FDA.reportPublic FDA data

Desonide

Product NDC
45802-423
11-digit product format
458020423
Labeler code
45802
Product ID
45802-423_9d27c98f-5df2-45c7-a479-a4a04128e6b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
NDA017426
Marketing category
NDA
Marketing start
2006-08-22
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
Rxcui204135

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
45802-423-35Desonide15 g in 1 TUBEOINTMENT159
45802-423-35Desonide1 in 1 CARTONOINTMENT19
45802-423-37Desonide60 g in 1 TUBEOINTMENT609
45802-423-37Desonide1 in 1 CARTONOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-423-35GM - Gram45802-423cc836664-59c0-40f4-9171-064b78e3dc2712012-07-24
45802-423-37GM - Gram45802-423a794ac53-0fc6-4bc7-bb24-79668941665a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESONIDEACTIVE INGREDIENTJ280872D1ODESONIDE OINTMENT [PERRIGO NEW YORK INC]5
DESONIDEACTIVE MOIETYJ280872D1ODESONIDE OINTMENT [PERRIGO NEW YORK INC]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDESONIDE OINTMENT [PERRIGO NEW YORK INC]5
DESONIDEACTIVE INGREDIENTJ280872D1ODESONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
DESONIDEACTIVE MOIETYJ280872D1ODESONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-423DESONIDE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]9Current NDC, Legacy NDC, 4 package rows20231117_525c035d-d54b-41c0-90c5-bcd284b1abe3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204135desonide 0.05 % Topical OintmentPSN525c035d-d54b-41c0-90c5-bcd284b1abe39
204135desonide 0.0005 MG/MG Topical OintmentSCD525c035d-d54b-41c0-90c5-bcd284b1abe39
204135desonide 0.05 % Topical OintmentSY525c035d-d54b-41c0-90c5-bcd284b1abe39
204135desonide 0.05 % Topical OintmentPSN10feb882-10f0-4e5a-8481-bcaac54dfd522
204135desonide 0.0005 MG/MG Topical OintmentSCD10feb882-10f0-4e5a-8481-bcaac54dfd522
204135desonide 0.05 % Topical OintmentSY10feb882-10f0-4e5a-8481-bcaac54dfd522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-423-35458020423351 TUBE in 1 CARTON (45802-423-35) / 15 g in 1 TUBE1 tube2006-08-220000-00-00NoNoCurrent
45802-423-37458020423371 TUBE in 1 CARTON (45802-423-37) / 60 g in 1 TUBE1 tube2006-09-180000-00-00NoNoCurrent