FDA.reportPublic FDA data

DESONIDE

Product NDC
21695-944
11-digit product format
216950944
Labeler code
21695
Product ID
21695-944_4eff4778-6ae6-4727-821d-66df5683dd9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESONIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA073548
Marketing category
ANDA
Marketing start
1992-06-30
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
21695-944-152019-09-24C16284748780-1934fe258-4bea-48b1-e053-8cdaa90a720aDesonide Cream 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-944-15DESONIDE15 g in 1 TUBECREAM151
21695-944-15DESONIDE1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-944-15GM - Gram21695-9447993af1b-7fd7-4ed4-9309-4363b7646fb612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESONIDEACTIVE INGREDIENTJ280872D1ODESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
DESONIDEACTIVE MOIETYJ280872D1ODESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
ALUMINUM SUBACETATEINACTIVE INGREDIENTFGL8577C9SDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-944DESONIDE CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110524_4eff4778-6ae6-4727-821d-66df5683dd9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349351desonide 0.05 % Topical CreamPSN4eff4778-6ae6-4727-821d-66df5683dd9b1
349351desonide 0.5 MG/ML Topical CreamSCD4eff4778-6ae6-4727-821d-66df5683dd9b1
349351desonide 0.05 % Topical CreamSY4eff4778-6ae6-4727-821d-66df5683dd9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-944-152169509441515 g in 1 TUBE15 gHistorical