itraconazole

Generic: itraconazole

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name itraconazole
Generic Name itraconazole
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

itraconazole 100 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-204
Product ID 46708-204_13a86518-48bc-421b-ad49-c253bd65b488
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206741
Listing Expiration 2026-12-31
Marketing Start 2016-12-16

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 46708204
Hyphenated Format 46708-204

Supplemental Identifiers

RxCUI
311204
UPC
0346708204303
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 ANDA206741 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 CARTON (46708-204-04)
  • 100 CAPSULE in 1 CARTON (46708-204-10)
  • 30 CAPSULE in 1 BOTTLE (46708-204-30)
  • 500 CAPSULE in 1 BOTTLE (46708-204-71)
  • 90 CAPSULE in 1 BOTTLE (46708-204-90)
source: ndc

Packages (5)

46708-204-04 28 CAPSULE in 1 CARTON (46708-204-04) 46708-204-10 100 CAPSULE in 1 CARTON (46708-204-10) 46708-204-30 30 CAPSULE in 1 BOTTLE (46708-204-30) 46708-204-71 500 CAPSULE in 1 BOTTLE (46708-204-71) 46708-204-90 90 CAPSULE in 1 BOTTLE (46708-204-90)

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": "13a86518-48bc-421b-ad49-c253bd65b488", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000185503", "N0000190113"], "upc": ["0346708204303"], "unii": ["304NUG5GF4"], "rxcui": ["311204"], "spl_set_id": ["f9d8b5a7-435f-40e6-8596-5f2376b92c74"], "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": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 CARTON (46708-204-04)", "package_ndc": "46708-204-04", "marketing_start_date": "20161216"}, {"sample": false, "description": "100 CAPSULE in 1 CARTON (46708-204-10)", "package_ndc": "46708-204-10", "marketing_start_date": "20161216"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (46708-204-30)", "package_ndc": "46708-204-30", "marketing_start_date": "20161216"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (46708-204-71)", "package_ndc": "46708-204-71", "marketing_start_date": "20161216"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (46708-204-90)", "package_ndc": "46708-204-90", "marketing_start_date": "20161216"}], "brand_name": "ITRACONAZOLE", "product_id": "46708-204_13a86518-48bc-421b-ad49-c253bd65b488", "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": "46708-204", "generic_name": "itraconazole", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ITRACONAZOLE", "active_ingredients": [{"name": "ITRACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA206741", "marketing_category": "ANDA", "marketing_start_date": "20161216", "listing_expiration_date": "20261231"}