NDC 57344-110

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 ID57344-110_55f21d7c-3c42-4044-965a-aaadefcc4ba1
NDC57344-110
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 57344-110-01

1 BOTTLE, PLASTIC in 1 CARTON (57344-110-01) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Start Date2017-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57344-110-10 [57344011010]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-01
Marketing End Date2019-09-12

NDC 57344-110-05 [57344011005]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-01
Marketing End Date2019-09-12

NDC 57344-110-06 [57344011006]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-01
Marketing End Date2019-09-12

NDC 57344-110-02 [57344011002]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-01
Marketing End Date2015-06-30

NDC 57344-110-08 [57344011008]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-01
Marketing End Date2019-09-12

NDC 57344-110-01 [57344011001]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-01

NDC 57344-110-04 [57344011004]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-01
Marketing End Date2019-09-12

NDC 57344-110-03 [57344011003]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-01
Marketing End Date2019-10-12

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:39e55ec1-213f-4996-adca-68a5ffbc409b
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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