CLOBETASOL PROPIONATE

Product NDC
0591-4039
11-digit product format
005914039
Labeler code
0591
Product ID
0591-4039_e7004240-ad1f-4260-81bf-08757355c270
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBETASOL PROPIONATE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
NDA021835
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-08-28
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
0 g/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-4039-46ML - Milliliter0591-4039b87c5b44-fd78-4d24-bfb7-6f6d8989f7d712015-09-10
0591-4039-74ML - Milliliter0591-4039124a2f56-a57a-40f6-a58f-75ba7179809112015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE SPRAY [ACTAVIS PHARMA, INC.]1
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE SPRAY [ACTAVIS PHARMA, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLOBETASOL PROPIONATE SPRAY [ACTAVIS PHARMA, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSCLOBETASOL PROPIONATE SPRAY [ACTAVIS PHARMA, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLOBETASOL PROPIONATE SPRAY [ACTAVIS PHARMA, INC.]1
UNDECYLENIC ACIDINACTIVE INGREDIENTK3D86KJ24NCLOBETASOL PROPIONATE SPRAY [ACTAVIS PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-4039CLOBETASOL PROPIONATE SPRAY [ACTAVIS PHARMA, INC.]4Legacy NDC20241030_907e425a-720a-4180-b97c-9e25008a3658.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-4039-46005914039461 BOTTLE in 1 CARTON (0591-4039-46) > 59 mL in 1 BOTTLE1 bottle2015-08-280000-00-00NoNoCurrent
0591-4039-74005914039741 BOTTLE in 1 CARTON (0591-4039-74) > 125 mL in 1 BOTTLE1 bottle2015-08-280000-00-00NoNoCurrent