diflucan

Generic: fluconazole

Labeler: roerig
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name diflucan
Generic Name fluconazole
Labeler roerig
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

fluconazole 1400 mg/35mL

Manufacturer
Roerig

Identifiers & Regulatory

Product NDC 0049-3450
Product ID 0049-3450_b567d13c-db7a-4302-8409-c57731fe6e37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020090
Listing Expiration 2026-12-31
Marketing Start 1993-12-23

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 2c19 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] cytochrome p450 2c9 inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00493450
Hyphenated Format 0049-3450

Supplemental Identifiers

RxCUI
197698 197699 197700 197701 201900 201901 207106 207107 207108 207112 310352 310353
UPC
0300493420300 0300493450192 0300493430309 0300493410301
UNII
8VZV102JFY
NUI
N0000175487 M0002083 N0000182140 N0000182141 N0000185504

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diflucan (source: ndc)
Generic Name fluconazole (source: ndc)
Application Number NDA020090 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1400 mg/35mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0049-3450-19) / 35 mL in 1 BOTTLE
source: ndc

Packages (1)

0049-3450-19 1 BOTTLE in 1 CARTON (0049-3450-19) / 35 mL in 1 BOTTLE

Ingredients (1)

fluconazole (1400 mg/35mL)

Linked Drug Pages (1)

Diflucan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b567d13c-db7a-4302-8409-c57731fe6e37", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "upc": ["0300493420300", "0300493450192", "0300493430309", "0300493410301"], "unii": ["8VZV102JFY"], "rxcui": ["197698", "197699", "197700", "197701", "201900", "201901", "207106", "207107", "207108", "207112", "310352", "310353"], "spl_set_id": ["f694c617-3383-416c-91b6-b94fda371204"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Roerig"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0049-3450-19)  / 35 mL in 1 BOTTLE", "package_ndc": "0049-3450-19", "marketing_start_date": "19931223"}], "brand_name": "Diflucan", "product_id": "0049-3450_b567d13c-db7a-4302-8409-c57731fe6e37", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "0049-3450", "generic_name": "fluconazole", "labeler_name": "Roerig", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diflucan", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "1400 mg/35mL"}], "application_number": "NDA020090", "marketing_category": "NDA", "marketing_start_date": "19931223", "listing_expiration_date": "20261231"}