itraconazole

Generic: itraconazole

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name itraconazole
Generic Name itraconazole
Labeler amneal pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

itraconazole 10 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-087
Product ID 65162-087_fabca3d3-1b0c-48a3-bd56-5e5a11b1fb3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205573
Listing Expiration 2026-12-31
Marketing Start 2014-04-30

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa] breast cancer resistance protein inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162087
Hyphenated Format 65162-087

Supplemental Identifiers

RxCUI
348506
UPC
0365162087741
UNII
304NUG5GF4
NUI
N0000175487 M0002083 N0000182141 N0000185503 N0000190113

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 itraconazole (source: ndc)
Generic Name itraconazole (source: ndc)
Application Number ANDA205573 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34) / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13)
  • 150 mL in 1 BOTTLE, GLASS (65162-087-74)
source: ndc

Packages (2)

65162-087-34 10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34) / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13) 65162-087-74 150 mL in 1 BOTTLE, GLASS (65162-087-74)

Ingredients (1)

itraconazole (10 mg/mL)

Linked Drug Pages (1)

Itraconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fabca3d3-1b0c-48a3-bd56-5e5a11b1fb3b", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000185503", "N0000190113"], "upc": ["0365162087741"], "unii": ["304NUG5GF4"], "rxcui": ["348506"], "spl_set_id": ["43ded1aa-f825-40fe-aa9a-addd36a07f06"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34)  / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13)", "package_ndc": "65162-087-34", "marketing_start_date": "20140430"}, {"sample": false, "description": "150 mL in 1 BOTTLE, GLASS (65162-087-74)", "package_ndc": "65162-087-74", "marketing_start_date": "20140430"}], "brand_name": "Itraconazole", "product_id": "65162-087_fabca3d3-1b0c-48a3-bd56-5e5a11b1fb3b", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "65162-087", "generic_name": "Itraconazole", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Itraconazole", "active_ingredients": [{"name": "ITRACONAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA205573", "marketing_category": "ANDA", "marketing_start_date": "20140430", "listing_expiration_date": "20261231"}