FDA.reportPublic FDA data

Desonide

Product NDC
63187-747
11-digit product format
631870747
Labeler code
63187
Product ID
63187-747_c18f0f16-11f4-4c11-983a-27a30b71827b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
NDA019048
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-08-01
Substance
DESONIDE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESONIDE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ280872D1O
Rxcui349351

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dd568b3-c283-39c3-9c72-0b51d8c13e5dProduct name220201006
0d789796-3334-08b7-795a-b9c3762179bcProduct name220200506
6da396dc-a1b2-d109-14be-877a0fdbfa18Product name520200408
4fa39b20-3e53-46d7-85e4-edc2360cfdffProduct name120171115
a4783074-7e0b-e965-10c3-0421e26d5edeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-747-15Desonide1 in 1 CARTONCREAM15
63187-747-15Desonide15 g in 1 TUBECREAM155
63187-747-60Desonide1 in 1 CARTONCREAM15
63187-747-60Desonide60 g in 1 TUBECREAM605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-747-15GM - Gram63187-747d74eb538-4477-435a-a423-1fde373d899812016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-747DESONIDE CREAM [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20250529_81a8b199-524e-40e4-898a-c485cbf8bc22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349351desonide 0.05 % Topical CreamPSN81a8b199-524e-40e4-898a-c485cbf8bc225
349351desonide 0.5 MG/ML Topical CreamSCD81a8b199-524e-40e4-898a-c485cbf8bc225
349351desonide 0.05 % Topical CreamSY81a8b199-524e-40e4-898a-c485cbf8bc225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-747-15631870747151 TUBE in 1 CARTON (63187-747-15) / 15 g in 1 TUBE1 tube2016-10-030000-00-00NoNoCurrent
63187-747-60631870747601 TUBE in 1 CARTON (63187-747-60) / 60 g in 1 TUBE1 tube2016-10-030000-00-00NoNoCurrent