FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
50383-267
11-digit product format
503830267
Labeler code
50383
Product ID
50383-267_e5680f3e-ab53-4716-a708-3e12e118a867
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Akorn
Application
ANDA074220
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
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
50383-267-152024-01-30C16284748780-11030e365-156f-111a-e063-dadaa90a10e2Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%
50383-267-302024-01-30C16284748780-11030e365-156f-111a-e063-dadaa90a10e2Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%
50383-267-452024-01-30C16284748780-11030e365-156f-111a-e063-dadaa90a10e2Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%
50383-267-602024-01-30C16284748780-11030e365-156f-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
50383-267-15GM - Gram50383-267d818679e-9842-43fa-931f-37fc817223df12012-07-24
50383-267-30GM - Gram50383-2678bf43a57-6dd4-467d-9164-485e0c8d92b112012-07-24
50383-267-45GM - Gram50383-26763a19ad1-be96-44fb-ab48-b1951d22ab7512012-07-24
50383-267-60GM - Gram50383-26777031d40-f72d-45e1-9fb6-9f7150908f3412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0ECLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
LANOLININACTIVE INGREDIENT7EV65EAW6HCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
POLYOXYL 8 STEARATEINACTIVE INGREDIENT2P9L47VI5ECLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]3
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
50383-267CLOBETASOL 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
861495clobetasol propionate 0.05 % Topical CreamPSN4ceb8fa2-c592-45e6-b6c1-81130ec72b9c9
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD4ceb8fa2-c592-45e6-b6c1-81130ec72b9c9
861495clobetasol propionate 0.05 % Topical CreamSY4ceb8fa2-c592-45e6-b6c1-81130ec72b9c9
861495clobetasol propionate 0.05 % Topical CreamPSN954dee1c-8667-462a-a7bb-a32b0f4c26245
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD954dee1c-8667-462a-a7bb-a32b0f4c26245
861495clobetasol propionate 0.05 % Topical CreamSY954dee1c-8667-462a-a7bb-a32b0f4c26245
861495clobetasol propionate 0.05 % Topical CreamPSN39f719f6-4e44-4aff-bad1-7529bf75bda23
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD39f719f6-4e44-4aff-bad1-7529bf75bda23
861495clobetasol propionate 0.05 % Topical CreamSY39f719f6-4e44-4aff-bad1-7529bf75bda23
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
50383-267-15503830267151 TUBE in 1 CARTON (50383-267-15) > 15 g in 1 TUBE1 tube2010-06-070000-00-00NoNoCurrent
50383-267-30503830267301 TUBE in 1 CARTON (50383-267-30) > 30 g in 1 TUBE1 tube2010-06-070000-00-00NoNoCurrent
50383-267-45503830267451 TUBE in 1 CARTON (50383-267-45) > 45 g in 1 TUBE1 tube2010-06-070000-00-00NoNoCurrent
50383-267-60503830267601 TUBE in 1 CARTON (50383-267-60) > 60 g in 1 TUBE1 tube2010-06-070000-00-00NoNoCurrent