Antifungal

Product NDC
50382-004
11-digit product format
503820004
Labeler code
50382
Product ID
50382-004_64c54ba8-05dd-48a2-b8c3-c26d7f869233
Type
HUMAN OTC DRUG
Nonproprietary name
Antifungal
Dosage form
CREAM
Route
TOPICAL
Labeler
Galentic Pharma (India) Priva Te Limited
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-08-07
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
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
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50382-004-012019-11-27C16284748780-19855d018-e2fd-cd31-e053-dbdaa90ab51aAntifungal Cream
50382-004-022019-11-27C16284748780-19855d018-e2fd-cd31-e053-dbdaa90ab51aAntifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50382-004-01Antifungal28.25 g in 1 TUBECREAM28.251
50382-004-02Antifungal113 g in 1 TUBECREAM1131

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50382-004ANTIFUNGAL CREAM [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]1Legacy NDC, 2 package rows20130808_7c48c331-adb8-4e9e-b6b9-e633b5188189.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN7c48c331-adb8-4e9e-b6b9-e633b51881891
309367clotrimazole 10 MG/ML Topical CreamSCD7c48c331-adb8-4e9e-b6b9-e633b51881891
309367clotrimazole 1 % Topical CreamSY7c48c331-adb8-4e9e-b6b9-e633b51881891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50382-004-015038200040128.25 g in 1 TUBE28.25 gHistorical
50382-004-0250382000402113 g in 1 TUBE113 gHistorical