Clobetasol Propionate

Product NDC
0472-0403
11-digit product format
004720403
Labeler code
0472
Product ID
0472-0403_69a83d92-46be-4387-9d1c-f36e640f56ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA078854
Marketing category
ANDA
Marketing start
2012-01-03
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
0 g/100mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0403-94ML - Milliliter0472-04033429704d-61a4-46b8-9b83-2cae939b1e6412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]2
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]2
POLYQUATERNIUM-10 (400 CPS AT 2%)INACTIVE INGREDIENTHB1401PQFSCLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0CLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0403CLOBETASOL PROPIONATE SHAMPOO [ACTAVIS PHARMA, INC.]8Legacy NDC20241222_9539c24e-3fc4-44a6-a40c-bb53260df2f2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0403-94004720403941 BOTTLE in 1 CARTON (0472-0403-94) > 118 mL in 1 BOTTLE1 bottle2012-01-030000-00-00NoNoCurrent