itraconazole

Generic: itraconazole

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name itraconazole
Generic Name itraconazole
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

itraconazole 100 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-450
Product ID 50268-450_4823fc2f-1a82-9e54-e063-6294a90abb18
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205080
Listing Expiration 2027-12-31
Marketing Start 2018-03-23

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 50268450
Hyphenated Format 50268-450

Supplemental Identifiers

RxCUI
311204
UNII
304NUG5GF4
NUI
N0000175487 M0002083 N0000182141 N0000185503 N0000190113

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 ANDA205080 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-450-12) / 1 CAPSULE in 1 BLISTER PACK (50268-450-11)
source: ndc

Packages (1)

50268-450-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-450-12) / 1 CAPSULE in 1 BLISTER PACK (50268-450-11)

Ingredients (1)

itraconazole (100 mg/1)

Linked Drug Pages (1)

Itraconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4823fc2f-1a82-9e54-e063-6294a90abb18", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000185503", "N0000190113"], "unii": ["304NUG5GF4"], "rxcui": ["311204"], "spl_set_id": ["68165d90-953c-e2f5-e053-2a91aa0ada25"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-450-12)  / 1 CAPSULE in 1 BLISTER PACK (50268-450-11)", "package_ndc": "50268-450-12", "marketing_start_date": "20180323"}], "brand_name": "Itraconazole", "product_id": "50268-450_4823fc2f-1a82-9e54-e063-6294a90abb18", "dosage_form": "CAPSULE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "50268-450", "generic_name": "Itraconazole", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Itraconazole", "active_ingredients": [{"name": "ITRACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA205080", "marketing_category": "ANDA", "marketing_start_date": "20180323", "listing_expiration_date": "20271231"}