NDC 24478-130

QuilliChew ER

Methylphenidate Hydrochloride

QuilliChew ER is a Oral Tablet, Chewable, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Nextwave Pharmaceuticals, Inc.. The primary component is Methylphenidate Hydrochloride.

Product ID24478-130_25328c32-7c32-4809-b38c-e8db1756e8a5
NDC24478-130
Product TypeHuman Prescription Drug
Proprietary NameQuilliChew ER
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet, Chewable, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-04-18
Marketing CategoryNDA / NDA
Application NumberNDA207960
Labeler NameNextWave Pharmaceuticals, Inc.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength30 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 24478-130-01

100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-130-01)
Marketing Start Date2016-04-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24478-130-01 [24478013001]

QuilliChew ER TABLET, CHEWABLE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA207960
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-18

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:167d6c89-747d-486d-969d-dcaeba48c178
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1734928
  • 1734930
  • 1734953
  • 1734951
  • 1727450
  • 1727443
    • UPC Code
  • 0324478130015
  • 0324478140014
  • 0324478120016

    • 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

    24478013001 QUILLICHEW ER 30 MG CHEW TAB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "QuilliChew ER" or generic name "Methylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    24478-075QuilliChew ERQuilliChew ER
    24478-140QuilliChew ERQuilliChew ER
    24478-074QuilliChew ERQuilliChew ER
    24478-120QuilliChew ERQuilliChew ER
    24478-076QuilliChew ERQuilliChew ER
    24478-130QuilliChew ERQuilliChew ER
    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 [QuilliChew ER]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    QUILLICHEW ER
    QUILLICHEW ER
    86817633 5120845 Live/Registered
    NextWave Pharmaceuticals, Inc.
    2015-11-12
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.