NDC 21695-069

NUCYNTA

Tapentadol Hydrochloride

NUCYNTA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Tapentadol Hydrochloride.

Product ID21695-069_7997e6da-7e98-4520-9d1b-0b8341bac64a
NDC21695-069
Product TypeHuman Prescription Drug
Proprietary NameNUCYNTA
Generic NameTapentadol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-06-01
Marketing CategoryNDA / NDA
Application NumberNDA022304
Labeler NameRebel Distributors Corp
Substance NameTAPENTADOL HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-069-72

120 TABLET, FILM COATED in 1 BOTTLE (21695-069-72)
Marketing Start Date2009-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-069-72 [21695006972]

NUCYNTA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022304
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-01
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
TAPENTADOL HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:7997e6da-7e98-4520-9d1b-0b8341bac64a
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.