posaconazole

Generic: posaconazole

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler northstar rxllc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

posaconazole 100 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-535
Product ID 16714-535_f00461e3-12cb-3905-e053-2a95a90a4e12
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214321
Listing Expiration 2026-12-31
Marketing Start 2023-04-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714535
Hyphenated Format 16714-535

Supplemental Identifiers

RxCUI
1482908
UPC
0316714535012
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 ANDA214321 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (16714-535-01)
source: ndc

Packages (1)

16714-535-01 60 TABLET, DELAYED RELEASE in 1 BOTTLE (16714-535-01)

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": "f00461e3-12cb-3905-e053-2a95a90a4e12", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0316714535012"], "unii": ["6TK1G07BHZ"], "rxcui": ["1482908"], "spl_set_id": ["4de6d839-e4bd-405c-83c5-8efc6abd0829"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (16714-535-01)", "package_ndc": "16714-535-01", "marketing_start_date": "20230402"}], "brand_name": "Posaconazole", "product_id": "16714-535_f00461e3-12cb-3905-e053-2a95a90a4e12", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "16714-535", "generic_name": "Posaconazole", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Posaconazole", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA214321", "marketing_category": "ANDA", "marketing_start_date": "20230402", "listing_expiration_date": "20261231"}