NDC 57344-112

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 ID57344-112_19d120e6-ff7a-4e2e-bd25-e8c89c99beb7
NDC57344-112
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2012-12-04
Marketing CategoryANDA / ANDA
Application NumberANDA091355
Labeler NameAAA Pharmaceutical, Inc.
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57344-112-05

500 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-112-05)
Marketing Start Date2012-12-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57344-112-10 [57344011210]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-04
Marketing End Date2012-12-05

NDC 57344-112-04 [57344011204]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-04
Marketing End Date2012-12-05

NDC 57344-112-05 [57344011205]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-04
Marketing End Date2012-12-05

NDC 57344-112-01 [57344011201]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-04
Marketing End Date2012-12-05

NDC 57344-112-02 [57344011202]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-04
Marketing End Date2012-12-05

NDC 57344-112-03 [57344011203]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-04
Marketing End Date2012-12-05

NDC 57344-112-06 [57344011206]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-04
Marketing End Date2012-12-05

NDC 57344-112-08 [57344011208]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-04
Marketing End Date2012-12-05

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:7a47d216-be3c-44b5-9a7f-ee18e8e5b235
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.