tolsura

Generic: itraconazole

Labeler: mayne pharma commercial llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolsura
Generic Name itraconazole
Labeler mayne pharma commercial llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

itraconazole 65 mg/1

Manufacturer
Mayne Pharma Commercial LLC

Identifiers & Regulatory

Product NDC 51862-462
Product ID 51862-462_2a3303f1-eee7-4c07-9532-e153be149369
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208901
Listing Expiration 2026-12-31
Marketing Start 2018-12-11

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 51862462
Hyphenated Format 51862-462

Supplemental Identifiers

RxCUI
2106642 2106648
UPC
0351862462605
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 tolsura (source: ndc)
Generic Name itraconazole (source: ndc)
Application Number NDA208901 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 65 mg/1
source: ndc
Packaging
  • 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60)
source: ndc

Packages (1)

51862-462-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60)

Ingredients (1)

itraconazole (65 mg/1)

Linked Drug Pages (1)

Tolsura ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a3303f1-eee7-4c07-9532-e153be149369", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000185503", "N0000190113"], "upc": ["0351862462605"], "unii": ["304NUG5GF4"], "rxcui": ["2106642", "2106648"], "spl_set_id": ["306352d1-9d5a-49ad-b72d-893b99546861"], "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": ["Mayne Pharma Commercial LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60)", "package_ndc": "51862-462-60", "marketing_start_date": "20181211"}], "brand_name": "Tolsura", "product_id": "51862-462_2a3303f1-eee7-4c07-9532-e153be149369", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "51862-462", "generic_name": "Itraconazole", "labeler_name": "Mayne Pharma Commercial LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolsura", "active_ingredients": [{"name": "ITRACONAZOLE", "strength": "65 mg/1"}], "application_number": "NDA208901", "marketing_category": "NDA", "marketing_start_date": "20181211", "listing_expiration_date": "20261231"}