posaconazole

Generic: posaconazole

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler hikma pharmaceuticals usa inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

posaconazole 40 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0449
Product ID 0054-0449_de8dabbe-fb1c-4bab-b877-116a146fd75c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208773
Listing Expiration 2026-12-31
Marketing Start 2023-03-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540449
Hyphenated Format 0054-0449

Supplemental Identifiers

RxCUI
665019
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 ANDA208773 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (0054-0449-49) / 105 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

0054-0449-49 1 BOTTLE, GLASS in 1 CARTON (0054-0449-49) / 105 mL in 1 BOTTLE, GLASS

Ingredients (1)

posaconazole (40 mg/mL)

Linked Drug Pages (1)

posaconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "de8dabbe-fb1c-4bab-b877-116a146fd75c", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["6TK1G07BHZ"], "rxcui": ["665019"], "spl_set_id": ["282ddea7-47d8-44e4-8806-169d7cafa951"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (0054-0449-49)  / 105 mL in 1 BOTTLE, GLASS", "package_ndc": "0054-0449-49", "marketing_start_date": "20230329"}], "brand_name": "posaconazole", "product_id": "0054-0449_de8dabbe-fb1c-4bab-b877-116a146fd75c", "dosage_form": "SUSPENSION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0054-0449", "generic_name": "posaconazole", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "posaconazole", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "40 mg/mL"}], "application_number": "ANDA208773", "marketing_category": "ANDA", "marketing_start_date": "20230329", "listing_expiration_date": "20261231"}