NDC 51862-611

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 Mayne Pharma. The primary component is Methylphenidate Hydrochloride.

Product ID51862-611_298af4ea-31db-41d8-9ff9-aebed31dbd34
NDC51862-611
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate Hydrochloride (LA)
Generic NameMethylphenidate Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-12-06
Marketing CategoryANDA / ANDA
Application NumberANDA078458
Labeler NameMayne Pharma
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength30 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51862-611-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-611-01)
Marketing Start Date2019-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-611-01 [51862061101]

Methylphenidate Hydrochloride (LA) CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078458
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-10

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:e5db854a-1c77-4faf-9e60-daf9c9b6cfa0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1806195
  • 1806185
  • UPC Code
  • 0351862611010
  • 0351862612017
  • 0351862610013
  • 0351862614301
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.