FDA.reportPublic FDA data

Topicort

Product NDC
51672-5281
11-digit product format
516725281
Labeler code
51672
Product ID
51672-5281_38f9cadb-290c-0c68-e063-6394a90a38d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
SPRAY
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA204141
Marketing category
NDA
Marketing start
2013-04-11
Substance
DESOXIMETASONE
Active strength
2.5 mg/mL
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
Topicort
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESOXIMETASONE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4E07GXB7AU
Rxcui1376338, 1376340

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83e6065d-d4c9-f323-882e-7de38bb4d6acProduct name920200701
7b3bb32e-bbfd-11d9-a253-bc78b5f7d7beProduct name320190204
08e04f33-a0f6-279a-7d07-56df7c40d693Product name320180605
d67f22fb-500c-d680-0b1d-d0de623f55e7Product name720171113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-5281-0Topicort6 mL in 1 BOTTLESPRAY611
51672-5281-0Topicort1 in 1 CARTONSPRAY111
51672-5281-3Topicort1 in 1 CARTONSPRAY111
51672-5281-3Topicort30 mL in 1 BOTTLESPRAY3011
51672-5281-4Topicort1 in 1 CARTONSPRAY111
51672-5281-4Topicort50 mL in 1 BOTTLESPRAY5011
51672-5281-6Topicort50 mL in 1 BOTTLESPRAY5011
51672-5281-6Topicort2 in 1 CARTONSPRAY211
51672-5281-7Topicort1 in 1 CARTONSPRAY111
51672-5281-7Topicort100 mL in 1 BOTTLESPRAY10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5281-7ML - Milliliter51672-52810e7fc8c6-31ce-4017-bb8e-13a30f3d955612013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesoximetasoneACTIVE INGREDIENT4E07GXB7AUTOPICORT (DESOXIMETASONE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]4
DesoximetasoneACTIVE MOIETY4E07GXB7AUTOPICORT (DESOXIMETASONE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]4
glyceryl oleateINACTIVE INGREDIENT4PC054V79PTOPICORT (DESOXIMETASONE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]4
isopropyl alcoholINACTIVE INGREDIENTND2M416302TOPICORT (DESOXIMETASONE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]4
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTOPICORT (DESOXIMETASONE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]4
LevomentholINACTIVE INGREDIENTBZ1R15MTK7TOPICORT (DESOXIMETASONE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]4
mineral oilINACTIVE INGREDIENTT5L8T28FGPTOPICORT (DESOXIMETASONE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5281TOPICORT (DESOXIMETASONE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]10Current NDC, Legacy NDC, 10 package rows20211016_e417856a-b760-4626-bc34-8e4bc62c026c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1376338desoximetasone 0.25 % Topical SprayPSNe417856a-b760-4626-bc34-8e4bc62c026c11
1376340Topicort 0.25 % Topical SprayPSNe417856a-b760-4626-bc34-8e4bc62c026c11
1376340desoximetasone 2.5 MG/ML Topical Spray [Topicort]SBDe417856a-b760-4626-bc34-8e4bc62c026c11
1376338desoximetasone 2.5 MG/ML Topical SpraySCDe417856a-b760-4626-bc34-8e4bc62c026c11
1376338desoximetasone 0.25 % Topical SpraySYe417856a-b760-4626-bc34-8e4bc62c026c11
1376340Topicort 0.25 % Topical SpraySYe417856a-b760-4626-bc34-8e4bc62c026c11
1376340Topicort 2.5 MG/ML Topical SpraySYe417856a-b760-4626-bc34-8e4bc62c026c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-5281-0516725281001 BOTTLE in 1 CARTON (51672-5281-0) / 6 mL in 1 BOTTLE1 bottle2013-04-110000-00-00NoNoCurrent
51672-5281-3516725281031 BOTTLE in 1 CARTON (51672-5281-3) / 30 mL in 1 BOTTLE1 bottle2013-04-110000-00-00NoNoCurrent
51672-5281-4516725281041 BOTTLE in 1 CARTON (51672-5281-4) / 50 mL in 1 BOTTLE1 bottle2013-04-110000-00-00NoNoCurrent
51672-5281-6516725281062 BOTTLE in 1 CARTON (51672-5281-6) / 50 mL in 1 BOTTLE2 bottle2013-04-110000-00-00NoNoCurrent
51672-5281-7516725281071 BOTTLE in 1 CARTON (51672-5281-7) / 100 mL in 1 BOTTLE1 bottle2013-04-110000-00-00NoNoCurrent