NDC 49884-428

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 Par Pharmaceuticals, Inc.. The primary component is Dexmethylphenidate Hydrochloride.

Product ID49884-428_367b71aa-e462-4aeb-8f7e-a27728d7d4d5
NDC49884-428
Product TypeHuman Prescription Drug
Proprietary NameDexmethylphenidate Hydrochloride Extended-Release
Generic NameDexmethylphenidate Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-11-19
Marketing CategoryANDA / ANDA
Application NumberANDA078992
Labeler NamePar Pharmaceuticals, 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 49884-428-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-428-01)
Marketing Start Date2013-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49884-428-10 [49884042810]

Dexmethylphenidate Hydrochloride Extended-Release CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078992
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-11-19

NDC 49884-428-01 [49884042801]

Dexmethylphenidate Hydrochloride Extended-Release CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078992
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-11-19

Drug Details

Active Ingredients

IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE15 mg/1

OpenFDA Data

SPL SET ID:4ed9f3c8-c71f-499e-bb91-c19847bf4444
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 899495
  • 899461
    • UPC Code
  • 0349884123451

    • Pharmacological Class

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

    Medicade Reported Pricing

    49884042801 DEXMETHYLPHENIDATE ER 15 MG CP

    Pricing Unit: EA | Drug Type:

    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
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