NDC 71376-204

JORNAY PM Extended-Release

Methylphenidate Hydrochloride

JORNAY PM Extended-Release is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Ironshore Pharmaceuticals, Inc.. The primary component is Methylphenidate Hydrochloride.

Product ID71376-204_580e79aa-6f44-40af-8020-48ff142c66bb
NDC71376-204
Product TypeHuman Prescription Drug
Proprietary NameJORNAY PM Extended-Release
Generic NameMethylphenidate Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-05-20
Marketing CategoryNDA / NDA
Application NumberNDA209311
Labeler NameIronshore Pharmaceuticals, Inc.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength80 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 71376-204-03

100 CAPSULE in 1 BOTTLE (71376-204-03)
Marketing Start Date2019-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71376-204-03 [71376020403]

JORNAY PM Extended-Release CAPSULE
Marketing CategoryNDA
Application NumberNDA209311
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-20

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE80 mg/1

OpenFDA Data

SPL SET ID:d95dede0-b1ff-4489-8f91-3bbe122852bf
Manufacturer
UNII
UPC Code
  • 0371376202030
  • 0371376204034
  • 0371376203037
  • 0371376205031

    • Pharmacological Class

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

    NDC Crossover Matching brand name "JORNAY PM Extended-Release" or generic name "Methylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    71376-205JORNAY PM Extended-ReleaseJORNAY PM Extended-Release
    71376-203JORNAY PM Extended-ReleaseJORNAY PM Extended-Release
    71376-201JORNAY PM Extended-ReleaseJORNAY PM Extended-Release
    71376-202JORNAY PM Extended-ReleaseJORNAY PM Extended-Release
    71376-204JORNAY PM Extended-ReleaseJORNAY PM Extended-Release
    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 [JORNAY PM]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    JORNAY PM
    JORNAY PM
    88095957 5922142 Live/Registered
    Ironshore Pharmaceuticals & Development, Inc.
    2018-08-28
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