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 ID: 0049-3440_50a8f024-8f49-41de-8f50-d40dd422b8f7
• NDC: 0049-3440
• Product Type: Human Prescription Drug
• Proprietary Name: Diflucan
• Generic Name: Fluconazole
• Dosage Form: Powder, For Suspension
• Route of Administration: ORAL
• Marketing Start Date: 1993-12-23
• Marketing Category: NDA / NDA
• Application Number: NDA020090
• Labeler Name: Roerig
• Substance Name: FLUCONAZOLE
• Active Ingredient Strength: 350 mg/35mL
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0049-3440-19

1 BOTTLE in 1 CARTON (0049-3440-19) > 35 mL in 1 BOTTLE

• Marketing Start Date: 1993-12-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0049-3440-19 [00049344019]

Diflucan POWDER, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA020090
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1993-12-23

Drug Details

Active Ingredients

Ingredient	Strength
FLUCONAZOLE	350 mg/35mL

OpenFDA Data

• SPL SET ID: f694c617-3383-416c-91b6-b94fda371204
• Manufacturer:
  • Roerig
• UNII:
  • 8VZV102JFY
• 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"

NDC	Brand Name	Generic Name
0049-3410	Diflucan	fluconazole
0049-3420	Diflucan	fluconazole
0049-3430	Diflucan	fluconazole
0049-3440	Diflucan	fluconazole
0049-3450	Diflucan	fluconazole
0049-3500	Diflucan	fluconazole
55289-148	Diflucan	Diflucan