noxafil

Generic: posaconazole

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name noxafil
Generic Name posaconazole
Labeler merck sharp & dohme llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

posaconazole 40 mg/mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0085-1328
Product ID 0085-1328_56740f7d-3b29-4786-b5c7-eea6c0f14400
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022003
Listing Expiration 2027-12-31
Marketing Start 2006-09-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00851328
Hyphenated Format 0085-1328

Supplemental Identifiers

RxCUI
665019 665022 1482908 1482912 1492043 1492047 2558603 2558607
UPC
0300854324025
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 noxafil (source: ndc)
Generic Name posaconazole (source: ndc)
Application Number NDA022003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

0085-1328-01 1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASS

Ingredients (1)

posaconazole (40 mg/mL)

Linked Drug Pages (1)

NOXAFIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "56740f7d-3b29-4786-b5c7-eea6c0f14400", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0300854324025"], "unii": ["6TK1G07BHZ"], "rxcui": ["665019", "665022", "1482908", "1482912", "1492043", "1492047", "2558603", "2558607"], "spl_set_id": ["b073b082-7b57-4423-8c06-4fd4263d6f84"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (0085-1328-01)  / 105 mL in 1 BOTTLE, GLASS", "package_ndc": "0085-1328-01", "marketing_start_date": "20060915"}], "brand_name": "NOXAFIL", "product_id": "0085-1328_56740f7d-3b29-4786-b5c7-eea6c0f14400", "dosage_form": "SUSPENSION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0085-1328", "generic_name": "posaconazole", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NOXAFIL", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "40 mg/mL"}], "application_number": "NDA022003", "marketing_category": "NDA", "marketing_start_date": "20060915", "listing_expiration_date": "20271231"}