NDC 0093-5348

Methylphenidate Hydrochloride (LA)

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride (LA) is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Methylphenidate Hydrochloride.

Product ID0093-5348_1c026445-a471-461a-81d4-15e2646a88db
NDC0093-5348
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate Hydrochloride (LA)
Generic NameMethylphenidate Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-07-16
Marketing CategoryANDA / ANDA
Application NumberANDA079031
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength40 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 0093-5348-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5348-01)
Marketing Start Date2012-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-5348-01 [00093534801]

Methylphenidate Hydrochloride (LA) CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079031
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-16

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:034fb7cd-e183-475e-8beb-64fd88facc8f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1806179
  • 1806183
  • 1806177
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Methylphenidate Hydrochloride (LA)" or generic name "Methylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    0093-3230Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0093-3231Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0093-3232Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0093-5346Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    0093-5347Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    0093-5348Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    51862-263Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    51862-614Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    51862-264Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    51862-267Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    51862-262Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    51862-265Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    51862-609Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    51862-610Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    51862-612Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    51862-611Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride (LA)
    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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