fluconazole

Generic: fluconazole

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler quality care products, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 150 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 55700-916
Product ID 55700-916_500be20b-3c04-4037-b4d4-e3e0ec28143c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076658
Marketing Start 2021-07-13
Marketing End 2026-03-31

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 55700916
Hyphenated Format 55700-916

Supplemental Identifiers

RxCUI
197699
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 ANDA076658 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1 TABLET in 1 DOSE PACK (55700-916-01)
source: ndc

Packages (1)

55700-916-01 1 TABLET in 1 DOSE PACK (55700-916-01)

Ingredients (1)

fluconazole (150 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": "500be20b-3c04-4037-b4d4-e3e0ec28143c", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197699"], "spl_set_id": ["b27a22b7-9ac1-45f5-9bb1-536f2792ff98"], "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": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET in 1 DOSE PACK (55700-916-01)", "package_ndc": "55700-916-01", "marketing_end_date": "20260331", "marketing_start_date": "20210713"}], "brand_name": "Fluconazole", "product_id": "55700-916_500be20b-3c04-4037-b4d4-e3e0ec28143c", "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": "55700-916", "generic_name": "Fluconazole", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "150 mg/1"}], "application_number": "ANDA076658", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20210713"}