NDC 57344-109

Ibuprofen

Ibuprofen

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

Product ID57344-109_60e8efbe-7e39-4698-9bdf-50b6487bf523
NDC57344-109
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2012-12-04
Marketing CategoryANDA / ANDA
Application NumberANDA079129
Labeler NameAAA Pharmaceutical, Inc.
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57344-109-02

1 BOTTLE, PLASTIC in 1 CARTON (57344-109-02) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Start Date2019-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57344-109-02 [57344010902]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-01

NDC 57344-109-01 [57344010901]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-01
Marketing End Date2019-09-12

NDC 57344-109-10 [57344010910]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-01
Marketing End Date2019-09-12

NDC 57344-109-04 [57344010904]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-01
Marketing End Date2019-09-12

NDC 57344-109-05 [57344010905]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-01

NDC 57344-109-03 [57344010903]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-01

NDC 57344-109-08 [57344010908]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-01
Marketing End Date2019-09-12

NDC 57344-109-06 [57344010906]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-01
Marketing End Date2019-09-12

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:fbc7fb61-d295-464b-9f3b-52262ed6f31a
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
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