0078-0493 : Focalin XR 15 mg 24 Hr Extended Release Capsule


NDC0078-0493
Labeler: Novartis Pharmaceuticals Corporation
Product Type: Human Prescription Drug
Drug Name:  Focalin XR
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:

  • 0078-0493-05: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0078‑0493‑05)

Active Ingredients:

  • Dexmethylphenidate Hydrochloride

Dosage Strength:

  • 15 mg

Inactive Ingredients:

  • Fd&c Blue No. 2
  • Ferric Oxide Yellow
  • Gelatin
  • Polyethylene Glycols
  • 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.
  • 0078-0380 Focalin 2.5 mg Oral Tablet by Novartis Pharmaceuticals Corporation
  • 0078-0381 Focalin 5 mg Oral Tablet by Novartis Pharmaceuticals Corporation
  • 0078-0382 Focalin 10 mg Oral Tablet by Novartis Pharmaceuticals Corporation
  • 0078-0430 Focalin XR 5 mg 24 Hr Extended Release Capsule by Novartis Pharmaceuticals Corporation
  • 0078-0431 24 Hr Focalin 10 mg Extended Release Capsule by Novartis Pharmaceuticals Corporation
  • 0078-0432 Focalin XR 20 mg 24 Hr Extended Release Capsule by Novartis Pharmaceuticals Corporation
  • 0078-0433 Focalin XR 30 mg 24 Hr Extended Release Capsule by Novartis Pharmaceuticals Corporation
  • 0078-0434 24 Hr Focalin 40 mg Extended Release Capsule by Novartis Pharmaceuticals Corporation
  • 0078-0608 24 Hr Focalin 25 mg Extended Release Capsule by Novartis Pharmaceuticals Corporation
  • 0078-0609 24 Hr Focalin 35 mg Extended Release Capsule by Novartis Pharmaceuticals Corporation
  • 16590-649 Focalin XR 15 mg 24 Hr Extended Release Capsule by Stat Rx USA LLC

NDC QR Code

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