NDC 57664-379

Dexmethylphenidate hydrochloride

Dexmethylphenidate Hydrochloride

Dexmethylphenidate hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Dexmethylphenidate Hydrochloride.

Product ID57664-379_2aed0f6c-f52d-4fe6-b40b-058dbc8318b2
NDC57664-379
Product TypeHuman Prescription Drug
Proprietary NameDexmethylphenidate hydrochloride
Generic NameDexmethylphenidate Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-09-26
Marketing CategoryANDA / ANDA
Application NumberANDA201231
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameDEXMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength10 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 57664-379-08

100 TABLET in 1 BOTTLE (57664-379-08)
Marketing Start Date2013-09-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57664-379-83 [57664037983]

Dexmethylphenidate hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA201231
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-26

NDC 57664-379-08 [57664037908]

Dexmethylphenidate hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA201231
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-26

NDC 57664-379-88 [57664037988]

Dexmethylphenidate hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA201231
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-26

NDC 57664-379-13 [57664037913]

Dexmethylphenidate hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA201231
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-26

NDC 57664-379-18 [57664037918]

Dexmethylphenidate hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA201231
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-26

Drug Details

Active Ingredients

IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:987b4983-1edc-40f1-adc9-724747080969
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 899548
  • 899557
  • 899518
    • UPC Code
  • 0357664376881
  • 0357664378885
  • 0357664379882

    • Pharmacological Class

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

    Medicade Reported Pricing

    57664037988 DEXMETHYLPHENIDATE 10 MG TAB

    Pricing Unit: EA | Drug Type:

    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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