urea cream 40%

Generic: urea

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

Drug Facts

Product Profile

Brand Name urea cream 40%
Generic Name urea
Labeler laser pharmaceuticals, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

urea 400 mg/g

Manufacturer
Laser Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 16477-340
Product ID 16477-340_42f70c2c-33ab-99df-e063-6394a90a5f86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2018-05-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16477340
Hyphenated Format 16477-340

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 cream 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 (16477-340-01) / 28.35 g in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-03) / 85 g in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-07) / 198.4 g in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

16477-340-01 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-01) / 28.35 g in 1 BOTTLE, PLASTIC 16477-340-03 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-03) / 85 g in 1 BOTTLE, PLASTIC 16477-340-07 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-07) / 198.4 g in 1 BOTTLE, PLASTIC

Ingredients (1)

urea (400 mg/g)

Linked Drug Pages (1)

Urea Cream 40% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "42f70c2c-33ab-99df-e063-6394a90a5f86", "openfda": {"unii": ["8W8T17847W"], "rxcui": ["198342"], "spl_set_id": ["ef2db58d-e760-417d-8574-45a411c49b47"], "manufacturer_name": ["Laser Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16477-340-01)  / 28.35 g in 1 BOTTLE, PLASTIC", "package_ndc": "16477-340-01", "marketing_start_date": "20180504"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16477-340-03)  / 85 g in 1 BOTTLE, PLASTIC", "package_ndc": "16477-340-03", "marketing_start_date": "20180504"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16477-340-07)  / 198.4 g in 1 BOTTLE, PLASTIC", "package_ndc": "16477-340-07", "marketing_start_date": "20180504"}], "brand_name": "Urea Cream 40%", "product_id": "16477-340_42f70c2c-33ab-99df-e063-6394a90a5f86", "dosage_form": "CREAM", "product_ndc": "16477-340", "generic_name": "Urea", "labeler_name": "Laser Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Urea Cream 40%", "active_ingredients": [{"name": "UREA", "strength": "400 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20180504", "listing_expiration_date": "20261231"}