posaconazole

Generic: posaconazole

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler avpak
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

posaconazole 100 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-683
Product ID 50268-683_2b4c1730-ff8e-04ea-e063-6394a90a136b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212500
Listing Expiration 2026-12-31
Marketing Start 2022-05-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268683
Hyphenated Format 50268-683

Supplemental Identifiers

RxCUI
1482908
UNII
6TK1G07BHZ
NUI
N0000175487 M0002083

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 ANDA212500 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 BOX (50268-683-12) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-683-11)
source: ndc

Packages (1)

50268-683-12 20 BLISTER PACK in 1 BOX (50268-683-12) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-683-11)

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": "2b4c1730-ff8e-04ea-e063-6394a90a136b", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["6TK1G07BHZ"], "rxcui": ["1482908"], "spl_set_id": ["de95df83-a495-1900-e053-2995a90abf24"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX (50268-683-12)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-683-11)", "package_ndc": "50268-683-12", "marketing_start_date": "20220509"}], "brand_name": "Posaconazole", "product_id": "50268-683_2b4c1730-ff8e-04ea-e063-6394a90a136b", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "50268-683", "generic_name": "Posaconazole", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Posaconazole", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA212500", "marketing_category": "ANDA", "marketing_start_date": "20220509", "listing_expiration_date": "20261231"}