NDC 0078-0381

Focalin

Dexmethylphenidate Hydrochloride

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

Product ID0078-0381_4ca8780c-8d1c-4c8f-a027-a26b97acdce5
NDC0078-0381
Product TypeHuman Prescription Drug
Proprietary NameFocalin
Generic NameDexmethylphenidate Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2001-11-30
Marketing CategoryNDA / NDA
Application NumberNDA021278
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameDEXMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength5 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 0078-0381-05

100 TABLET in 1 BOTTLE (0078-0381-05)
Marketing Start Date2001-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0381-05 [00078038105]

Focalin TABLET
Marketing CategoryNDA
Application NumberNDA021278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-11-30

Drug Details

Active Ingredients

IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:7c552f11-e24a-4d9b-bb8d-be10c928eca8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 899549
  • 899548
  • 899559
  • 899557
  • 899518
  • 899519

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Focalin" or generic name "Dexmethylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    0078-0380Focalindexmethylphenidate hydrochloride
    0078-0381Focalindexmethylphenidate hydrochloride
    0078-0382Focalindexmethylphenidate hydrochloride
    0078-0430Focalindexmethylphenidate hydrochloride
    0078-0431Focalindexmethylphenidate hydrochloride
    0078-0432Focalindexmethylphenidate hydrochloride
    0078-0433Focalindexmethylphenidate hydrochloride
    0078-0434Focalindexmethylphenidate hydrochloride

    Trademark Results [Focalin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FOCALIN
    FOCALIN
    78056439 2978115 Live/Registered
    Novartis AG
    2001-04-03
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