Drugplain

posaconazole 40 mg/mL

posaconazole · SUSPENSION · Hikma Pharmaceuticals USA Inc.

2 Recalls on Record
Plain English

posaconazole is a suspension containing posaconazole at 40 mg/mL, taken oral. Manufactured by Hikma Pharmaceuticals USA Inc..

Key Facts

Brand Name
posaconazole
Generic Name
posaconazole
NDC Code (Product)
0054-0449
Manufacturer
Hikma Pharmaceuticals USA Inc.
Strength
40 mg/mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
ANDA208773
Drug Class
Azole Antifungal [EPC]
Marketing Start
03/29/2023

Recall History

2 Recalls on Record
Class II01/31/2023

BIOCON PHARMA INC

Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.

TerminatedVoluntary: Firm initiated
Class II12/12/2025

Merck Sharp & Dohme LLC

Presence of particulate matter: potential presence of metal particulates in the product.

OngoingVoluntary: Firm initiated

Frequently Asked Questions

What is posaconazole used for?

posaconazole contains posaconazole. It is a suspension taken oral. Consult your doctor for specific uses.

Is posaconazole a controlled substance?

posaconazole is not classified as a controlled substance by the DEA.

What is the generic name for posaconazole?

The generic name for posaconazole is posaconazole. There are 11 other brand versions of posaconazole.

What is the NDC code for posaconazole 40 mg/mL?

The NDC (National Drug Code) for posaconazole 40 mg/mL is 0054-0449, listed by Hikma Pharmaceuticals USA Inc..