FDA.reportPublic FDA data

Desonide

Product NDC
51672-1280
11-digit product format
516721280
Labeler code
51672
Product ID
51672-1280_38f4eb47-a888-b419-e063-6394a90a6442
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA073548
Marketing category
ANDA
Marketing start
1992-06-30
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, 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
51672-1280-1Desonide1 in 1 CARTONCREAM19
51672-1280-1Desonide15 g in 1 TUBECREAM159
51672-1280-3Desonide1 in 1 CARTONCREAM19
51672-1280-3Desonide60 g in 1 TUBECREAM609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1280-1GM - Gram51672-12807bb4bcb0-d929-4b4c-8b65-c4581204b76e12013-02-13
51672-1280-3GM - Gram51672-12805c3d95cf-3284-4daa-92c0-9c1b90268e3e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesonideACTIVE INGREDIENTJ280872D1ODESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
DesonideACTIVE MOIETYJ280872D1ODESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
aluminum subacetateINACTIVE INGREDIENTFGL8577C9SDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
methylparabenINACTIVE INGREDIENTA2I8C7HI9TDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
mineral oilINACTIVE INGREDIENTT5L8T28FGPDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
petrolatumINACTIVE INGREDIENT4T6H12BN9UDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium cetostearyl sulfateINACTIVE INGREDIENT7ZBS06BH4BDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
waterINACTIVE INGREDIENT059QF0KO0RDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
white waxINACTIVE INGREDIENT7G1J5DA97FDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
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
51672-1280DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]8Current NDC, Legacy NDC, 4 package rows20230202_6cea3912-23ae-45f3-b535-6fea29c7594f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349351desonide 0.05 % Topical CreamPSN6cea3912-23ae-45f3-b535-6fea29c7594f9
204135desonide 0.05 % Topical OintmentPSN6cea3912-23ae-45f3-b535-6fea29c7594f9
204135desonide 0.0005 MG/MG Topical OintmentSCD6cea3912-23ae-45f3-b535-6fea29c7594f9
349351desonide 0.5 MG/ML Topical CreamSCD6cea3912-23ae-45f3-b535-6fea29c7594f9
349351desonide 0.05 % Topical CreamSY6cea3912-23ae-45f3-b535-6fea29c7594f9
204135desonide 0.05 % Topical OintmentSY6cea3912-23ae-45f3-b535-6fea29c7594f9
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1280-1516721280011 TUBE in 1 CARTON (51672-1280-1) / 15 g in 1 TUBE1 tube1992-06-300000-00-00NoNoCurrent
51672-1280-3516721280031 TUBE in 1 CARTON (51672-1280-3) / 60 g in 1 TUBE1 tube1992-06-300000-00-00NoNoCurrent