FDA.reportPublic FDA data

Urea 41 Percent

Product NDC
63629-1150
Requested package NDC
63629-1150-1
11-digit product format
636291150
Labeler code
63629
Product ID
63629-1150_78efe6a8-420d-4790-af68-588055d4634f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-04-23
Marketing end
0000-00-00
Substance
UREA
Active strength
410 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-115063629-1150-1DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1150-1GM - Gram63629-1150228aa289-ab0c-49db-b3b8-ee81fc2184a012021-01-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1150-163629115001227 g in 1 BOTTLE (63629-1150-1) 227 g2020-11-050000-00-00NoNoCurrent