Urea 40 Percent

Product NDC
63629-9267
11-digit product format
636299267
Labeler code
63629
Product ID
63629-9267_e91f44df-bbf1-484a-b84f-73ca9e47545e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-11-15
Substance
UREA
Active strength
400 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 40 Percent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA400 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui198342

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9267-1Urea 40 Percent198.4 g in 1 BOTTLECREAM198.4103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9267-1GM - Gram63629-9267d0479f43-1538-4d17-9058-c15560f7f1d112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9267UREA 40 PERCENT (UREA) CREAM [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240511_6701225c-2c2e-41e8-8d43-ef77c00a9946.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSN6701225c-2c2e-41e8-8d43-ef77c00a9946103
198342urea 400 MG/ML Topical CreamSCD6701225c-2c2e-41e8-8d43-ef77c00a9946103
198342urea 40 % Topical CreamSY6701225c-2c2e-41e8-8d43-ef77c00a9946103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9267-163629926701198.4 g in 1 BOTTLE (63629-9267-1) 198.4 g2024-04-040000-00-00NoNoCurrent