FDA.reportPublic FDA data

DESONATE

Product NDC
10922-828
11-digit product format
109220828
Labeler code
10922
Product ID
10922-828_71fcf85b-04ff-4630-872d-cd2df7ba6842
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desonide
Dosage form
GEL
Route
TOPICAL
Labeler
Intendis Inc.
Application
NDA021844
Marketing category
NDA
Marketing start
2010-01-28
Marketing end
0000-00-00
Substance
DESONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10922-828-062019-10-29C16284748780-1960f7f55-cc0e-8e05-e053-dbdaa90a074aThese highlights do not include all the information needed to use DESONATE Gel safely and effectively. See full prescribing information for DESONATE Gel. DESONATE (desonide) Gel for topical use only Initial U.S. Approval: 1972
10922-828-122019-10-29C16284748780-1960f7f55-cc0e-8e05-e053-dbdaa90a074aThese highlights do not include all the information needed to use DESONATE Gel safely and effectively. See full prescribing information for DESONATE Gel. DESONATE (desonide) Gel for topical use only Initial U.S. Approval: 1972
10922-828-712019-10-29C16284748780-1960f7f55-cc0e-8e05-e053-dbdaa90a074aThese highlights do not include all the information needed to use DESONATE Gel safely and effectively. See full prescribing information for DESONATE Gel. DESONATE (desonide) Gel for topical use only Initial U.S. Approval: 1972

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10922-828-06DESONATE1 in 1 CARTONGEL14
10922-828-06DESONATE60 g in 1 TUBEGEL604
10922-828-12DESONATE60 g in 1 TUBEGEL604
10922-828-12DESONATE2 in 1 CARTONGEL24
10922-828-71DESONATE3.5 g in 1 TUBEGEL3.54
10922-828-71DESONATE1 in 1 BLISTER PACKGEL14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10922-828-06GM - Gram10922-8286561be4e-f802-4abd-aff2-529d74f3af8312012-07-24
10922-828-12GM - Gram10922-82810cd5a81-d58f-4da3-b13f-1156884bde8c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESONIDEACTIVE INGREDIENTJ280872D1ODESONATE (DESONIDE) GEL [INTENDIS INC.]4
DESONIDEACTIVE MOIETYJ280872D1ODESONATE (DESONIDE) GEL [INTENDIS INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDESONATE (DESONIDE) GEL [INTENDIS INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDESONATE (DESONIDE) GEL [INTENDIS INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDESONATE (DESONIDE) GEL [INTENDIS INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DESONATE (DESONIDE) GEL [INTENDIS INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDESONATE (DESONIDE) GEL [INTENDIS INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDESONATE (DESONIDE) GEL [INTENDIS INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RDESONATE (DESONIDE) GEL [INTENDIS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10922-828DESONATE (DESONIDE) GEL [INTENDIS INC.]4Legacy NDC, 6 package rows20101112_4ae18cfa-0451-466d-80cd-73f6748405b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692757Desonate 0.05 % Topical GelPSN4ae18cfa-0451-466d-80cd-73f6748405b64
669081desonide 0.05 % Topical GelPSN4ae18cfa-0451-466d-80cd-73f6748405b64
692757desonide 0.0005 MG/MG Topical Gel [Desonate]SBD4ae18cfa-0451-466d-80cd-73f6748405b64
669081desonide 0.0005 MG/MG Topical GelSCD4ae18cfa-0451-466d-80cd-73f6748405b64
692757Desonate 0.0005 MG/MG Topical GelSY4ae18cfa-0451-466d-80cd-73f6748405b64
692757Desonate 0.05 % Topical GelSY4ae18cfa-0451-466d-80cd-73f6748405b64
692757Desonate 0.5 MG/GM Topical GelSY4ae18cfa-0451-466d-80cd-73f6748405b64
669081desonide 0.05 % Topical GelSY4ae18cfa-0451-466d-80cd-73f6748405b64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
10922-828-06109220828061 in 1 CARTONHistorical
10922-828-121092208281260 g in 1 TUBE60 gHistorical
10922-828-71109220828713.5 g in 1 TUBE3.5 gHistorical