NDC 0007-4883

REQUIP XL

Ropinirole Hydrochloride

REQUIP XL is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Ropinirole Hydrochloride.

Product ID0007-4883_6ec48051-7c39-4ba2-9722-9e990be69139
NDC0007-4883
Product TypeHuman Prescription Drug
Proprietary NameREQUIP XL
Generic NameRopinirole Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-08-03
Marketing End Date2020-10-31
Marketing CategoryNDA / NDA
Application NumberNDA022008
Labeler NameGlaxoSmithKline LLC
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength6 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN

Packaging

NDC 0007-4883-13

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0007-4883-13)
Marketing Start Date2009-08-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0007-4883-13 [00007488313]

REQUIP XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022008
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-03
Marketing End Date2020-10-31

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE6 mg/1

OpenFDA Data

SPL SET ID:c1859eee-b5b9-401e-34ac-254a30218555
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 799056
  • 799054
  • 799055
  • 824961
  • 824959
  • 848584
  • 848582
  • 800497
  • 800499
  • 799832
    • UPC Code
  • 0300074883135
  • 0300074882138
  • 0300074887133
  • 0300074888130
  • 0300074885139

    • Pharmacological Class

    • Dopamine Agonists [MoA]
    • Nonergot Dopamine Agonist [EPC]
    • Dopamine Agonists [MoA]
    • Nonergot Dopamine Agonist [EPC]

    NDC Crossover Matching brand name "REQUIP XL" or generic name "Ropinirole Hydrochloride"

    NDCBrand NameGeneric Name
    0007-4882REQUIPropinirole hydrochloride
    0007-4883REQUIPropinirole hydrochloride
    0007-4885REQUIPropinirole hydrochloride
    0007-4887REQUIPropinirole hydrochloride
    0007-4888REQUIPropinirole hydrochloride
    0615-7536Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7537Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7538Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7539Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7567Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-8188ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0615-8189ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0615-8190ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0615-8191ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0904-6373ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0904-6374ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    21695-792ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    21695-793ropinirole hydrochlorideropinirole hydrochloride
    21695-794ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    21695-798ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    43353-194ropinirole hydrochlorideropinirole hydrochloride
    43353-195ropinirole hydrochlorideropinirole hydrochloride
    43353-196ropinirole hydrochlorideropinirole hydrochloride
    43353-198ropinirole hydrochlorideropinirole hydrochloride
    43547-268ropinirole hydrochlorideropinirole hydrochloride
    43547-269ropinirole hydrochlorideropinirole hydrochloride
    43547-270ropinirole hydrochlorideropinirole hydrochloride

    Trademark Results [REQUIP]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    REQUIP
    REQUIP
    87100700 5292435 Live/Registered
    REQUIP LLC
    2016-07-12
    REQUIP
    REQUIP
    78625377 3403033 Dead/Cancelled
    GLAXO GROUP LIMITED
    2005-05-09
    REQUIP
    REQUIP
    77551884 3675446 Dead/Cancelled
    Net Equity LLC
    2008-08-20
    REQUIP
    REQUIP
    75686892 2493192 Dead/Cancelled
    Remote Equipment Systems, Inc.
    1999-04-20
    REQUIP
    REQUIP
    75295316 2402319 Dead/Cancelled
    SMITHKLINE BEECHAM LIMITED
    1997-05-20
    REQUIP
    REQUIP
    74419880 2142934 Live/Registered
    GLAXO GROUP LIMITED
    1993-07-27
    REQUIP
    REQUIP
    74227962 1720742 Dead/Cancelled
    AMERICAN STERILIZER COMPANY
    1991-12-06
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.