NDC 53014-594

Metadate ER

Methylphenidate Hydrochloride

Metadate ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Unither Manufacturing, Llc. The primary component is Methylphenidate Hydrochloride.

Product ID53014-594_6470b9ad-04b8-4386-b2c3-184518ac6957
NDC53014-594
Product TypeHuman Prescription Drug
Proprietary NameMetadate ER
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date1988-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA089601
Labeler NameUnither Manufacturing, LLC
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53014-594-07

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (53014-594-07)
Marketing Start Date1988-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53014-594-07 [53014059407]

Metadate ER TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089601
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-06-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:739bbd64-d9e1-4771-967b-a2cd08f4eaf5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091488
  • 1091225
    • UPC Code
  • 0353014594073

    • Pharmacological Class

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

    Medicade Reported Pricing

    53014059407 METADATE ER 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Metadate ER" or generic name "Methylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    0527-2562Metadate ERMetadate ER
    53014-594Metadate ERMetadate ER
    65580-594Metadate ERMetadate ER
    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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