NDC 55700-565

Nucynta ER

Tapentadol Hydrochloride

Nucynta ER is a Oral Tablet, Film Coated, 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 Tapentadol Hydrochloride.

Product ID55700-565_51034f23-626c-483c-960c-d6346fa0b9cc
NDC55700-565
Product TypeHuman Prescription Drug
Proprietary NameNucynta ER
Generic NameTapentadol Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-06-16
Marketing CategoryNDA / NDA
Application NumberNDA200533
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameTAPENTADOL HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55700-565-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-565-60)
Marketing Start Date2017-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-565-60 [55700056560]

Nucynta ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA200533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-08

Drug Details

Active Ingredients

IngredientStrength
TAPENTADOL HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:86044479-4ad5-435e-9e15-4d7f34a4c320
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1149378
  • 1148809

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    69865-265Nucynta ERNucynta ER
    69865-250Nucynta ERNucynta ER
    69865-245Nucynta ERNucynta ER
    69865-260Nucynta ERNucynta ER
    69865-240Nucynta ERNucynta ER
    55700-796Nucynta ERNucynta ER
    55700-797Nucynta ERNucynta ER
    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

    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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