NDC 50458-830

NUCYNTA

Tapentadol Hydrochloride

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

Product ID50458-830_926544cc-122c-4f9f-9434-a886827b0871
NDC50458-830
Product TypeHuman Prescription Drug
Proprietary NameNUCYNTA
Generic NameTapentadol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-06-01
Marketing End Date2020-03-31
Marketing CategoryNDA / NDA
Application NumberNDA022304
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameTAPENTADOL HYDROCHLORIDE
Active Ingredient Strength75 mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 50458-830-04

100 TABLET, FILM COATED in 1 BOTTLE (50458-830-04)
Marketing Start Date2009-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-830-02 [50458083002]

NUCYNTA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022304
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-01
Marketing End Date2018-06-30

NDC 50458-830-04 [50458083004]

NUCYNTA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022304
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-01
Marketing End Date2020-02-29

Drug Details

Active Ingredients

IngredientStrength
TAPENTADOL HYDROCHLORIDE75 mg/1

OpenFDA Data

SPL SET ID:00a8921e-46a6-4df1-a744-9e532b6fb06f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854142
  • 825409
  • 854144
  • 854140
  • 825411
  • 825413
    • UPC Code
  • 0350458840049
  • 0350458820041
  • 0350458830040

    • Pharmacological Class

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

    Medicade Reported Pricing

    50458083004 NUCYNTA 75 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458083002 NUCYNTA 75 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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