posaconazole

Generic: posaconazole

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler mylan institutional llc
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

posaconazole 18 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-665
Product ID 67457-665_834e282d-211e-4896-9be0-76e83f960859
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211500
Listing Expiration 2026-12-31
Marketing Start 2024-03-22

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457665
Hyphenated Format 67457-665

Supplemental Identifiers

RxCUI
1492043
UNII
6TK1G07BHZ
NUI
N0000175487 M0002083

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 posaconazole (source: ndc)
Generic Name posaconazole (source: ndc)
Application Number ANDA211500 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 18 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (67457-665-20) / 16.7 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

67457-665-20 1 VIAL, GLASS in 1 CARTON (67457-665-20) / 16.7 mL in 1 VIAL, GLASS

Ingredients (1)

posaconazole (18 mg/mL)

Linked Drug Pages (1)

posaconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "834e282d-211e-4896-9be0-76e83f960859", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["6TK1G07BHZ"], "rxcui": ["1492043"], "spl_set_id": ["1ebbd88b-547b-4b49-ab73-98094a2d5a79"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (67457-665-20)  / 16.7 mL in 1 VIAL, GLASS", "package_ndc": "67457-665-20", "marketing_start_date": "20240322"}], "brand_name": "posaconazole", "product_id": "67457-665_834e282d-211e-4896-9be0-76e83f960859", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "67457-665", "generic_name": "posaconazole", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "posaconazole", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "18 mg/mL"}], "application_number": "ANDA211500", "marketing_category": "ANDA", "marketing_start_date": "20240322", "listing_expiration_date": "20261231"}