posaconazole

Generic: posaconazole

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler endo usa, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

posaconazole 18 mg/mL

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 42023-195
Product ID 42023-195_92a5aca2-481e-466e-a3de-5ed8fb915d2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208768
Listing Expiration 2026-12-31
Marketing Start 2023-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42023195
Hyphenated Format 42023-195

Supplemental Identifiers

RxCUI
1492043
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 ANDA208768 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 18 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (42023-195-01) / 16.7 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

42023-195-01 1 VIAL, GLASS in 1 CARTON (42023-195-01) / 16.7 mL in 1 VIAL, GLASS

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": "92a5aca2-481e-466e-a3de-5ed8fb915d2f", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["6TK1G07BHZ"], "rxcui": ["1492043"], "spl_set_id": ["4032672e-1bb0-427d-a3b3-09cda4beaf34"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (42023-195-01)  / 16.7 mL in 1 VIAL, GLASS", "package_ndc": "42023-195-01", "marketing_start_date": "20230101"}], "brand_name": "Posaconazole", "product_id": "42023-195_92a5aca2-481e-466e-a3de-5ed8fb915d2f", "dosage_form": "INJECTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "42023-195", "generic_name": "Posaconazole", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Posaconazole", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "18 mg/mL"}], "application_number": "ANDA208768", "marketing_category": "ANDA", "marketing_start_date": "20230101", "listing_expiration_date": "20261231"}