posaconazole

Generic: posaconazole

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler aurobindo pharma limited
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

posaconazole 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-596
Product ID 59651-596_8c734106-02cb-47c6-89fd-e4fe1cdff758
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217119
Listing Expiration 2026-12-31
Marketing Start 2024-07-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651596
Hyphenated Format 59651-596

Supplemental Identifiers

RxCUI
1482908
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 ANDA217119 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-596-60)
source: ndc

Packages (1)

59651-596-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-596-60)

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": "8c734106-02cb-47c6-89fd-e4fe1cdff758", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["6TK1G07BHZ"], "rxcui": ["1482908"], "spl_set_id": ["f8a26673-261c-4e8e-b1e1-9e23aaf7f285"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-596-60)", "package_ndc": "59651-596-60", "marketing_start_date": "20240718"}], "brand_name": "POSACONAZOLE", "product_id": "59651-596_8c734106-02cb-47c6-89fd-e4fe1cdff758", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "59651-596", "generic_name": "POSACONAZOLE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "POSACONAZOLE", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA217119", "marketing_category": "ANDA", "marketing_start_date": "20240718", "listing_expiration_date": "20261231"}