NDC 55312-248

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Western Family Foods, Inc.. The primary component is Ibuprofen.

Product ID55312-248_87c30ab9-aa0b-4ead-a468-6c4a0d60dd85
NDC55312-248
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2013-11-30
Marketing End Date2019-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA079174
Labeler NameWestern Family Foods, Inc.
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN

Packaging

NDC 55312-248-01

1 BOTTLE, PLASTIC in 1 BOX (55312-248-01) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Start Date2013-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55312-248-01 [55312024801]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079174
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-11-30
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:500da235-9c52-44b6-be0c-20f37bc00584
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0015400034562
    • 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.