NDC 55289-460

Diflunisal

Diflunisal

Diflunisal is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Diflunisal.

Product ID55289-460_7c1fbdf5-8b1a-6114-e053-2a91aa0aa2e4
NDC55289-460
Product TypeHuman Prescription Drug
Proprietary NameDiflunisal
Generic NameDiflunisal
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1992-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA073673
Labeler NamePD-Rx Pharmaceuticals, Inc.
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 55289-460-15

15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-460-15)
Marketing Start Date2010-08-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-460-30 [55289046030]

Diflunisal TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA073673
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-08-20
Marketing End Date2019-09-12

NDC 55289-460-10 [55289046010]

Diflunisal TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA073673
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-08-20
Marketing End Date2019-09-12

NDC 55289-460-20 [55289046020]

Diflunisal TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA073673
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-08-20
Marketing End Date2019-09-12

NDC 55289-460-15 [55289046015]

Diflunisal TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA073673
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-08-20
Marketing End Date2019-09-12

Drug Details

Active Ingredients

IngredientStrength
DIFLUNISAL500 mg/1

OpenFDA Data

SPL SET ID:93bc2682-30e3-42b7-9eae-fd75234a2e6c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197603
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0355289460305
  • 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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