NDC 59917-110

Dexmethylphenidate HCl

Dexmethylphenidate Hcl Extended-release

Dexmethylphenidate HCl is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Adare Pharmaceuticals Inc. The primary component is Dexmethylphenidate Hydrochloride.

Product ID59917-110_ad9630c5-54f3-4595-b6fd-9a0112a6628b
NDC59917-110
Product TypeHuman Prescription Drug
Proprietary NameDexmethylphenidate HCl
Generic NameDexmethylphenidate Hcl Extended-release
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA210279
Labeler NameAdare Pharmaceuticals Inc
Substance NameDEXMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength25 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 59917-110-01

100 CAPSULE in 1 BOTTLE (59917-110-01)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:c35cb07b-f176-4155-b5be-93e341aa4856
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 899485
  • 899495
  • 1006608
  • 899511
  • 1101926
  • 1101932
  • 899461
  • 899439
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Dexmethylphenidate HCl" or generic name "Dexmethylphenidate Hcl Extended-release"

    NDCBrand NameGeneric Name
    59917-106Dexmethylphenidate HClDexmethylphenidate HCl Extended-Release
    59917-107Dexmethylphenidate HClDexmethylphenidate HCl Extended-Release
    59917-108Dexmethylphenidate HClDexmethylphenidate HCl Extended-Release
    59917-109Dexmethylphenidate HClDexmethylphenidate HCl Extended-Release Capsules, 20 mg
    59917-110Dexmethylphenidate HClDexmethylphenidate HCl Extended-Release
    59917-111Dexmethylphenidate HClDexmethylphenidate HCl Extended-Release
    59917-112Dexmethylphenidate HClDexmethylphenidate HCl Extended-Release
    59917-113Dexmethylphenidate HClDexmethylphenidate HCl Extended-Release

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