NDC 70165-100

Cotempla XR-ODT

Methylphenidate

Cotempla XR-ODT is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Neos Therapeutics, Lp. The primary component is Methylphenidate.

Product ID70165-100_7dec6513-60e0-42e3-890d-dedee031c696
NDC70165-100
Product TypeHuman Prescription Drug
Proprietary NameCotempla XR-ODT
Generic NameMethylphenidate
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2017-06-20
Marketing CategoryNDA / NDA
Application NumberNDA205489
Labeler NameNeos Therapeutics, LP
Substance NameMETHYLPHENIDATE
Active Ingredient Strength9 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 70165-100-30

5 BLISTER PACK in 1 CARTON (70165-100-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date2017-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70165-100-30 [70165010030]

Cotempla XR-ODT TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA205489
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-20

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE8.6 mg/1

OpenFDA Data

SPL SET ID:33f70f58-c871-42c8-8adb-345caeafefcd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1926849
  • 1926853
  • 1926847
  • 1926851
  • 1926840
  • 1926855
  • Pharmacological Class

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

    Medicade Reported Pricing

    70165010030 COTEMPLA XR-ODT 8.6 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Cotempla XR-ODT" or generic name "Methylphenidate"

    NDCBrand NameGeneric Name
    70165-100Cotempla XR-ODTMethylphenidate
    70165-200Cotempla XR-ODTCotempla XR-ODT
    70165-300Cotempla XR-ODTCotempla XR-ODT
    68968-5552Daytranamethylphenidate
    68968-5553Daytranamethylphenidate
    68968-5554Daytranamethylphenidate
    68968-5555Daytranamethylphenidate
    0378-8260MethylphenidateMethylphenidate
    0378-8261MethylphenidateMethylphenidate
    0378-8262MethylphenidateMethylphenidate
    0378-8263MethylphenidateMethylphenidate
    0781-2361Methylphenidatemethylphenidate
    0781-2362Methylphenidatemethylphenidate
    0781-2363Methylphenidatemethylphenidate
    0781-2364Methylphenidatemethylphenidate

    Trademark Results [Cotempla XR-ODT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COTEMPLA XR-ODT
    COTEMPLA XR-ODT
    86847780 5387222 Live/Registered
    Neos Therapeutics, Inc.
    2015-12-14

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