urea 40%

Generic: urea

Labeler: patrin pharma, inc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name urea 40%
Generic Name urea
Labeler patrin pharma, inc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

urea 400 mg/g

Manufacturer
Patrin Pharma, Inc

Identifiers & Regulatory

Product NDC 39328-019
Product ID 39328-019_2a3a53e2-6a1d-4422-b058-c9799cb3fa79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2025-10-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 39328019
Hyphenated Format 39328-019

Supplemental Identifiers

RxCUI
198342
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 40% (source: ndc)
Generic Name urea (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (39328-019-01) / 28.35 g in 1 BOTTLE, PLASTIC
  • 85 g in 1 BOTTLE, PLASTIC (39328-019-03)
  • 198.4 g in 1 BOTTLE, PLASTIC (39328-019-07)
source: ndc

Packages (3)

39328-019-01 1 BOTTLE, PLASTIC in 1 CARTON (39328-019-01) / 28.35 g in 1 BOTTLE, PLASTIC 39328-019-03 85 g in 1 BOTTLE, PLASTIC (39328-019-03) 39328-019-07 198.4 g in 1 BOTTLE, PLASTIC (39328-019-07)

Ingredients (1)

urea (400 mg/g)

Linked Drug Pages (1)

Urea 40% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2a3a53e2-6a1d-4422-b058-c9799cb3fa79", "openfda": {"unii": ["8W8T17847W"], "rxcui": ["198342"], "spl_set_id": ["53ccf801-c1c6-42c8-a511-da33c308076f"], "manufacturer_name": ["Patrin Pharma, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (39328-019-01)  / 28.35 g in 1 BOTTLE, PLASTIC", "package_ndc": "39328-019-01", "marketing_start_date": "20251001"}, {"sample": false, "description": "85 g in 1 BOTTLE, PLASTIC (39328-019-03)", "package_ndc": "39328-019-03", "marketing_start_date": "20251001"}, {"sample": false, "description": "198.4 g in 1 BOTTLE, PLASTIC (39328-019-07)", "package_ndc": "39328-019-07", "marketing_start_date": "20251001"}], "brand_name": "Urea 40%", "product_id": "39328-019_2a3a53e2-6a1d-4422-b058-c9799cb3fa79", "dosage_form": "CREAM", "product_ndc": "39328-019", "generic_name": "Urea", "labeler_name": "Patrin Pharma, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Urea 40%", "active_ingredients": [{"name": "UREA", "strength": "400 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20251001", "listing_expiration_date": "20261231"}