NDC 35356-525

Nucynta

Tapentadol Hydrochloride

Nucynta is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Tapentadol.

Product ID35356-525_6ecb6e76-4197-47b4-b3b3-0bc8fb9367e8
NDC35356-525
Product TypeHuman Prescription Drug
Proprietary NameNucynta
Generic NameTapentadol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-09-29
Marketing CategoryNDA / NDA
Application NumberNDA022304
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameTAPENTADOL
Active Ingredient Strength50 mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 35356-525-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-525-30)
Marketing Start Date2010-09-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-525-30 [35356052530]

Nucynta TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022304
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-29
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
TAPENTADOL50 mg/1

OpenFDA Data

SPL SET ID:07c33315-90c9-4a73-bf1d-bca70c7e0ff5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854142
  • 825411

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Nucynta" or generic name "Tapentadol Hydrochloride"

    NDCBrand NameGeneric Name
    21695-069NUCYNTAtapentadol hydrochloride
    24510-050Nucyntatapentadol hydrochloride
    24510-058Nucyntatapentadol hydrochloride
    24510-075Nucyntatapentadol hydrochloride
    24510-100Nucyntatapentadol hydrochloride
    24510-116Nucyntatapentadol hydrochloride
    24510-174Nucyntatapentadol hydrochloride
    24510-232Nucyntatapentadol hydrochloride
    24510-291Nucyntatapentadol hydrochloride
    35356-525NucyntaTapentadol hydrochloride
    35356-593NUCYNTAtapentadol hydrochloride
    35356-611NUCYNTAtapentadol hydrochloride
    50458-820NUCYNTAtapentadol hydrochloride
    50458-830NUCYNTAtapentadol hydrochloride
    50458-840NUCYNTAtapentadol hydrochloride
    50458-860Nucyntatapentadol hydrochloride
    50458-861Nucyntatapentadol hydrochloride
    50458-862Nucyntatapentadol hydrochloride
    50458-863Nucyntatapentadol hydrochloride
    50458-864Nucyntatapentadol hydrochloride
    55700-555Nucyntatapentadol hydrochloride
    55700-565Nucyntatapentadol hydrochloride
    55700-606Nucyntatapentadol hydrochloride
    69865-230NucyntaNucynta
    69865-210NucyntaNucynta
    69865-220NucyntaNucynta
    55700-792NucyntaNucynta

    Trademark Results [Nucynta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NUCYNTA
    NUCYNTA
    87085846 5133557 Live/Registered
    Depo NF Sub, LLC
    2016-06-28
    NUCYNTA
    NUCYNTA
    87085841 not registered Live/Pending
    Depo NF Sub, LLC
    2016-06-28
    NUCYNTA
    NUCYNTA
    77620713 3732548 Live/Registered
    DEPO NF SUB, LLC
    2008-11-24
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