NDC 69452-165

METHYLPHENIDATE HYDROCHLORIDE

Methylphenidate Hydrochloride

METHYLPHENIDATE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bionpharma Inc.. The primary component is Methylphenidate Hydrochloride.

Product ID69452-165_8d60188d-9517-4335-be77-4de5bdd77064
NDC69452-165
Product TypeHuman Prescription Drug
Proprietary NameMETHYLPHENIDATE HYDROCHLORIDE
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-03-21
Marketing CategoryANDA / ANDA
Application NumberANDA209753
Labeler NameBionpharma Inc.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69452-165-20

100 TABLET in 1 BOTTLE (69452-165-20)
Marketing Start Date2018-03-21
Marketing End Date2021-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69452-165-20 [69452016520]

METHYLPHENIDATE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA209753
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-21

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:3fe86f60-9a58-43d6-b955-c698ddcc95d0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091497
  • 1091392
  • 1091150

    • Pharmacological Class

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