66758-235 : Focalin 5 mg Oral Capsule, Extended Release


NDC66758-235
Labeler: Sandoz Inc
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.

NDC Package Codes:

  • 66758-235-01: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (66758‑235‑01)

Active Ingredients:

  • Dexmethylphenidate Hydrochloride

Dosage Strength:

  • 5 mg

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 66758-236 Focalin 10 mg Oral Capsule, Extended Release by Sandoz Inc
  • 66758-237 Focalin 15 mg Oral Capsule, Extended Release by Sandoz Inc
  • 66758-238 Focalin 20 mg Oral Capsule, Extended Release by Sandoz Inc
  • 66758-239 Focalin 25 mg Oral Capsule, Extended Release by Sandoz Inc
  • 66758-240 Focalin 30 mg Oral Capsule, Extended Release by Sandoz Inc
  • 66758-241 Focalin 35 mg Oral Capsule, Extended Release by Sandoz Inc
  • 66758-242 Focalin 40 mg Oral Capsule, Extended Release by Sandoz Inc

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.