itraconazole oral

Generic: itraconazole

Labeler: natco pharma usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name itraconazole oral
Generic Name itraconazole
Labeler natco pharma usa llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

itraconazole 10 mg/mL

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-159
Product ID 69339-159_2af07b39-fe93-4961-90cb-ed9c5e2f424d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212239
Listing Expiration 2026-12-31
Marketing Start 2022-04-25

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 69339159
Hyphenated Format 69339-159

Supplemental Identifiers

RxCUI
348506
UPC
0369339159019
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 oral (source: ndc)
Generic Name itraconazole (source: ndc)
Application Number ANDA212239 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-159-17) / 10 mL in 1 CUP, UNIT-DOSE (69339-159-01)
source: ndc

Packages (1)

69339-159-17 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-159-17) / 10 mL in 1 CUP, UNIT-DOSE (69339-159-01)

Ingredients (1)

itraconazole (10 mg/mL)

Linked Drug Pages (1)

Itraconazole Oral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2af07b39-fe93-4961-90cb-ed9c5e2f424d", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000185503", "N0000190113"], "upc": ["0369339159019"], "unii": ["304NUG5GF4"], "rxcui": ["348506"], "spl_set_id": ["da63870d-b426-4e49-9591-5bb51f962e66"], "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": ["Natco Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-159-17)  / 10 mL in 1 CUP, UNIT-DOSE (69339-159-01)", "package_ndc": "69339-159-17", "marketing_start_date": "20220425"}], "brand_name": "Itraconazole Oral", "product_id": "69339-159_2af07b39-fe93-4961-90cb-ed9c5e2f424d", "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": "69339-159", "generic_name": "Itraconazole", "labeler_name": "Natco Pharma USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Itraconazole Oral", "active_ingredients": [{"name": "ITRACONAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA212239", "marketing_category": "ANDA", "marketing_start_date": "20220425", "listing_expiration_date": "20261231"}