NDC 50458-587

CONCERTA

Methylphenidate Hydrochloride

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

Product ID50458-587_4d35b5ab-fa7a-476a-9d38-a18483a53bc4
NDC50458-587
Product TypeHuman Prescription Drug
Proprietary NameCONCERTA
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2000-08-01
Marketing CategoryNDA / NDA
Application NumberNDA021121
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength54 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 50458-587-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-587-01)
Marketing Start Date2000-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-587-01 [50458058701]

CONCERTA TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021121
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-08-01

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE54 mg/1

OpenFDA Data

SPL SET ID:1a88218c-5b18-4220-8f56-526de1a276cd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091210
  • 1091212
  • 1091170
  • 1091172
  • 1091185
  • 1091157
  • 1091187
  • 1091155

    • Pharmacological Class

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

    Medicade Reported Pricing

    50458058701 CONCERTA ER 54 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    50458-588CONCERTACONCERTA
    50458-587CONCERTACONCERTA
    50458-585CONCERTACONCERTA
    50458-586CONCERTACONCERTA
    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

    Trademark Results [CONCERTA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CONCERTA
    CONCERTA
    75681011 2483160 Live/Registered
    ALZA Corporation
    1999-04-12
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