posaconazole

Generic: posaconazole delayed-release

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole delayed-release
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

posaconazole 100 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-429
Product ID 62135-429_f043ffa5-9564-4a98-e053-2995a90af810
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212411
Listing Expiration 2026-12-31
Marketing Start 2019-08-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135429
Hyphenated Format 62135-429

Supplemental Identifiers

RxCUI
1482908
UPC
0362135429607
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 delayed-release (source: ndc)
Application Number ANDA212411 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (62135-429-60)
source: ndc

Packages (1)

62135-429-60 60 TABLET in 1 BOTTLE (62135-429-60)

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": "f043ffa5-9564-4a98-e053-2995a90af810", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0362135429607"], "unii": ["6TK1G07BHZ"], "rxcui": ["1482908"], "spl_set_id": ["f2baa339-75ff-4c03-8334-a88648f701f7"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (62135-429-60)", "package_ndc": "62135-429-60", "marketing_start_date": "20221212"}], "brand_name": "POSACONAZOLE", "product_id": "62135-429_f043ffa5-9564-4a98-e053-2995a90af810", "dosage_form": "TABLET", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "62135-429", "generic_name": "Posaconazole Delayed-Release", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "POSACONAZOLE", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA212411", "marketing_category": "ANDA", "marketing_start_date": "20190828", "listing_expiration_date": "20261231"}