NDC 0115-9919

Dexmethylphenidate hydrochloride

Dexmethylphenidate Hydrochloride

Dexmethylphenidate hydrochloride is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Dexmethylphenidate Hydrochloride.

Product ID0115-9919_086cb5c4-0c3f-4485-a162-b23d5388688e
NDC0115-9919
Product TypeHuman Prescription Drug
Proprietary NameDexmethylphenidate hydrochloride
Generic NameDexmethylphenidate Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-08-06
Marketing CategoryANDA / ANDA
Application NumberANDA079108
Labeler NameAmneal Pharmaceuticals of New York LLC
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 Through2020-12-31

Packaging

NDC 0115-9919-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-9919-01)
Marketing Start Date2015-08-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-9919-01 [00115991901]

Dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079108
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-06

Drug Details

Active Ingredients

IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:93e56455-0f15-4ed9-a63a-7fbd0697d520
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 899439
  • 899485
  • 899511
  • 899495
  • 899461
    • UPC Code
  • 0301159918018
  • 0301159919015
  • 0301159921018

    • 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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