NDC 57910-403

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 ID57910-403_a3090bcd-9963-4f6a-9c19-37175ddbd53f
NDC57910-403
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2011-03-28
Marketing CategoryANDA / ANDA
Application NumberANDA079129
Labeler NameShasun Pharmaceuticals Limited
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 57910-403-23

1 BOTTLE in 1 CARTON (57910-403-23) > 50 TABLET, COATED in 1 BOTTLE
Marketing Start Date2011-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57910-403-29 [57910040329]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-03-28
Marketing End Date2019-09-12

NDC 57910-403-23 [57910040323]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-03-28
Marketing End Date2019-09-12

NDC 57910-403-25 [57910040325]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-03-28
Marketing End Date2019-09-12

NDC 57910-403-28 [57910040328]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-03-28
Marketing End Date2019-09-12

NDC 57910-403-30 [57910040330]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-03-28
Marketing End Date2019-09-12

NDC 57910-403-31 [57910040331]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-03-28
Marketing End Date2019-09-12

NDC 57910-403-27 [57910040327]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-03-28
Marketing End Date2019-09-12

NDC 57910-403-22 [57910040322]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-03-28
Marketing End Date2019-09-12

NDC 57910-403-24 [57910040324]

IBUPROFEN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-03-28
Marketing End Date2019-09-12

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:e347da1c-cb2b-4d87-b28e-c7c267756115
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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