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 SUSPENSION
Routes
ORAL
Active Ingredients

posaconazole 40 mg/mL

Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 0254-1016
Product ID 0254-1016_15fdf050-71cb-476f-a7ce-38c40262f381
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022003
Listing Expiration 2027-12-31
Marketing Start 2023-03-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02541016
Hyphenated Format 0254-1016

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 NDA022003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (0254-1016-36) / 105 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

0254-1016-36 1 BOTTLE, GLASS in 1 CARTON (0254-1016-36) / 105 mL in 1 BOTTLE, GLASS

Ingredients (1)

posaconazole (40 mg/mL)

Linked Drug Pages (1)

POSACONAZOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "15fdf050-71cb-476f-a7ce-38c40262f381", "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": "1 BOTTLE, GLASS in 1 CARTON (0254-1016-36)  / 105 mL in 1 BOTTLE, GLASS", "package_ndc": "0254-1016-36", "marketing_start_date": "20230329"}], "brand_name": "POSACONAZOLE", "product_id": "0254-1016_15fdf050-71cb-476f-a7ce-38c40262f381", "dosage_form": "SUSPENSION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0254-1016", "generic_name": "posaconazole", "labeler_name": "ENDO USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "POSACONAZOLE", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "40 mg/mL"}], "application_number": "NDA022003", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230329", "listing_expiration_date": "20271231"}