NDC 68025-089

RELEXXII

Methylphyenidate Hydrochloride Extended-release

RELEXXII is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Vertical Pharmaceuticals, Llc. The primary component is Methylphenidate Hydrochloride.

Product ID68025-089_ff11a57c-30b9-4b83-bc95-68272d324923
NDC68025-089
Product TypeHuman Prescription Drug
Proprietary NameRELEXXII
Generic NameMethylphyenidate Hydrochloride Extended-release
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2022-06-23
Marketing CategoryNDA /
Application NumberNDA216117
Labeler NameVertical Pharmaceuticals, LLC
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength63 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68025-089-10

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-089-10)
Marketing Start Date2022-06-23
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "RELEXXII" or generic name "Methylphyenidate Hydrochloride Extended-release"

NDCBrand NameGeneric Name
68025-084RELEXXIImethylphenidate hydrochloride
68025-088RELEXXIImethylphyenidate hydrochloride extended-release
68025-089RELEXXIImethylphyenidate hydrochloride extended-release

Trademark Results [RELEXXII]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RELEXXII
RELEXXII
87662730 5764504 Live/Registered
Vertical Pharmaceuticals, LLC
2017-10-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.