posaconazole

Generic: posaconazole

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

posaconazole 100 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-168
Product ID 72205-168_0bdf77ae-3639-49c1-b7c7-533f9d073084
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218434
Listing Expiration 2026-12-31
Marketing Start 2025-02-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205168
Hyphenated Format 72205-168

Supplemental Identifiers

RxCUI
1482908
UPC
0372205168602
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 ANDA218434 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, COATED in 1 BOTTLE (72205-168-60)
source: ndc

Packages (1)

72205-168-60 60 TABLET, COATED in 1 BOTTLE (72205-168-60)

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": "0bdf77ae-3639-49c1-b7c7-533f9d073084", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0372205168602"], "unii": ["6TK1G07BHZ"], "rxcui": ["1482908"], "spl_set_id": ["0bdf77ae-3639-49c1-b7c7-533f9d073084"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (72205-168-60)", "package_ndc": "72205-168-60", "marketing_start_date": "20250401"}], "brand_name": "posaconazole", "product_id": "72205-168_0bdf77ae-3639-49c1-b7c7-533f9d073084", "dosage_form": "TABLET, COATED", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "72205-168", "generic_name": "posaconazole", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "posaconazole", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA218434", "marketing_category": "ANDA", "marketing_start_date": "20250224", "listing_expiration_date": "20261231"}