NDC 51991-612

methylphenidate hydrochloride

Methylphenidate Hydrochloride

methylphenidate hydrochloride is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Methylphenidate Hydrochloride.

Product ID51991-612_cda48b63-94c7-4bec-bcd0-9e4b7d2dd358
NDC51991-612
Product TypeHuman Prescription Drug
Proprietary Namemethylphenidate hydrochloride
Generic NameMethylphenidate Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2017-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA201466
Labeler NameBreckenridge Pharmaceutical, Inc.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 51991-612-50

500 mL in 1 BOTTLE (51991-612-50)
Marketing Start Date2017-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51991-612-50 [51991061250]

methylphenidate hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA201466
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-01

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:e0a3cc3c-db6f-4693-9ad5-2b719b62fd92
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091341
  • 1091133
  • UPC Code
  • 0351991611509
  • 0351991612506
  • Pharmacological Class

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

    Medicade Reported Pricing

    51991061250 METHYLPHENIDATE 10 MG/5 ML SOL

    Pricing Unit: ML | Drug Type:

    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.