FDA.reportPublic FDA data

Desoximetasone

Product NDC
51672-1396
11-digit product format
516721396
Labeler code
51672
Product ID
51672-1396_39702ff5-c8de-79c1-e063-6294a90a6dfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
SPRAY
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA204141
Marketing category
NDA AUTHORIZED GENERIC
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
Desoximetasone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESOXIMETASONE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4E07GXB7AU
Rxcui1376338

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
51672-1396-3Desoximetasone1 in 1 CARTONSPRAY15
51672-1396-3Desoximetasone30 mL in 1 BOTTLE, SPRAYSPRAY305
51672-1396-4Desoximetasone1 in 1 CARTONSPRAY15
51672-1396-4Desoximetasone50 mL in 1 BOTTLE, SPRAYSPRAY505
51672-1396-6Desoximetasone50 mL in 1 BOTTLE, SPRAYSPRAY505
51672-1396-6Desoximetasone2 in 1 CARTONSPRAY25
51672-1396-7Desoximetasone1 in 1 CARTONSPRAY15
51672-1396-7Desoximetasone100 mL in 1 BOTTLE, SPRAYSPRAY1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1396-7ML - Milliliter51672-13962c364ead-513c-4bde-8361-f74e8dda652012018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1396DESOXIMETASONE SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 8 package rows20241222_b046ab97-ba1a-4be6-a238-09670b38b397.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1376338desoximetasone 0.25 % Topical SprayPSNb046ab97-ba1a-4be6-a238-09670b38b3975
1376338desoximetasone 2.5 MG/ML Topical SpraySCDb046ab97-ba1a-4be6-a238-09670b38b3975
1376338desoximetasone 0.25 % Topical SpraySYb046ab97-ba1a-4be6-a238-09670b38b3975

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-1396-3516721396031 BOTTLE, SPRAY in 1 CARTON (51672-1396-3) / 30 mL in 1 BOTTLE, SPRAY2018-07-270000-00-00NoNoCurrent
51672-1396-4516721396041 BOTTLE, SPRAY in 1 CARTON (51672-1396-4) / 50 mL in 1 BOTTLE, SPRAY2018-07-270000-00-00NoNoCurrent
51672-1396-6516721396062 BOTTLE, SPRAY in 1 CARTON (51672-1396-6) / 50 mL in 1 BOTTLE, SPRAY2018-07-270000-00-00NoNoCurrent
51672-1396-7516721396071 BOTTLE, SPRAY in 1 CARTON (51672-1396-7) / 100 mL in 1 BOTTLE, SPRAY2018-07-270000-00-00NoNoCurrent