fluconazole

Generic: fluconazole

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 150 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4425
Product ID 50090-4425_db5ecbc8-7329-45c5-b19a-d0e79fbe1659
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208963
Listing Expiration 2027-12-31
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 500904425
Hyphenated Format 50090-4425

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 ANDA208963 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (50090-4425-0) / 1 TABLET in 1 BLISTER PACK
  • 12 BLISTER PACK in 1 CARTON (50090-4425-1) / 1 TABLET in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (50090-4425-2) / 1 TABLET in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (50090-4425-3) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

50090-4425-0 1 BLISTER PACK in 1 CARTON (50090-4425-0) / 1 TABLET in 1 BLISTER PACK 50090-4425-1 12 BLISTER PACK in 1 CARTON (50090-4425-1) / 1 TABLET in 1 BLISTER PACK 50090-4425-2 2 BLISTER PACK in 1 CARTON (50090-4425-2) / 1 TABLET in 1 BLISTER PACK 50090-4425-3 4 BLISTER PACK in 1 CARTON (50090-4425-3) / 1 TABLET in 1 BLISTER PACK

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": "db5ecbc8-7329-45c5-b19a-d0e79fbe1659", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197699"], "spl_set_id": ["1a8bd42a-2bce-4b41-8678-67033e7707dd"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50090-4425-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "50090-4425-0", "marketing_start_date": "20190719"}, {"sample": false, "description": "12 BLISTER PACK in 1 CARTON (50090-4425-1)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "50090-4425-1", "marketing_start_date": "20190719"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50090-4425-2)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "50090-4425-2", "marketing_start_date": "20190719"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (50090-4425-3)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "50090-4425-3", "marketing_start_date": "20190719"}], "brand_name": "fluconazole", "product_id": "50090-4425_db5ecbc8-7329-45c5-b19a-d0e79fbe1659", "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": "50090-4425", "generic_name": "fluconazole", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "150 mg/1"}], "application_number": "ANDA208963", "marketing_category": "ANDA", "marketing_start_date": "20170406", "listing_expiration_date": "20271231"}