posaconazole

Generic: posaconazole

Labeler: fresensius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler fresensius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

posaconazole 18 mg/mL

Manufacturer
Fresensius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-685
Product ID 63323-685_3ed81dc8-a1e0-4513-be2a-7a16aea62198
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209983
Listing Expiration 2026-12-31
Marketing Start 2023-12-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323685
Hyphenated Format 63323-685

Supplemental Identifiers

RxCUI
1492043
UPC
0363323685171
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 ANDA209983 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 18 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-685-17) / 16.7 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63323-685-17 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-685-17) / 16.7 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

posaconazole (18 mg/mL)

Linked Drug Pages (1)

Posaconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3ed81dc8-a1e0-4513-be2a-7a16aea62198", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0363323685171"], "unii": ["6TK1G07BHZ"], "rxcui": ["1492043"], "spl_set_id": ["86be8cdb-c991-4754-b8f4-1ab79ac40bda"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Fresensius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-685-17)  / 16.7 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-685-17", "marketing_start_date": "20231226"}], "brand_name": "Posaconazole", "product_id": "63323-685_3ed81dc8-a1e0-4513-be2a-7a16aea62198", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "63323-685", "generic_name": "Posaconazole", "labeler_name": "Fresensius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Posaconazole", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "18 mg/mL"}], "application_number": "ANDA209983", "marketing_category": "ANDA", "marketing_start_date": "20231226", "listing_expiration_date": "20261231"}