NDC 23635-115

Xartemis XR

Oxycodone Hydrochloride And Acetaminophen

Xartemis XR is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Oxycodone Hydrochloride; Acetaminophen.

Product ID23635-115_07db75be-c9b9-425c-9024-f908a104ecfe
NDC23635-115
Product TypeHuman Prescription Drug
Proprietary NameXartemis XR
Generic NameOxycodone Hydrochloride And Acetaminophen
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2013-04-30
Marketing End Date2019-05-31
Marketing CategoryNDA / NDA
Application NumberNDA204031
Labeler NameSpecGx LLC
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 23635-115-62

10 BLISTER PACK in 1 CARTON (23635-115-62) > 10 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2013-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 23635-115-62 [23635011562]

Xartemis XR TABLET, COATED
Marketing CategoryNDA
Application NumberNDA204031
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-30
Marketing End Date2019-05-31

NDC 23635-115-01 [23635011501]

Xartemis XR TABLET, COATED
Marketing CategoryNDA
Application NumberNDA204031
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-30
Marketing End Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE7.5 mg/1

OpenFDA Data

SPL SET ID:efcb1e8b-c0be-47ee-b09e-7a6b41e64bdd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1491834
  • 1491832
    • UPC Code
  • 0323635115018

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    Medicade Reported Pricing

    23635011501 XARTEMIS XR 7.5-325 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Xartemis XR" or generic name "Oxycodone Hydrochloride And Acetaminophen"

    NDCBrand NameGeneric Name
    0406-0512OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    0406-0522OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    0406-0523OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    0603-4978Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    0603-4979Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    0603-4982Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    0603-4998Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    0904-6437Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    0904-6438Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    0904-6439Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    10544-287OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    21695-233OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    21695-616Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    52959-556Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    55700-983OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    55700-984OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    63187-406Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    29033-405Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and Acetaminophen
    46672-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophen
    60760-200Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and Acetaminophen
    63481-623PERCOCEToxycodone hydrochloride and acetaminophen
    63481-627PERCOCEToxycodone hydrochloride and acetaminophen
    23635-115Xartemisoxycodone hydrochloride and acetaminophen

    Trademark Results [Xartemis]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XARTEMIS
    XARTEMIS
    85705518 4632837 Live/Registered
    Mallinckrodt LLC
    2012-08-16
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