FDA.reportPublic FDA data

Cloderm

Product NDC
71403-804
11-digit product format
714030804
Labeler code
71403
Product ID
71403-804_f2adc2da-070a-4520-a6fc-5b50d1032608
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clocortolone pivalate
Dosage form
CREAM
Route
TOPICAL
Labeler
EPI Health, Inc
Application
NDA017765
Marketing category
NDA
Marketing start
2018-10-30
Marketing end
0000-00-00
Substance
CLOCORTOLONE PIVALATE
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
5b4db253-13f4-a186-daf6-9b4e39d96457Product name220200729

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71403-804-232023-07-28C16284748780-10191ceaa-667a-198a-e063-dbdaa90aec3eCloderm ® Cream, 0.1% (clocortolone pivalate)
71403-804-452023-07-28C16284748780-10191ceaa-667a-198a-e063-dbdaa90aec3eCloderm ® Cream, 0.1% (clocortolone pivalate)
71403-804-752023-07-28C16284748780-10191ceaa-667a-198a-e063-dbdaa90aec3eCloderm ® Cream, 0.1% (clocortolone pivalate)
71403-804-902023-07-28C16284748780-10191ceaa-667a-198a-e063-dbdaa90aec3eCloderm ® Cream, 0.1% (clocortolone pivalate)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71403-804-23Cloderm2 g in 1 TUBECREAM24
71403-804-45Cloderm1 in 1 CARTONCREAM14
71403-804-45Cloderm45 g in 1 TUBECREAM454
71403-804-75Cloderm1 in 1 CARTONCREAM14
71403-804-75Cloderm75 g in 1 BOTTLE, PUMPCREAM754
71403-804-90Cloderm90 g in 1 TUBECREAM904
71403-804-90Cloderm1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71403-804-45GM - Gram71403-80472b7182e-abe8-46d4-9f88-91f32aef1fd612019-09-05
71403-804-75GM - Gram71403-804abc9ba30-80ee-48bc-b2da-a264e44c318612019-11-12
71403-804-90GM - Gram71403-804d6f429bc-3ae5-490d-a1ff-47da11f4c60e12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71403-804CLODERM (CLOCORTOLONE PIVALATE) CREAM [EPI HEALTH, INC]4Legacy NDC, 7 package rows20221103_a8f6ef34-471c-4f30-961b-08cb777a7cd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197520clocortolone (as clocortolone pivalate) 0.1 % Topical CreamPSNa8f6ef34-471c-4f30-961b-08cb777a7cd84
206048Cloderm 0.1 % Topical CreamPSNa8f6ef34-471c-4f30-961b-08cb777a7cd84
206048clocortolone 1 MG/ML Topical Cream [Cloderm]SBDa8f6ef34-471c-4f30-961b-08cb777a7cd84
197520clocortolone 1 MG/ML Topical CreamSCDa8f6ef34-471c-4f30-961b-08cb777a7cd84
197520clocortolone (as clocortolone pivalate) 0.1 % Topical CreamSYa8f6ef34-471c-4f30-961b-08cb777a7cd84
206048Cloderm 0.1 % Topical CreamSYa8f6ef34-471c-4f30-961b-08cb777a7cd84
206048Cloderm 1 MG/ML Topical CreamSYa8f6ef34-471c-4f30-961b-08cb777a7cd84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71403-804-23714030804232 g in 1 TUBE (71403-804-23) 2 g2018-10-300000-00-00NoNoCurrent
71403-804-45714030804451 TUBE in 1 CARTON (71403-804-45) > 45 g in 1 TUBE1 tube2018-10-300000-00-00NoNoCurrent
71403-804-75714030804751 BOTTLE, PUMP in 1 CARTON (71403-804-75) > 75 g in 1 BOTTLE, PUMP2018-10-300000-00-00NoNoCurrent
71403-804-90714030804901 TUBE in 1 CARTON (71403-804-90) > 90 g in 1 TUBE1 tube2018-10-300000-00-00NoNoCurrent