FDA.reportPublic FDA data

UREA

Product NDC
44523-617
11-digit product format
445230617
Labeler code
44523
Product ID
44523-617_4629c716-aa54-7dc4-e063-6294a90a3dec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-03-15
Substance
UREA
Active strength
400 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
UREA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA400 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui198342

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44523-617-012024-03-06C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream
44523-617-032024-03-06C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream
44523-617-072024-03-06C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream
44523-617-012024-01-30C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream
44523-617-032024-01-30C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream
44523-617-072024-01-30C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream
44523-617-012020-04-28C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream
44523-617-032020-04-28C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream
44523-617-072020-04-28C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream
44523-617-012020-01-31C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream
44523-617-032020-01-31C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream
44523-617-072020-01-31C16284748780-19d75b9d0-116b-f424-e053-dadaa90a57ceUrea 40% Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-617-01UREA1 in 1 CARTONCREAM16
44523-617-01UREA28.35 g in 1 BOTTLE, PLASTICCREAM28.356
44523-617-03UREA85 g in 1 BOTTLE, PLASTICCREAM856
44523-617-07UREA198.4 g in 1 BOTTLE, PLASTICCREAM198.46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-617UREA CREAM [BIOCOMP PHARMA, INC.]5Current NDC, Legacy NDC, 4 package rows20240308_6774a5ef-9bb0-4e7a-e053-2a91aa0af47f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSN6774a5ef-9bb0-4e7a-e053-2a91aa0af47f6
198342urea 400 MG/ML Topical CreamSCD6774a5ef-9bb0-4e7a-e053-2a91aa0af47f6
198342urea 40 % Topical CreamSY6774a5ef-9bb0-4e7a-e053-2a91aa0af47f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-617-01445230617011 BOTTLE, PLASTIC in 1 CARTON (44523-617-01) / 28.35 g in 1 BOTTLE, PLASTIC2018-03-150000-00-00NoNoCurrent
44523-617-034452306170385 g in 1 BOTTLE, PLASTIC (44523-617-03) 85 g2018-03-150000-00-00NoNoCurrent
44523-617-0744523061707198.4 g in 1 BOTTLE, PLASTIC (44523-617-07) 198.4 g2018-03-150000-00-00NoNoCurrent