UREA

Product NDC
44523-618
11-digit product format
445230618
Labeler code
44523
Product ID
44523-618_4846c3d5-f1ff-20dc-e063-6394a90a2a3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-02-15
Substance
UREA
Active strength
200 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
UREA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui198886

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-618-03UREA85 g in 1 BOTTLE, PLASTICCREAM852

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-618-03GM - Gram44523-61825e3c267-e914-4a6b-bd69-1970ef009a2b12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-618UREA CREAM [BIOCOMP PHARMA, INC.]1Current NDC, 1 package rows20240215_0fb373f8-5328-2f10-e063-6294a90a2484.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198886urea 20 % Topical CreamPSN0fb373f8-5328-2f10-e063-6294a90a24842
198886urea 200 MG/ML Topical CreamSCD0fb373f8-5328-2f10-e063-6294a90a24842
198886urea 17 GM in 85 GM Topical CreamSY0fb373f8-5328-2f10-e063-6294a90a24842
198886urea 20 % Topical CreamSY0fb373f8-5328-2f10-e063-6294a90a24842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44523-618-034452306180385 g in 1 BOTTLE, PLASTIC (44523-618-03) 85 g2024-02-15NoNoHistorical