NDC 57910-100

Ibuprofen Immediate release

Ibuprofen

Ibuprofen Immediate release is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Shasun Pharmaceuticals Limited. The primary component is Ibuprofen.

Product ID57910-100_46faf860-1949-4729-a4d7-3248e9012013
NDC57910-100
Product TypeHuman Prescription Drug
Proprietary NameIbuprofen Immediate release
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-02-05
Marketing CategoryANDA / ANDA
Application NumberANDA078329
Labeler NameShasun Pharmaceuticals Limited
Substance NameIBUPROFEN
Active Ingredient Strength800 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57910-100-25

2500 TABLET in 1 BAG (57910-100-25)
Marketing Start Date2009-02-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57910-100-01 [57910010001]

Ibuprofen Immediate release TABLET
Marketing CategoryANDA
Application NumberANDA078329
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-02-05
Marketing End Date2019-09-10

NDC 57910-100-05 [57910010005]

Ibuprofen Immediate release TABLET
Marketing CategoryANDA
Application NumberANDA078329
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-02-05
Marketing End Date2019-09-10

NDC 57910-100-25 [57910010025]

Ibuprofen Immediate release TABLET
Marketing CategoryANDA
Application NumberANDA078329
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-02-05
Marketing End Date2019-09-10

NDC 57910-100-11 [57910010011]

Ibuprofen Immediate release TABLET
Marketing CategoryANDA
Application NumberANDA078329
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-02-05
Marketing End Date2019-09-10

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN800 mg/1

OpenFDA Data

SPL SET ID:751887d9-71da-4226-8ae1-d7ca59259cbe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197805
  • 197807
  • 197806
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "Ibuprofen Immediate release" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    53943-401IBUPROFEN IMMEDIATE RELEASEIBUPROFEN IMMEDIATE RELEASE
    53943-403IBUPROFEN IMMEDIATE RELEASEIBUPROFEN IMMEDIATE RELEASE
    57910-200Ibuprofen Immediate releaseIbuprofen Immediate release
    57910-100Ibuprofen Immediate releaseIbuprofen Immediate release
    57910-300Ibuprofen Immediate releaseIbuprofen Immediate release
    59556-811IBUPROFEN IMMEDIATE RELEASEIBUPROFEN IMMEDIATE RELEASE
    59556-855Ibuprofen Immediate ReleaseIbuprofen Immediate Release
    59556-856Ibuprofen Immediate ReleaseIbuprofen Immediate Release
    59556-805IBUPROFEN IMMEDIATE RELEASEIBUPROFEN IMMEDIATE RELEASE
    59556-806IBUPROFEN IMMEDIATE RELEASEIBUPROFEN IMMEDIATE RELEASE
    59556-812IBUPROFEN IMMEDIATE RELEASEIBUPROFEN IMMEDIATE RELEASE
    0113-1461basic care childrens ibuprofenIbuprofen
    0113-7619basic care childrens ibuprofenibuprofen
    0113-7660basic care childrens ibuprofenIbuprofen
    0113-7897Basic Care childrens ibuprofenIbuprofen
    0113-0788Basic Care ibuprofenIbuprofen
    0113-7131basic care ibuprofenIbuprofen
    0113-7517basic care ibuprofenIbuprofen
    0113-7604Basic Care IbuprofenIbuprofen
    0121-0917Childrens IbuprofenIbuprofen
    0121-0914Childrens Ibuprofen Oral SuspensionIbuprofen
    0113-2461Good Sense Childrens IbuprofenIbuprofen
    0113-0057Good Sense ibuprofenibuprofen
    0113-0074Good Sense ibuprofenIbuprofen
    0113-0166good sense ibuprofenIbuprofen
    0113-0298good sense ibuprofenIbuprofen
    0113-0461Good Sense ibuprofenIbuprofen
    0113-0517Good Sense ibuprofenIbuprofen
    0113-0604good sense ibuprofenIbuprofen
    0113-0647good sense ibuprofenIbuprofen
    0113-0660Good Sense IbuprofenIbuprofen
    0113-0685Good Sense IbuprofenIbuprofen
    0113-0897good sense ibuprofenIbuprofen
    0113-1212Good Sense IbuprofenIbuprofen
    0113-4501good sense ibuprofenibuprofen
    0113-0040Good Sense Infants IbuprofenIbuprofen
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