posaconazole

Generic: posaconazole

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

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

posaconazole 100 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1476
Product ID 69238-1476_e5dd752f-8c59-429e-94ef-b94708120a73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216626
Listing Expiration 2026-12-31
Marketing Start 2022-12-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381476
Hyphenated Format 69238-1476

Supplemental Identifiers

RxCUI
1482908
UPC
0369238147636
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 ANDA216626 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1476-3)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1476-6)
source: ndc

Packages (2)

69238-1476-3 30 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1476-3) 69238-1476-6 60 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1476-6)

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": "e5dd752f-8c59-429e-94ef-b94708120a73", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0369238147636"], "unii": ["6TK1G07BHZ"], "rxcui": ["1482908"], "spl_set_id": ["5f795eca-7a03-4c91-9a0e-c1235791b665"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1476-3)", "package_ndc": "69238-1476-3", "marketing_start_date": "20221230"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1476-6)", "package_ndc": "69238-1476-6", "marketing_start_date": "20221230"}], "brand_name": "Posaconazole", "product_id": "69238-1476_e5dd752f-8c59-429e-94ef-b94708120a73", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "69238-1476", "generic_name": "Posaconazole", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Posaconazole", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA216626", "marketing_category": "ANDA", "marketing_start_date": "20221230", "listing_expiration_date": "20261231"}