NDC 0078-0440

Ritalin

Methylphenidate Hydrochloride

Ritalin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Methylphenidate Hydrochloride.

Product ID0078-0440_24697cdc-7470-4b76-a755-5c223048c1ce
NDC0078-0440
Product TypeHuman Prescription Drug
Proprietary NameRitalin
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1955-12-31
Marketing CategoryNDA / NDA
Application NumberNDA010187
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength10 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 0078-0440-05

100 TABLET in 1 BOTTLE (0078-0440-05)
Marketing Start Date1955-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0440-05 [00078044005]

Ritalin TABLET
Marketing CategoryNDA
Application NumberNDA010187
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1955-12-31

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:c0bf0835-6a2f-4067-a158-8b86c4b0668a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091500
  • 1091497
  • 1091395
  • 1091379
  • 1091392
  • 1091150

    • Pharmacological Class

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

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

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

    Trademark Results [Ritalin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RITALIN
    RITALIN
    71560984 0517928 Live/Registered
    CIBA LIMITED
    1948-07-09
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