Not Applicable

Product NDC
69336-810
11-digit product format
693360810
Labeler code
69336
Product ID
69336-810_54990261-8036-41f2-b58b-e1dd0aac2e16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Protexa
Dosage form
CREAM
Route
TOPICAL
Labeler
Sterling-Knight Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-02-18
Marketing end
0000-00-00
Substance
UREA
Active strength
42 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69336-810-452022-01-28C16284748780-1d6a99b39-876a-a426-e053-dadaa90af4c2Protexa Urea 42% CreamRx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69336-810-45Not Applicable1 in 1 CARTONCREAM12
69336-810-45Not Applicable45 g in 1 CONTAINERCREAM452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-810NOT APPLICABLE (PROTEXA) CREAM [STERLING-KNIGHT PHARMACEUTICALS, LLC]2Legacy NDC, 2 package rows20200219_78f23668-5590-4a4e-9547-272ddc70af3a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69336-810-45693360810451 CONTAINER in 1 CARTON (69336-810-45) > 45 g in 1 CONTAINER1 container2020-02-180000-00-00NoNoCurrent