FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
50383-268
11-digit product format
503830268
Labeler code
50383
Product ID
50383-268_e5680f3e-ab53-4716-a708-3e12e118a867
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Akorn
Application
ANDA074221
Marketing category
ANDA
Marketing start
2010-06-07
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
50383-268-152024-01-30C16284748780-11030e365-156f-111a-e063-dadaa90a10e2Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%
50383-268-302024-01-30C16284748780-11030e365-156f-111a-e063-dadaa90a10e2Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%
50383-268-452024-01-30C16284748780-11030e365-156f-111a-e063-dadaa90a10e2Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%
50383-268-602024-01-30C16284748780-11030e365-156f-111a-e063-dadaa90a10e2Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-268-15GM - Gram50383-268bad222a5-9b9d-4d57-8608-d1039db6287412012-07-24
50383-268-30GM - Gram50383-26881b54a45-a08e-47af-9148-fef6df3e680312012-07-24
50383-268-45GM - Gram50383-2681a252a46-6da2-4b1b-98d2-3006052fedf212012-07-24
50383-268-60GM - Gram50383-268e7e0b30c-7fa8-461b-a216-c0ac4ae8970b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0ECLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
LANOLININACTIVE INGREDIENT7EV65EAW6HCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5ECLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ACLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.]2
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0ECLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
LANOLININACTIVE INGREDIENT7EV65EAW6HCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5ECLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ACLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-268CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [AKORN]6Legacy NDC20221202_fb29b17b-96af-4a78-bc91-83cf8c5c2b1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN6e4dd0cf-b5f8-406c-8c4a-d8a3ac50b1ce11
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD6e4dd0cf-b5f8-406c-8c4a-d8a3ac50b1ce11
861448clobetasol propionate 0.05 % Topical OintmentSY6e4dd0cf-b5f8-406c-8c4a-d8a3ac50b1ce11
861495clobetasol propionate 0.05 % Topical CreamPSNb6b530b3-5218-4838-adee-08e477757b981
861448clobetasol propionate 0.05 % Topical OintmentPSNb6b530b3-5218-4838-adee-08e477757b981
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCDb6b530b3-5218-4838-adee-08e477757b981
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDb6b530b3-5218-4838-adee-08e477757b981
861495clobetasol propionate 0.05 % Topical CreamSYb6b530b3-5218-4838-adee-08e477757b981
861448clobetasol propionate 0.05 % Topical OintmentSYb6b530b3-5218-4838-adee-08e477757b981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-268-15503830268151 TUBE in 1 CARTON (50383-268-15) > 15 g in 1 TUBE1 tube2010-06-070000-00-00NoNoCurrent
50383-268-30503830268301 TUBE in 1 CARTON (50383-268-30) > 30 g in 1 TUBE1 tube2010-06-070000-00-00NoNoCurrent
50383-268-45503830268451 TUBE in 1 CARTON (50383-268-45) > 45 g in 1 TUBE1 tube2010-06-070000-00-00NoNoCurrent
50383-268-60503830268601 TUBE in 1 CARTON (50383-268-60) > 60 g in 1 TUBE1 tube2010-06-070000-00-00NoNoCurrent