NDC 0406-3010

Methylphenidate HCl

Methylphenidate Hydrochloride

Methylphenidate HCl is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Methylphenidate Hydrochloride.

Product ID0406-3010_01cb123a-736f-4e5e-834a-f7a48fd2e33c
NDC0406-3010
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate HCl
Generic NameMethylphenidate Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2013-08-01
Marketing End Date2021-01-31
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021419
Labeler NameSpecGx LLC
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 0406-3010-50

500 mL in 1 BOTTLE (0406-3010-50)
Marketing Start Date2013-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-3010-50 [00406301050]

Methylphenidate HCl SOLUTION
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-08-01
Marketing End Date2021-01-31

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE10 mg/5mL

OpenFDA Data

SPL SET ID:7b372d74-7ba7-437a-be8c-6e8335b78818
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091341
  • 1091133
    • UPC Code
  • 0304063010502
  • 0304063005508

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    39328-054Methylphenidate HClMethylphenidate HCl
    39328-154Methylphenidate HClMethylphenidate HCl
    0406-3005Methylphenidate HClMethylphenidate HCl
    0406-3010Methylphenidate HClMethylphenidate HCl
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.