NDC 55629-095

IBUPROFEN

Ibuprofen

IBUPROFEN is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by One2zee Limited Liability Company. The primary component is Ibuprofen.

Product ID55629-095_45eb41cb-b00b-4da9-8862-2f032b6403c7
NDC55629-095
Product TypeHuman Otc Drug
Proprietary NameIBUPROFEN
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-04-02
Marketing CategoryANDA / ANDA
Application NumberANDA079129
Labeler NameOne2Zee Limited Liability Company
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55629-095-01

1 BAG in 1 BOX (55629-095-01) > 30000 TABLET in 1 BAG
Marketing Start Date2019-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55629-095-01 [55629009501]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-04-02
Marketing End Date2019-09-11

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:aafdafad-2587-4d62-9705-c68beab87ba6
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 "IBUPROFEN" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    67877-120ibuprofenibuprofen
    67877-119ibuprofenibuprofen
    67877-295ibuprofenibuprofen
    67877-121ibuprofenibuprofen
    67877-294ibuprofenibuprofen
    67877-296ibuprofenibuprofen
    67877-321IbuprofenIbuprofen
    67877-319IbuprofenIbuprofen
    67877-320IbuprofenIbuprofen
    68016-116IbuprofenIbuprofen
    68016-633IbuprofenIbuprofen
    68016-626IbuprofenIbuprofen
    68016-634IbuprofenIbuprofen
    68016-645IbuprofenIbuprofen
    68016-295IbuprofenIbuprofen
    68016-635IbuprofenIbuprofen
    68071-3074IbuprofenIbuprofen
    68071-3362IBUPROFENIBUPROFEN
    68071-4129IbuprofenIbuprofen
    68071-4009IBUPROFENIBUPROFEN
    68071-3388IbuprofenIbuprofen
    68071-4253IbuprofenIbuprofen
    68071-4306IbuprofenIbuprofen
    68071-4357IbuprofenIbuprofen
    68071-4563IbuprofenIbuprofen
    68071-4280IbuprofenIbuprofen
    68071-4243IBUPROFENIBUPROFEN
    68071-4820IbuprofenIbuprofen
    68071-4305IbuprofenIbuprofen
    68071-4459IBUPROFENIBUPROFEN
    68084-703IbuprofenIbuprofen
    68084-658IbuprofenIbuprofen
    68084-772IbuprofenIbuprofen
    68196-980IbuprofenIbuprofen
    68196-981IbuprofenIbuprofen
    68210-0200IBUPROFENIBUPROFEN
    68196-199IbuprofenIbuprofen
    68210-0009IBUPROFENIBUPROFEN
    68196-745IbuprofenIbuprofen
    68387-208IbuprofenIbuprofen
    0472-2002IbuprofenIbuprofen
    68387-210IbuprofenIbuprofen
    68391-121IbuprofenIbuprofen
    68391-199IbuprofenIbuprofen
    0472-1270IbuprofenIbuprofen
    68645-531IbuprofenIbuprofen
    68645-563IbuprofenIbuprofen
    68645-562IbuprofenIbuprofen
    68645-561IbuprofenIbuprofen
    0113-1461basic care childrens ibuprofenIbuprofen

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