posaconazole

Generic: posaconazole

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler eugia us llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

posaconazole 18 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-388
Product ID 55150-388_6d1e5905-71b9-480b-82ae-5c92a2374e1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214842
Listing Expiration 2026-12-31
Marketing Start 2023-12-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150388
Hyphenated Format 55150-388

Supplemental Identifiers

RxCUI
1492043
UPC
0355150388011
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 ANDA214842 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 18 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-388-01) / 16.7 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-388-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-388-01) / 16.7 mL in 1 VIAL, SINGLE-DOSE

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": "6d1e5905-71b9-480b-82ae-5c92a2374e1d", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0355150388011"], "unii": ["6TK1G07BHZ"], "rxcui": ["1492043"], "spl_set_id": ["2e88e379-b712-4dec-97a2-c90ef3638372"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-388-01)  / 16.7 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-388-01", "marketing_start_date": "20231226"}], "brand_name": "POSACONAZOLE", "product_id": "55150-388_6d1e5905-71b9-480b-82ae-5c92a2374e1d", "dosage_form": "INJECTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "55150-388", "generic_name": "POSACONAZOLE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "POSACONAZOLE", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "18 mg/mL"}], "application_number": "ANDA214842", "marketing_category": "ANDA", "marketing_start_date": "20231226", "listing_expiration_date": "20261231"}