itraconazole

Generic: itraconazole

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name itraconazole
Generic Name itraconazole
Labeler camber pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

itraconazole 10 mg/mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-006
Product ID 31722-006_2cd3622f-a50f-ec9c-e063-6294a90a3a30
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212239
Listing Expiration 2026-12-31
Marketing Start 2020-09-01

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 31722006
Hyphenated Format 31722-006

Supplemental Identifiers

RxCUI
348506
UPC
0331722006316
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 ANDA212239 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (31722-006-31) / 150 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

31722-006-31 1 BOTTLE, GLASS in 1 CARTON (31722-006-31) / 150 mL in 1 BOTTLE, GLASS

Ingredients (1)

itraconazole (10 mg/mL)

Linked Drug Pages (1)

Itraconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2cd3622f-a50f-ec9c-e063-6294a90a3a30", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000185503", "N0000190113"], "upc": ["0331722006316"], "unii": ["304NUG5GF4"], "rxcui": ["348506"], "spl_set_id": ["5af0b33d-bfa6-420b-86f0-067f95b402b2"], "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": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (31722-006-31)  / 150 mL in 1 BOTTLE, GLASS", "package_ndc": "31722-006-31", "marketing_start_date": "20200901"}], "brand_name": "Itraconazole", "product_id": "31722-006_2cd3622f-a50f-ec9c-e063-6294a90a3a30", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "31722-006", "generic_name": "Itraconazole", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Itraconazole", "active_ingredients": [{"name": "ITRACONAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA212239", "marketing_category": "ANDA", "marketing_start_date": "20200901", "listing_expiration_date": "20261231"}