 54868-5683-0: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (54868‑5683‑0)
  • 54868-5683-1: 10 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (54868‑5683‑1)

Active Ingredients:

  • Dexmethylphenidate Hydrochloride

Dosage Strength:

  • 15 mg

Inactive Ingredients:

  • Fd&c Blue No. 2
  • Ferric Oxide Yellow
  • Gelatin
  • Polyethylene Glycol
  • Dextrose
  • Talc
  • Titanium Dioxide
  • Triethyl Citrate

Pharmaceutical Classes:

  • Central Nervous System Stimulant [EPC]
  • Central Nervous System Stimulation [PE]

Related Products:

Based on records with the same trade name.
  • 54868-5681 Focalin XR 5 mg 24 Hr Extended Release Capsule by Physicians Total Care, Inc.
  • 54868-5682 24 Hr Focalin 10 mg Extended Release Capsule by Physicians Total Care, Inc.
  • 54868-5684 Focalin XR 20 mg 24 Hr Extended Release Capsule by Physicians Total Care, Inc.

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