NDC 0078-0432

Focalin XR

Dexmethylphenidate Hydrochloride

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

Product ID0078-0432_1994ede6-bb5d-43ea-9d09-ed27a81578dd
NDC0078-0432
Product TypeHuman Prescription Drug
Proprietary NameFocalin XR
Generic NameDexmethylphenidate Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2005-05-31
Marketing CategoryNDA / NDA
Application NumberNDA021802
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameDEXMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0078-0432-05

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0432-05)
Marketing Start Date2005-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0432-05 [00078043205]

Focalin XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021802
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-05-31

Drug Details

Active Ingredients

IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:1a1da905-42a0-4748-9c39-67eca45deccc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 899485
  • 899487
  • 899497
  • 899513
  • 899495
  • 899511
  • 899441
  • 1101934
  • 1101926
  • 1101932
  • 899463
  • 899461
  • 1006610
  • 1101928
  • 899439
  • 1006608
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0078-0493Focalin XRFocalin XR
    0078-0608Focalin XRFocalin XR
    0078-0609Focalin XRFocalin XR
    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.