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NDC 68083-0577-01 posaconazole 18 mg/mL Details

posaconazole 18 mg/mL

posaconazole is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Gland Pharma Limited. The primary component is POSACONAZOLE.

MedlinePlus Drug Summary

Posaconazole injection is used to prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection. Posaconazole injection is also used to treat invasive aspergillosis (a serious fungal infection that begins in the lungs and spreads through the bloodstream to other organs) in adults and teenagers 13 years of age and older. Posaconazole injection is in a class of medications called azole antifungals. It works by slowing the growth of fungi that cause infection.

Related Packages: 68083-0577-01
Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Posaconazole Injection

Product Information

NDC	68083-0577
Product ID	68083-577_82592eeb-2109-4990-8d99-001f07e1c6cb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	posaconazole
Proprietary Name Suffix	n/a
Non-Proprietary Name	posaconazole
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	INJECTION, SOLUTION
Route	INTRAVENOUS
Active Ingredient Strength	18
Active Ingredient Units	mg/mL
Substance Name	POSACONAZOLE
Labeler Name	Gland Pharma Limited
Pharmaceutical Class	Azole Antifungal [EPC], Azoles [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA217553
Listing Certified Through	2024-12-31

Package

NDC 68083-0577-01 (68083057701)

Pricing Information	N/A
NDC Package Code	68083-577-01
Billing NDC	68083057701
Package	1 VIAL in 1 CARTON (68083-577-01) / 16.7 mL in 1 VIAL
Marketing Start Date	2023-12-26
NDC Exclude Flag	N