UREA

Product NDC
50268-872
11-digit product format
502680872
Labeler code
50268
Product ID
50268-872_34145ca3-6034-8c33-e063-6394a90acb55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
AvPAK
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-07-13
Substance
UREA
Active strength
40 g/100g
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
UREA40 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui198342

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-872-19UREA198.4 g in 1 BOTTLECREAM198.44
50268-872-28UREA28.35 g in 1 TUBECREAM28.354
50268-872-85UREA85 g in 1 TUBECREAM854

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-872-19GM - Gram50268-8721a371e6c-1190-4221-a9c9-80dab0dbf4d912023-04-07
50268-872-28GM - Gram50268-872ed0097dc-c800-41b8-a195-2633bce7a96d12022-08-04
50268-872-85GM - Gram50268-872c107996f-c90b-4848-840b-c32cc8a74a2612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-872UREA CREAM [AVPAK]4Current NDC, Legacy NDC, 3 package rows20250502_e3b31a1c-8be2-29f6-e053-2a95a90af526.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSNe3b31a1c-8be2-29f6-e053-2a95a90af5264
198342urea 400 MG/ML Topical CreamSCDe3b31a1c-8be2-29f6-e053-2a95a90af5264
198342urea 40 % Topical CreamSYe3b31a1c-8be2-29f6-e053-2a95a90af5264

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-872-1950268087219198.4 g in 1 BOTTLE (50268-872-19) 198.4 g2023-02-24NoNoHistorical
50268-872-285026808722828.35 g in 1 TUBE (50268-872-28) 28.35 g2022-07-130000-00-00NoNoCurrent
50268-872-855026808728585 g in 1 TUBE (50268-872-85) 85 g2023-02-24NoNoHistorical