urea 41%

Generic: urea

Labeler: oncora pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name urea 41%
Generic Name urea
Labeler oncora pharma, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

urea 410 mg/g

Manufacturer
Oncora Pharma, LLC

Identifiers & Regulatory

Product NDC 85477-905
Product ID 85477-905_37576876-738d-ac79-e063-6394a90a84fe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2025-06-11

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85477905
Hyphenated Format 85477-905

Supplemental Identifiers

RxCUI
1436933
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 urea 41% (source: ndc)
Generic Name urea (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 410 mg/g
source: ndc
Packaging
  • 227 g in 1 BOTTLE (85477-905-30)
source: ndc

Packages (1)

85477-905-30 227 g in 1 BOTTLE (85477-905-30)

Ingredients (1)

urea (410 mg/g)

Linked Drug Pages (1)

Urea 41% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "37576876-738d-ac79-e063-6394a90a84fe", "openfda": {"unii": ["8W8T17847W"], "rxcui": ["1436933"], "spl_set_id": ["37576876-738c-ac79-e063-6394a90a84fe"], "manufacturer_name": ["Oncora Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "227 g in 1 BOTTLE (85477-905-30)", "package_ndc": "85477-905-30", "marketing_start_date": "20250611"}], "brand_name": "Urea 41%", "product_id": "85477-905_37576876-738d-ac79-e063-6394a90a84fe", "dosage_form": "CREAM", "product_ndc": "85477-905", "generic_name": "Urea", "labeler_name": "Oncora Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Urea 41%", "active_ingredients": [{"name": "UREA", "strength": "410 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20250611", "listing_expiration_date": "20261231"}