Evara

Product NDC
85477-308
11-digit product format
854770308
Labeler code
85477
Product ID
85477-308_3fc2bb16-70ef-41f8-9a6a-a6a42bf58e5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea 40.5 Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Oncora Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-04-29
Substance
UREA
Active strength
405 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
Evara
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA405 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui2741686

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-308-08Evara227 g in 1 BOTTLECREAM2272

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741686urea 40.5 % Topical CreamPSN098d85ca-7f48-45a1-80ed-4d57936842b92
2741686urea 405 MG/ML Topical CreamSCD098d85ca-7f48-45a1-80ed-4d57936842b92
2741686urea 40.5 % Topical CreamSY098d85ca-7f48-45a1-80ed-4d57936842b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85477-308-0885477030808227 g in 1 BOTTLE (85477-308-08) 227 g2026-04-29NoNoCurrent