NDC 0603-4578

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Methylphenidate Hydrochloride.

Product ID0603-4578_05374d64-a42c-404c-b16a-7c0873b2c7f0
NDC0603-4578
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate Hydrochloride
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-09-23
Marketing End Date2021-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA202892
Labeler NamePar Pharmaceutical
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 0603-4578-21

100 TABLET in 1 BOTTLE, PLASTIC (0603-4578-21)
Marketing Start Date2014-09-23
Marketing End Date2021-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-4578-21 [00603457821]

Methylphenidate Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202892
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-23
Marketing End Date2021-04-30

NDC 0603-4578-32 [00603457832]

Methylphenidate Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202892
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-23
Marketing End Date2017-03-20

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:e6f6e86b-01f4-42eb-9054-42c8be1797c8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091497
  • 1091392
  • 1091150
    • UPC Code
  • 0306034577212
  • 0306034576215
  • 0306034578219

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    68084-805Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    68084-816methylphenidate hydrochloridemethylphenidate hydrochloride
    68084-823Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    68084-829methylphenidate hydrochloridemethylphenidate hydrochloride
    68084-833methylphenidate hydrochloridemethylphenidate hydrochloride
    0527-2531Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    0527-2530Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    0527-2532Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    69452-167METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
    69452-165METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
    69452-166METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
    70010-042METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
    70010-043METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
    0591-2715methylphenidate hydrochloridemethylphenidate hydrochloride
    0591-2716methylphenidate hydrochloridemethylphenidate hydrochloride
    0591-2717methylphenidate hydrochloridemethylphenidate hydrochloride
    0591-2718methylphenidate hydrochloridemethylphenidate hydrochloride
    0591-5882Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    0591-5883Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    0591-5884Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    0603-4577Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    0603-4578Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    0603-4576Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    71335-0838Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    71335-0892Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    71930-024Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    71930-025Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    0781-5748Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    0781-5749Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    0781-5753Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    10147-0687methylphenidate Hydrochloridemethylphenidate Hydrochloride
    10147-0688methylphenidate Hydrochloridemethylphenidate Hydrochloride
    10147-0686methylphenidate Hydrochloridemethylphenidate Hydrochloride
    10147-0685methylphenidate Hydrochloridemethylphenidate Hydrochloride
    10702-102Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    10702-100Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    10702-101Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    13107-380Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    13107-382Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    13107-381Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    13811-709Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    13811-710Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    13811-706Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    13811-708Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    13811-707Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    16714-823METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
    16714-821METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
    16714-822METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
    27808-058Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    0115-1741Methylphenidate HydrochlorideMethylphenidate Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.