posaconazole

Generic: posaconazole

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler endo usa, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

posaconazole 100 mg/1

Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 0254-2045
Product ID 0254-2045_14185fb6-bebf-4b06-a446-56901f1b44c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA205053
Listing Expiration 2026-12-31
Marketing Start 2019-08-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02542045
Hyphenated Format 0254-2045

Supplemental Identifiers

RxCUI
665019 1482908
UPC
0302542045021
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 NDA205053 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, COATED in 1 BOTTLE (0254-2045-02)
source: ndc

Packages (1)

0254-2045-02 60 TABLET, COATED in 1 BOTTLE (0254-2045-02)

Ingredients (1)

posaconazole (100 mg/1)

Linked Drug Pages (1)

POSACONAZOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "14185fb6-bebf-4b06-a446-56901f1b44c0", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0302542045021"], "unii": ["6TK1G07BHZ"], "rxcui": ["665019", "1482908"], "spl_set_id": ["e031b632-8e57-4359-87bd-a5da02bdc55f"], "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": "60 TABLET, COATED in 1 BOTTLE (0254-2045-02)", "package_ndc": "0254-2045-02", "marketing_start_date": "20190830"}], "brand_name": "POSACONAZOLE", "product_id": "0254-2045_14185fb6-bebf-4b06-a446-56901f1b44c0", "dosage_form": "TABLET, COATED", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0254-2045", "generic_name": "posaconazole", "labeler_name": "ENDO USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "POSACONAZOLE", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "100 mg/1"}], "application_number": "NDA205053", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190830", "listing_expiration_date": "20261231"}