NDC 72865-126

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Xlcare Pharmaceuticals, Inc. The primary component is Methylphenidate Hydrochloride.

Product ID72865-126_20ba3710-024d-41ed-b4eb-73878c14b5e9
NDC72865-126
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate Hydrochloride
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2020-02-17
Marketing CategoryANDA / ANDA
Application NumberANDA210354
Labeler NameXLCare Pharmaceuticals, 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 Through2022-12-31

Packaging

NDC 72865-126-01

100 TABLET, CHEWABLE in 1 BOTTLE (72865-126-01)
Marketing Start Date2020-02-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72865-126-01 [72865012601]

Methylphenidate Hydrochloride TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA210354
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-17

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:91833146-fa95-471a-8b8d-6d36a2db5c9a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091322
  • 1091152
  • 1091389
  • UPC Code
  • 0372865127018
  • 0372865125014
  • 0372865126011
  • 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.