fluconazole

Generic: fluconazole

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 100 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-645
Product ID 43063-645_4139d4e5-b633-82bb-e063-6394a90adf79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077731
Listing Expiration 2026-12-31
Marketing Start 2008-10-07

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 43063645
Hyphenated Format 43063-645

Supplemental Identifiers

RxCUI
197698
UPC
0343063645109
UNII
8VZV102JFY
NUI
N0000175487 M0002083 N0000182140 N0000182141 N0000185504

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 fluconazole (source: ndc)
Generic Name fluconazole (source: ndc)
Application Number ANDA077731 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE, PLASTIC (43063-645-10)
source: ndc

Packages (1)

43063-645-10 10 TABLET in 1 BOTTLE, PLASTIC (43063-645-10)

Ingredients (1)

fluconazole (100 mg/1)

Linked Drug Pages (1)

Fluconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4139d4e5-b633-82bb-e063-6394a90adf79", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "upc": ["0343063645109"], "unii": ["8VZV102JFY"], "rxcui": ["197698"], "spl_set_id": ["28d53f27-a0cd-4d8d-e054-00144ff8d46c"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (43063-645-10)", "package_ndc": "43063-645-10", "marketing_start_date": "20160108"}], "brand_name": "Fluconazole", "product_id": "43063-645_4139d4e5-b633-82bb-e063-6394a90adf79", "dosage_form": "TABLET", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "43063-645", "generic_name": "Fluconazole", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA077731", "marketing_category": "ANDA", "marketing_start_date": "20081007", "listing_expiration_date": "20261231"}