NDC 55700-796

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 Quality Care Products, Llc. The primary component is Tapentadol Hydrochloride.

Product ID55700-796_08c74097-d4f5-45be-b8e5-5fcb9aa5cadf
NDC55700-796
Product TypeHuman Prescription Drug
Proprietary NameNucynta ER
Generic NameTapentadol Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-09-27
Marketing CategoryNDA / NDA
Application NumberNDA200533
Labeler NameQuality 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 55700-796-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-796-60)
Marketing Start Date2019-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-796-60 [55700079660]

Nucynta ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA200533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-27

Drug Details

Active Ingredients

IngredientStrength
TAPENTADOL HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:77e6cb78-88b9-4488-8aa0-fd507083ff94
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1149378
  • 1149367
  • 1148797
  • 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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