FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
21695-358
11-digit product format
216950358
Labeler code
21695
Product ID
21695-358_8cfa527c-69c5-4722-8246-c3b4ce591a5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA075205
Marketing category
ANDA
Marketing start
1998-11-13
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-358-252019-09-24C16284748780-1934fe258-4a6a-48b1-e053-8cdaa90a720aCLOBETASOL PROPIONATE TOPICAL SOLUTION, USP 0.05% (potency expressed as clobetasol propionate)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-358-25Clobetasol Propionate25 mL in 1 BOTTLESOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-358-25ML - Milliliter21695-358f81f1a3f-d896-4fc1-9f5c-df89f819498512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clobetasol PropionateACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1
ClobetasolACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31CLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302CLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-358CLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101210_8cfa527c-69c5-4722-8246-c3b4ce591a5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861487clobetasol propionate 0.05 % Topical SolutionPSN8cfa527c-69c5-4722-8246-c3b4ce591a5f1
861487clobetasol propionate 0.5 MG/ML Topical SolutionSCD8cfa527c-69c5-4722-8246-c3b4ce591a5f1
861487clobetasol propionate 0.05 % Topical SolutionSY8cfa527c-69c5-4722-8246-c3b4ce591a5f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-358-252169503582525 mL in 1 BOTTLE25 mlHistorical