Urea

Generic: Urea

Labeler: Exact-Rx, Inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Active

Drug Facts

Product Profile

Brand Name Urea
Generic Name Urea
Labeler Exact-Rx, Inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

UREA 450 mg/mL

Identifiers & Regulatory

Product NDC 42808-204
Product ID 42808-204_45c69d86-b79a-dd73-e063-6294a90a07ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2011-08-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42808204
Hyphenated Format 42808-204

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 (source: ndc)
Generic Name Urea (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (42808-204-28) / 28 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

42808-204-28 1 BOTTLE, GLASS in 1 CARTON (42808-204-28) / 28 mL in 1 BOTTLE, GLASS

Ingredients (1)

UREA (450 mg/mL)

Linked Drug Pages (1)

Urea ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "45c69d86-b79a-dd73-e063-6294a90a07ed", "openfda": {"unii": ["8W8T17847W"], "rxcui": ["827406"], "spl_set_id": ["b58e175d-60e8-4206-ac7a-c67b68ac80f0"], "manufacturer_name": ["Exact-Rx, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (42808-204-28)  / 28 mL in 1 BOTTLE, GLASS", "package_ndc": "42808-204-28", "marketing_start_date": "20110801"}], "brand_name": "Urea", "product_id": "42808-204_45c69d86-b79a-dd73-e063-6294a90a07ed", "dosage_form": "GEL", "product_ndc": "42808-204", "generic_name": "Urea", "labeler_name": "Exact-Rx, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Urea", "active_ingredients": [{"name": "UREA", "strength": "450 mg/mL"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20110801", "listing_expiration_date": "20261231"}