Urea 20

Product NDC
50268-820
11-digit product format
502680820
Labeler code
50268
Product ID
50268-820_48379414-bcb9-1797-e063-6394a90aa8fd
Type
HUMAN OTC DRUG
Nonproprietary name
Urea
Dosage form
GEL
Route
TOPICAL
Labeler
AvPAK
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-09-19
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 20
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-820-85Urea 201 in 1 CARTONGEL14
50268-820-85Urea 2085 g in 1 TUBEGEL854

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-820-85GM - Gram50268-820f43ce712-7d5f-42c8-82fc-a34279c4130512022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-820UREA 20 (UREA) GEL [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240308_e994fa05-a457-2555-e053-2a95a90ae83b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-820-85502680820851 TUBE in 1 CARTON (50268-820-85) / 85 g in 1 TUBE1 tube2022-09-190000-00-00NoNoCurrent