FDA.reportPublic FDA data

Desonide

Product NDC
0713-0661
11-digit product format
007130661
Labeler code
0713
Product ID
0713-0661_ee0cb97f-162c-0dc0-e053-2995a90a8db3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA074027
Marketing category
ANDA
Marketing start
2016-08-19
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
Rxcui349351

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
5dd568b3-c283-39c3-9c72-0b51d8c13e5dProduct name220201006
0d789796-3334-08b7-795a-b9c3762179bcProduct name220200506
6da396dc-a1b2-d109-14be-877a0fdbfa18Product name520200408
4fa39b20-3e53-46d7-85e4-edc2360cfdffProduct name120171115
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
a4783074-7e0b-e965-10c3-0421e26d5edeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0661-15Desonide15 g in 1 TUBECREAM156
0713-0661-15Desonide1 in 1 CARTONCREAM16
0713-0661-60Desonide1 in 1 CARTONCREAM16
0713-0661-60Desonide60 g in 1 TUBECREAM606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0661-15GM - Gram0713-06618a591811-ab0a-40e5-9b31-2cb46dde087712015-07-20
0713-0661-60GM - Gram0713-066107ecee49-bbd7-4b6a-95b1-571a6928b4b712015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesonideACTIVE INGREDIENTJ280872D1ODESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
DesonideACTIVE MOIETYJ280872D1ODESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
Aluminum SulfateINACTIVE INGREDIENT34S289N54EDESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
Calcium AcetateINACTIVE INGREDIENTY882YXF34XDESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1SDESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
IcodextrinINACTIVE INGREDIENT2NX48Z0A9GDESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPDESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UDESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JDESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
Synthetic Wax (1200 Mw)INACTIVE INGREDIENTQ3Z4BCH099DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RDESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0661DESONIDE CREAM [COSETTE PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 4 package rows20221123_51e39fd1-2ae7-9ed6-5f24-c4656dd97f0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349351desonide 0.05 % Topical CreamPSN51e39fd1-2ae7-9ed6-5f24-c4656dd97f0b6
349351desonide 0.5 MG/ML Topical CreamSCD51e39fd1-2ae7-9ed6-5f24-c4656dd97f0b6
349351desonide 0.05 % Topical CreamSY51e39fd1-2ae7-9ed6-5f24-c4656dd97f0b6
349351desonide 0.05 % Topical CreamPSN843dc9e3-9edf-43da-aa0b-ff25dcd440e62
349351desonide 0.5 MG/ML Topical CreamSCD843dc9e3-9edf-43da-aa0b-ff25dcd440e62
349351desonide 0.05 % Topical CreamSY843dc9e3-9edf-43da-aa0b-ff25dcd440e62
349351desonide 0.05 % Topical CreamPSN1d7632a7-0f27-9e5d-e063-6294a90ad21f1
349351desonide 0.5 MG/ML Topical CreamSCD1d7632a7-0f27-9e5d-e063-6294a90ad21f1
349351desonide 0.05 % Topical CreamSY1d7632a7-0f27-9e5d-e063-6294a90ad21f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0661-15007130661151 TUBE in 1 CARTON (0713-0661-15) / 15 g in 1 TUBE1 tube2016-08-190000-00-00NoNoCurrent
0713-0661-60007130661601 TUBE in 1 CARTON (0713-0661-60) / 60 g in 1 TUBE1 tube2016-08-190000-00-00NoNoCurrent