NDC 59630-222

SYMPROIC

Naldemedine

SYMPROIC is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Shionogi Inc.. The primary component is Naldemedine Tosylate.

Product ID59630-222_41985d7d-0aa5-4ca5-a730-997330c1108e
NDC59630-222
Product TypeHuman Prescription Drug
Proprietary NameSYMPROIC
Generic NameNaldemedine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-03-23
Marketing CategoryNDA / NDA
Application NumberNDA208854
Labeler NameShionogi Inc.
Substance NameNALDEMEDINE TOSYLATE
Active Ingredient Strength0 mg/1
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 59630-222-30

30 TABLET in 1 BOTTLE (59630-222-30)
Marketing Start Date2018-07-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59630-222-90 [59630022290]

SYMPROIC TABLET
Marketing CategoryNDA
Application NumberNDA208854
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-05
Marketing End Date2020-12-31

NDC 59630-222-07 [59630022207]

SYMPROIC TABLET
Marketing CategoryNDA
Application NumberNDA208854
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-05
Marketing End Date2020-12-31

NDC 59630-222-30 [59630022230]

SYMPROIC TABLET
Marketing CategoryNDA
Application NumberNDA208854
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-05
Marketing End Date2020-12-31

Drug Details

Active Ingredients

IngredientStrength
NALDEMEDINE TOSYLATE.2 mg/1

OpenFDA Data

SPL SET ID:12ca7d88-2a0c-4c3b-b61e-f58849c7e9e3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1876609
  • 1876603
  • UPC Code
  • 0359630222901
  • Pharmacological Class

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

    Medicade Reported Pricing

    59630022290 SYMPROIC 0.2 MG TABLET

    Pricing Unit: EA | Drug Type:

    59630022230 SYMPROIC 0.2 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "SYMPROIC" or generic name "Naldemedine"

    NDCBrand NameGeneric Name
    59011-523Symproicnaldemedine
    59385-041SYMPROICnaldemedine tosylate
    59630-222SYMPROICnaldemedine

    Trademark Results [SYMPROIC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SYMPROIC
    SYMPROIC
    79168243 4887392 Live/Registered
    SHIONOGI & CO., LTD.
    2015-01-27

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