fluconazole

Generic: fluconazole

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 150 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-132
Product ID 62135-132_25892746-5194-5955-e063-6294a90a3b7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076665
Listing Expiration 2026-12-31
Marketing Start 2004-07-29

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 62135132
Hyphenated Format 62135-132

Supplemental Identifiers

RxCUI
197698 197699 197700 197701
UPC
0362135133306 0362135130305 0362135132774 0362135131302
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 ANDA076665 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1 TABLET in 1 BOTTLE (62135-132-77)
source: ndc

Packages (1)

62135-132-77 1 TABLET in 1 BOTTLE (62135-132-77)

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": "25892746-5194-5955-e063-6294a90a3b7f", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "upc": ["0362135133306", "0362135130305", "0362135132774", "0362135131302"], "unii": ["8VZV102JFY"], "rxcui": ["197698", "197699", "197700", "197701"], "spl_set_id": ["f86ea347-78f5-43b8-9574-a52569a4237b"], "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": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET in 1 BOTTLE (62135-132-77)", "package_ndc": "62135-132-77", "marketing_start_date": "20221208"}], "brand_name": "FLUCONAZOLE", "product_id": "62135-132_25892746-5194-5955-e063-6294a90a3b7f", "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": "62135-132", "generic_name": "FLUCONAZOLE", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUCONAZOLE", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "150 mg/1"}], "application_number": "ANDA076665", "marketing_category": "ANDA", "marketing_start_date": "20040729", "listing_expiration_date": "20261231"}