fluconazole

Generic: fluconazole

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 100 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1138
Product ID 70710-1138_e8f911c2-10c7-4e95-a696-cf5a29b912d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208963
Listing Expiration 2026-12-31
Marketing Start 2017-04-06

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 707101138
Hyphenated Format 70710-1138

Supplemental Identifiers

RxCUI
197698 197699 197700 197701
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 ANDA208963 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70710-1138-1)
  • 30 TABLET in 1 BOTTLE (70710-1138-3)
  • 10 BLISTER PACK in 1 CARTON (70710-1138-4) / 10 TABLET in 1 BLISTER PACK
  • 500 TABLET in 1 BOTTLE (70710-1138-5)
source: ndc

Packages (4)

70710-1138-1 100 TABLET in 1 BOTTLE (70710-1138-1) 70710-1138-3 30 TABLET in 1 BOTTLE (70710-1138-3) 70710-1138-4 10 BLISTER PACK in 1 CARTON (70710-1138-4) / 10 TABLET in 1 BLISTER PACK 70710-1138-5 500 TABLET in 1 BOTTLE (70710-1138-5)

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": "e8f911c2-10c7-4e95-a696-cf5a29b912d6", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197698", "197699", "197700", "197701"], "spl_set_id": ["d1364455-1537-46d4-b093-38cca3be778f"], "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": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70710-1138-1)", "package_ndc": "70710-1138-1", "marketing_start_date": "20170406"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70710-1138-3)", "package_ndc": "70710-1138-3", "marketing_start_date": "20170406"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70710-1138-4)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70710-1138-4", "marketing_start_date": "20170406"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70710-1138-5)", "package_ndc": "70710-1138-5", "marketing_start_date": "20170406"}], "brand_name": "fluconazole", "product_id": "70710-1138_e8f911c2-10c7-4e95-a696-cf5a29b912d6", "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": "70710-1138", "generic_name": "fluconazole", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA208963", "marketing_category": "ANDA", "marketing_start_date": "20170406", "listing_expiration_date": "20261231"}