NDC 0406-0127

Methylphenidate Hydrochloride Extended-Release

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride Extended-Release is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Methylphenidate Hydrochloride.

Product ID0406-0127_0578d4da-cb07-447d-903f-937f2df3a321
NDC0406-0127
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate Hydrochloride Extended-Release
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-12-28
Marketing CategoryANDA / ANDA
Application NumberANDA202608
Labeler NameSpecGx LLC
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength27 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 0406-0127-01

100 TABLET in 1 BOTTLE (0406-0127-01)
Marketing Start Date2012-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-0127-01 [00406012701]

Methylphenidate Hydrochloride Extended-Release TABLET
Marketing CategoryANDA
Application NumberANDA202608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-28

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE27 mg/1

OpenFDA Data

SPL SET ID:b1b0f2ff-d9df-42ab-b471-226ecf97e075
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2001565
  • 2001566
  • 2001568
  • UPC Code
  • 0304060154018
  • 0304060136014
  • 0304060127012
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Methylphenidate Hydrochloride Extended-Release" or generic name "Methylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    0406-1860Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate Hydrochloride Extended-Release
    0406-0154Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate Hydrochloride Extended-Release
    0406-0136Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate Hydrochloride Extended-Release
    0406-1820Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate Hydrochloride Extended-Release
    0406-1850Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate Hydrochloride Extended-Release
    0406-1810Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate Hydrochloride Extended-Release
    0406-1830Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate Hydrochloride Extended-Release
    0406-0127Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate Hydrochloride Extended-Release
    0406-1840Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate Hydrochloride Extended-Release
    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

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