NDC 55700-557

XTAMPZA ER

Oxycodone

XTAMPZA ER is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Oxycodone.

Product ID55700-557_68240be4-abbb-4160-bedb-b057e3da30aa
NDC55700-557
Product TypeHuman Prescription Drug
Proprietary NameXTAMPZA ER
Generic NameOxycodone
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-05-10
Marketing CategoryNDA / NDA
Application NumberNDA208090
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameOXYCODONE
Active Ingredient Strength14 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55700-557-30

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55700-557-30)
Marketing Start Date2017-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-557-30 [55700055730]

XTAMPZA ER CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA208090
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-06
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE13.5 mg/1

OpenFDA Data

SPL SET ID:e61ca86e-5306-4e1d-a99f-3a48300f2688
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1791560
  • 1791558

    • Pharmacological Class

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

    NDC Crossover Matching brand name "XTAMPZA ER" or generic name "Oxycodone"

    NDCBrand NameGeneric Name
    67877-623OxycodoneOxycodone
    67877-625OxycodoneOxycodone
    0904-6966Oxycodone HydrochlorideOxycodone
    0904-7180Oxycodone HydrochlorideOxycodone
    65162-047Oxycodone HydrochlorideOxycodone
    65162-048Oxycodone HydrochlorideOxycodone
    65162-049Oxycodone HydrochlorideOxycodone
    65162-050Oxycodone HydrochlorideOxycodone
    65162-051Oxycodone HydrochlorideOxycodone
    68071-5055Oxycodone HydrochlorideOxycodone
    24510-110XTAMPZAOXYCODONE
    24510-115XTAMPZAOXYCODONE
    24510-120XTAMPZAOXYCODONE
    24510-130XTAMPZAOXYCODONE
    24510-140XTAMPZAOXYCODONE
    55700-557XTAMPZAOXYCODONE

    Trademark Results [XTAMPZA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XTAMPZA
    XTAMPZA
    86525672 5027886 Live/Registered
    Collegium Pharmaceutical, Inc.
    2015-02-05
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