NDC 50458-861

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 Janssen Pharmaceuticals, Inc.. The primary component is Tapentadol Hydrochloride.

Product ID50458-861_e4d6e211-2c12-4507-b371-610ee57379fa
NDC50458-861
Product TypeHuman Prescription Drug
Proprietary NameNucynta ER
Generic NameTapentadol Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-08-25
Marketing End Date2020-03-31
Marketing CategoryNDA / NDA
Application NumberNDA200533
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameTAPENTADOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 50458-861-02

10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-861-02) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2011-08-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-861-02 [50458086102]

Nucynta ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA200533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-25
Marketing End Date2020-01-31

NDC 50458-861-01 [50458086101]

Nucynta ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA200533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-08-25
Marketing End Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TAPENTADOL HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:f4c911f3-484b-44fa-833e-2d970d39be8f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1148807
  • 1148800
  • 1148803
  • 1148809
  • 1149370
  • 1149373
  • 1149367
  • 1149376
  • 1149378
  • 1148797
    • UPC Code
  • 0350458863017
  • 0350458864014
  • 0350458862010
  • 0350458860016
  • 0350458861013

    • Pharmacological Class

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

    Medicade Reported Pricing

    50458086101 NUCYNTA ER 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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