FDA.reportPublic FDA data

Desoximetasone

Product NDC
51672-1261
11-digit product format
516721261
Labeler code
51672
Product ID
51672-1261_38f63e0c-c4d2-523e-e063-6394a90a0272
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
GEL
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA074904
Marketing category
ANDA
Marketing start
1998-07-14
Substance
DESOXIMETASONE
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
Desoximetasone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESOXIMETASONE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4E07GXB7AU
Rxcui197573, 197574, 315059

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
51672-1261-1Desoximetasone1 in 1 CARTONGEL111
51672-1261-1Desoximetasone15 g in 1 TUBEGEL1511
51672-1261-2Desoximetasone1 in 1 CARTONGEL111
51672-1261-2Desoximetasone30 g in 1 TUBEGEL3011
51672-1261-3Desoximetasone60 g in 1 TUBEGEL6011
51672-1261-3Desoximetasone1 in 1 CARTONGEL111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1261-1GM - Gram51672-12614d6f12df-686e-4222-9ef9-5c981ff512c112012-07-24
51672-1261-3GM - Gram51672-1261f3e78bf1-7999-47d9-8eff-4deeddf32eb212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesoximetasoneACTIVE INGREDIENT4E07GXB7AUDESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
DesoximetasoneACTIVE MOIETY4E07GXB7AUDESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
carbomer homopolymer type c (allyl pentaerythritol crosslinked)INACTIVE INGREDIENT4Q93RCW27EDESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SDESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0DESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
edetate disodiumINACTIVE INGREDIENT7FLD91C86KDESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSDESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HEDESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
mineral oilINACTIVE INGREDIENTT5L8T28FGPDESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
petrolatumINACTIVE INGREDIENT4T6H12BN9UDESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
trolamineINACTIVE INGREDIENT9O3K93S3TKDESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
waterINACTIVE INGREDIENT059QF0KO0RDESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
DESOXIMETASONEACTIVE INGREDIENT4E07GXB7AUDESOXIMETASONE GEL [PHYSICIANS TOTAL CARE, INC.]1
DESOXIMETASONEACTIVE MOIETY4E07GXB7AUDESOXIMETASONE GEL [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EDESOXIMETASONE GEL [PHYSICIANS TOTAL CARE, INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0DESOXIMETASONE GEL [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDESOXIMETASONE GEL [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSDESOXIMETASONE GEL [PHYSICIANS TOTAL CARE, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKDESOXIMETASONE GEL [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDESOXIMETASONE GEL [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1261DESOXIMETASONE CREAM DESOXIMETASONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]10Current NDC, Legacy NDC, 6 package rows20190322_37eb1205-1743-4480-8631-b0bbcaeb8359.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197573desoximetasone 0.05 % Topical CreamPSN37eb1205-1743-4480-8631-b0bbcaeb835911
315059desoximetasone 0.05 % Topical GelPSN37eb1205-1743-4480-8631-b0bbcaeb835911
197574desoximetasone 0.25 % Topical CreamPSN37eb1205-1743-4480-8631-b0bbcaeb835911
315059desoximetasone 0.0005 MG/MG Topical GelSCD37eb1205-1743-4480-8631-b0bbcaeb835911
197573desoximetasone 0.5 MG/ML Topical CreamSCD37eb1205-1743-4480-8631-b0bbcaeb835911
197574desoximetasone 2.5 MG/ML Topical CreamSCD37eb1205-1743-4480-8631-b0bbcaeb835911
197573desoximetasone 0.05 % Topical CreamSY37eb1205-1743-4480-8631-b0bbcaeb835911
315059desoximetasone 0.05 % Topical GelSY37eb1205-1743-4480-8631-b0bbcaeb835911
197574desoximetasone 0.25 % Topical CreamSY37eb1205-1743-4480-8631-b0bbcaeb835911
315059desoximetasone 0.5 MG per GM Topical GelSY37eb1205-1743-4480-8631-b0bbcaeb835911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1261-1516721261011 TUBE in 1 CARTON (51672-1261-1) / 15 g in 1 TUBE1 tube1998-07-140000-00-00NoNoCurrent
51672-1261-2516721261021 TUBE in 1 CARTON (51672-1261-2) / 30 g in 1 TUBE1 tube1998-07-140000-00-00NoNoCurrent
51672-1261-3516721261031 TUBE in 1 CARTON (51672-1261-3) / 60 g in 1 TUBE1 tube1998-07-140000-00-00NoNoCurrent