NDC 0527-2562

Metadate ER

Methylphenidate Hydrochloride

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

Product ID0527-2562_844ddb57-efae-4705-becb-70661414b441
NDC0527-2562
Product TypeHuman Prescription Drug
Proprietary NameMetadate ER
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA089601
Labeler NameLannett Company, Inc.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength20 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 0527-2562-37

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2562-37)
Marketing Start Date2014-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-2562-37 [00527256237]

Metadate ER TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089601
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-01

NDC 0527-2562-01 [00527256201]

Metadate ER TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089601
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-01
Marketing End Date2018-10-09

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:8f15c7e1-dba3-49cb-ab67-484f3a147f29
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091488
  • 1091225
    • UPC Code
  • 0305272562370

    • Pharmacological Class

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

    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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