NDC 0406-1850

Methylphenidate Hydrochloride Extended-Release

Methylphenidate Hydrochloride

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

Product ID0406-1850_21b09bf5-0a20-404a-9185-75499e7765d4
NDC0406-1850
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate Hydrochloride Extended-Release
Generic NameMethylphenidate Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-09-29
Marketing CategoryANDA / ANDA
Application NumberANDA203583
Labeler NameSpecGx LLC
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0406-1850-01

100 CAPSULE in 1 BOTTLE, PLASTIC (0406-1850-01)
Marketing Start Date2015-09-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-1850-01 [00406185001]

Methylphenidate Hydrochloride Extended-Release CAPSULE
Marketing CategoryANDA
Application NumberANDA203583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-29

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:9e11e093-4ff3-4bed-8fe9-3ee460b47303
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1806181
  • 1806187
  • 1806189
  • 1806197
  • 1806193
  • 1806191
    • UPC Code
  • 0304061860017
  • 0304061820011
  • 0304061840019
  • 0304061810012
  • 0304061850018
  • 0304061830010

    • 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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