itraconazole

Generic: itraconazole

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

Drug Facts

Product Profile

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

itraconazole 100 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-463
Product ID 13668-463_190020d3-1073-4c51-a948-ed1e371b72ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209460
Listing Expiration 2026-12-31
Marketing Start 2018-08-24

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 13668463
Hyphenated Format 13668-463

Supplemental Identifiers

RxCUI
311204
UPC
0313668463309
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 ANDA209460 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (13668-463-05)
  • 30 CAPSULE in 1 BOTTLE (13668-463-30)
  • 28 CAPSULE in 1 CARTON (13668-463-37)
  • 90 CAPSULE in 1 BOTTLE (13668-463-90)
source: ndc

Packages (4)

13668-463-05 500 CAPSULE in 1 BOTTLE (13668-463-05) 13668-463-30 30 CAPSULE in 1 BOTTLE (13668-463-30) 13668-463-37 28 CAPSULE in 1 CARTON (13668-463-37) 13668-463-90 90 CAPSULE in 1 BOTTLE (13668-463-90)

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": "190020d3-1073-4c51-a948-ed1e371b72ea", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000185503", "N0000190113"], "upc": ["0313668463309"], "unii": ["304NUG5GF4"], "rxcui": ["311204"], "spl_set_id": ["b1274d78-1096-4ae3-8299-a2e94eaa0ea5"], "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": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (13668-463-05)", "package_ndc": "13668-463-05", "marketing_start_date": "20180824"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (13668-463-30)", "package_ndc": "13668-463-30", "marketing_start_date": "20180824"}, {"sample": false, "description": "28 CAPSULE in 1 CARTON (13668-463-37)", "package_ndc": "13668-463-37", "marketing_start_date": "20180824"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (13668-463-90)", "package_ndc": "13668-463-90", "marketing_start_date": "20180824"}], "brand_name": "Itraconazole", "product_id": "13668-463_190020d3-1073-4c51-a948-ed1e371b72ea", "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": "13668-463", "generic_name": "Itraconazole", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Itraconazole", "active_ingredients": [{"name": "ITRACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA209460", "marketing_category": "ANDA", "marketing_start_date": "20180824", "listing_expiration_date": "20261231"}