NDC 24510-116

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 Collegium Pharmaceutical, Inc.. The primary component is Tapentadol Hydrochloride.

Product ID24510-116_18999ed0-2969-4957-a981-ae456c932e37
NDC24510-116
Product TypeHuman Prescription Drug
Proprietary NameNucynta ER
Generic NameTapentadol Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-04-19
Marketing CategoryNDA / NDA
Application NumberNDA200533
Labeler NameCollegium Pharmaceutical, Inc.
Substance NameTAPENTADOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 24510-116-01

10 BLISTER PACK in 1 CARTON (24510-116-01) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2019-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24510-116-60 [24510011660]

Nucynta ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA200533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-19

NDC 24510-116-01 [24510011601]

Nucynta ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA200533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-19

Drug Details

OpenFDA Data

SPL SET ID:c3d04d70-0155-4147-9ce4-a3b1fad4b373
Manufacturer
UNII
UPC Code
  • 0324510232608
  • 0324510058604
  • 0324510174601
  • 0324510291605
  • 0324510116601

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.