NDC 0049-3440

Diflucan

Fluconazole

Diflucan is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Roerig. The primary component is Fluconazole.

Product ID0049-3440_50a8f024-8f49-41de-8f50-d40dd422b8f7
NDC0049-3440
Product TypeHuman Prescription Drug
Proprietary NameDiflucan
Generic NameFluconazole
Dosage FormPowder, For Suspension
Route of AdministrationORAL
Marketing Start Date1993-12-23
Marketing CategoryNDA / NDA
Application NumberNDA020090
Labeler NameRoerig
Substance NameFLUCONAZOLE
Active Ingredient Strength350 mg/35mL
Pharm ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0049-3440-19

1 BOTTLE in 1 CARTON (0049-3440-19) > 35 mL in 1 BOTTLE
Marketing Start Date1993-12-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0049-3440-19 [00049344019]

Diflucan POWDER, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA020090
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1993-12-23

Drug Details

Active Ingredients

IngredientStrength
FLUCONAZOLE350 mg/35mL

OpenFDA Data

SPL SET ID:f694c617-3383-416c-91b6-b94fda371204
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 207108
  • 197698
  • 197699
  • 310352
  • 310353
  • 197700
  • 197701
  • 207106
  • 207107
  • 207112
  • 201900
  • 201901
  • UPC Code
  • 0300493420300
  • 0300493410301
  • 0300493440193
  • 0300493430309
  • 0300493450192
  • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]
    • Cytochrome P450 2C19 Inhibitors [MoA]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 2C9 Inhibitors [MoA]

    NDC Crossover Matching brand name "Diflucan" or generic name "Fluconazole"

    NDCBrand NameGeneric Name
    0049-3410Diflucanfluconazole
    0049-3420Diflucanfluconazole
    0049-3430Diflucanfluconazole
    0049-3440Diflucanfluconazole
    0049-3450Diflucanfluconazole
    0049-3500Diflucanfluconazole
    55289-148DiflucanDiflucan

    Trademark Results [Diflucan]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DIFLUCAN
    DIFLUCAN
    73709115 1504567 Live/Registered
    PFIZER INC.
    1988-02-02

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