NDC 55700-792

Nucynta

Tapentadol Hydrochloride

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

Product ID55700-792_493218dd-b469-45e8-aa1f-cd050c45fbc7
NDC55700-792
Product TypeHuman Prescription Drug
Proprietary NameNucynta
Generic NameTapentadol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-09-13
Marketing CategoryNDA / NDA
Application NumberNDA022304
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 55700-792-30

30 TABLET, FILM COATED in 1 BOTTLE (55700-792-30)
Marketing Start Date2019-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-792-30 [55700079230]

Nucynta TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022304
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-13

Drug Details

Active Ingredients

IngredientStrength
TAPENTADOL HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:ff50cf44-bc12-482e-8c67-3f020e1c2333
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854142
  • 825411

    • Pharmacological Class

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