NDC 57910-401

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 ID57910-401_ddeff1be-cd83-4536-b29b-3420e29d7812
NDC57910-401
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2011-04-28
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 57910-401-16

1 BAG in 1 BOX (57910-401-16) > 10000 TABLET, COATED in 1 BAG
Marketing Start Date2011-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57910-401-10 [57910040110]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-28
Marketing End Date2019-09-10

NDC 57910-401-14 [57910040114]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-28
Marketing End Date2019-09-10

NDC 57910-401-15 [57910040115]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-28
Marketing End Date2019-09-10

NDC 57910-401-11 [57910040111]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-28
Marketing End Date2019-09-10

NDC 57910-401-17 [57910040117]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-28
Marketing End Date2019-09-10

NDC 57910-401-16 [57910040116]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-28
Marketing End Date2019-09-10

NDC 57910-401-09 [57910040109]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-28
Marketing End Date2019-09-10

NDC 57910-401-13 [57910040113]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-28
Marketing End Date2019-09-10

NDC 57910-401-08 [57910040108]

Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-28
Marketing End Date2019-09-10

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:fe5a5bc6-9ab0-4e8c-8349-201f590a2a8a
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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