FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
0168-0162
11-digit product format
001680162
Labeler code
0168
Product ID
0168-0162_42f6771f-30f7-467e-94da-2334ea31fdab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA074407
Marketing category
ANDA
Marketing start
1996-02-23
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/g
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.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861434, 861448, 861495

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0162-152025-08-11C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-302025-08-11C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-462025-08-11C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-602025-08-11C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-152025-07-29C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-302025-07-29C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-462025-07-29C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-602025-07-29C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-152020-09-18C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-302020-09-18C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-462020-09-18C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-602020-09-18C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-152020-07-22C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-302020-07-22C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-462020-07-22C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
0168-0162-602020-07-22C16284748780-1ab0e2407-28f3-f274-e053-dbdaa90a6471CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0162-15Clobetasol Propionate15 g in 1 TUBEOINTMENT1513
0168-0162-30Clobetasol Propionate30 g in 1 TUBEOINTMENT3013
0168-0162-46Clobetasol Propionate45 g in 1 TUBEOINTMENT4513
0168-0162-60Clobetasol Propionate60 g in 1 TUBEOINTMENT6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0162-15GM - Gram0168-0162f771af8b-b83b-41fd-b1b7-5f1945f2694d12012-07-24
0168-0162-30GM - Gram0168-0162fcb0fa01-5d5f-4381-9c76-e4664525dad512012-07-24
0168-0162-46GM - Gram0168-0162aa7e0b5c-1ed6-48cf-a68c-1c865da725e412012-07-24
0168-0162-60GM - Gram0168-016231f4e67f-9a76-4220-ae2a-2efdaa9ece5c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGACLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ACLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
clobetasol propionateACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
clobetasolACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
anhydrous trisodium citrateINACTIVE INGREDIENTRS7A450LGACLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
chlorocresolINACTIVE INGREDIENT36W53O7109CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
polyoxyl 100 stearateINACTIVE INGREDIENTYD01N1999RCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
white waxINACTIVE INGREDIENT7G1J5DA97FCLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0162CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 4 package rows20200919_2d4fa3a3-dc1c-4d3c-9959-4751e09d25be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN2d4fa3a3-dc1c-4d3c-9959-4751e09d25be13
861434clobetasol propionate 0.05 % Topical GelPSN2d4fa3a3-dc1c-4d3c-9959-4751e09d25be13
861448clobetasol propionate 0.05 % Topical OintmentPSN2d4fa3a3-dc1c-4d3c-9959-4751e09d25be13
861434clobetasol propionate 0.0005 MG/MG Topical GelSCD2d4fa3a3-dc1c-4d3c-9959-4751e09d25be13
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD2d4fa3a3-dc1c-4d3c-9959-4751e09d25be13
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD2d4fa3a3-dc1c-4d3c-9959-4751e09d25be13
861495clobetasol propionate 0.05 % Topical CreamSY2d4fa3a3-dc1c-4d3c-9959-4751e09d25be13
861434clobetasol propionate 0.05 % Topical GelSY2d4fa3a3-dc1c-4d3c-9959-4751e09d25be13
861448clobetasol propionate 0.05 % Topical OintmentSY2d4fa3a3-dc1c-4d3c-9959-4751e09d25be13
861495clobetasol propionate 0.05 % Topical CreamPSNdf79a35c-ce5c-452e-b81e-50a014fc94f41
861448clobetasol propionate 0.05 % Topical OintmentPSNdf79a35c-ce5c-452e-b81e-50a014fc94f41
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCDdf79a35c-ce5c-452e-b81e-50a014fc94f41
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDdf79a35c-ce5c-452e-b81e-50a014fc94f41
861495clobetasol propionate 0.05 % Topical CreamSYdf79a35c-ce5c-452e-b81e-50a014fc94f41
861448clobetasol propionate 0.05 % Topical OintmentSYdf79a35c-ce5c-452e-b81e-50a014fc94f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0162-150016801621515 g in 1 TUBE (0168-0162-15) 15 g1996-02-230000-00-00NoNoCurrent
0168-0162-300016801623030 g in 1 TUBE (0168-0162-30) 30 g1996-02-230000-00-00NoNoCurrent
0168-0162-460016801624645 g in 1 TUBE (0168-0162-46) 45 g1996-02-230000-00-00NoNoCurrent
0168-0162-600016801626060 g in 1 TUBE (0168-0162-60) 60 g1996-02-230000-00-00NoNoCurrent