NDC 57910-400

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Shasun Pharmaceuticals Limited. The primary component is Ibuprofen.

Product ID57910-400_87234f8f-29b7-493f-8cd3-2e69ef44825c
NDC57910-400
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2011-04-04
Marketing CategoryANDA / ANDA
Application NumberANDA091355
Labeler NameShasun Pharmaceuticals Limited
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 57910-400-06

1000 TABLET, COATED in 1 BOTTLE (57910-400-06)
Marketing Start Date2011-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57910-400-08 [57910040008]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-04
Marketing End Date2019-09-12

NDC 57910-400-09 [57910040009]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-04
Marketing End Date2019-09-12

NDC 57910-400-10 [57910040010]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-04
Marketing End Date2019-09-12

NDC 57910-400-01 [57910040001]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-04
Marketing End Date2019-09-12

NDC 57910-400-06 [57910040006]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-04
Marketing End Date2019-09-12

NDC 57910-400-03 [57910040003]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-04
Marketing End Date2019-09-12

NDC 57910-400-07 [57910040007]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-04
Marketing End Date2019-09-12

NDC 57910-400-04 [57910040004]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-04
Marketing End Date2019-09-12

NDC 57910-400-02 [57910040002]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-04
Marketing End Date2019-09-12

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:6f1b2915-2579-4416-88ac-d3dfae3fa585
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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