NDC 70771-1083

Diflunisal

Diflunisal

Diflunisal is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Diflunisal.

Product ID70771-1083_70a93a13-8b9b-4d48-a79d-dd1d348ac8b6
NDC70771-1083
Product TypeHuman Prescription Drug
Proprietary NameDiflunisal
Generic NameDiflunisal
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-09-14
Marketing CategoryANDA / ANDA
Application NumberANDA203547
Labeler NameZydus Lifesciences Limited
Substance NameDIFLUNISAL
Active Ingredient Strength500 mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70771-1083-0

1000 TABLET in 1 BOTTLE (70771-1083-0)
Marketing Start Date2017-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1083-1 [70771108301]

Diflunisal TABLET
Marketing CategoryANDA
Application NumberANDA203547
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-14

NDC 70771-1083-0 [70771108300]

Diflunisal TABLET
Marketing CategoryANDA
Application NumberANDA203547
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-14

NDC 70771-1083-9 [70771108309]

Diflunisal TABLET
Marketing CategoryANDA
Application NumberANDA203547
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-14

NDC 70771-1083-3 [70771108303]

Diflunisal TABLET
Marketing CategoryANDA
Application NumberANDA203547
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-14

NDC 70771-1083-6 [70771108306]

Diflunisal TABLET
Marketing CategoryANDA
Application NumberANDA203547
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-14

NDC 70771-1083-8 [70771108308]

Diflunisal TABLET
Marketing CategoryANDA
Application NumberANDA203547
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-14

NDC 70771-1083-5 [70771108305]

Diflunisal TABLET
Marketing CategoryANDA
Application NumberANDA203547
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-14

Drug Details

Active Ingredients

IngredientStrength
DIFLUNISAL500 mg/1

OpenFDA Data

SPL SET ID:d7a722be-4612-4b2e-827d-56fb5eef0aae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197603
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0370771108312
  • 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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