NDC 24510-120

XTAMPZA ER

Oxycodone

XTAMPZA ER is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Collegium Pharmaceutical, Inc.. The primary component is Oxycodone.

Product ID24510-120_1f9ccc6c-e3be-4e4b-a5e0-cfdf69253a2b
NDC24510-120
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 NameCollegium Pharmaceutical, Inc.
Substance NameOXYCODONE
Active Ingredient Strength18 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 24510-120-10

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-120-10)
Marketing Start Date2016-05-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24510-120-20 [24510012020]

XTAMPZA ER CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA208090
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-10

NDC 24510-120-10 [24510012010]

XTAMPZA ER CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA208090
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-10

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE18 mg/1

OpenFDA Data

SPL SET ID:b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1790533
  • 1791558
  • 1791574
  • 1791576
  • 1791567
  • 1791560
  • 1791580
  • 1791582
  • 1790527
  • 1791569
  • UPC Code
  • 0324510115109
  • 0324510140101
  • 0324510110104
  • 0324510130102
  • 0324510120103
  • Pharmacological Class

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

    Medicade Reported Pricing

    24510012010 XTAMPZA ER 18 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.