posaconazole

Generic: posaconazole

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

posaconazole 18 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-577
Product ID 68083-577_dea5abae-8195-49f7-89bb-2e624208abf0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217553
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 68083577
Hyphenated Format 68083-577

Supplemental Identifiers

RxCUI
1492043
UPC
0368083577018
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 ANDA217553 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 18 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-577-01) / 16.7 mL in 1 VIAL
source: ndc

Packages (1)

68083-577-01 1 VIAL in 1 CARTON (68083-577-01) / 16.7 mL in 1 VIAL

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": "dea5abae-8195-49f7-89bb-2e624208abf0", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0368083577018"], "unii": ["6TK1G07BHZ"], "rxcui": ["1492043"], "spl_set_id": ["52d9d29e-4a37-4926-aa57-8477f5447b34"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-577-01)  / 16.7 mL in 1 VIAL", "package_ndc": "68083-577-01", "marketing_start_date": "20231226"}], "brand_name": "posaconazole", "product_id": "68083-577_dea5abae-8195-49f7-89bb-2e624208abf0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "68083-577", "generic_name": "posaconazole", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "posaconazole", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "18 mg/mL"}], "application_number": "ANDA217553", "marketing_category": "ANDA", "marketing_start_date": "20231226", "listing_expiration_date": "20261231"}