FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
0168-0269
11-digit product format
001680269
Labeler code
0168
Product ID
0168-0269_3ae739b7-7eaa-4dbd-a696-a3a0e3998f38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA075391
Marketing category
ANDA
Marketing start
1999-02-08
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clobetasol Propionate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861487

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
0168-0269-50Clobetasol Propionate50 mL in 1 BOTTLE, PLASTICSOLUTION5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0269-50ML - Milliliter0168-026963b13de9-122d-40a2-b35d-ca754a5d247312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clobetasol propionateACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
clobetasolACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208CLOBETASOL PROPIONATE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
isopropyl alcoholINACTIVE INGREDIENTND2M416302CLOBETASOL PROPIONATE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
waterINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0269CLOBETASOL PROPIONATE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 1 package rows20240404_736325f3-a369-4d70-b608-3d6ba37b6a6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861487clobetasol propionate 0.05 % Topical SolutionPSN736325f3-a369-4d70-b608-3d6ba37b6a6b11
861487clobetasol propionate 0.5 MG/ML Topical SolutionSCD736325f3-a369-4d70-b608-3d6ba37b6a6b11
861487clobetasol propionate 0.05 % Topical SolutionSY736325f3-a369-4d70-b608-3d6ba37b6a6b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0269-500016802695050 mL in 1 BOTTLE, PLASTIC (0168-0269-50) 50 ml1999-02-080000-00-00NoNoCurrent