FDA.reportPublic FDA data

Desonide

Product NDC
0472-0804
11-digit product format
004720804
Labeler code
0472
Product ID
0472-0804_f3953b9e-138f-4d86-8eea-0fc03c3c2747
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
NDA019048
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-08-01
Marketing end
2026-07-31
Substance
DESONIDE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desonide

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESONIDE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ280872D1O
Rxcui197572, 349351

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
0472-0804-15Desonide1 in 1 CARTONCREAM15
0472-0804-15Desonide15 g in 1 TUBECREAM155
0472-0804-60Desonide60 g in 1 TUBECREAM605
0472-0804-60Desonide1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0804-15GM - Gram0472-080469b86945-05ce-4521-afd1-605ba6ece01412013-09-04
0472-0804-60GM - Gram0472-0804c02ee2ff-70d6-43dc-9980-537fbe23015c12013-09-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0804DESONIDE CREAM DESONIDE LOTION [ACTAVIS PHARMA, INC.]3Current NDC, Legacy NDC, 4 package rows20190206_ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349351desonide 0.05 % Topical CreamPSN81a8b199-524e-40e4-898a-c485cbf8bc225
349351desonide 0.05 % Topical CreamPSNff5d4cd8-ab4d-4a9e-b84b-445c81eeea995
197572desonide 0.05 % Topical LotionPSNff5d4cd8-ab4d-4a9e-b84b-445c81eeea995
349351desonide 0.5 MG/ML Topical CreamSCD81a8b199-524e-40e4-898a-c485cbf8bc225
349351desonide 0.5 MG/ML Topical CreamSCDff5d4cd8-ab4d-4a9e-b84b-445c81eeea995
197572desonide 0.5 MG/ML Topical LotionSCDff5d4cd8-ab4d-4a9e-b84b-445c81eeea995
349351desonide 0.05 % Topical CreamSY81a8b199-524e-40e4-898a-c485cbf8bc225
349351desonide 0.05 % Topical CreamSYff5d4cd8-ab4d-4a9e-b84b-445c81eeea995
197572desonide 0.05 % Topical LotionSYff5d4cd8-ab4d-4a9e-b84b-445c81eeea995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0804-15004720804151 TUBE in 1 CARTON (0472-0804-15) / 15 g in 1 TUBE1 tube2013-08-012026-07-31NoNoCurrent
0472-0804-60004720804601 TUBE in 1 CARTON (0472-0804-60) / 60 g in 1 TUBE1 tube2013-08-012026-07-31NoNoCurrent