fluconazole

Generic: fluconazole

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 100 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-2415
Product ID 70518-2415_4a183b7d-3a1d-5557-e063-6294a90a5493
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208963
Listing Expiration 2027-12-31
Marketing Start 2019-11-11

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 705182415
Hyphenated Format 70518-2415

Supplemental Identifiers

RxCUI
197698
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 ANDA208963 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 16 TABLET in 1 BOTTLE, PLASTIC (70518-2415-1)
  • 8 TABLET in 1 BOTTLE, PLASTIC (70518-2415-2)
source: ndc

Packages (2)

70518-2415-1 16 TABLET in 1 BOTTLE, PLASTIC (70518-2415-1) 70518-2415-2 8 TABLET in 1 BOTTLE, PLASTIC (70518-2415-2)

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": "4a183b7d-3a1d-5557-e063-6294a90a5493", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197698"], "spl_set_id": ["b5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d"], "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": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "16 TABLET in 1 BOTTLE, PLASTIC (70518-2415-1)", "package_ndc": "70518-2415-1", "marketing_start_date": "20240823"}, {"sample": false, "description": "8 TABLET in 1 BOTTLE, PLASTIC (70518-2415-2)", "package_ndc": "70518-2415-2", "marketing_start_date": "20240823"}], "brand_name": "fluconazole", "product_id": "70518-2415_4a183b7d-3a1d-5557-e063-6294a90a5493", "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": "70518-2415", "generic_name": "fluconazole", "labeler_name": "REMEDYREPACK 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": "20191111", "listing_expiration_date": "20271231"}