uredex

Generic: urea

Labeler: blue heron pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name uredex
Generic Name urea
Labeler blue heron pharmaceuticals, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

urea 200 mg/g

Manufacturer
Blue Heron Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 85622-601
Product ID 85622-601_08af3450-45c1-4a9c-ba34-b2db7d605f5c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2027-12-31
Marketing Start 2026-01-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85622601
Hyphenated Format 85622-601

Supplemental Identifiers

RxCUI
198886
UNII
8W8T17847W

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 uredex (source: ndc)
Generic Name urea (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/g
source: ndc
Packaging
  • 85 g in 1 BOTTLE, PLASTIC (85622-601-03)
source: ndc

Packages (1)

85622-601-03 85 g in 1 BOTTLE, PLASTIC (85622-601-03)

Ingredients (1)

urea (200 mg/g)

Linked Drug Pages (1)

UREDEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "08af3450-45c1-4a9c-ba34-b2db7d605f5c", "openfda": {"unii": ["8W8T17847W"], "rxcui": ["198886"], "spl_set_id": ["0e4d7b03-527f-4cff-9154-7e5e485a8f80"], "manufacturer_name": ["Blue Heron Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "85 g in 1 BOTTLE, PLASTIC (85622-601-03)", "package_ndc": "85622-601-03", "marketing_start_date": "20260107"}], "brand_name": "UREDEX", "product_id": "85622-601_08af3450-45c1-4a9c-ba34-b2db7d605f5c", "dosage_form": "CREAM", "product_ndc": "85622-601", "generic_name": "UREA", "labeler_name": "Blue Heron Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "UREDEX", "active_ingredients": [{"name": "UREA", "strength": "200 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20260107", "listing_expiration_date": "20271231"}