itraconazole

Generic: itraconazole

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name itraconazole
Generic Name itraconazole
Labeler ascend laboratories, llc
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

itraconazole 100 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-454
Product ID 67877-454_17ebcbb4-d52b-44b8-a4ef-42ddae5034db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208591
Listing Expiration 2026-12-31
Marketing Start 2017-06-12

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 67877454
Hyphenated Format 67877-454

Supplemental Identifiers

RxCUI
311204
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 ANDA208591 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-05)
  • 30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-30)
  • 3 BLISTER PACK in 1 CARTON (67877-454-84) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (67877-454-33)
  • 90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-90)
source: ndc

Packages (4)

67877-454-05 500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-05) 67877-454-30 30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-30) 67877-454-84 3 BLISTER PACK in 1 CARTON (67877-454-84) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (67877-454-33) 67877-454-90 90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-90)

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": "17ebcbb4-d52b-44b8-a4ef-42ddae5034db", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000185503", "N0000190113"], "unii": ["304NUG5GF4"], "rxcui": ["311204"], "spl_set_id": ["349ffcf4-b2cd-4c93-9411-13c39275b8f3"], "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": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-05)", "package_ndc": "67877-454-05", "marketing_start_date": "20171206"}, {"sample": false, "description": "30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-30)", "package_ndc": "67877-454-30", "marketing_start_date": "20171206"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (67877-454-84)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (67877-454-33)", "package_ndc": "67877-454-84", "marketing_start_date": "20171206"}, {"sample": false, "description": "90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-90)", "package_ndc": "67877-454-90", "marketing_start_date": "20171206"}], "brand_name": "Itraconazole", "product_id": "67877-454_17ebcbb4-d52b-44b8-a4ef-42ddae5034db", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "67877-454", "generic_name": "Itraconazole", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Itraconazole", "active_ingredients": [{"name": "ITRACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA208591", "marketing_category": "ANDA", "marketing_start_date": "20170612", "listing_expiration_date": "20261231"}