NDC 55758-004

DOLEX

Ibuprofen

DOLEX is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Pharmadel Llc. The primary component is Ibuprofen.

Product ID55758-004_20cd6922-e370-4cce-affb-a049b9f8d500
NDC55758-004
Product TypeHuman Otc Drug
Proprietary NameDOLEX
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-03-25
Marketing CategoryANDA / ANDA
Application NumberANDA079129
Labeler NamePharmadel LLC
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 55758-004-24

1 BOTTLE in 1 CARTON (55758-004-24) > 24 TABLET in 1 BOTTLE
Marketing Start Date2013-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55758-004-24 [55758000424]

DOLEX TABLET
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-03-25
Marketing End Date2018-12-27

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:548bbd08-73ed-4e87-8b7a-1dfec7aafcd9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • NDC Crossover Matching brand name "DOLEX" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    55758-004DOLEXDOLEX
    0113-1461basic care childrens ibuprofenIbuprofen
    0113-7619basic care childrens ibuprofenibuprofen
    0113-7660basic care childrens ibuprofenIbuprofen
    0113-7897Basic Care childrens ibuprofenIbuprofen
    0113-0788Basic Care ibuprofenIbuprofen
    0113-7131basic care ibuprofenIbuprofen
    0113-7517basic care ibuprofenIbuprofen
    0113-7604Basic Care IbuprofenIbuprofen
    0121-0917Childrens IbuprofenIbuprofen
    0121-0914Childrens Ibuprofen Oral SuspensionIbuprofen
    0113-2461Good Sense Childrens IbuprofenIbuprofen
    0113-0057Good Sense ibuprofenibuprofen
    0113-0074Good Sense ibuprofenIbuprofen
    0113-0166good sense ibuprofenIbuprofen
    0113-0298good sense ibuprofenIbuprofen
    0113-0461Good Sense ibuprofenIbuprofen
    0113-0517Good Sense ibuprofenIbuprofen
    0113-0604good sense ibuprofenIbuprofen
    0113-0647good sense ibuprofenIbuprofen
    0113-0660Good Sense IbuprofenIbuprofen
    0113-0685Good Sense IbuprofenIbuprofen
    0113-0897good sense ibuprofenIbuprofen
    0113-1212Good Sense IbuprofenIbuprofen
    0113-4501good sense ibuprofenibuprofen
    0113-0040Good Sense Infants IbuprofenIbuprofen

    Trademark Results [DOLEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DOLEX
    DOLEX
    88537319 not registered Live/Pending
    DolEx Dollar Express, Inc.
    2019-07-25
    DOLEX
    DOLEX
    88537314 not registered Live/Pending
    DolEx Dollar Express, Inc.
    2019-07-25
    DOLEX
    DOLEX
    88537304 not registered Live/Pending
    DolEx Dollar Express, Inc.
    2019-07-25
    DOLEX
    DOLEX
    85890732 4458098 Live/Registered
    DolEx Dollar Express, Inc.
    2013-03-29
    DOLEX
    DOLEX
    85889692 4458091 Live/Registered
    DolEx Dollar Express, Inc.
    2013-03-28
    DOLEX
    DOLEX
    85889615 4425630 Live/Registered
    DolEx Dollar Express, Inc.
    2013-03-28
    DOLEX
    DOLEX
    85495471 4306332 Live/Registered
    Pharmadel, LLC
    2011-12-14
    DOLEX
    DOLEX
    79201638 5283257 Live/Registered
    Power Tools Spräckutrustning i Herrljunga AB
    2016-10-25
    DOLEX
    DOLEX
    76467197 not registered Dead/Abandoned
    Endo Pharmaceuticals Inc.
    2002-11-08
    DOLEX
    DOLEX
    75749503 2338800 Live/Registered
    Dolex Dollar Express, Inc.
    1999-07-13
    DOLEX
    DOLEX
    75749501 2370880 Live/Registered
    Dolex Dollar Express, Inc.
    1999-07-13
    DOLEX
    DOLEX
    75561014 not registered Dead/Abandoned
    ALGOS PHARMACEUTICAL CORPORATION
    1998-09-29
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