NDC 67919-020

Entereg

Alvimopan

Entereg is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Alvimopan.

Product ID67919-020_11d40fc9-6ca5-4259-a7ac-c5e29d7e8513
NDC67919-020
Product TypeHuman Prescription Drug
Proprietary NameEntereg
Generic NameAlvimopan
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2012-04-16
Marketing CategoryNDA / NDA
Application NumberNDA021775
Labeler NameMerck Sharp & Dohme Corp.
Substance NameALVIMOPAN
Active Ingredient Strength12 mg/1
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67919-020-10

6 BLISTER PACK in 1 CARTON (67919-020-10) > 5 CAPSULE in 1 BLISTER PACK
Marketing Start Date2012-04-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67919-020-10 [67919002010]

Entereg CAPSULE
Marketing CategoryNDA
Application NumberNDA021775
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-16

Drug Details

Active Ingredients

IngredientStrength
ALVIMOPAN12 mg/1

OpenFDA Data

SPL SET ID:77a67dc6-35d3-48ff-9d18-292d4d442f70
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 799835
  • 801731
  • Pharmacological Class

    • Opioid Antagonist [EPC]
    • Opioid Antagonists [MoA]

    NDC Crossover Matching brand name "Entereg" or generic name "Alvimopan"

    NDCBrand NameGeneric Name
    67919-020Enteregalvimopan
    0591-2312AlvimopanAlvimopan

    Trademark Results [Entereg]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ENTEREG
    ENTEREG
    87123814 not registered Live/Pending
    Merck Sharp & Dohme Corp.
    2016-08-02
    ENTEREG
    ENTEREG
    87123810 not registered Live/Pending
    Merck Sharp & Dohme Corp.
    2016-08-02
    ENTEREG
    ENTEREG
    78449167 not registered Dead/Abandoned
    ADOLOR CORPORATION
    2004-07-12
    ENTEREG
    ENTEREG
    78432539 not registered Dead/Abandoned
    ADOLOR CORPORATION
    2004-06-09
    ENTEREG
    ENTEREG
    77549901 3591151 Dead/Cancelled
    Adolor Corporation
    2008-08-18
    ENTEREG
    ENTEREG
    77549881 3615172 Dead/Cancelled
    Adolor Corporation
    2008-08-18
    ENTEREG
    ENTEREG
    76287429 2946371 Live/Registered
    MERCK SHARP & DOHME CORP.
    2001-07-19

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