NDC 55700-559

DIFLUNISAL

Diflunisal

DIFLUNISAL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Diflunisal.

Product ID55700-559_63e91478-52da-400a-bc19-f9c161c94314
NDC55700-559
Product TypeHuman Prescription Drug
Proprietary NameDIFLUNISAL
Generic NameDiflunisal
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA202845
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameDIFLUNISAL
Active Ingredient Strength500 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 55700-559-60

60 TABLET, FILM COATED in 1 BOTTLE (55700-559-60)
Marketing Start Date2017-11-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-559-60 [55700055960]

DIFLUNISAL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202845
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-03
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
DIFLUNISAL500 mg/1

OpenFDA Data

SPL SET ID:d9572e38-ee9c-4ca0-83b5-f93e08ed6694
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197603
  • 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 "DIFLUNISAL" or generic name "Diflunisal"

    NDCBrand NameGeneric Name
    0093-0755DiflunisalDiflunisal
    0093-9222DiflunisalDiflunisal
    14539-673diflunisaldiflunisal
    23155-673diflunisaldiflunisal
    50090-0450DIFLUNISALDIFLUNISAL
    52959-379DIFLUNISALDIFLUNISAL
    55289-460DiflunisalDiflunisal
    55700-559DIFLUNISALDIFLUNISAL
    60760-756DiflunisalDiflunisal
    64980-181DIFLUNISALDIFLUNISAL
    68151-0848DiflunisalDiflunisal
    68382-530DiflunisalDiflunisal
    70771-1083DiflunisalDiflunisal

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