NDC 0527-8108

Dexmethylphenidate Hydrochloride Extended-Release

Dexmethylphenidate Hydrochloride

Dexmethylphenidate Hydrochloride Extended-Release is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Dexmethylphenidate Hydrochloride.

Product ID0527-8108_33dad43d-456a-4cb9-aa50-7a5192465427
NDC0527-8108
Product TypeHuman Prescription Drug
Proprietary NameDexmethylphenidate Hydrochloride Extended-Release
Generic NameDexmethylphenidate Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-10-09
Marketing CategoryANDA / ANDA
Application NumberANDA210279
Labeler NameLannett Company, Inc.
Substance NameDEXMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength15 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 0527-8108-37

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8108-37)
Marketing Start Date2018-10-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-8108-37 [00527810837]

Dexmethylphenidate Hydrochloride Extended-Release CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-09

Drug Details

Active Ingredients

IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE15 mg/1

OpenFDA Data

SPL SET ID:edad7c67-a872-41ad-a8bd-169278693cc2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 899485
  • 899495
  • 1006608
  • 899511
  • 1101926
  • 1101932
  • 899461
  • 899439
    • UPC Code
  • 0305278109371
  • 0305278107377
  • 0305278113378
  • 0305278110377
  • 0305278111374
  • 0305278108374
  • 0305278112371
  • 0305278106370

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Dexmethylphenidate Hydrochloride Extended-Release" or generic name "Dexmethylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    0527-8106Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0527-8107Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    69189-2685Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0527-8108Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0527-8113Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0527-8110Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0527-8109Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0527-8112Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0527-8111Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0781-2686Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0781-2688Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0781-2684Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0781-2685Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0781-2687Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0781-2689Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0781-2682Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0781-2683Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    49884-430Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    49884-428Dexmethylphenidate Hydrochloride Extended-ReleaseDexmethylphenidate Hydrochloride Extended-Release
    0078-0380Focalindexmethylphenidate hydrochloride
    0078-0381Focalindexmethylphenidate hydrochloride
    0078-0382Focalindexmethylphenidate hydrochloride
    0078-0430Focalindexmethylphenidate hydrochloride
    0078-0431Focalindexmethylphenidate hydrochloride
    0078-0432Focalindexmethylphenidate hydrochloride
    0078-0433Focalindexmethylphenidate hydrochloride
    0078-0434Focalindexmethylphenidate hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.