NDC 52959-379

DIFLUNISAL

Diflunisal

DIFLUNISAL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by H. J. Harkins Company Inc.. The primary component is Diflunisal.

Product ID52959-379_60e0ecab-9d00-3b1b-e053-2a91aa0af663
NDC52959-379
Product TypeHuman Prescription Drug
Proprietary NameDIFLUNISAL
Generic NameDiflunisal
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-12-22
Marketing CategoryANDA / ANDA
Application NumberANDA073673
Labeler NameH. J. Harkins Company Inc.
Substance NameDIFLUNISAL
Active Ingredient Strength500 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52959-379-90

90 TABLET, FILM COATED in 1 CONTAINER (52959-379-90)
Marketing Start Date2017-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-379-30 [52959037930]

DIFLUNISAL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA073673
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-22
Inactivation Date2020-01-31

NDC 52959-379-15 [52959037915]

DIFLUNISAL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA073673
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-22
Inactivation Date2020-01-31

NDC 52959-379-60 [52959037960]

DIFLUNISAL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA073673
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-22
Inactivation Date2020-01-31

NDC 52959-379-90 [52959037990]

DIFLUNISAL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA073673
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-22
Inactivation Date2020-01-31

NDC 52959-379-20 [52959037920]

DIFLUNISAL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA073673
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-22
Inactivation Date2020-01-31

NDC 52959-379-14 [52959037914]

DIFLUNISAL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA073673
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-22
Inactivation Date2020-01-31

NDC 52959-379-21 [52959037921]

DIFLUNISAL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA073673
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-22
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIFLUNISAL500 mg/1

OpenFDA Data

SPL SET ID:60e0ecab-9cff-3b1b-e053-2a91aa0af663
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]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

    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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