Cloderm

Product NDC
67857-804
11-digit product format
678570804
Labeler code
67857
Product ID
67857-804_47135e54-5a8a-575b-3a6c-541fbda7153f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clocortolone pivalate
Dosage form
CREAM
Route
TOPICAL
Labeler
Promius Pharma, LLC
Application
NDA017765
Marketing category
NDA
Marketing start
1977-08-22
Marketing end
0000-00-00
Substance
CLOCORTOLONE PIVALATE
Active strength
0 g/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5b4db253-13f4-a186-daf6-9b4e39d96457Product name220200729

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67857-804-23Cloderm2 g in 1 TUBECREAM27
67857-804-45Cloderm45 g in 1 TUBECREAM457
67857-804-48Cloderm10 in 1 CARTONCREAM107
67857-804-51Cloderm75 g in 1 BOTTLE, PUMPCREAM757
67857-804-90Cloderm90 g in 1 TUBECREAM907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67857-804-30GM - Gram67857-8042417c3bd-1896-451d-b35b-91225ecfc93112012-07-24
67857-804-45GM - Gram67857-8049c11f33b-523a-40b3-8442-102e84d2c2c712012-07-24
67857-804-51GM - Gram67857-8041b2acf2f-6d5b-4334-8f48-c066fe95d4c412013-02-13
67857-804-90GM - Gram67857-804302b5505-1d35-4f92-9aea-2203c1f5ee4212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67857-804CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]7Legacy NDC, 5 package rows20190918_4abc01f2-03d4-43d5-a085-f452443cfca2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197520clocortolone (as clocortolone pivalate) 0.1 % Topical CreamPSN4abc01f2-03d4-43d5-a085-f452443cfca27
206048Cloderm 0.1 % Topical CreamPSN4abc01f2-03d4-43d5-a085-f452443cfca27
206048clocortolone 1 MG/ML Topical Cream [Cloderm]SBD4abc01f2-03d4-43d5-a085-f452443cfca27
197520clocortolone 1 MG/ML Topical CreamSCD4abc01f2-03d4-43d5-a085-f452443cfca27
197520clocortolone (as clocortolone pivalate) 0.1 % Topical CreamSY4abc01f2-03d4-43d5-a085-f452443cfca27
206048Cloderm 0.1 % Topical CreamSY4abc01f2-03d4-43d5-a085-f452443cfca27
206048Cloderm 1 MG/ML Topical CreamSY4abc01f2-03d4-43d5-a085-f452443cfca27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67857-804-23678570804232 g in 1 TUBE2 gHistorical
67857-804-456785708044545 g in 1 TUBE (67857-804-45) 45 g2011-04-010000-00-00NoNoCurrent
67857-804-486785708044810 TUBE in 1 CARTON (67857-804-48) > 2 g in 1 TUBE (67857-804-23) 10 tube2011-04-010000-00-00NoNoCurrent
67857-804-516785708045175 g in 1 BOTTLE, PUMP (67857-804-51) 75 g2011-04-010000-00-00NoNoCurrent
67857-804-906785708049090 g in 1 TUBE (67857-804-90) 90 g2011-04-010000-00-00NoNoCurrent