NDC 68382-530

Diflunisal

Diflunisal

Diflunisal is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Diflunisal.

Product ID68382-530_5263ec06-c18a-41a8-9d3c-61e7326c1f9d
NDC68382-530
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 Pharmaceuticals (USA) 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 Through2020-12-31

Packaging

NDC 68382-530-01

100 TABLET in 1 BOTTLE (68382-530-01)
Marketing Start Date2017-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-530-01 [68382053001]

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

NDC 68382-530-10 [68382053010]

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

NDC 68382-530-06 [68382053006]

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

NDC 68382-530-14 [68382053014]

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

NDC 68382-530-30 [68382053030]

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

NDC 68382-530-05 [68382053005]

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

NDC 68382-530-16 [68382053016]

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:5baf9f35-6b5e-4666-a14a-ac0f9d4e9f76
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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