NDC 42858-401

APTENSIO XR

(methylphenidate Hydrochloride)

APTENSIO XR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rhodes Pharmaceuticals L.p.. The primary component is Methylphenidate Hydrochloride.

Product ID42858-401_9468380f-2590-4c7a-9451-81776fa2cfaf
NDC42858-401
Product TypeHuman Prescription Drug
Proprietary NameAPTENSIO XR
Generic Name(methylphenidate Hydrochloride)
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-04-17
Marketing CategoryNDA / NDA
Application NumberNDA205831
Labeler NameRhodes Pharmaceuticals L.P.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 42858-401-45

90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-401-45)
Marketing Start Date2015-04-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42858-401-45 [42858040145]

APTENSIO XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA205831
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-04-17

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:5adedc01-ebf0-11e3-ac10-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648185
  • 1648192
  • 1806200
  • 1806204
  • 1648180
  • 1648183
  • 1648195
  • 1648198
  • 1648189
  • 1806202
  • 1648201
  • 1806206
  • 1806208
  • 1806210
  • Pharmacological Class

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

    NDC Crossover Matching brand name "APTENSIO XR" or generic name "(methylphenidate Hydrochloride)"

    NDCBrand NameGeneric Name
    42858-401APTENSIO XR(methylphenidate hydrochloride)
    42858-402APTENSIO XR(methylphenidate hydrochloride)
    42858-403APTENSIO XR(methylphenidate hydrochloride)
    42858-404APTENSIO XR(methylphenidate hydrochloride)
    42858-405APTENSIO XR(methylphenidate hydrochloride)
    42858-406APTENSIO XR(methylphenidate hydrochloride)
    42858-407APTENSIO XR(methylphenidate hydrochloride)

    Trademark Results [APTENSIO XR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    APTENSIO XR
    APTENSIO XR
    85838161 4822493 Live/Registered
    Rhodes Pharmaceuticals L.P.
    2013-02-01

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