NDC 0781-5676

Dexmethylphenidate Hydrochloride

Dexmethylphenidate Hydrochloride

Dexmethylphenidate Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Dexmethylphenidate Hydrochloride.

Product ID0781-5676_17113e81-49e5-46d5-b102-de30a89a7817
NDC0781-5676
Product TypeHuman Prescription Drug
Proprietary NameDexmethylphenidate Hydrochloride
Generic NameDexmethylphenidate Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-04-27
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021278
Labeler NameSandoz Inc
Substance NameDEXMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength3 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 0781-5676-01

100 TABLET in 1 BOTTLE (0781-5676-01)
Marketing Start Date2015-04-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5676-01 [00781567601]

Dexmethylphenidate Hydrochloride TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA021278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-04-27
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE2.5 mg/1

OpenFDA Data

SPL SET ID:07efe5d5-9857-490a-9a31-9dd07ea9386e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 899548
  • 899557
  • 899518
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Dexmethylphenidate Hydrochloride" or generic name "Dexmethylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    0527-1899Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0527-1901Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0527-1900Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0781-5689Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0781-5676Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0781-5691Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    10702-106Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    10702-108Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    10702-107Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0093-5045Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0093-5277Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0093-5275Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0093-5276Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0093-5046Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0093-5550Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0093-5551Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0093-5562Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0093-5553Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0093-5552Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0093-5554Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    27808-092Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    27808-091Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0115-1685Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    27808-093Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    0115-1682Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    0115-1684Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    0115-1710Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    0115-9918Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    0115-9921Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    0115-1683Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    0115-1686Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    0115-1709Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    0115-9919Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    0115-9920Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    0115-9922Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride
    42858-011DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
    42858-225DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
    42858-410DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
    43386-860Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    43386-861Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    43386-862Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    49884-539Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    49884-049Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    49884-248Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    49884-333Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    49884-339Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    49884-090Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    49884-048Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    49884-546Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
    57664-376Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride

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