NDC 0093-5046

Dexmethylphenidate Hydrochloride

Dexmethylphenidate Hydrochloride

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

Product ID0093-5046_32a6c8eb-8b96-47c3-a250-6437ad8c8787
NDC0093-5046
Product TypeHuman Prescription Drug
Proprietary NameDexmethylphenidate Hydrochloride
Generic NameDexmethylphenidate Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-07-05
Marketing CategoryANDA / ANDA
Application NumberANDA202731
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameDEXMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength35 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 0093-5046-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5046-01)
Marketing Start Date2017-07-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-5046-01 [00093504601]

Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202731
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-05

Drug Details

Active Ingredients

IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE35 mg/1

OpenFDA Data

SPL SET ID:dd659d39-41f5-4612-8f17-bad602b4784d
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 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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