NDC 55700-606

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 Hydrochloride.

Product ID55700-606_b09da754-192b-4390-892c-1946dedf704a
NDC55700-606
Product TypeHuman Prescription Drug
Proprietary NameNucynta
Generic NameTapentadol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-04-20
Marketing CategoryNDA / NDA
Application NumberNDA022304
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 55700-606-30

30 TABLET, FILM COATED in 1 BOTTLE (55700-606-30)
Marketing Start Date2018-04-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-606-30 [55700060630]

Nucynta TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022304
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-20
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
TAPENTADOL HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:b8403182-0de8-4dea-8af6-c5ec1c87a735
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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