NDC 24478-200

Quillivant XR

Methylphenidate Hydrochloride

Quillivant XR is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Nextwave Pharmaceuticals, Inc. The primary component is Methylphenidate Hydrochloride.

Product ID24478-200_3c243fb6-41ad-44b8-a644-1d5a9d3df322
NDC24478-200
Product TypeHuman Prescription Drug
Proprietary NameQuillivant XR
Generic NameMethylphenidate Hydrochloride
Dosage FormSuspension, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-10-01
Marketing CategoryNDA / NDA
Application NumberNDA202100
Labeler NameNextWave Pharmaceuticals, Inc
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength600 mg/120mL
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 24478-200-20

1 BOTTLE in 1 CARTON (24478-200-20) > 120 mL in 1 BOTTLE
Marketing Start Date2012-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24478-200-20 [24478020020]

Quillivant XR SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA202100
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-10-01

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE600 mg/120mL

OpenFDA Data

SPL SET ID:e0157005-6e3e-4763-b910-9eb0937608c9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1312589
  • 1312583
    • UPC Code
  • 0324478190101

    • Pharmacological Class

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

    Medicade Reported Pricing

    24478020020 QUILLIVANT XR 25 MG/5 ML SUSP

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Quillivant XR" or generic name "Methylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    24478-322Quillivant XRQuillivant XR
    24478-205Quillivant XRQuillivant XR
    24478-210Quillivant XRQuillivant XR
    24478-200Quillivant XRQuillivant XR
    24478-190Quillivant XRQuillivant XR
    24478-324Quillivant XRQuillivant XR
    24478-321Quillivant XRQuillivant XR
    24478-323Quillivant XRQuillivant XR
    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 [Quillivant]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    QUILLIVANT
    QUILLIVANT
    85332659 4392798 Live/Registered
    NextWave Pharmaceuticals, Inc.
    2011-05-27
    QUILLIVANT
    QUILLIVANT
    85332657 not registered Dead/Abandoned
    NextWave Pharmaceuticals, Inc.
    2011-05-27
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