NDC 68025-084

RELEXXII

Methylphenidate Hydrochloride

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 ID68025-084_50a51b88-518b-46bb-b24e-8a60c8459337
NDC68025-084
Product TypeHuman Prescription Drug
Proprietary NameRELEXXII
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-11-08
Marketing CategoryANDA / ANDA
Application NumberANDA205327
Labeler NameVertical Pharmaceuticals, LLC
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength72 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68025-084-10

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-084-10)
Marketing Start Date2018-11-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68025-084-10 [68025008410]

RELEXXII TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-08

NDC 68025-084-30 [68025008430]

RELEXXII TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-01

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE72 mg/1

OpenFDA Data

SPL SET ID:b7677cf9-95e0-4091-ac51-8f237c3f2635
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1995461
  • 2052826
    • UPC Code
  • 0368025084109

    • Pharmacological Class

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

    NDC Crossover Matching brand name "RELEXXII" or generic name "Methylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    68025-084RELEXXIIRELEXXII
    0093-3230Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0093-3231Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0093-3232Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0078-0370Ritalinmethylphenidate hydrochloride
    0078-0371Ritalinmethylphenidate hydrochloride
    0078-0372Ritalinmethylphenidate hydrochloride
    0078-0424Ritalinmethylphenidate hydrochloride
    0078-0439Ritalinmethylphenidate hydrochloride
    0078-0440Ritalinmethylphenidate hydrochloride
    0078-0441Ritalinmethylphenidate hydrochloride

    Trademark Results [RELEXXII]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RELEXXII
    RELEXXII
    87662730 5764504 Live/Registered
    Vertical Pharmaceuticals, LLC
    2017-10-27
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.