fluconazole

Generic: fluconazole

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler dr. reddy's laboratories limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 200 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-146
Product ID 55111-146_69e67aa4-a859-7ab0-79df-d9bf8489998d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076658
Listing Expiration 2026-12-31
Marketing Start 2014-06-20

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 55111146
Hyphenated Format 55111-146

Supplemental Identifiers

RxCUI
197698 197699 197700 197701
UPC
0355111145127
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 fluconazole (source: ndc)
Generic Name fluconazole (source: ndc)
Application Number ANDA076658 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (55111-146-01)
  • 500 TABLET in 1 BOTTLE (55111-146-05)
  • 30 TABLET in 1 BOTTLE (55111-146-30)
  • 10 DOSE PACK in 1 CARTON (55111-146-78) / 10 TABLET in 1 DOSE PACK (55111-146-79)
source: ndc

Packages (4)

55111-146-01 100 TABLET in 1 BOTTLE (55111-146-01) 55111-146-05 500 TABLET in 1 BOTTLE (55111-146-05) 55111-146-30 30 TABLET in 1 BOTTLE (55111-146-30) 55111-146-78 10 DOSE PACK in 1 CARTON (55111-146-78) / 10 TABLET in 1 DOSE PACK (55111-146-79)

Ingredients (1)

fluconazole (200 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": "69e67aa4-a859-7ab0-79df-d9bf8489998d", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "upc": ["0355111145127"], "unii": ["8VZV102JFY"], "rxcui": ["197698", "197699", "197700", "197701"], "spl_set_id": ["d7fa1d79-4cd3-4a55-b74b-b31e82e616a3"], "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": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (55111-146-01)", "package_ndc": "55111-146-01", "marketing_start_date": "20140620"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (55111-146-05)", "package_ndc": "55111-146-05", "marketing_start_date": "20140620"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (55111-146-30)", "package_ndc": "55111-146-30", "marketing_start_date": "20140620"}, {"sample": false, "description": "10 DOSE PACK in 1 CARTON (55111-146-78)  / 10 TABLET in 1 DOSE PACK (55111-146-79)", "package_ndc": "55111-146-78", "marketing_start_date": "20140620"}], "brand_name": "Fluconazole", "product_id": "55111-146_69e67aa4-a859-7ab0-79df-d9bf8489998d", "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": "55111-146", "generic_name": "Fluconazole", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA076658", "marketing_category": "ANDA", "marketing_start_date": "20140620", "listing_expiration_date": "20261231"}