68025-088 : Relexxii 45 mg Oral Tablet, Extended Release

NDC:	68025-088
Labeler:	Vertical Pharmaceuticals, LLC
Product Type:	Human Prescription Drug
Drug Name:	Relexxii
Dosage Form:	Oral Tablet, Extended Release
Application #:	NDA216117
Rev. Date:	Jun 23, 2022
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:

• 68025-088-10: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68025‑088‑10)
• 68025-088-30: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68025‑088‑30)

Active Ingredients:

• Methylphenidate Hydrochloride

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 68025-084 Relexxii 72 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC
• 68025-089 Relexxii 63 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC
• 68025-095 Relexxii 18 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC
• 68025-096 Relexxii 27 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC
• 68025-097 Relexxii 36 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC
• 68025-098 Relexxii 54 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC
• 68025-709 Relexxii 54 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC

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