NDC 0781-2361

Methylphenidate

Methylphenidate

Methylphenidate is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Methylphenidate Hydrochloride.

Product ID0781-2361_2c0c77e1-92d7-4fde-8159-140539f1961f
NDC0781-2361
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate
Generic NameMethylphenidate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-11-24
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021284
Labeler NameSandoz Inc
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0781-2361-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2361-01)
Marketing Start Date2018-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-2361-01 [00781236101]

Methylphenidate CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA021284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-28

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:1f8983ce-71b8-4c62-830d-e4692ddededa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1806179
  • 1806183
  • 1806195
  • 1806177
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0378-8260MethylphenidateMethylphenidate
    0378-8261MethylphenidateMethylphenidate
    0378-8262MethylphenidateMethylphenidate
    0378-8263MethylphenidateMethylphenidate
    0781-2361Methylphenidatemethylphenidate
    0781-2362Methylphenidatemethylphenidate
    0781-2363Methylphenidatemethylphenidate
    0781-2364Methylphenidatemethylphenidate
    10702-163MethylphenidateMethylphenidate Hydrochloride
    10702-164MethylphenidateMethylphenidate Hydrochloride
    68968-5552Daytranamethylphenidate
    68968-5553Daytranamethylphenidate
    68968-5554Daytranamethylphenidate
    68968-5555Daytranamethylphenidate

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