FDA.reportPublic FDA data

Desoximetasone

Product NDC
0472-0478
11-digit product format
004720478
Labeler code
0472
Product ID
0472-0478_29695558-45f1-48cc-89b1-4063d16e2a5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
CREAM
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA205082
Marketing category
ANDA
Marketing start
2016-03-31
Marketing end
2026-07-31
Substance
DESOXIMETASONE
Active strength
2.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desoximetasone

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESOXIMETASONE2.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4E07GXB7AU
Rxcui197574

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0472-0478-15Desoximetasone1 in 1 CARTONCREAM17
0472-0478-15Desoximetasone15 g in 1 TUBECREAM157
0472-0478-60Desoximetasone1 in 1 CARTONCREAM17
0472-0478-60Desoximetasone60 g in 1 TUBECREAM607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0478-15GM - Gram0472-0478d310a737-0b3e-41b3-b8ab-184b3777d58412016-05-16
0472-0478-60GM - Gram0472-047877d558c0-321d-4c92-94c3-cc6eafcb367512016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0478DESOXIMETASONE CREAM [ACTAVIS PHARMA, INC.]6Current NDC, Legacy NDC, 4 package rows20200403_1c472cf0-bf2c-45bb-be8b-e1137794de71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197574desoximetasone 0.25 % Topical CreamPSN1c472cf0-bf2c-45bb-be8b-e1137794de717
197574desoximetasone 2.5 MG/ML Topical CreamSCD1c472cf0-bf2c-45bb-be8b-e1137794de717
197574desoximetasone 0.25 % Topical CreamSY1c472cf0-bf2c-45bb-be8b-e1137794de717
197574desoximetasone 0.25 % Topical CreamPSN03214a63-5ec2-49c5-9847-908bdfb06df85
197574desoximetasone 0.25 % Topical CreamPSN24f3d9cc-5376-4d8e-b113-9e675bd0ceec5
197574desoximetasone 2.5 MG/ML Topical CreamSCD03214a63-5ec2-49c5-9847-908bdfb06df85
197574desoximetasone 2.5 MG/ML Topical CreamSCD24f3d9cc-5376-4d8e-b113-9e675bd0ceec5
197574desoximetasone 0.25 % Topical CreamSY03214a63-5ec2-49c5-9847-908bdfb06df85
197574desoximetasone 0.25 % Topical CreamSY24f3d9cc-5376-4d8e-b113-9e675bd0ceec5
197574desoximetasone 0.25 % Topical CreamPSNf30b6fcc-43bc-4d65-9c3b-8d6ca780a0244
197574desoximetasone 2.5 MG/ML Topical CreamSCDf30b6fcc-43bc-4d65-9c3b-8d6ca780a0244
197574desoximetasone 0.25 % Topical CreamSYf30b6fcc-43bc-4d65-9c3b-8d6ca780a0244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0478-15004720478151 TUBE in 1 CARTON (0472-0478-15) / 15 g in 1 TUBE1 tube2016-03-312026-07-31NoNoCurrent
0472-0478-60004720478601 TUBE in 1 CARTON (0472-0478-60) / 60 g in 1 TUBE1 tube2016-03-312026-07-31NoNoCurrent