Drugplain

posaconazole 18 mg/mL

posaconazole · INJECTION, SOLUTION · Gland Pharma Limited

2 Recalls on Record
Plain English

posaconazole is a injection, solution containing posaconazole at 18 mg/mL, taken intravenous. Manufactured by Gland Pharma Limited.

Key Facts

Brand Name
posaconazole
Generic Name
posaconazole
NDC Code (Product)
68083-577
Manufacturer
Gland Pharma Limited
Strength
18 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA217553
Drug Class
Azole Antifungal [EPC]
Marketing Start
12/26/2023

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 injection, solution taken intravenous. 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 18 mg/mL?

The NDC (National Drug Code) for posaconazole 18 mg/mL is 68083-577, listed by Gland Pharma Limited.