FDA.reportPublic FDA data

clobetasol propionate

Product NDC
45802-961
11-digit product format
458020961
Labeler code
45802
Product ID
45802-961_4fa40080-5565-4900-b95b-c07f05c7f789
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA090974
Marketing category
ANDA
Marketing start
2012-08-10
Substance
CLOBETASOL PROPIONATE
Active strength
.05 g/100mL
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
clobetasol propionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.05 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861490

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-961-26clobetasol propionate118 mL in 1 BOTTLESHAMPOO11813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-961-26ML - Milliliter45802-961d0639ffa-ecb8-4990-b88c-e311758abfb812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]6
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]6
COCO-BETAINEINACTIVE INGREDIENT03DH2IZ3FYCLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]6
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP0CLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]6
WATERINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-961CLOBETASOL PROPIONATE SHAMPOO [PADAGIS ISRAEL PHARMACEUTICALS LTD]13Current NDC, Legacy NDC, 1 package rows20240926_49bfff2e-9e4d-48a4-9f74-d6cf5b312aca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861490clobetasol propionate 0.05 % Medicated ShampooPSN40c3b94f-a61c-4fc1-a411-5bf4e3fe6791104
861490clobetasol propionate 0.5 MG/ML Medicated ShampooSCD40c3b94f-a61c-4fc1-a411-5bf4e3fe6791104
861490clobetasol propionate 0.05 % Medicated ShampooSY40c3b94f-a61c-4fc1-a411-5bf4e3fe6791104
861490clobetasol propionate 0.05 % Medicated ShampooPSN2d0b48d9-dbfb-4265-b73b-07faf217ae6e100
861490clobetasol propionate 0.5 MG/ML Medicated ShampooSCD2d0b48d9-dbfb-4265-b73b-07faf217ae6e100
861490clobetasol propionate 0.05 % Medicated ShampooSY2d0b48d9-dbfb-4265-b73b-07faf217ae6e100
861490clobetasol propionate 0.05 % Medicated ShampooPSN49bfff2e-9e4d-48a4-9f74-d6cf5b312aca13
861490clobetasol propionate 0.5 MG/ML Medicated ShampooSCD49bfff2e-9e4d-48a4-9f74-d6cf5b312aca13
861490clobetasol propionate 0.05 % Medicated ShampooSY49bfff2e-9e4d-48a4-9f74-d6cf5b312aca13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-961-2645802096126118 mL in 1 BOTTLE (45802-961-26) 118 ml2012-08-100000-00-00NoNoCurrent